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LIXTE BIOTECHNOLOGY HOLDINGS, INC.
Awaiting Response
0 company response(s)
High
LIXTE BIOTECHNOLOGY HOLDINGS, INC.
Response Received
1 company response(s)
High - file number match
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Company responded
2025-07-24
LIXTE BIOTECHNOLOGY HOLDINGS, INC.
References: July 16, 2025
LIXTE BIOTECHNOLOGY HOLDINGS, INC.
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1 company response(s)
Low - unmatched response
LIXTE BIOTECHNOLOGY HOLDINGS, INC.
Response Received
3 company response(s)
Medium - date proximity
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LIXTE BIOTECHNOLOGY HOLDINGS, INC.
Response Received
1 company response(s)
High - file number match
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LIXTE BIOTECHNOLOGY HOLDINGS, INC.
Response Received
1 company response(s)
High - file number match
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LIXTE BIOTECHNOLOGY HOLDINGS, INC.
Response Received
1 company response(s)
High - file number match
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LIXTE BIOTECHNOLOGY HOLDINGS, INC.
Response Received
1 company response(s)
High - file number match
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LIXTE BIOTECHNOLOGY HOLDINGS, INC.
Response Received
2 company response(s)
High - file number match
SEC wrote to company
2020-09-11
LIXTE BIOTECHNOLOGY HOLDINGS, INC.
Summary
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Company responded
2020-11-16
LIXTE BIOTECHNOLOGY HOLDINGS, INC.
Summary
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Company responded
2020-11-19
LIXTE BIOTECHNOLOGY HOLDINGS, INC.
Summary
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LIXTE BIOTECHNOLOGY HOLDINGS, INC.
Orphan - no UPLOAD in window
1 company response(s)
Low - unmatched response
Company responded
2020-11-19
LIXTE BIOTECHNOLOGY HOLDINGS, INC.
Summary
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LIXTE BIOTECHNOLOGY HOLDINGS, INC.
Orphan - no UPLOAD in window
1 company response(s)
Low - unmatched response
Company responded
2020-11-16
LIXTE BIOTECHNOLOGY HOLDINGS, INC.
Summary
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LIXTE BIOTECHNOLOGY HOLDINGS, INC.
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2013-11-13
LIXTE BIOTECHNOLOGY HOLDINGS, INC.
Summary
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LIXTE BIOTECHNOLOGY HOLDINGS, INC.
Response Received
2 company response(s)
High - file number match
SEC wrote to company
2008-12-22
LIXTE BIOTECHNOLOGY HOLDINGS, INC.
Summary
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Company responded
2013-09-30
LIXTE BIOTECHNOLOGY HOLDINGS, INC.
Summary
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Company responded
2013-10-08
LIXTE BIOTECHNOLOGY HOLDINGS, INC.
Summary
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LIXTE BIOTECHNOLOGY HOLDINGS, INC.
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2013-09-16
LIXTE BIOTECHNOLOGY HOLDINGS, INC.
Summary
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LIXTE BIOTECHNOLOGY HOLDINGS, INC.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2009-01-08
LIXTE BIOTECHNOLOGY HOLDINGS, INC.
Summary
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LIXTE BIOTECHNOLOGY HOLDINGS, INC.
Response Received
3 company response(s)
High - file number match
SEC wrote to company
2006-10-04
LIXTE BIOTECHNOLOGY HOLDINGS, INC.
Summary
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Company responded
2007-05-14
LIXTE BIOTECHNOLOGY HOLDINGS, INC.
Summary
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Company responded
2007-05-14
LIXTE BIOTECHNOLOGY HOLDINGS, INC.
Summary
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Company responded
2007-05-14
LIXTE BIOTECHNOLOGY HOLDINGS, INC.
Summary
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LIXTE BIOTECHNOLOGY HOLDINGS, INC.
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2007-05-03
LIXTE BIOTECHNOLOGY HOLDINGS, INC.
Summary
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LIXTE BIOTECHNOLOGY HOLDINGS, INC.
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2007-04-03
LIXTE BIOTECHNOLOGY HOLDINGS, INC.
Summary
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LIXTE BIOTECHNOLOGY HOLDINGS, INC.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2007-02-13
LIXTE BIOTECHNOLOGY HOLDINGS, INC.
Summary
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LIXTE BIOTECHNOLOGY HOLDINGS, INC.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2006-12-15
LIXTE BIOTECHNOLOGY HOLDINGS, INC.
Summary
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LIXTE BIOTECHNOLOGY HOLDINGS, INC.
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2005-08-09
LIXTE BIOTECHNOLOGY HOLDINGS, INC.
Summary
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Summary
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-08-07 | SEC Comment Letter | LIXTE BIOTECHNOLOGY HOLDINGS, INC. | DE | 001-39717 | Read Filing View |
| 2025-07-24 | Company Response | LIXTE BIOTECHNOLOGY HOLDINGS, INC. | DE | N/A | Read Filing View |
| 2025-07-16 | SEC Comment Letter | LIXTE BIOTECHNOLOGY HOLDINGS, INC. | DE | 001-39717 | Read Filing View |
| 2025-07-14 | Company Response | LIXTE BIOTECHNOLOGY HOLDINGS, INC. | DE | N/A | Read Filing View |
| 2025-06-26 | Company Response | LIXTE BIOTECHNOLOGY HOLDINGS, INC. | DE | N/A | Read Filing View |
| 2025-06-24 | Company Response | LIXTE BIOTECHNOLOGY HOLDINGS, INC. | DE | N/A | Read Filing View |
| 2025-06-24 | Company Response | LIXTE BIOTECHNOLOGY HOLDINGS, INC. | DE | N/A | Read Filing View |
| 2025-05-07 | SEC Comment Letter | LIXTE BIOTECHNOLOGY HOLDINGS, INC. | DE | 377-07971 | Read Filing View |
| 2025-04-09 | Company Response | LIXTE BIOTECHNOLOGY HOLDINGS, INC. | DE | N/A | Read Filing View |
| 2025-04-08 | SEC Comment Letter | LIXTE BIOTECHNOLOGY HOLDINGS, INC. | DE | 333-286385 | Read Filing View |
| 2024-04-30 | Company Response | LIXTE BIOTECHNOLOGY HOLDINGS, INC. | DE | N/A | Read Filing View |
| 2024-04-29 | SEC Comment Letter | LIXTE BIOTECHNOLOGY HOLDINGS, INC. | DE | 333-278874 | Read Filing View |
| 2023-08-18 | Company Response | LIXTE BIOTECHNOLOGY HOLDINGS, INC. | DE | N/A | Read Filing View |
| 2023-08-15 | SEC Comment Letter | LIXTE BIOTECHNOLOGY HOLDINGS, INC. | DE | N/A | Read Filing View |
| 2021-02-03 | Company Response | LIXTE BIOTECHNOLOGY HOLDINGS, INC. | DE | N/A | Read Filing View |
| 2021-02-02 | SEC Comment Letter | LIXTE BIOTECHNOLOGY HOLDINGS, INC. | DE | N/A | Read Filing View |
| 2020-11-19 | Company Response | LIXTE BIOTECHNOLOGY HOLDINGS, INC. | DE | N/A | Read Filing View |
| 2020-11-19 | Company Response | LIXTE BIOTECHNOLOGY HOLDINGS, INC. | DE | N/A | Read Filing View |
| 2020-11-16 | Company Response | LIXTE BIOTECHNOLOGY HOLDINGS, INC. | DE | N/A | Read Filing View |
| 2020-11-16 | Company Response | LIXTE BIOTECHNOLOGY HOLDINGS, INC. | DE | N/A | Read Filing View |
| 2020-09-11 | SEC Comment Letter | LIXTE BIOTECHNOLOGY HOLDINGS, INC. | DE | N/A | Read Filing View |
| 2013-11-13 | SEC Comment Letter | LIXTE BIOTECHNOLOGY HOLDINGS, INC. | DE | N/A | Read Filing View |
| 2013-10-08 | Company Response | LIXTE BIOTECHNOLOGY HOLDINGS, INC. | DE | N/A | Read Filing View |
| 2013-09-30 | Company Response | LIXTE BIOTECHNOLOGY HOLDINGS, INC. | DE | N/A | Read Filing View |
| 2013-09-16 | SEC Comment Letter | LIXTE BIOTECHNOLOGY HOLDINGS, INC. | DE | N/A | Read Filing View |
| 2009-01-08 | SEC Comment Letter | LIXTE BIOTECHNOLOGY HOLDINGS, INC. | DE | N/A | Read Filing View |
| 2008-12-22 | SEC Comment Letter | LIXTE BIOTECHNOLOGY HOLDINGS, INC. | DE | N/A | Read Filing View |
| 2007-05-14 | Company Response | LIXTE BIOTECHNOLOGY HOLDINGS, INC. | DE | N/A | Read Filing View |
| 2007-05-14 | Company Response | LIXTE BIOTECHNOLOGY HOLDINGS, INC. | DE | N/A | Read Filing View |
| 2007-05-14 | Company Response | LIXTE BIOTECHNOLOGY HOLDINGS, INC. | DE | N/A | Read Filing View |
| 2007-05-03 | SEC Comment Letter | LIXTE BIOTECHNOLOGY HOLDINGS, INC. | DE | N/A | Read Filing View |
| 2007-04-03 | SEC Comment Letter | LIXTE BIOTECHNOLOGY HOLDINGS, INC. | DE | N/A | Read Filing View |
| 2007-02-13 | SEC Comment Letter | LIXTE BIOTECHNOLOGY HOLDINGS, INC. | DE | N/A | Read Filing View |
| 2006-12-15 | SEC Comment Letter | LIXTE BIOTECHNOLOGY HOLDINGS, INC. | DE | N/A | Read Filing View |
| 2006-10-04 | SEC Comment Letter | LIXTE BIOTECHNOLOGY HOLDINGS, INC. | DE | N/A | Read Filing View |
| 2005-08-09 | SEC Comment Letter | LIXTE BIOTECHNOLOGY HOLDINGS, INC. | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-08-07 | SEC Comment Letter | LIXTE BIOTECHNOLOGY HOLDINGS, INC. | DE | 001-39717 | Read Filing View |
| 2025-07-16 | SEC Comment Letter | LIXTE BIOTECHNOLOGY HOLDINGS, INC. | DE | 001-39717 | Read Filing View |
| 2025-05-07 | SEC Comment Letter | LIXTE BIOTECHNOLOGY HOLDINGS, INC. | DE | 377-07971 | Read Filing View |
| 2025-04-08 | SEC Comment Letter | LIXTE BIOTECHNOLOGY HOLDINGS, INC. | DE | 333-286385 | Read Filing View |
| 2024-04-29 | SEC Comment Letter | LIXTE BIOTECHNOLOGY HOLDINGS, INC. | DE | 333-278874 | Read Filing View |
| 2023-08-15 | SEC Comment Letter | LIXTE BIOTECHNOLOGY HOLDINGS, INC. | DE | N/A | Read Filing View |
| 2021-02-02 | SEC Comment Letter | LIXTE BIOTECHNOLOGY HOLDINGS, INC. | DE | N/A | Read Filing View |
| 2020-09-11 | SEC Comment Letter | LIXTE BIOTECHNOLOGY HOLDINGS, INC. | DE | N/A | Read Filing View |
| 2013-11-13 | SEC Comment Letter | LIXTE BIOTECHNOLOGY HOLDINGS, INC. | DE | N/A | Read Filing View |
| 2013-09-16 | SEC Comment Letter | LIXTE BIOTECHNOLOGY HOLDINGS, INC. | DE | N/A | Read Filing View |
| 2009-01-08 | SEC Comment Letter | LIXTE BIOTECHNOLOGY HOLDINGS, INC. | DE | N/A | Read Filing View |
| 2008-12-22 | SEC Comment Letter | LIXTE BIOTECHNOLOGY HOLDINGS, INC. | DE | N/A | Read Filing View |
| 2007-05-03 | SEC Comment Letter | LIXTE BIOTECHNOLOGY HOLDINGS, INC. | DE | N/A | Read Filing View |
| 2007-04-03 | SEC Comment Letter | LIXTE BIOTECHNOLOGY HOLDINGS, INC. | DE | N/A | Read Filing View |
| 2007-02-13 | SEC Comment Letter | LIXTE BIOTECHNOLOGY HOLDINGS, INC. | DE | N/A | Read Filing View |
| 2006-12-15 | SEC Comment Letter | LIXTE BIOTECHNOLOGY HOLDINGS, INC. | DE | N/A | Read Filing View |
| 2006-10-04 | SEC Comment Letter | LIXTE BIOTECHNOLOGY HOLDINGS, INC. | DE | N/A | Read Filing View |
| 2005-08-09 | SEC Comment Letter | LIXTE BIOTECHNOLOGY HOLDINGS, INC. | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-07-24 | Company Response | LIXTE BIOTECHNOLOGY HOLDINGS, INC. | DE | N/A | Read Filing View |
| 2025-07-14 | Company Response | LIXTE BIOTECHNOLOGY HOLDINGS, INC. | DE | N/A | Read Filing View |
| 2025-06-26 | Company Response | LIXTE BIOTECHNOLOGY HOLDINGS, INC. | DE | N/A | Read Filing View |
| 2025-06-24 | Company Response | LIXTE BIOTECHNOLOGY HOLDINGS, INC. | DE | N/A | Read Filing View |
| 2025-06-24 | Company Response | LIXTE BIOTECHNOLOGY HOLDINGS, INC. | DE | N/A | Read Filing View |
| 2025-04-09 | Company Response | LIXTE BIOTECHNOLOGY HOLDINGS, INC. | DE | N/A | Read Filing View |
| 2024-04-30 | Company Response | LIXTE BIOTECHNOLOGY HOLDINGS, INC. | DE | N/A | Read Filing View |
| 2023-08-18 | Company Response | LIXTE BIOTECHNOLOGY HOLDINGS, INC. | DE | N/A | Read Filing View |
| 2021-02-03 | Company Response | LIXTE BIOTECHNOLOGY HOLDINGS, INC. | DE | N/A | Read Filing View |
| 2020-11-19 | Company Response | LIXTE BIOTECHNOLOGY HOLDINGS, INC. | DE | N/A | Read Filing View |
| 2020-11-19 | Company Response | LIXTE BIOTECHNOLOGY HOLDINGS, INC. | DE | N/A | Read Filing View |
| 2020-11-16 | Company Response | LIXTE BIOTECHNOLOGY HOLDINGS, INC. | DE | N/A | Read Filing View |
| 2020-11-16 | Company Response | LIXTE BIOTECHNOLOGY HOLDINGS, INC. | DE | N/A | Read Filing View |
| 2013-10-08 | Company Response | LIXTE BIOTECHNOLOGY HOLDINGS, INC. | DE | N/A | Read Filing View |
| 2013-09-30 | Company Response | LIXTE BIOTECHNOLOGY HOLDINGS, INC. | DE | N/A | Read Filing View |
| 2007-05-14 | Company Response | LIXTE BIOTECHNOLOGY HOLDINGS, INC. | DE | N/A | Read Filing View |
| 2007-05-14 | Company Response | LIXTE BIOTECHNOLOGY HOLDINGS, INC. | DE | N/A | Read Filing View |
| 2007-05-14 | Company Response | LIXTE BIOTECHNOLOGY HOLDINGS, INC. | DE | N/A | Read Filing View |
2025-08-07 - UPLOAD - LIXTE BIOTECHNOLOGY HOLDINGS, INC. File: 001-39717
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> August 7, 2025 Robert Weingarten Vice President and Chief Financial Officer LIXTE BIOTECHNOLOGY HOLDINGS, INC. 680 East Colorado Boulevard Suite 180 Pasadena, CA 91101 Re: LIXTE BIOTECHNOLOGY HOLDINGS, INC. Form 10-K for the Fiscal Year Ended December 31, 2024 File No. 001-39717 Dear Robert Weingarten: 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 cc: David Ficksman, Esq. </TEXT> </DOCUMENT>
2025-07-24 - CORRESP - LIXTE BIOTECHNOLOGY HOLDINGS, INC.
CORRESP 1 filename1.htm Lixte Biotechnology Holdings, Inc. 680 East Colorado Boulevard, Suite 180 Pasadena, CA 91101 July 24, 2025 VIA EDGAR Securities and Exchange Commission Division of Corporation Finance Washington, D.C. 20549 Attention: Jessica Dickerson Re: Lixte Biotechnology Holdings, Inc. Form 10-K for the Fiscal Year Ended December 31, 2024 Filed March 24, 2025 File No. 001-39717 Ladies and Gentlemen: By letter dated July 16, 2025, the staff (the "Staff") of the Securities and Exchange Commission (the "Commission") provided Lixte Biotechnology Holdings, Inc. (the "Company") with comments on the Company's Form 10-K for the Fiscal Year Ended December 31, 2024, described above. This letter contains the Company's responses to the Staff's comments. The numbered responses and the headings set forth below correspond to the numbered comments and headings in the Staff's letter. Annual Report on Form 10-K for the Fiscal Year Ended December 31, 2024 Item 1. Business, page 4 1. In future filings, please remove all statements indicating that your product candidates are safe and effective, as such determinations are solely within the authority of the FDA and comparable foreign regulatory authorities. For example only, without limitation, we note your statements throughout your annual report that LB-100 has been found to improve the effectiveness of anticancer drugs, as well as your disclosure on page 9 that LB-100 has "proven safe in patients at doses associated with anti-tumor activity." COMPANY'S RESPONSE In future filings, the Company will make the requested changes to the disclosures regarding its product candidates. Securities and Exchange Commission Division of Corporation Finance Attention: Jessica Dickerson Page 2 Description of Business, page 4 2. We note your pipeline table on page 6. In future filings, please shorten the length of the arrows in your pipeline table as appropriate to accurately reflect the status of the product candidate. In this regard, we note the arrows in the second and third rows of the table extend through the end of the "Phase 1b" column, which may indicate the Phase 1b trials have been completed, but your disclosures on pages 7 and 8 indicate that the Phase 1b trial in patients with metastatic colon cancer is still enrolling patients and that the Phase 1b trial in patients with ASTS is still ongoing. Similarly, we note that the arrow in the first row of the table extends through most of the "Phase 2" column, which may indicate that a Phase 1b clinical trial has been completed and the Phase 2 clinical trial is nearly complete; however, your disclosures on pages 8 and F-32 indicate that this is a Phase 1b/2 clinical trial and that you expect the clinical trial will be completed by December 31, 2027. COMPANY'S RESPONSE In its future filings, the Company will make the requested changes to the pipeline table. Clinical Trial Agreements, page 7 3. We note your discussion on page 8 of your Phase 1b/2 collaborative clinical trial to assess whether adding LB-100, your lead product candidate, to dostarlimab-gsly may enhance the effectiveness of immunotherapy in the treatment of ovarian clear cell carcinoma. In future filings, please file the applicable clinical trial agreement as an exhibit, or tell us why you do not believe such exhibit is required. Refer to Item 601(b)(10) of Regulation S-K. COMPANY'S RESPONSE The Company will file as an exhibit the clinical trial agreement for ovarian clear cell carcinoma in its next applicable securities filing. Securities and Exchange Commission Division of Corporation Finance Attention: Jessica Dickerson Page 3 If you have any questions regarding this response, please direct them to our counsel David Ficksman at 310-789-1290 or dficksman@troygould.com . Sincerely, Lixte Biotechnology Holdings, Inc. /s/ Geordan Pursglove By: Geordan Pursglove Chief Executive Officer cc: David L. Ficksman
2025-07-16 - UPLOAD - LIXTE BIOTECHNOLOGY HOLDINGS, INC. File: 001-39717
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> July 16, 2025 Robert Weingarten Vice President and Chief Financial Officer LIXTE BIOTECHNOLOGY HOLDINGS, INC. 680 East Colorado Boulevard Suite 180 Pasadena, CA 91101 Re: LIXTE BIOTECHNOLOGY HOLDINGS, INC. Form 10-K for the Fiscal Year Ended December 31, 2024 Filed March 24, 2025 File No. 001-39717 Dear Robert Weingarten: We have reviewed your filing and have the following comments. Please respond to this letter within ten business days by providing the requested information or advise us as soon as possible when you will respond. If you do not believe a comment applies to your facts and circumstances, please tell us why in your response. After reviewing your response to this letter, we may have additional comments. Annual Report on Form 10-K for the Fiscal Year Ended December 31, 2024 Item 1. Business, page 4 1. In future filings, please remove all statements indicating that your product candidates are safe and effective, as such determinations are solely within the authority of the FDA and comparable foreign regulatory authorities. For example only, without limitation, we note your statements throughout your annual report that LB-100 has been found to improve the effectiveness of anticancer drugs, as well as your disclosure on page 9 that LB-100 has "proven safe in patients at doses associated with anti-tumor activity." Description of Business, page 4 2. We note your pipeline table on page 6. In future filings, please shorten the length of the arrows in your pipeline table as appropriate to accurately reflect the status of the product candidate. In this regard, we note the arrows in the second and third rows of the table extend through the end of the "Phase 1b" column, which may indicate the July 16, 2025 Page 2 Phase 1b trials have been completed, but your disclosures on pages 7 and 8 indicate that the Phase 1b trial in patients with metastatic colon cancer is still enrolling patients and that the Phase 1b trial in patients with ASTS is still ongoing. Similarly, we note that the arrow in the first row of the table extends through most of the "Phase 2" column, which may indicate that a Phase 1b clinical trial has been completed and the Phase 2 clinical trial is nearly complete; however, your disclosures on pages 8 and F- 32 indicate that this is a Phase 1b/2 clinical trial and that you expect the clinical trial will be completed by December 31, 2027. Clinical Trial Agreements, page 7 3. We note your discussion on page 8 of your Phase 1b/2 collaborative clinical trial to assess whether adding LB-100, your lead product candidate, to dostarlimab-gsly may enhance the effectiveness of immunotherapy in the treatment of ovarian clear cell carcinoma. In future filings, please file the applicable clinical trial agreement as an exhibit, or tell us why you do not believe such exhibit is required. Refer to Item 601(b)(10) of Regulation S-K. 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 Jessica Dickerson at 202-551-8013 or Laura Crotty at 202-551-7614 if you have questions regarding the comments. Sincerely, Division of Corporation Finance Office of Life Sciences cc: David Ficksman </TEXT> </DOCUMENT>
2025-07-14 - CORRESP - LIXTE BIOTECHNOLOGY HOLDINGS, INC.
CORRESP 1 filename1.htm LIXTE BIOTECHNOLOGY HOLDINGS, INC. 680 East Colorado Boulevard, Suite 180 Pasadena, California 91101 July 14, 2025 VIA EDGAR Securities and Exchange Commission Division of Corporation Finance 100 F. Street, N.E. Washington, D.C. 20549 Re: Lixte Biotechnology Holdings, Inc. Registration Statement on Form S-1 File No. 333-288120 Ladies and Gentlemen: In accordance with Rule 461 under the Securities Act of 1933, as amended, Lixte Biotechnology Holdings, Inc., a Delaware corporation, respectfully requests that the effective date of the above-referenced Registration Statement be accelerated so that the same will become effective at 5:00 p.m., Eastern Time, on Tuesday, July 15, 2025, or as soon thereafter as is practicable. Please call our counsel, David Ficksman of TroyGould PC at 818 469 4200 to provide notice of effectiveness. Very truly yours, LIXTE BIOTECHNOLOGY HOLDINGS, INC. By: /s/ Geordan Pursglove Geordan Pursglove Chief Executive Officer
2025-06-26 - CORRESP - LIXTE BIOTECHNOLOGY HOLDINGS, INC.
CORRESP 1 filename1.htm LIXTE BIOTECHNOLOGY HOLDINGS, INC. 680 East Colorado Boulevard, Suite 180 Pasadena, California 91101 June 26, 2025 VIA EDGAR Securities and Exchange Commission Division of Corporation Finance 100 F. Street, N.E. Washington, D.C. 20549 Re: Lixte Biotechnology Holdings, Inc. Registration Statement on Form S-1 File No. 333-288120 Ladies and Gentlemen: Reference is made to our letter, filed as correspondence via EDGAR on June 24,2025, in which we requested the acceleration of the effective date of the above-referenced Registration Statement for Thursday June 26, 2025 at 5:00 p.m. Eastern Time in accordance with Rule 461 under the Securities Act of 1933, as amended, We are no longer requesting that the Registration Statement be declared effective at this time and we are hereby formally withdrawing our request for acceleration of the effective date. Please call our counsel, David Ficksman of TroyGould PC at 818 469 4200 if you have any questions. Very truly yours, LIXTE BIOTECHNOLOGY HOLDINGS, INC. By: /s/ Geordan Pursglove Geordan Pursglove Chief Executive Officer
2025-06-24 - CORRESP - LIXTE BIOTECHNOLOGY HOLDINGS, INC.
CORRESP 1 filename1.htm June 24, 2025 VIA EDGAR Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, DC 20549 RE: LIXTE BIOTECHNOLOGY HOLDINGS, INC. (CIK: 0001335105) Registration Statement No. 333-288120 on Form S-1/A (the "Registration Statement") Ladies and Gentlemen: Pursuant to Rule 461 of the General Rules and Regulations of the U.S. Securities and Exchange Commission under the Securities Act of 1933, as amended (the "Securities Act" ), Spartan Capital Securities, LLC 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, June 26, 2025, or as soon thereafter as practicable. Pursuant to Rule 460 under the Securities Act, please be advised that we will distribute as many electronic copies of the proposed form of preliminary prospectus as appears to be reasonable to secure adequate distribution. The undersigned has complied and will comply with the requirements of Rule 15c2-8 under the Securities Exchange Act of 1934, as amended. By: SPARTAN CAPITAL SECURITIES, LLC By: /s/ Kim Monchik Name: Kim Monchik Title: Chief Administrative Officer
2025-06-24 - CORRESP - LIXTE BIOTECHNOLOGY HOLDINGS, INC.
CORRESP 1 filename1.htm LIXTE BIOTECHNOLOGY HOLDINGS, INC. 680 East Colorado Boulevard, Suite 180 Pasadena, California 91101 June 24, 2025 VIA EDGAR Securities and Exchange Commission Division of Corporation Finance 100 F. Street, N.E. Washington, D.C. 20549 Re: Lixte Biotechnology Holdings, Inc. Registration Statement on Form S-1 File No. 333-288120 Ladies and Gentlemen: In accordance with Rule 461 under the Securities Act of 1933, as amended, Lixte Biotechnology Holdings, Inc., a Delaware corporation, respectfully requests that the effective date of the above-referenced Registration Statement be accelerated so that the same will become effective at 5:00 p.m., Eastern Time, on Thursday, June 26, 2025, or as soon thereafter as is practicable. Please call our counsel, David Ficksman of TroyGould PC at 818 469 4200 to provide notice of effectiveness. Very truly yours, LIXTE BIOTECHNOLOGY HOLDINGS, INC. By: /s/ Geordan Pursglove Geordan Pursglove Chief Executive Officer
2025-05-07 - UPLOAD - LIXTE BIOTECHNOLOGY HOLDINGS, INC. File: 377-07971
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> May 7, 2025 Bastiaan van der Baan President and Chief Executive Officer Lixte Biotechnology Holdings, Inc. 680 East Colorado Boulevard, Suite 180 Pasadena, CA 91101 Re: Lixte Biotechnology Holdings, Inc. Draft Registration Statement on Form S-1 Submitted May 2, 2025 CIK No. 0001335105 Dear Bastiaan van der Baan: This is to advise you that we do not intend to review your registration statement. We request that you publicly file your registration statement at least two business days 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 Daniel Crawford at 202-551-7767 with any questions. Sincerely, Division of Corporation Finance Office of Life Sciences cc: David Ficksman, Esq. </TEXT> </DOCUMENT>
2025-04-09 - CORRESP - LIXTE BIOTECHNOLOGY HOLDINGS, INC.
CORRESP 1 filename1.htm LIXTE BIOTECHNOLOGY HOLDINGS, INC. 680 East Colorado Boulevard, Suite 180 Pasadena, California 91101 April 9, 2025 VIA EDGAR Securities and Exchange Commission Division of Corporation Finance 100 F. Street, N.E. Washington, D.C. 20549 Re: Lixte Biotechnology Holdings, Inc. Registration Statement on Form S-1 File No. 333-286385 Ladies and Gentlemen: In accordance with Rule 461 under the Securities Act of 1933, as amended, Lixte Biotechnology Holdings, Inc., a Delaware corporation, respectfully requests that the effective date of the above-referenced Registration Statement be accelerated so that the same will become effective at 5:00 p.m., Eastern Time, on Thursday, April 10, 2025, or as soon thereafter as is practicable. Please call our counsel, David Ficksman of TroyGould PC at 818 469 4200 to provide notice of effectiveness. Very truly yours, LIXTE BIOTECHNOLOGY HOLDINGS, INC. By: /s/ Bas van der Baan Bas van der Baan Chief Executive Officer
2025-04-08 - UPLOAD - LIXTE BIOTECHNOLOGY HOLDINGS, INC. File: 333-286385
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> April 8, 2025 Bastiaan van der Baan Chief Executive Officer Lixte Biotechnology Holdings, Inc. 680 East Colorado Boulevard, Suite 180 Pasadena, CA 91101 Re: Lixte Biotechnology Holdings, Inc. Registration Statement of Form S-1 Filed April 4, 2025 File No. 333-286385 Dear Bastiaan van der Baan: This is to advise you that we have not reviewed and will not review your registration statement. Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you that the company and its management are responsible for the accuracy and adequacy of their disclosures, notwithstanding any review, comments, action or absence of action by the staff. Please contact Chris Edwards at 202-551-6761 with any questions. Sincerely, Division of Corporation Finance Office of Life Sciences cc: David L. Ficksman, Esq. </TEXT> </DOCUMENT>
2024-04-30 - CORRESP - LIXTE BIOTECHNOLOGY HOLDINGS, INC.
CORRESP
1
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LIXTE
BIOTECHNOLOGY HOLDINGS, INC.
680
East Colorado Boulevard, Suite 180
Pasadena,
California 91101
April 30, 2024
VIA
EDGAR
Securities
and Exchange Commission
Division
of Corporation Finance
100
F. Street, N.E.
Washington,
D.C. 20549
Re:
Lixte
Biotechnology Holdings, Inc.
Registration
Statement on Form S-3
Filed
April 23, 2024
File
No. 333-278874
Ladies
and Gentlemen:
In
accordance with Rule 461 under the Securities Act of 1933, as amended, Lixte Biotechnology Holdings, Inc., a Delaware corporation,
respectfully requests that the effective date of the above-referenced Registration Statement be accelerated so that the same will
become effective at 4:00 p.m., Eastern Time, on Thursday, May 2, 2024, or as soon thereafter as is practicable. Please call our
counsel, David Ficksman of TroyGould PC, at 818 469 4200 to provide notice of effectiveness.
Very
truly yours,
LIXTE
BIOTECHNOLOGY HOLDINGS, INC.
By:
/s/
Bastiaan van der Baan
Bastiaan
van der Baan
Chief
Executive Officer
2024-04-29 - UPLOAD - LIXTE BIOTECHNOLOGY HOLDINGS, INC. File: 333-278874
United States securities and exchange commission logo
April 29, 2024
Bas van der Baan
Chief Executive Officer
Lixte Biotechnology Holdings, Inc.
680 East Colorado Boulevard, Suite 180
Pasadena, California 91101
Re:Lixte Biotechnology Holdings, Inc.
Registration Statement on Form S-3
Filed April 23, 2024
File No. 333-278874
Dear Bas van der Baan:
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: David Ficksman, Esq.
2023-08-18 - CORRESP - LIXTE BIOTECHNOLOGY HOLDINGS, INC.
CORRESP
1
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LIXTE
BIOTECHNOLOGY HOLDINGS, INC.
680
East Colorado Boulevard, Suite 180
Pasadena,
California 91101
August
18, 2023
VIA
EDGAR
Securities
and Exchange Commission
Division
of Corporation Finance
100
F. Street, N.E.
Washington,
D.C. 20549
Re:
Lixte
Biotechnology Holdings, Inc.
Registration
Statement on Form S-3
Filed
August 11, 2023
File
No. 333-273932
Ladies
and Gentlemen:
In
accordance with Rule 461 under the Securities Act of 1933, as amended, Lixte Biotechnology Holdings, Inc., a Delaware corporation, respectfully
requests that the effective date of the above-referenced Registration Statement be accelerated so that the same will become effective
at 4:00 p.m., Eastern Time, on Monday, August 21, 2023, or as soon thereafter as is practicable. Please call our counsel, David Ficksman
of TroyGould PC at 310-789-1290 to provide notice of effectiveness.
Very
truly yours,
LIXTE
BIOTECHNOLOGY HOLDINGS, INC.
By:
/s/
John Kovach
John
Kovach
Chief
Executive Officer
2023-08-15 - UPLOAD - LIXTE BIOTECHNOLOGY HOLDINGS, INC.
United States securities and exchange commission logo
August 15, 2023
John Kovach
Chief Executive Officer
Lixte Biotechnology Holdings, Inc.
680 East Colorado Boulevard, Suite 180
Pasadena, California 91101
Re:Lixte Biotechnology Holdings, Inc.
Registration Statement on Form S-3
Filed August 11, 2023
File No. 333-273932
Dear John Kovach:
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: David L. Ficksman, Esq.
2021-02-03 - CORRESP - LIXTE BIOTECHNOLOGY HOLDINGS, INC.
CORRESP
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LIXTE
BIOTECHNOLGY HOLDINGS, INC.
248
Route 25A, No.2
East
Setauket, NY 11733
February
3,2021
VIA
EDGAR
Securities
and Exchange Commission
100
F Street, N.E.
Washington,
D.C. 20549-6010
Re:
Lixte
Biotechnology Holdings, Inc.
Filed
January 26,2021
Registration
Statement on Form S-3 (Reg. No. 333-252430)
Ladies
and Gentlemen:
On
behalf of Lixte Biotechnology Holdings, Inc., the undersigned hereby requests that the Securities and Exchange Commission issue
an order declaring the above-referenced Registration Statement effective at 4:00 P.M., Washington, D.C. time, on Friday February
5, 2021, or as soon thereafter as is practicable.
Very
truly yours,
/s/
John Kovach
John
Kovach
President
and Chief Executive Officer
2021-02-02 - UPLOAD - LIXTE BIOTECHNOLOGY HOLDINGS, INC.
United States securities and exchange commission logo
February 2, 2021
John S. Kovach
Chief Executive Officer
Lixte Biotechnology Holdings, Inc.
248 Route 25A, No. 2
East Setauket, NY 11733
Re:Lixte Biotechnology Holdings, Inc.
Registration Statement on Form S-3
Filed January 26, 2021
File No. 333-252430
Dear Mr. Kovach:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please contact Ada D. Sarmento at 202-551-3798 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: David Ficksman, Esq.
2020-11-19 - CORRESP - LIXTE BIOTECHNOLOGY HOLDINGS, INC.
CORRESP
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WestPark
Capital, Inc.
1900
Avenue of the Stars, Suite 310
Los
Angeles, CA90067
As
representative of the several underwriters
VIA
EDGAR
November
19, 2020
United
States Securities and Exchange Commission
Division
of Corporation Finance
100
F Street, N.E.
Washington,
D.C. 20549
Re:
Lixte
Biotechnology Holdings, Inc. (the “Company”)
Registration
Statement on Form S-1
Filed
on September 3, 2020
CIK
No. 0001335105
Ladies
and Gentlemen:
Reference
is made to our letter, filed as correspondence with the U.S. Securities and Exchange Commission via EDGAR on November 17, 2020,
in which we requested the acceleration of the effectiveness of the above-captioned Registration Statement to 4:00 p.m., New York
City time on November 19, 2020. We hereby formally withdraw our prior request for acceleration of the effective date of the above-captioned
Registration Statement and hereby join the Company’s
request that the effective date of the above-referenced Registration Statement be accelerated so that the above-referenced Registration
Statement will be declared effective at 4:00 p.m., Eastern Time, on November 23, 2020, or as soon thereafter as is practicable.
[Remainder
of Page Intentionally Left Blank]
-1-
Very
truly yours,
WestPark
Capital, Inc.
By:
/s/
Richard Rappaport
Richard Rappaport,
Authorized Representative
Acting on behalf of themselves and as the Representative of the several Underwriters
-2-
2020-11-19 - CORRESP - LIXTE BIOTECHNOLOGY HOLDINGS, INC.
CORRESP
1
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LIXTE
BIOTECHNOLGY HOLDINGS, INC.
248
Route 25A, No.2
East
Setauket, NY 11733
November
19.2020
VIA
EDGAR
Securities
and Exchange Commission
100
F Street, N.E.
Washington,
D.C. 20549-6010
Re:
Lixte
Biotechnology Holdings, Inc.
Registration
Statement on Form S-1 (Reg. No. 333-248588)
Ladies
and Gentlemen:
On
behalf of Lixte Biotechnology Holdings, Inc., the undersigned hereby (a) withdraws the previous request that the above referenced
Registration Statement be declared effective on Thursday November 19, 2020 and (b) requests that the Securities and Exchange Commission
issue an order declaring the Registration Statement effective at 4:00 P.M., Washington, D.C. time, on Monday November 23,2020
or as soon thereafter as is practicable. This will confirm that no securities have been sold pursuant to the Registration Statement.
Please call our counsel, David Ficksman, at 310-789-1290 to inform him of the effectiveness.
Very
truly yours,
/s/
John Kovach
John
Kovach
President
and Chief Executive Officer
2020-11-16 - CORRESP - LIXTE BIOTECHNOLOGY HOLDINGS, INC.
CORRESP
1
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LIXTE
BIOTECHNOLGY HOLDINGS, INC.
248
Route 25A, No.2
East
Setauket, NY 11733
November
16.2020
VIA
EDGAR
Securities
and Exchange Commission
100
F Street, N.E.
Washington,
D.C. 20549-6010
Re:
Lixte
Biotechnology Holdings, Inc.
Registration
Statement on Form S-1 (Reg. No. 333-248588)
Ladies
and Gentlemen:
On
behalf of Lixte Biotechnology Holdings, Inc., the undersigned hereby requests that the Securities and Exchange Commission issue
an order declaring the above-referenced Registration Statement effective at 4:00 P.M., Washington, D.C. time, on Wednesday, November
18,2020 or as soon thereafter as is practicable. Please call our counsel, David Ficksman, at 310-789-1290 to inform him of the
effectiveness.
Very
truly yours,
/s/
John Kovach
John
Kovach
President
and Chief Executive Officer
2020-11-16 - CORRESP - LIXTE BIOTECHNOLOGY HOLDINGS, INC.
CORRESP
1
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WestPark
Capital, Inc.
1900
Avenue of the Stars, Suite 310
Los
Angeles, CA90067
As
representative of the several underwriters
VIA
EDGAR
November
16, 2020
United
States Securities and Exchange Commission
Division
of Corporation Finance
100
F Street, N.E.
Washington,
D.C. 20549
Re:
Lixte
Biotechnology Holdings, Inc. (the “Company”)
Registration
Statement on Form S-1
Filed
on September 3, 2020
CIK
No. 0001335105
Ladies
and Gentlemen:
Pursuant
to Rule 461 under the Securities Act of 1933, as amended (the “Securities Act”), we, as
representative of the several underwriters of the Company’s proposed public offering, hereby join the Company’s request
that the effective date of the above-referenced Registration Statement be accelerated so that the above-referenced Registration
Statement will be declared effective at 4:00 p.m., Eastern Time, on November 18, 2020, or as soon thereafter as is practicable.
Pursuant
to Rule 460 of the General Rules and Regulations of the Commission under the Securities Act, please be advised that there will
be distributed to each underwriter or dealer, who is reasonably anticipated to participate in the distribution of the securities
in this offering, as many copies of the Preliminary Prospectus, dated November 2, 2020, as appears to be reasonable to secure
adequate distribution of the Preliminary Prospectus.
The
undersigned advise that they have complied and will continue to comply, and that they have been informed by the participating
underwriters and dealers that they have complied with and will continue to comply, with the requirements of Rule 15c2-8 under
the Securities Exchange Act of 1934, as amended.
[Remainder
of Page Intentionally Left Blank]
-1-
Very
truly yours,
WESTPARK
CAPITAL, INC
By:
/s/
Richard Rappaport Chief Executive Officer
Authorized
Representative
Acting
on behalf of themselves and as the Representatives of the several Underwriters
-2-
2020-09-11 - UPLOAD - LIXTE BIOTECHNOLOGY HOLDINGS, INC.
United States securities and exchange commission logo
September 10, 2020
John Kovach, M.D.
Chief Executive Officer
Lixte Biotechnology Holdings, Inc.
248 Route 25A, No. 2
East Setauket, NY 11733
Re:Lixte Biotechnology Holdings, Inc.
Registration Statement on Form S-1
Filed September 3, 2020
File No. 333-248588
Dear Dr. Kovach:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please contact Jason L. Drory at 202-551-8342 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: David L. Ficksman, Esq.
2013-11-13 - UPLOAD - LIXTE BIOTECHNOLOGY HOLDINGS, INC.
November 1 3, 2013 Via E -mail John S. Kovach Chief Executive Officer and Chief Financial Officer Lixte Biotechnology Holdings, Inc. 248 Route 25A, No. 2 East Setauket, New York 11733 Re: Lixte Biotechnology Holdings , Inc. Annual Report on Form 10-K for the Fiscal Year ended December 31, 2012 Filed March 15, 2013 File No. 00 0-51476 Dear Mr. Kovach : We have completed our review of your filing. We remind you that our comments or changes to disclosure in response to our comments do not foreclose the Commission from taking any action with respect to the company or the filing and the company may not assert staff comments as a defense in any proceeding initiated by the Com mission or any person under the federal securities laws of the United States. 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 Excha nge Act of 1934 and all applicable rules require. Sincerely, /s/ Daniel Greenspan for Jeffrey P. Riedler Assistant Director cc: David L. Ficksman, Esq. TroyGould 1801 Century Park East, Suite 1600 Los Angeles, CA 90067
2013-10-08 - CORRESP - LIXTE BIOTECHNOLOGY HOLDINGS, INC.
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Lixte Biotechnology Holdings, Inc.
248 Route 25A, No. 2
East Setauket, New York 11733
October 8, 2013
VIA EDGAR AND FACSIMILE
Scot J. Foley
U.S. Securities and Exchange Commission
Division of Corporate Finance
100 F Street NE
Washington, DC 20549
Re:
Lixte Biotechnology Holdings, Inc.
Annual Report on Form 10-K for the Fiscal Year Ended December 31, 2012
Filed March 15, 2013
File No. 000-51476
Dear Mr. Foley:
This is in response to your letter to the
Company of September 13, 2013.
We have reproduced below in bold face the
text of your comments, followed by our responses. The numbered paragraphs below correspond to the numbered paragraphs in your letter.
Item 1, Business
Company Overview, page 4
1. Please disclose the material terms
of your collaboration agreement with the National Cancer Institute. Your description should include, as may be applicable:
· Nature of the collaboration;
· Material payment provisions including initial, annual, milestone or royalty provisions;
· Other material rights and obligations of both parties; and
· Duration, term and termination provisions.
Please also file the collaboration agreement
as an exhibit to your next quarterly report on Form 10-Q and incorporate the exhibit by reference to your next Form 10-K. If you
believe that this agreement is not required to be filed pursuant to Item 601(b)(10) of Regulation S-K, please provide us with an
analysis supporting this conclusion.
Scot J. Foley
U.S. Securities and Exchange Commission
October 8, 2013
Page 2
COMPANY RESPONSE:
The Company will modify the disclosure in
its filings regarding the NExT program to make it clear that there was no binding agreement, payment requirements or other material
obligations between the parties. Accordingly, no exhibit is required to be filed pursuant to Item 601(b)(10) or any other exhibit
item. The proposed disclosure is as follows:
On September 17, 2010, the National Cancer
Institute (NCI) Experimental Therapeutics (NExT) Program Senior Advisory Committee (SAC) approved a collaboration by the NCI with
the Company for clinical evaluation of LB-100, one of the Company’s drug compounds. This collaboration is a milestone-based
approach in which NCI will first confirm studies of the LB-100 compound in an animal model of glioblastoma multiforme, the most
common form of brain tumor of adults, and conduct an initial exploratory toxicology study in an animal model. At milestone intervals,
the SAC will re-evaluate project progress before considering assignment of additional support and resources to this project. As
noted below, the NExT group advised the Company on several aspects of the process of pre-clinical characterization of LB-100 needed
for submission of an IND and carried out an initial toxicological study of LB-100 in rats. This study was used to guide the subsequent
formal toxicology studies based on good laboratory practice (GLP) completed in rats and dogs by the Company with a contract research
organization. The Company subsequently conducted its own GLP toxicity studies and submitted an IND for a clinical trial of LB-100,
which acknowledged the early assistance of the NExT program in planning the design of animal studies.
The NExT program of the NCI is a unique
partnership with the NCI to facilitate oncology drug discovery and development. The program is not a grant or a contract, but provides
access to the NCI’s drug discovery and preclinical development resources, including expert advice concerning the various
requirements for bringing a new compound to initial clinical trial. Participation in the NExT program is via a competitive application.
The Company was admitted to the program in September 2010. The Company received advice as to how to proceed with pre-clinical development
of its lead compound LB-100 and the NCI performed one rodent toxicology study with LB-100. The Company was not responsible for
any costs or payments, and neither party obtained or incurred any material rights or obligations. As is standard for the NExT program,
there was no specific agreement, other than to limit support to pre-clinical development pending validation of anti-tumor activity
in a specific tumor model. Activity deemed less than sufficient to warrant extension of NExTsupport toward clinical development
led to termination of the Company’s participation in the program on July 21, 2011. The Company subsequently carried out the
pre-clinical studies for and obtained an IND from the FDA to study LB-100 in a Phase I clinical trial.
Scot J. Foley
U.S. Securities and Exchange Commission
October 8, 2013
Page 3
Intellectual Property, page 5
2. Please expand this disclosure to
list each of your material patents and indicate the product candidates to which they relate and the indications they are intended
to treat, the jurisdictions in which the patent applications were filed, their expiration dates, and the type of patent protection,
e.g. composition of matter, use or process.
COMPANY RESPONSE:
The Company will expand its disclosures
in its filings regarding its patents as follows:
The Company’s products will derive
directly from its intellectual property, including the property covered by its patents. These patents now cover sole rights to
the composition and synthesis of the LB-100 and LB-200 series of drugs. Joint patent applications with the NIH have been filed
for the treatment of glioblastoma multiforme, medulloblastoma, and neuroblastoma. The Company has also filed claims for the use
of certain homologs of both series of drugs for the potential treatment of neurodegenerative diseases such as Alzheimer’s
Disease and Parkinson’s Disease, Amyotrophic Lateral Sclerosis (ALS, or Lou Gehrig’s Disease), stroke, and traumatic
brain injury and of homologs of the LB-200 series for treatment of serious systemic fungal infections and for the treatment of
common fungal infections of the skin and nails. Other claims cover biomarkers uniquely associated with specific types of cancer
that may provide the bases for assays suitable for cancer detection and patents for development of a tool for screening new compounds
for anti-cancer activity.
Patents for composition of matter and for
several uses of both the LB-100 series (oxabicycloheptanes and –heptenes) and the LB-200 series (histone deacetylase inhibitors;
HDACi) have been filed. Patents for the LB-100 series and the LB-200 series have been filed in the U.S. and widely internationally
(PCT). International filings are currently all pending.
Issued patents are:
LB-100 Series Compounds
Oxabicycloheptanes and Oxabicycloheptenes, Their Preparation
and Use
Patent
Priority Date
Type
Expiration Date
US 7,998,957
Feb 6, 2008
Composition and Use in Cancer Treatment
2/20/2030
US 8,227,473
Aug 1, 2009
Composition and Use in Cancer Treatment
2/20/2030
US 8,426,444 Div
Feb 6, 2008
Composition and Use in Cancer Treatment
2/6/2028
Scot J. Foley
U.S. Securities and Exchange Commission
October 8, 2013
Page 4
LB-200 Series Compounds
HDAC Inhibitors
US 8,143,445
Oct 1, 2008
Composition and Use in Cancer Treatment
8/23/2029
US 8,455,688 Divisional
Oct 1, 2008
Composition and Use in Cancer Treatment
10/1/2028
LB-100 and LB-200 Series Compounds
Neuroprotective Agents for the Prevention and Treatment of
Neurodegenerative Diseases
US 8,058,268
Aug 1, 2009
Use in Treatment of Multiple CNS Diseases
12/31/2029
US 8,329,719 Divisional
Aug 1, 2009
Use in Treatment of Multiple CNS Diseases
7/29/2029
This will 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 Securities and Exchange Commission from taking any action with respect to the filing; and
the Company may not assert staff comments as a defense in any proceeding initiated by the Commission or any person under the federal
securities laws of the United States.
Very truly yours,
Lixte Biotechnology Holdings, Inc.
By:
/s/ John Kovach
Name:
John Kovach
Title:
President
2013-09-30 - CORRESP - LIXTE BIOTECHNOLOGY HOLDINGS, INC.
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Lixte Biotechnology Holdings, Inc.
248 Route 25A, No. 2
East Setauket, New York 11733
VIA EDGAR AND FAX
Scot J. Foley
U.S. Securities and Exchange Commission
Division of Corporate Finance
100 F Street NE
Washington, DC 20549
Re:
Lixte Biotechnology Holdings, Inc.
Annual Report on Form 10-K for the Fiscal Year Ended December 31, 2012
Filed March 15, 2013
File No. 000-51476
Dear Mr. Foley:
Confirming your conversation with our counsel,
Lixte Biotechnology Holdings, Inc. (the “Company”) acknowledges receipt of your letter to the Company of September 13,
2013 and intends to file by October 11, 2013 a response containing the disclosure we plan to insert in our next periodic filing.
This will 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 Securities and Exchange Commission from taking any action with respect to the filing; and
the Company may not assert staff comments as a defense in any proceeding initiated by the Commission or any person under the federal
securities laws of the United States.
Very truly yours,
Lixte Biotechnology Holdings, Inc.
Date: September 30, 2013
By:
/s/ John Kovach
Name:
John Kovach
Title:
President
2013-09-16 - UPLOAD - LIXTE BIOTECHNOLOGY HOLDINGS, INC.
September 1 3, 2013 Via E -mail John S. Kovach Chief Executive Officer and Chief Financial Officer Lixte Biotechnology Holdings, Inc. 248 Route 25A, No. 2 East Setauket, New York 11733 Re: Lixte Biotechnology Holdings , Inc. Annual Report on Form 10-K for the Fiscal Year ended December 31, 2012 Filed March 15, 2013 File No. 00 0-51476 Dear Mr. Kovach : We have reviewed your filing an d have the following comments. In some of our comments, we may ask you to provide us with information so we may better understand your disclosure. Please respond to this letter within ten business days by amending your filing, 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 circumstances or do not believe an amendment is appropriate, please tell us why in your response. After reviewing any amendment to your filing and the information you provide in response to these comments, we may have additional comments. Item 1. Business Company Overview, page 4 1. Please disclose the material terms of your collaboration agreement with the National Cancer Institute. Your de scription should include, as may be applicable: Nature of the collaboration; Material payment provisions including initial, annual, milestone or royalty provisions; Other material rights and obligations of both parties; and John S. Kovach Lixte Biotechnology Holdings, Inc. September 1 3, 2013 Page 2 Duration, term and terminat ion provisions. Please also file the collaboration agreement as an exhibit to your next quarterly report on Form 10 -Q and incorporate the exhibit by reference to your next Form 10 -K. If you believe that this agreement is not required to be filed pursuant to Item 601(b)(10) of Regulation S -K, please provide us with an analysis supporting this conclusion. Intellectual Property, page 5 2. Please expand this disclosure to list each of your material patents and indicate the product candidates to which they rel ate and the indications they are intended to treat, the jurisdictions in which the patent applications were filed, their expiration dates, and the type of patent protection, e.g. composition of matter, use or process. We urge all persons who are responsi ble for the accuracy and adequacy of the disclosure in the filing to be certain that the filing includes the information the Securities Exchange Act of 1934 and all applicable Exchange Act rules require. Since the company and its management are in possess ion 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 provide a written statement from the company acknowledging that: the compa ny 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. John S. Kovach Lixte Biotechnology Holdings, Inc. September 1 3, 2013 Page 3 Please contact Scot Foley at (202) 551 -3383 , John Krug at (202) 551 -3862, or me at (202) 551 -3715 with any other questions. Sincerely, /s/ Daniel Greenspan Jeffrey P. Riedler Assistant Director cc: David L. Ficksman, Esq. TroyGould 1801 Century Park East, Suite 1600 Los Angeles, CA 90067
2009-01-08 - UPLOAD - LIXTE BIOTECHNOLOGY HOLDINGS, INC.
Via Facsimile and U.S. Mail Mail Stop 6010 January 8, 2009 Dr. John S. Kovach Lixte Biotechnology Holdings, Inc. Chief Executive Officer and Chief Financial Officer (Principal Executive Officer and Principal Financial Officer)
248 Route 25A, No. 2 East Setauket, New York 11733
Re: Lixte Biotechnology Holdings, Inc.
Item 4.01 Form 8-K File No. 000-51476
Dear Dr. Kovach:
We have completed our review of your Form 8-K and have no further comments
at this time.
S i n c e r e l y , T a b a t h a A k i n s S t a f f A c c o u n t a n t
2008-12-22 - UPLOAD - LIXTE BIOTECHNOLOGY HOLDINGS, INC.
Via Facsimile and U.S. Mail Mail Stop 6010 December 22, 2008 Mr. John S. Kovach Lixte Biotechnology Holdings, Inc. Chief Executive Officer and Chief Financial Officer (Principal Executive Officer and Principal Financial Officer)
248 Route 25A, No. 2 East Setauket, New York 11733
Re: Lixte Biotechnology Holdings, Inc.
Item 4.01 Form 8-K
Filed December 22, 2008
File No. 000-51476
Dear Mr. Kovach:
We have reviewed your filing and have the following comments. Where
indicated, we think you should re vise your document in response to these comments. If
you disagree, we will consider your explanation as to why our comment is inapplicable or
a revision is unnecessary. Please be as deta iled as necessary in your explanation. In
some of our comments, we may ask you to provi de us with more information so we may
better understand your disclosure. After re viewing this information, we may raise
additional comments. Please understand that the purpose of our re view process is to assist you in your
compliance with the applicable disclosure requirements and to enhance the overall
disclosure in your filing. We look forward to working with you in these respects. We
welcome any questions you may have about our comments or any other aspect of our
review. Feel free to call us at the telephone numbers listed at the end of this letter.
Item 4.01 Form 8-K
1. It appears AJ Robbins, P.C. disclosed an un certainty of the Regi strant to continue
as a going concern in your Form 10-KS B filed March 31, 2008. Please amend
your filing to provide a description of natu re of their conclusion. Refer to Item
304(a)(1)(ii) of Regulation S-K.
Mr. John S. Kovach
Lixte Biotechnology Holdings, Inc. December 22, 2008 Page 2
2. The current disclosure in the third para graph is absent with respect to Item
304(a)(2)(ii). Please amend your filing to include the disclosures required under
this guidance.
3. Upon amending your filing, please include, as Exhibit 16, an updated letter from
your former accountants, AJ Robbins, P. C., as required by Item 304(a)(3) of
Regulation S-K. Please ensure that your former accountants date their letter.
* * * *
As appropriate, please amend your filing and respond to these comments within
five business days or tell us when you will provide us with a response. You may wish to provide us with marked copies of the amendm ent to expedite our review. Please furnish
a cover letter with your amendment that keys your responses to our comments and
provides any requested information. Detailed co ver letters greatly faci litate our review.
Please understand that we may have addi tional comments after reviewing your
amendment and responses to our comments. We urge all persons who are responsi ble for the accuracy an d adequacy of the
disclosure in the filing to be certain that the filing includes all in formation required under
the Securities Exchange Act of 1934 and th at they have provided all information
investors require for an informed invest ment decision. Since the company and its
management are in possession of all facts re lating to a company’s disclosure, they are
responsible for the accuracy and adequacy of the disclosures they have made.
In connection with responding to our comments, please provide, in writing, a
statement from the company acknowledging that: the company is responsible for the adequacy and accuracy of the disclosure in the
filing;
staff comments or changes to disclosure in response to staff comments do not
foreclose the Commission from taking any action with respect to the filing; and
the company may not assert staff comments as a defense in any proceeding initiated
by the Commission or any person under the federal securities laws of the United States.
In addition, please be advise d that the Division of Enfo rcement has access to all
information you provide to the staff of the Divi sion of Corporation Fi nance in our review
of your filing or in response to our comments on your filing.
Mr. John S. Kovach
Lixte Biotechnology Holdings, Inc. December 22, 2008 Page 3
If you have any questions, please do not hesitate to call me at (202) 551-3658.
S i n c e r e l y , T a b a t h a A k i n s S t a f f A c c o u n t a n t
2007-05-14 - CORRESP - LIXTE BIOTECHNOLOGY HOLDINGS, INC.
CORRESP
1
filename1.htm
Unassociated Document
File
No. 2392-1
May
11,
2007
Via
Fax ((202) 772-9218) and Edgar
Mr. Russell
Mancuso
Branch
Chief
United
States Securities and Exchange Commission
Office
of
Emerging Growth Companies
Mail
Stop
3561
100
F
Street, N.E.
Washington,
D.C. 20549
Re:
Lixte
Biotechnology Holdings, Inc.
Amendment No. 5 to Form
SB-2
Filed May 5,
2007
File No.
333-137208
Dear
Mr. Mancuso:
Confirming
our telephone conversation, we respond to your comments as follows:
1.
Status
of Form 10Q-SB filing for the quarter ended March 31,
2007.
Response
Currently
the financial statements and notes are being reviewed by the Company’s outside
accountants. The Company continued to conduct its research and development
business activities during the three months ended March 31,
2007. Transactions during the three months ended March 31, 2007,
all within the scope of the Company's previously described business
activities and transactions, included the recording of an advance on
research and development costs of $200,000 and a related current liability
under
the CRADA, and a charge to operations of $31,000 for the fair value of a
fully-vested, non-forfeitable stock option issued under a services agreement
during the period.
2.
Opinion
letter comments:
Response
This
will
confirm that the reference in our opinion to the Delaware General Corporation
Law includes all applicable provisions of the Delaware Constitution. We also
confirm that our reference to “Shares” includes all the shares covered by the
Registration Statement and that all of such shares are currently
outstanding.
Mr. Russell
Mancuso
May
11,
2007
Page
2
3.
Status
of “December 2006 Agreement.”
Response
We
now
understand that your inquiry was as to the status of the proposed license
agreement between NINDS, NIH and the Company. As disclosed in Amendment
No. 5 the Company has received a form of proposed license agreement and
intends to negotiate the economic terms.
* * *
We
are
concurrently attaching herewith a request for acceleration.
All
questions and comments regarding the foregoing should be addressed to me at
(310) 789-1290.
Very truly yours,
/s/ David L.
Ficksman
DLF/wp
cc:
John Kovach, M.D.
Dale Campbell
Robert Weingarten
Eduardo
Aleman
2007-05-14 - CORRESP - LIXTE BIOTECHNOLOGY HOLDINGS, INC.
CORRESP
1
filename1.htm
Unassociated Document
May
11,
2007
VIA
ELECTRONIC TRANSMISSION AND FACSIMILE
Securities
and Exchange Commission
100
F
Street, N.E.
Washington,
D.C. 20549-6010
Re:
Lixte
Biotechnology Holdings, Inc. - Registration Statement on Form
SB-2
Registration
No. 333-137208
Ladies
and Gentlemen:
On
behalf
of Lixte Biotechnology Holdings, Inc., a Delaware corporation (the “Company”),
the undersigned hereby requests that the Securities and Exchange Commission
issue an order declaring the above-referenced Registration Statement effective
at 4:00 p.m., Washington, D.C. time, on Monday, May 14, 2007, or as soon
thereafter as is practicable.
The
Company hereby acknowledges that:
1. Should
the Commission or the staff, acting pursuant to delegated authority, declare
the
Registration Statement effective, that act will not foreclose the Commission
from taking any action with respect to the filing;
2. The
action of the Commission or the staff, acting pursuant to delegated authority,
in declaring the Registration Statement effective does not relieve the Company
from its full responsibility for the adequacy and accuracy of the disclosures
in
the Registration Statement; and
3. The
Company may not assert staff comments or 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.
The
Company also understands that this request for acceleration will be considered
a
confirmation of its awareness of its obligations under the Securities Act of
1933 and the Securities Exchange Act of 1934 with respect to the offering of
securities pursuant to the Registration Statement.
Very
truly
yours,
By:
/s/ John
S.
Kovach
John
S. Kovach
Chief
Executive Officer
Lixte
Biotechnology Holdings, Inc.
2007-05-14 - CORRESP - LIXTE BIOTECHNOLOGY HOLDINGS, INC.
CORRESP
1
filename1.htm
File
No. 2392-1
May
14,
2007
Via
Fax (202) 772-9218 and Edgar
Mr. Russell
Mancuso
Branch
Chief
United
States Securities and Exchange Commission
Office
of
Emerging Growth Companies
Mail
Stop
3561
100
F
Street, N.E.
Washington,
D.C. 20549
Re:
Lixte
Biotechnology Holdings, Inc.
Amendment
No. 5 to Form SB-2
Filed
May 5, 2007
File
No. 333-137208
Dear
Mr. Mancuso:
Lixte
Biotechnology Holdings, Inc. (the “Company”) hereby represents that there are no
material changes in the financial conditions and results of operations from
the
financial statements as previously reported in Amendment No. 5 to the
Registration Statement on Form SB-2.
Very
truly yours,
/s/
John Kovach, M.D.
Chief
Executive Officer
cc:
David
Ficksman
Eduardo
Aleman
2007-02-13 - UPLOAD - LIXTE BIOTECHNOLOGY HOLDINGS, INC.
February 7, 2007
Mail Stop 6010
John S. Kovach
Chairman and Chief Executive Officer
Lixte Biotechnology Holdings, Inc.
248 Route 25A, No. 2
East Setauket, NY 11733
Re: Lixte Biotechnology Holdings, Inc.
Amendment No. 2 to Form SB-2
Filed January 23, 2007
File No. 333-137208
Dear Mr. Kovach:
We have reviewed your filing and have the following comments. Where
indicated, we think you should re vise your document in response to these comments. If
you disagree, we will consider your explanation as to why our comment is inapplicable or
a revision is unnecessary. Please be as deta iled as necessary in your explanation. In
some of our comments, we may ask you to provi de us with information so we may better
understand your disclosure. After reviewing th is information, we may raise additional
comments.
We welcome any questions you may have about our comments or any other
aspect of our review. Feel fr ee to call us at the telephone numbe rs listed at the end of this
letter.
Amendment No. 2 to Form SB-2
1. Due to your name change, when you use the shortened name “Lixte” throughout
your document, it is unclear whether you are referring to your company or the
company you acquired in the reverse me rger. Please revi se throughout your
document so your disclosure is clear from context.
Shares Eligible for Future Sale, page 16
2. If the “former stockholder of Lixte” to which you issued all of the shares in the
reverse merger is your CEO, please say so directly here and each place in your
document where you refer to issuing sh ares in the reverse merger.
John S. Kovach
Lixte Biotechnology Holdings, Inc.
February 7, 2007 Page 2
Business, page 28
Intellectual Property, page 29
3. Your revision in response to prior co mment 7 continues to summarize the opinion
of an expert. Therefore, we reissue the comment.
4. We note your response to comment 6. Th at comment sought disclosure of the
material terms of the agreement you were negotiating with the NIH relating to
commercial rights to certain inventions. Your added disclosure under “Access to
Clinical Materials” appears to relate to a different agreement. We reissue
comment 6 in our letter to you dated December 15, 2006.
Government Regulation, page 34
5. We note your added disclosure in resp onse to prior comment 8. Please expand
your disclosure to clarify the nature, extent and duration of the FDA approval
process.
Scientific Advisory Committee, page 37
6. We note your response to prior comment 10; however, this disclosure continues to
appear in the section of your prospectus where you discuss your management.
Therefore, we reissue the comment.
Executive Compensation, page 38
7. Please update your disclosure to incl ude all required ex ecutive compensation
information for your last completed fiscal year. Please ensure that your updated
disclosure is in complian ce with Release No. 33-8732A.
Security Ownership, page 39
8. We note the disclaimer in footnote 2. If securities are beneficially owned as
defined in Regulation S-B It em 403, you must include them in the table, even if
ownership is disclaimed. Please revise.
Selling Stockholders, page 41
9. We note your response to prior comment 40 and reissue the comment. Please see
telephone interpretation 4S under Regulation S-K in the Manual of Publicly
Available Telephone Interpretations (March 1999 Supplement) available on our
website. If you cannot provide the required information regarding the individuals
John S. Kovach
Lixte Biotechnology Holdings, Inc.
February 7, 2007 Page 3
who beneficially own the shares held by the entities listed in the table, those
entities should be removed as selling sh areholders and the related shares should
be removed from the registration statement.
Financial Statements
10. We note your response to prior comment 14. However, if the financial statements
need to be “read in conjunction with” disc losure in a Form 8-K, it is unclear how
the disclosure in this registration statement is complete without inappropriate incorporation by reference.
Recent Sales of Unregister ed Securities, page II-2
11. We note your response to comment 17. Please explain:
• Why you have not disclosed in Item 26 (Recent Sales of Unregistered
Securities) the May 17, 2006 transaction mentioned in Appendix B;
• Why over four million shares were returned in the reverse merger; and
• Why you issued the 4,005,177 shares in the reverse merger.
Undertakings, page II-4
12. We note your response to prior comment 18. However, because the selling
stockholders might engage in transactions that indicate that th ey are in substance
primary transactions, you should include the undertaking. Therefore, we reissue
the comment.
Exhibits
13. Please file complete exhibits with all atta chments. For example, it appears that
Appendix A is missing from exhibit 10.2.
As appropriate, please amend your regist ration statement in response to these
comments. You may wish to provide us with marked copies of the amendment to expedite our review. Please furnish a cove r letter with your amendment that keys your
responses to our comments and provides any requested information. Detailed cover
letters greatly facilitate our review. Please understand that we may have additional comments after reviewing your amendmen t and responses to our comments.
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 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.
John S. Kovach
Lixte Biotechnology Holdings, Inc.
February 7, 2007 Page 4
We will consider a written request for acceleration of the effective date of the
registration statement as conf irmation of the fact that t hose requesting acceleration are
aware of their respective re sponsibilities under the S ecurities Act of 1933 and the
Securities Exchange Act of 1934 as they rela te 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 acce leration of the effective date.
We direct your attention to Rules 46 0 and 461 regarding requesting acceleration
of a registration statement. Please allow ad equate 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 a dvance of the requested effective date.
You may contact David Bu rton at (202) 551-3626 or Jay Webb at (202) 551-3603
if you have questions regarding comments on the financial statements and related
matters. Please contact Eduardo Aleman at (202) 551-3646 or me at (202) 551-3617 with
any other questions.
S i n c e r e l y ,
R u s s e l l M a n c u s o
Branch Chief
cc(via facsimile): David Ficksman – Troy & Gould, P.C.
2006-12-15 - UPLOAD - LIXTE BIOTECHNOLOGY HOLDINGS, INC.
December 15, 2006
Mail Stop 6010
John S. Kovach
Chairman and Chief Executive Officer
SRKP 7, Inc.
248 Route 25A, No. 2
East Setauket, NY 11733
Re: SRKP 7, Inc.
Amendment No. 1 to Form SB-2
Filed December 1, 2006
File No. 333-137208
Dear Mr. Kovach:
We have reviewed your filing and have the following comments. Where
indicated, we think you should re vise your document in response to these comments. If
you disagree, we will consider your explanation as to why our comment is inapplicable or
a revision is unnecessary. Please be as deta iled as necessary in your explanation. In
some of our comments, we may ask you to provi de us with information so we may better
understand your disclosure. After reviewing th is information, we may raise additional
comments.
We welcome any questions you may have about our comments or any other
aspect of our review. Feel fr ee to call us at the telephone numbe rs listed at the end of this
letter.
Amendment No. 1 to Form SB-2
Prospectus Cover
1. We note your response to comment 1 in our letter to you dated October 4, 2006.
Your revised disclosure does not disc lose the price at which your selling
shareholders will sell their securities. Ther efore, we reissue the first sentence of
comment 1.
The Offering, page 2
2. Please ensure that the information disclose d here matches the number of securities
included in the fee table and the numbers in your table of selling stockholders.
John S. Kovach
SRKP 7, Inc.
December 15, 2006 Page 2
Risk Factors, page 5
If our products were derived from tissue or other samples from a patient…, page 13
3. We note your response to comment 9. Howe ver, that comment sought disclosure
in your prospectus. Please revise your document to disclose when the
negotiations began and update any changes in the status of the negotiations. If the
negotiations are completed, please file the resulting agreement as an exhibit and disclose in an appropriate section of your document the material terms, including
duration and terminati on provisions.
Management’s Discussion and Analysis, page 24
Results of Operations, page 26
4. Please refer to prior comment 16. We note your expanded disclosure included
under “Going Concern” on page 27 about the additional funding of approximately
$2.3 million to establish a wet laboratory. However, to adequately address all of
the requirements in Item 303(a) of Regul ation S-B, add a separate section to
describe in detail your plan of opera tions for the next twelve months.
Research and Development Costs, page 26
5. We note in the first sentence of the second paragraph of this s ection that you state
the current amount due pursuant to the CRA DA “was recorded as a liability”.
Based on your response to prior comment 49 and revisions made on the balance sheet as of September 30, 2006, please tell us where the referenced liability is
presented in your September 30, 2006 bala nce sheet or revise the filing as
necessary based on our concern.
Intellectual Property, page 29
6. Please file and disclose the material terms of the December 2006 agreement
mentioned in your response to prior comment 19.
7. Please name the patent counsel mentione d in the fourth paragraph. Also, file
counsel’s consent as an exhi bit that expressly states that counsel consents to your
summarization of its opinion in the registration statement.
John S. Kovach
SRKP 7, Inc.
December 15, 2006 Page 3
Government Regulation, page 34
8. We note your response to prior comment 24. Please disclose the nature of the
FDA regulation to which you will be subjec t when you “begin to pursue clinical
trials.”
Management, page 35
9. We note your response to prior comment 28 and the description of Dr. Palmedo’s
work for the Government of Sudan in 1980. However, you did not address whether you have other past, current or anticipated contacts with Sudan, through
subsidiaries, affiliates or other direct or indirect arrangements. If you have no
past, current or anticipate d contacts with Sudan in addition to Dr. Palmedo’s
contacts described in your Decembe r 1, 2006 letter, please state so.
Scientific Advisory Committee, page 37
10. We note your revised disclosure in respons e to comment 31. It is not clear why
you have identified the committee in the ma nagement section of your prospectus
given your response that the committee does not serve any management function. Please move this disclosure to an ap propriate section of your prospectus.
Security Ownership, page 39
11. Please provide the disclosure requested in the last sentence of prior comment 32.
General, page 40
12. Please tell us why your disclosure in response to prior comment 39 does not
address the warrants mentioned in the fourth paragraph on page 40.
Selling Stockholders, page 41
13. We note your response to comment 40. Ho wever, it does not appear that the
selling stockholder table has been revise d to address the comment. We reissue
comment 40.
John S. Kovach
SRKP 7, Inc.
December 15, 2006 Page 4
Financial Statements, page F-1
14. Please expand your response to prior comme nt 44 to cite with specificity the
authority that permits you to incorpor ate a Form 8-K into a Form SB-2.
Note 6. Commitments and Contingencies, page F-21
15. Please refer to prior comment 49. We not e the revisions made on the balance
sheet as of September 30, 2006 and see you now present an asset labelled “advances on research and development contract services, net” of $100,000. We
further note that through the end of th is period you have made aggregate
payments of $200,000 and recorded resear ch and development expenses of
$100,100 in connection with the CRADA agreement. It is still not clear to us why
the $100,000 “advance” satisfies the definition of an asset as described in paragraph 25 of CON6. Please tell us and revise the notes to the financial
statements to specifically indicate why you believe it is appropria te to record the
referenced amount as an asset. Altern atively, revise the filing as necessary to
expense the amount in question. Your response should address whether you have
the right to receive a refund or return of amounts paid (and presented as an asset)
under the agreement – in this regard Ar ticle 10.3 of the agreement appears to
indicate no such right exists. Note the guidance at SFAS 2 and the concepts
outlined in FIN 4. Finally, we note you included a copy of the agreement in Exhibit 10.1. Please revise the filing to attach Appendix B, which includes the
payment schedule as indicated in Articl e 5.3 of the CRADA, to this exhibit.
Recent Sales of Unregister ed Securities, page II-2
16. With a view toward disclosure, please tell us the date and amount of the reverse
split mentioned in the first sentence. Also tell us when shareholders approved the
split.
17. Please provide us a table that clearly reconciles the information in this section
with the number of your outstanding shares.
Undertakings, page II-4
18. We note your revised disclosure and res ponse to comment 52. It does not appear
that you have provided the 512(a)(4) undertakings. Please provide the
undertakings required by Item 512(a)(4) of Regulation S-B.
John S. Kovach
SRKP 7, Inc.
December 15, 2006 Page 5
Exhibits
19. We note your response to prior comment 53. Please file complete exhibits with
all attachments.
Signatures
20. We reissue prior comment 55 in part. Please clarify below the second paragraph
required on the Signatures page who is signing the document in the capacity of
controller or principal accounting officer.
21. Please clarify whether a majority of your board of directors signed the document.
Form 10-QSB filed November 14, 2006
Item 3. Controls and Procedures, page 19
22. We note that your disclosure under the caption “Changes in Internal Controls”
refers only to internal controls. In future filings, if you are referring to the
information in Item 308(c) of Regulation S- B, please revise to state clearly that
you are referring to internal controls over financial reporting.
As appropriate, please amend your regist ration statement in response to these
comments. You may wish to provide us with marked copies of the amendment to expedite our review. Please furnish a cove r letter with your amendment that keys your
responses to our comments and provides any requested information. Detailed cover
letters greatly facilitate our review. Please understand that we may have additional comments after reviewing your amendmen t and responses to our comments.
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 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.
We will consider a written request for acceleration of the effective date of the
registration statement as conf irmation of the fact that t hose requesting acceleration are
aware of their respective re sponsibilities under the S ecurities Act of 1933 and the
Securities Exchange Act of 1934 as they rela te to the proposed public offering of the
John S. Kovach
SRKP 7, Inc.
December 15, 2006 Page 6
securities specified in the above registration statement. We will act on the request and,
pursuant to delegated authority, grant acce leration of the effective date.
We direct your attention to Rules 46 0 and 461 regarding requesting acceleration
of a registration statement. Please allow ad equate 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 a dvance of the requested effective date.
You may contact David Bu rton at (202) 551-3626 or Jay Webb at (202) 551-3603
if you have questions regarding comments on the financial statements and related
matters. Please contact Eduardo Aleman at (202) 551-3646 or me at (202) 551-3617 with
any other questions.
S i n c e r e l y ,
R u s s e l l M a n c u s o
Branch Chief
cc(via facsimile): David Ficksman – Troy & Gould, P.C.
2006-10-04 - UPLOAD - LIXTE BIOTECHNOLOGY HOLDINGS, INC.
October 4, 2006 Mail Stop 6010 John S. Kovach Chairman and Chief Executive Officer SRKP 7, Inc. 248 Route 25A, No. 2 East Setauket, NY 11733 Re: SRKP 7, Inc. Registration Statement on Form SB-2 Filed September 8, 2006 File No. 333-137208 Dear Mr. Kovach: We have reviewed your filing and have the following comments. Where indicated, we think you should re vise your document in response to these comments. If you disagree, we will consider your explanation as to why our comment is inapplicable or a revision is unnecessary. Please be as deta iled as necessary in your explanation. In some of our comments, we may ask you to provi de us with information so we may better understand your disclosure. After reviewing th is information, we may raise additional comments. Please understand that the purpose of our re view process is to assist you in your compliance with the applicable disclosure requirements and to enhance the overall disclosure in your filing. We look forward to working with you in these respects. We welcome any questions you may have about our comments or any other aspect of our review. Feel free to call us at the telephone numbers listed at the end of this letter. Form SB-2 Prospectus cover 1. Given that there is no market for your securities, please disclose the price at which your selling shareholders will sell th eir securities. See Schedule A Item 16 of the Securities Act and Regulation S-B Item 501(a)(9)(iv). We will not object if you also disclose that the se lling shareholders will sell at prevailing market prices or privately negotiated prices after th e shares are quoted on the OTC Bulletin Board. Please also modify your “Plan of Distribution” disclosure accordingly. John S. Kovach SRKP 7, Inc. October 4, 2006 Page 2 Prospectus Forepart 2. Please avoid reliance on defined terms lik e those in parentheses and quotation marks. If the terms are clear from cont ext, the definitions are unnecessary. If they are not clear, plea se revise for clarity. Prospectus Summary, page 1 3. The introductory paragraph to your summa ry states that the summary is not complete. A summary, by its very nature, does not and is not required to contain all of the detailed information that is in the prospectus. However, if you have elected to include a summary in your pr ospectus, it must be complete. Do you mean to say that, because this is a summary, it may not contain all of the information that is important to your i nvestors? Delete the reference to an incomplete summary from your prospectus. Private Placement, page 2 4. With a view toward clarified disclosu re, please tell us why you issued the placement agent two separate warrants with apparently the same terms. Risk Factors, page 5 5. Please add a separate risk factor to hi ghlight the going concern language in your auditor’s report. Disclose the reason fo r the language and its material effects, including its effect on your access to capital at market rates. We depend on certain key scientific personnel…, page 8 6. Revise to quantify the amount of time that Dr. Kovach devotes to your business. 7. In a separate risk factor, address the risk s associated with the fact that these key personnel are involved in other business activities and may face a conflict in selecting between their othe r business interests and you, as discussed on page 40. John S. Kovach SRKP 7, Inc. October 4, 2006 Page 3 We expect to rely heavily on third parties for the conduct of clin ical trials…, page 8 8. Revise to clarify what steps you will need to achieve before you begin conducting preclinical studies and clinic al trials in humans. If our products were derived from tissue or other samples from a patient…, page 13 9. In an appropriate section of your document, please disclose when the negotiations in the second sentence began. Also disclose the status of th e negotiations and the principal hurdles that remain befo re an agreement can be reached. 10. Revise to clarify whose obligation it will be to obtain the necessary consents. Also clarify why the consents might not be enforceable. 11. Please clarify why there is a material ri sk of willful misconduct. Does your supplier have a history of such conduct? If we fail to maintain effective internal controls, page 17 12. We note the disclosure in the first sent ence that you “may” have weaknesses. Please disclose the reasons for the doubt. Standards for compliance with Section 404 of the Sarbanes-Oxley Act…, page 17 13. We note your belief that the compliance dates for you will first apply to your annual report for fiscal 2008. Your disc losure on page F-11, however, indicates that you will be required to comply with these requirements with your year ending December 31, 2007. Please revise as appropriate to reconcile. Forward-Looking Statements, page 19 14. Please note that Section 27A of the Securities Act of 1933, and Section 21E of the Exchange Act of 1934, do not apply to issuer s of penny stock. Please remove the references to these sections. John S. Kovach SRKP 7, Inc. October 4, 2006 Page 4 Management’s Discussion and Analysis, page 24 Critical Accounting Policies – Stock-Based Compensation, page 25 15. We note in the last sentence of this secti on that you did not have any stock options or warrants issued or outstanding at December 31, 2005. This discussion should be expanded to include the stock options granted on June 30, 2006 as disclosed in Note 3 on page F-13 of the interim financ ial statements and the impact of SFAS 123(R) on these issuances. Results of Operations, page 26 16. Since Lixte has not generated revenue dur ing the periods pres ented, discussion of your plan of operation should be provided. Please revise the filing to comply with Item 303(a) of Regulation S-B. Going Concern, page 26 17. Please discuss your disclosed need for $2.3 million. We note your reference to a wet lab on page 6. It is unclear why this wet lab is necessary in the short term given your current operations. Als o, will you need additional property or employees to operate the lab? Are these costs included in the $2.3 million estimate? Business, page 28 Our company, page 28 18. Please state the date of your incorporati on. If you were organized in connection with affiliated companies, please describe those affiliations. Also, describe any change in control. John S. Kovach SRKP 7, Inc. October 4, 2006 Page 5 Intellectual Property, page 29 19. Please disclose when the negotiations me ntioned in the third sentence began. Also disclose: • the status of the negotiations; • the principal hurdles that remain befo re an agreement can be reached; and • the scope of your rights to the intell ectual property if no agreement can be reached. 20. With a view toward disclosure, please te ll us how Dr. Kovach was involved in developing the intellectual property to th e extent that he is co-owner. Access to Clinical Materials, page 29 21. Please expand your disclosure that “permi ssion has been obtained” to identify the entity who granted permission and the scope of such permission. 22. We note your disclosure that you are nego tiating an agreement to receive tissue and blood samples from the Institute of Pathology in Germany. Please revise to address how you currently obtain such samples. Research and Development, page 31 Tissue Acquisition, page 31 23. Expand your disclosure to clarify your obligations and potential liability, if any, under the regulatory requirements of th e Office of Protection of Research Subjects in the United States. Product Development, page 33 24. Please expand your disclosure to state at what stage your business activities will become subject to FDA regulation. John S. Kovach SRKP 7, Inc. October 4, 2006 Page 6 Competition, page 33 25. Please clarify whether any competitors have developed or are investigating biomarkers for the same cancer that you are studying. Properties, page 34 26. Please clarify the nature of your facility. Is this a leased office devoted solely to your business in a commercial office building with multiple unrelated tenants? Government Regulation, page 34 27. Please clarify how each cited regulation affects your business. Also clarify whether you are in compliance. Management, page 35 28. We note the statement on page 37 that your director, Dr. Philip Palmedo, has served as a consultant to the government of Sudan. Please advise us of the nature and extent of the consultancy. Tell us whether Dr. Palmedo has served as a consultant to the government of Sudan during the period he has served as your director, and whether he con tinues to serve as a consu ltant to the government of Sudan. Please also describe your past, current and anticipat ed contacts with Sudan, if any, whether through subsidiaries, affiliates or other direct or indirect arrangements. We may have further comment. 29. Please clarify when Dr. Palmedo joined the board. Scientific Advisory Committee, page 37 30. Please describe the role of the committ ee. For example, how often does the committee meet? On what matters have th ey deliberated and advised you? When did each member join the committee? John S. Kovach SRKP 7, Inc. October 4, 2006 Page 7 31. If the committee members serve a management role, please provide full disclosure regarding their background. See, for example, Regulation S-B Item 401(b). If the committee does not serve in a management role, please tell us why you have identified the committee in the management section of your prospectus. Executive Compensation, page 38 32. Please provide disclosure for each person who served as your CEO or acted in a similar capacity during the last completed fiscal year. See Regulation S-B Item 402 (a)(2)(i). Also, include a row for each such person in your table disclosing beneficial ownershi p of your stock. Director Compensation, page 39 33. Please revise to disclose when your di rectors and members of the Scientific Advisory Committee will receive the options. Certain Relationships and Relate d Party Transactions, page 40 34. We note your disclosure that most office se rvices are provided by the president. Revise to disclose the name of the indi vidual who serves in this capacity. 35. Tell us why you have not provided disclosu re under Item 404(a) of Regulation S- B for the commission and fee paid to WestPark Capital, Inc. for its services as placement agent in connection with your rece nt private placements. We note that at the time of the transaction, it appear s your president, Mr. Rappaport, was also CEO of WestPark Capital. 36. Please tell us why you have not described in this section the stockholder advances mentioned on pages 27 and F-2. 37. Please provide the disclosure required by Item 404(d) of Regulation S-B. Description of Securities, page 40 38. Please disclose when you split your securiti es as mentioned at the bottom of page 2. Also, tell us when shareholders approved the split. John S. Kovach SRKP 7, Inc. October 4, 2006 Page 8 39. Please quantify the amounts required by Regulation S-B Item 201(a)(2). Selling Stockholders, page 41 40. Please revise the selling stockholder ta ble to identify the individuals who beneficially own the shares held by the entities named in the table. 41. Please tell us whether any of the selli ng shareholders are broker-dealers or affiliates of broker-dealers. 42. Please disclose when each selling share holder acquired the offered shares and the consideration paid for those shares. Financial Statements, page F-1 43. Please update your financial statements, as necessary, to comply with Item 310(g) of Regulation S-B. 44. Please tell us your basis for incorporati ng by reference the information from your Form 8-K as disclosed on page F-7. Interim Financial Statements for the period ended June 30, 2006 Condensed Consolidated Balance Sheet, page F-2 45. There is no distinction made herein of which liability items are current or non- current. Based on the disclosure in MD &A about the amount of working capital at June 30, 2006, it appears that the resear ch and development contract liability represents a current liability at that da te. Please revise your balance sheet to classify liabilities as either current or long-term. Condensed Consolidated Statement of Stoc kholders’ Equity (Deficiency), page F-4 46. We note that the 4,005,177 shares issued in connection with the reverse merger transaction represent those held by the Company’s stockholders immediately prior to the share exchange and the value assigned to thes e shares ($62,500) was based John S. Kovach SRKP 7, Inc. October 4, 2006 Page 9 on the cash acquired in the transaction. According to Form 10-QSB for the quarter ended March 31, 2006, the Co mpany only had $3,000 in cash and negative working capital of approximate ly $10,000. Please provide us with a summary calculation of how the amount of cash acquired on June 30, 2006 was determined and tell us from what source it was derived. Also, tell us why you believe your accounting entry for the re verse merger was appropriate and compliant with GAAP. Finally, revise the filing as necessary based on our comment. Note 3. Share Exchange Agreement and Private Placement, page F-11 Private Placement, page F-12 47. Please disclose the terms of any registrati on rights agreements. We note that there was no financial penalty associated with these registration rights. Please tell us the accounting implications of the rights. Your response should address how EITF 05-04 impacts your conclusions. Note 4. Related Party Transactions, page F-13 48. Please disclose the terms and conditions of the non-interest bearing advances made by Lixte’s founding stockholder. Note 6. Commitments and Contingencies, page F-14 49. We note that on March 22, 2006 you entered into a contract (CRADA) with the U.S. Department of Health and Human Services whereupon you agreed to provide funds totaling $400,000 over a two-year term . We further note that this was recorded as a liability with the related amount of su ch contract recorded as “deferred research and development costs” (i.e., an asset). Please tell us why you believe you have correctly accounted for this agreement. Also, tell us how the latter satisfies the definition of an asset as described in paragraph 25 of CON6 and why you believe it was appropriate to reco rd it as a fixed asset. Reference your response to the guidance in CON6 or other applicable authoritative accounting literature. Also, please include a copy of the agreement as an exhibit to the filing. John S. Kovach SRKP 7, Inc. October 4, 2006 Page 10 Recent Sales of Unregister ed Securities, page II-2 50. Please provide the disclosure requir ed by Regulation S-B Item 701 for all securities sold during the past three years without registra tion under the Securities Act. 51. Please disclose the facts relied upon to make the cited exemption from registration available Item 28. Undertakings, page II-4 52. Please include the undertakings requ ired by item 512(a)(4) and 512(g) of Regulation S-B. Refer to Rule 424(b)(3) and Rule 430C(d). Item 27. Exhibits 53. Please tell us why you have not filed the Cooperative Research and Development Agreement as an exhibit. Exhibit 23.2 54. Please provide an updated consent fro m your independent accountant in any amendment. Signatures 55. Please indicate below the second paragr aph required on the Signatures page who is signing the document in the capacity of principal financial o fficer and controller or principal accounting officer . See “Instructions for si gnatures” at the end of Form SB-2. As appropriate, please amend your regist ration statement in response to these comments. You may wish to provide us with marked copies of the amendment to John S. Kovach SRKP 7, Inc. October 4, 2006 Page 11 expedite our review. Please furnish a cove r lett
2005-08-09 - UPLOAD - LIXTE BIOTECHNOLOGY HOLDINGS, INC.
<DOCUMENT>
<TYPE>LETTER
<SEQUENCE>1
<FILENAME>filename1.txt
<TEXT>
Mail Stop 3561 August 9, 2005
Richard A. Rappaport, President
SRKP 4, Inc., et al
210 South Federal Highway, Suite 205
Dearfield Beach, FL 33441
Re: SRKP 4, Inc.
File No. 0-51473
SRKP 5, Inc.
File No. 0-51474
SRKP 6, Inc.
File No. 0-51475
SRKP 7, Inc.
File No. 0-51476
SRKP 8, Inc.
File No. 0-51477
Form 10-SB Registration Statement
Filed August 3, 2005
Dear Mr. Rappaport:
This is to advise you that we have reviewed only those
portions of the above registration statements that relate to the
disclosure type indicated in this letter and we have the following
comments.
Part II
1. We direct your attention to the letter of January 21, 2000 to
Mr.
Ken Worm, Assistant Director of the OTC Compliance Unit at NASD.
This letter indicates our view that the securities issued by a
blank
check company cannot be resold under Rule 144 but must be
registered
under the Securities Act of 1933. Amend the registration
statements, as necessary, to make the appropriate additions to
conform to this comment.
No further review of your filing will be made at this time. You
are
requested to file an amendment on Form 10SB12G/A to include the
necessary information, within fifteen business days, or inform the
staff prior to that time when the amendment will be made.
Other
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
for
an informed 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 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 do not foreclose the Commission from taking any action
with
respect to the filing; and,
* the companies 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.
*******
Please be advised that your registration statements will
automatically become effective 60 days after filing. Upon
effectiveness, you will become subject to the reporting
requirements
of the Securities Exchange Act of 1934, even if we have not
cleared
your comments. In the event that it appears that you will not be
able to respond by the 60th day, you may wish to consider
withdrawing
your registration statements and refiling when you have prepared a
response to our comments. In addition, should the filing become
effective in its present form the Division would be required to
consider what recommendation, if any, it should make to the
Commission.
Please contact Goldie B. Walker at (202) 551-3234 or me at
(202)
551-3790 in regard to any questions pertaining to this letter.
Sincerely,
Michael E. Karney
Branch Chief - Legal
Office of Emerging Growth Companies
Division of Corporation Finance
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Richard A. Rappaport, President
SRKP 4, Inc., et al
August 9, 2005
Page 3
</TEXT>
</DOCUMENT>