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CORRESP Filing

LIXTE BIOTECHNOLOGY HOLDINGS, INC.
Date: July 24, 2025 · CIK: 0001335105 · Accession: 0001641172-25-020875

Regulatory Compliance Financial Reporting Business Model Clarity

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File numbers found in text: 001-39717

Referenced dates: July 16, 2025

Date
December 31, 2024
Author
Geordan Pursglove
Form
CORRESP
Company
LIXTE BIOTECHNOLOGY HOLDINGS, INC.

Letter

Lixte Biotechnology Holdings, Inc.

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

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.

Show Raw Text
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