# EDGAR Filing Document

**Accession Number:** 0001335105
**File Stem:** 0001641172-25-020875
**Filing Date:** 2025-7
**Character Count:** 5283
**Document Hash:** 67ce8001c1a5e142276f7f9e504eab7d
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001641172-25-020875.hdr.sgml**: 20250905

**ACCESSION NUMBER**: 0001641172-25-020875

**CONFORMED SUBMISSION TYPE**: CORRESP

**PUBLIC DOCUMENT COUNT**: 1

**FILED AS OF DATE**: 20250724

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** LIXTE BIOTECHNOLOGY HOLDINGS, INC.
- **CENTRAL INDEX KEY:** 0001335105
- **STANDARD INDUSTRIAL CLASSIFICATION:** PHARMACEUTICAL PREPARATIONS [2834]
- **ORGANIZATION NAME:** 03 Life Sciences
- **EIN:** 202903526
- **STATE OF INCORPORATION:** DE
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** CORRESP

**BUSINESS ADDRESS:**
- **STREET 1:** 248 ROUTE 25A
- **STREET 2:** NO. 2
- **CITY:** EAST SETAUKET
- **STATE:** NY
- **ZIP:** 11733
- **BUSINESS PHONE:** 310 203 2902

**MAIL ADDRESS:**
- **STREET 1:** 248 ROUTE 25A
- **STREET 2:** NO. 2
- **CITY:** EAST SETAUKET
- **STATE:** NY
- **ZIP:** 11733

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** SRKP 7 INC
- **DATE OF NAME CHANGE:** 20050803

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

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| | |
|:---|:---|
| Re: | Lixte Biotechnology Holdings, Inc. |
|  | **Form 10-K for the Fiscal Year Ended December 31, 2024** |
|  | **Filed March 24, 2025** |
|  | **File No. 001-39717** |

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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.

<u>Annual Report on Form 10-K for the Fiscal Year Ended December 31, 2024</u>

<u>Item 1. Business, page 4</u>

&nbsp;&nbsp;&nbsp;&nbsp;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."

<u>COMPANY'S RESPONSE</u>

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

<u>Description of Business, page 4</u>

&nbsp;&nbsp;&nbsp;&nbsp;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.

<u>COMPANY'S RESPONSE</u>

In its future filings, the Company will make the requested changes to the pipeline table.

<u>Clinical Trial Agreements, page 7</u>

&nbsp;&nbsp;&nbsp;&nbsp;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.

<u>COMPANY'S RESPONSE</u>

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 <u>dficksman@troygould.com</u>.

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| | |
|:---|:---|
| Sincerely, | Sincerely, |
| Lixte Biotechnology Holdings, Inc. | Lixte Biotechnology Holdings, Inc. |
| */s/ Geordan Pursglove* | */s/ Geordan Pursglove* |
| By: | Geordan Pursglove |
| Chief Executive Officer | Chief Executive Officer |

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cc: David L. Ficksman