# EDGAR Filing Document

**Accession Number:** 0001335105
**File Stem:** 0000000000-25-007513
**Filing Date:** 2025-7
**Character Count:** 4997
**Document Hash:** ac234b4f64d468a068713caf6b084d15
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0000000000-25-007513.hdr.sgml**: 20250905

**ACCESSION NUMBER**: 0000000000-25-007513

**CONFORMED SUBMISSION TYPE**: UPLOAD

**PUBLIC DOCUMENT COUNT**: 2

**FILED AS OF DATE**: 20250716

**FILED FOR**: 

**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:** UPLOAD
- **SEC FILE NUMBER:** 001-39717

**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
**PUBLIC REFERENCE ACCESSION NUMBER**: 0001641172-25-000208

## Text-Extract

```

                                                             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

```

### Attached PDF Documents

**Attachment 1:** `filename1`

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