LIXTE and its Collaborators Expand Clear Cell Ovarian Cancer Trial

Rhea-AI Summary

LIXTE (Nasdaq: LIXT) announced an expansion of its ongoing ovarian clear cell cancer trial combining its compound LB-100 with GSK's dostarlimab. The study, initiated in January 2024, will double enrollment from 21 to 42 patients across two sites: MD Anderson and the Robert H. Lurie Comprehensive Cancer Center at Northwestern. The trial is led by Amir Jazaeri, MD, and Emily M. Hinchcliff, MD, MPH. LIXTE expects initial data from the first 21 patients to be presented in the first half of 2026. The company framed the expansion as progress toward evaluating LB-100’s potential to enhance immunotherapy and chemotherapy outcomes.

Positive

• Enrollment increased from 21 to 42 patients
• Initial 21-patient data expected in H1 2026
• Collaboration includes MD Anderson, Northwestern, and GSK

Negative

• No efficacy or safety results released yet for the trial
• Trial remains small at 42 patients, limiting statistical power

Key Figures

Initial trial enrollment 21 patients Initial target reached in ovarian clear cell cancer trial

Planned enrollment 42 patients Planned doubled enrollment for LB-100 + dostarlimab trial

Q3 2025 net loss $1,980,398 Quarter ended September 30, 2025

Nine‑month 2025 net loss $3,465,626 Nine months ended September 30, 2025

Cash balance $2,887,874 As of September 30, 2025

Digital assets $2,454,473 Bitcoin and Ethereum at fair value, September 30, 2025

Series C conversion 2,700,000 common shares Convertible from 2,700 Series C Preferred Stock

Royalty cap $45,000,000 Cap on 10% Net Revenue royalty from LIGHT equipment

Market Reality Check

$3.92 Last Close

Volume Volume 43,680 is 0.41x the 20-day average of 105,652, indicating muted trading ahead of this news. low

Technical Shares at $4.17 were trading above the 200-day MA at $3.08, while still 33.39% below the 52-week high of $6.26.

Peers on Argus

LIXT was down 3.47% while close peers were mixed: AKTX -2.58%, ALLR -3.92%, PPCB -9.79%, QTTB +3.06%, BOLD flat. This points to stock-specific factors rather than a broad sector move.

Historical Context

Date	Event	Sentiment	Move	Catalyst
Dec 18	Registered direct offering	Negative	-1.0%	Capital raise via units and warrants under an existing registration statement.
Dec 08	Strategy update	Positive	+7.2%	Strategy shift toward multi‑modal oncology via LiGHT radiotherapy acquisition.
Dec 03	Platform expansion	Positive	+3.5%	Progress of LB‑100 combinations and acquisition of Liora to broaden platform.
Dec 03	Clinical progress	Positive	+3.5%	Positioning LB‑100 as a treatment amplifier with funded GSK and Roche studies.
Nov 25	Asset acquisition	Positive	-8.5%	Completion of Liora proton therapy acquisition and description of revenue strategy.

Pattern Detected

Recent LIXT news has typically aligned with price action: strategic and pipeline updates saw gains, while financing and a major acquisition coincided with pressure, suggesting investors differentiate between capital raises, asset deals, and clinical/strategy milestones.

Recent Company History

Over the past month, LIXT reported several strategic shifts. On November 25, 2025, it acquired Liora’s LiGHT proton therapy platform, followed by December updates detailing a transition to a multi‑modal oncology platform and expanded LB‑100 collaborations. A $4.3 million registered direct offering on December 18, 2025 modestly pressured shares. Today’s trial expansion for ovarian clear cell cancer builds on these LB‑100 combination efforts, extending the clinical footprint alongside the newly added proton therapy infrastructure.

Market Pulse Summary

This announcement expands the LB‑100 and dostarlimab ovarian clear cell cancer trial from 21 to 42 patients, adding another step in LIXTE’s combination‑therapy strategy. It follows recent moves into proton therapy hardware and broader oncology platforms, while the latest 10‑Q showed a Q3 2025 net loss of $1.98M and cash of $2.89M. Investors may watch for 2026 readouts, ongoing funding needs, and how clinical results influence the value of newly acquired radiotherapy assets.

Key Terms

clinical trial medical

"on an ongoing clinical trial with LIXTE’s proprietary compound, LB-100, to treat"

A clinical trial is a carefully controlled study in which a new medicine, medical device, or treatment is tested on people to see if it is safe and effective. For investors it matters because trial results determine whether a product can win regulatory approval and reach patients, much like a road test decides if a new car can be sold; positive or negative results can sharply change a company’s prospects and stock value.

immunotherapy medical

"Dostarlimab to enhance the effectiveness of immunotherapy, was initiated in January"

Treatment that uses or enhances the body’s immune system to detect and fight disease, most often cancers or chronic infections; think of it as training or arming the body’s own soldiers to find and destroy targets. It matters to investors because successful immunotherapies can lead to high-value drug approvals, recurring revenue from long-term treatments, and changes in competitive dynamics, while failures or safety issues in clinical trials can materially affect company valuations.

AI-generated analysis. Not financial advice.

--Plans to double the Number of Patients in Study-- 
--Company Expects Initial Findings to be presented in 2026--

BOCA RATON, Fla., Dec. 23, 2025 (GLOBE NEWSWIRE) -- LIXTE Biotechnology Holdings, Inc. (“LIXTE” or the “Company”) (Nasdaq: LIXT), a biotech company focused on advancing cancer treatments, today announced it is expanding its collaboration with The University of Texas MD Anderson Cancer Center and pharmaceutical manufacturer GSK on an ongoing clinical trial with LIXTE’s proprietary compound, LB-100, to treat ovarian clear cell cancer.

The trial, which combines LB-100 with GSK’s Dostarlimab to enhance the effectiveness of immunotherapy, was initiated in January 2024. It is directed by lead clinical investigator Amir Jazaeri, MD, Professor of Gynecologic Oncology, at MD Anderson.

A second trial site was added earlier this year at the Robert H. Lurie Comprehensive Cancer Center (Lurie Cancer Center) of Northwestern University, led by Emily M. Hinchcliff, MD, MPH.

MD Anderson and Northwestern Medical Center plan to double the number of enrollments in the trial to 42 patients, after successfully attaining its initial target of 21 patients earlier this year. The Company also announced that it expects data to be presented from the trial on the initial 21 patients in the first half of 2026.

“We are gratified to be expanding the patient population of this important clinical trial,” said Bas van der Baan, LIXTE’s Chief Scientific Officer, who leads the Company’s LB-100 program. “There is a tremendous unmet need in the treatment of ovarian clear cell cancer. Based on extensive published preclinical data, we believe LB-100 has the potential to significantly enhance chemotherapies and immunotherapies and improve patient outcomes.”

Geordan Pursglove, LIXTE’s Chief Executive Officer, added: “Expansion of this important trial is in keeping with LIXTE’s mission of treating cancer with exceptional, innovative therapies and cutting-edge technologies. With each step forward, we are hopeful of attaining our goal.”

About LIXTE Biotechnology Holdings, Inc.

LIXTE Biotechnology Holdings, Inc. is a clinical-stage pharmaceutical company focused on new targets for cancer drug development and developing and commercializing cancer therapies. LIXTE has demonstrated that its first-in-class lead clinical PP2A inhibitor, LB-100, is well-tolerated in cancer patients at doses associated with anti-cancer activity. Based on extensive published preclinical data (see www.lixte.com), LB-100 has the potential to significantly enhance chemotherapies and immunotherapies and improve outcomes for patients with cancer.

LIXTE’s lead compound, LB-100, is part of a pioneering effort in an entirely new field of cancer biology – activation lethality – that is advancing a new treatment paradigm. LIXTE's new approach is covered by a comprehensive patent portfolio. Proof-of-concept clinical trials are currently in progress for Ovarian Clear Cell Carcinoma and Metastatic Colon Cancer. Additional information about LIXTE can be found at www.lixte.com.

Forward-Looking Statement Disclaimer

This announcement contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, and Section 21E of the Securities Exchange Act of 1934. For example, statements regarding the Company's financial position, business strategy and other plans and objectives for future operations, and assumptions and predictions about future activities, including the continuing development of proprietary compounds, the planning, funding, coordination and potential results of clinical trials, the patent and legal costs to protect and maintain the Company's intellectual property worldwide, and the Company’s ability to maintain compliance with Nasdaq’s continued listing requirements, are all forward-looking statements. These statements, also including, but not limited to, expectation of presenting initial findings in the first half of 2026, are generally accompanied by words such as "intend," anticipate," "believe," "estimate," "potential(ly)," "continue," "forecast," "predict," "plan," "may," "will," "could," "would," "should," "expect" or the negative of such terms or other comparable terminology.

The Company believes that the assumptions and expectations reflected in such forward-looking statements are reasonable, based on information available to it on the date hereof, but the Company cannot provide assurances that these assumptions and expectations will prove to have been correct or that the Company will take any action that the Company may presently be planning. However, these forward-looking statements are inherently subject to known and unknown risks and uncertainties. Actual results or experience may differ materially from those expected or anticipated in the forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, regulatory policies, available cash resources, research results, competition from other similar businesses, and market and general economic factors.

Readers are urged to read the risk factors set forth in the Company’s filings with the United States Securities and Exchange Commission at https://www.sec.gov. The Company disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

For more information about LIXTE, contact: 

info@lixte.com
General Phone: (631) 830-7092; Investor Phone: (888) 289-5533
or
PondelWilkinson Inc. Investor Relations pwinvestor@pondel.com
Roger Pondel: (310) 279-5965; Laurie Berman: (310) 279-5962

FAQ

What change did LIXTE announce for its LB-100 ovarian clear cell cancer trial (LIXT)?

LIXTE said it is expanding enrollment from 21 to 42 patients and adding sites at MD Anderson and Northwestern.

When will LIXTE present initial results from the LB-100 clear cell ovarian cancer trial (LIXT)?

The company expects data from the first 21 patients to be presented in the first half of 2026.

Which therapies are being combined in LIXTE's clear cell ovarian cancer study (LIXT)?

The trial combines LIXTE’s LB-100 with GSK’s immune checkpoint inhibitor dostarlimab.

Who are the lead investigators for LIXTE’s expanded clear cell ovarian cancer trial (LIXT)?

Lead investigators are Amir Jazaeri, MD at MD Anderson and Emily M. Hinchcliff, MD, MPH at Northwestern.

When did LIXTE’s LB-100 clear cell ovarian cancer trial (LIXT) start?

The trial was initiated in January 2024.