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Favorable Results of Ovarian Cancer Study Presented at Annual Society of Gynecological Care Conference

(Moderate)
(Positive)
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LIXT (Nasdaq: LIXT) reported preliminary interim results from a Phase trial combining its proprietary compound LB-100 with dostarlimab in ovarian clear cell carcinoma presented April 13, 2026. All 21 planned patients enrolled; 20 were evaluable for efficacy. At median 12-month follow-up, median OS was not reached; 6-month OS probability was 0.84 and 12-month OS probability was 0.69. Disease Control Rate was 40% (8/20). An additional 21-patient cohort with higher LB-100 exposure is currently enrolling.

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Positive

  • All 21 planned patients enrolled in the trial
  • 20 patients evaluable for interim efficacy analysis
  • 6-month overall survival probability of 0.84
  • 12-month overall survival probability of 0.69
  • Disease Control Rate of 40% (8/20)
  • Additional 21-patient, higher-exposure LB-100 cohort enrolling

Negative

  • Small interim cohort size: only 20 patients evaluated
  • Median overall survival not reached at 12-month median follow-up
  • Wide confidence intervals around survival estimates (e.g., 12-month CI 0.44–0.84)
  • Disease Control Rate limited to 40%, indicating partial benefit

News Market Reaction – LIXT

-3.93%
-3.93% Session close to close

In the Apr 13 session, LIXT declined 3.93%, reflecting a moderate negative market reaction.

Data tracked by StockTitan Argus on the day of publication.

Market Context

This announcement highlights preliminary ovarian cancer trial results for LB-100 combined with dosta...
Analysis

This announcement highlights preliminary ovarian cancer trial results for LB-100 combined with dostarlimab, showing OS probabilities of 0.84 at 6 months and 0.69 at 12 months with a 40% disease control rate in 20 evaluable patients. It follows a prior decision to expand the study from 21 to 42 patients. Investors may watch future readouts from the additional 21-patient high-exposure cohort, as well as ongoing corporate and regulatory disclosures, to assess how this combination strategy progresses.

Key Figures

Planned participants: 21 patients Patients evaluated: 20 patients Median follow-up: 12 months +5 more
8 metrics
Planned participants 21 patients Ovarian cancer LB-100 plus dostarlimab trial enrollment target
Patients evaluated 20 patients Efficacy evaluable population in interim analysis
Median follow-up 12 months Ovarian cancer trial follow-up (range 1.4–22 months)
OS probability 6 months 0.84 (95% CI 0.64–0.94) Overall survival probability at 6 months
OS probability 12 months 0.69 (95% CI 0.44–0.84) Overall survival probability at 12 months
Disease Control Rate 40% (8/20, 95% CI 19.1–63.9%) LB-100 plus dostarlimab ovarian cancer trial
Prior OS PPP2R1A-mutant 66.9 months Reported OS with immune checkpoint blockade in PPP2R1A-mutant OCCC
Prior OS wild-type 9.2 months Reported OS with immune checkpoint blockade in wild-type OCCC

Historical Context

5 past events · Latest: Mar 31 (Positive)
Pattern 5 events
Date Event Sentiment 24h Move Catalyst
Mar 31 Annual report, financing Positive -1.9% 2025 Form 10-K with operational progress and >$11M in capital raised.
Feb 18 Subsidiary leadership change Positive +1.3% Appointment of Sidney Braun as CEO of Liora Technologies Europe.
Jan 21 Health summit sponsorship Positive +4.0% Sponsorship of Good Health Summit focusing on health equity initiatives.
Jan 20 Investor conference attendance Positive -8.4% Participation at DealFlow Discovery Conference highlighting LB-100 program.
Dec 23 Trial expansion Positive -1.9% Expansion of clear cell ovarian cancer trial from 21 to 42 patients.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Pattern Detected

Recent history shows mixed trading on generally positive or neutral news, with several instances of share price declines following constructive updates.

Recent Company History

Over the last six months, LIXTE reported multiple corporate and clinical milestones. The Dec 23, 2025 update expanded its ovarian clear cell cancer trial with LB-100 and dostarlimab and anticipated initial data from the first 21 patients in the first half of 2026. Subsequent news included conference attendance, a health equity summit sponsorship, leadership changes at Liora Technologies Europe, and the 2025 Form 10-K filing highlighting financings and trial enrollment. Today’s ovarian cancer study results represent the anticipated data readout from that expanded trial.

Key Terms

dostarlimab, anti pd1, immune checkpoint blockade, ovarian clear cell carcinoma, +4 more
8 terms
dostarlimab medical
"LIXTE’s proprietary compound, LB-100, combined with GSK’s anti PD1 drug Dostarlimab, has shown..."
Dostarlimab is a lab-made antibody drug that helps the immune system recognize and attack certain cancers by releasing the immune system’s “brakes.” Investors watch it because trial results, regulatory approvals, safety data and use in additional cancer types or drug combinations determine how widely it can be prescribed, which directly affects potential sales, clinical risk and competitive positioning in the cancer drug market.
anti pd1 medical
"LIXTE’s proprietary compound, LB-100, combined with GSK’s anti PD1 drug Dostarlimab, has shown..."
Anti‑PD‑1 are medicines that lift a brake on the immune system so white blood cells can better recognize and attack cancer cells; they work by blocking the PD‑1 protein on immune cells that tumors exploit to hide. Investors care because trial results, approvals, safety issues, and competition determine how widely these drugs will be used, shaping sales, licensing deals, and the valuation of companies developing or selling them.
immune checkpoint blockade medical
"reduction in PP2A activity may increase responsiveness to immune checkpoint blockade (ICB)..."
A cancer treatment approach that uses drugs to block proteins which act like “brakes” on the immune system, allowing immune cells to recognize and attack tumor cells more effectively. Investors watch these therapies because clinical trial results, regulatory approvals, safety profiles and companion diagnostics determine commercial potential and revenue risks—successful checkpoint blockade drugs can create large markets, while failures or safety concerns can sharply affect valuations.
ovarian clear cell carcinoma medical
"in Ovarian Clear Cell Carcinoma (OCCC), particularly in tumors harboring somatic PPP2R1A mutations..."
A type of ovarian cancer that develops from a specific group of cells in the ovary and gets its name from the clear appearance of the tumor cells under a microscope; it often behaves differently and can be less responsive to standard chemotherapy. For investors, it matters because therapies, tests or trial results aimed at this subtype can change a biotech or drugmaker’s prospects—think of it as a niche market where a successful new treatment can be a major commercial and regulatory catalyst.
ppp2r1a medical
"particularly in tumors harboring somatic PPP2R1A mutations resulting in loss of protein phosphatase 2A..."
PPP2R1A is a human gene that makes a key part of a molecular “brake” inside cells that helps control growth and repair by turning off certain biochemical signals. Mutations or abnormal activity in this gene are linked to some cancers and other diseases, so it matters to investors because it can be a target for drugs, affect the value of diagnostics or therapies, and influence the commercial outlook of biomedical projects.
protein phosphatase 2a medical
"somatic PPP2R1A mutations resulting in loss of protein phosphatase 2A (PP2A) function."
Protein phosphatase 2A (PP2A) is an enzyme that acts like a cellular brake, removing chemical tags from other proteins to help control cell growth, division and survival. Investors care because PP2A’s activity is linked to diseases such as cancer and neurodegeneration, so it is a focus for drug research, biomarkers and diagnostics—developments that can drive biotech valuations, clinical trial prospects and partnership or licensing deals.
monoclonal antibody medical
"anti-tumor effect of the PD-1 blocking monoclonal antibody, dostarlimab-gxly, in patients..."
A monoclonal antibody is a laboratory-made protein designed to recognize and attach to a specific target in the body, such as a disease-causing substance or cell. It functions like a highly precise lock-and-key tool, helping to treat or detect illnesses. For investors, companies developing monoclonal antibodies can represent promising opportunities in the healthcare sector, especially as these treatments often address unmet medical needs.
overall survival medical
"Specifically, prior investigation reported markedly prolonged overall survival (OS) with ICB..."
Overall survival is the average or median length of time patients remain alive after starting a treatment or entering a clinical study, measured regardless of cause of death. Investors care because it is a clear, hard measure of a therapy’s real-world benefit — like timing how long a new battery actually runs — and strong improvements in overall survival can drive regulatory approval, market adoption and revenue potential.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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 -Trial Combines LIXTE’s LB-100 with Dostarlimab; Results Give Patients New Hope
for a Challenging Disease with Limited Therapeutic Options-

BOCA RATON, Fla., April 13, 2026 (GLOBE NEWSWIRE) -- LIXTE Biotechnology Holdings, Inc. (“LIXTE” or the “Company”) (Nasdaq: LIXT), a clinical stage pharmaceutical and med-tech company focused on advancing cancer treatments, today announced the presentation of preliminary results for a clinical trial testing the combination of Lixte’s proprietary compound LB100 in combination with Dostarlimab at the 2026 Conference of the Society of Gynecological Cancer, April 10-13, in San Juan, Puerto Rico.

The annual conference brings together a diverse group of specialists, including gynecologic oncologists, radiation oncologists, nurses, researchers and others to share the latest scientific advancements. It features exhibitors from various medical device and pharmaceutical companies, showcasing cutting-edge products and services tailored for the gynecologic cancer care team.

“The findings being presented provide new hope for patients with ovarian cancer, a disease that thus far has limited therapeutic options,” said Bas van der Baan, LIXTE’s Chief Scientific Officer. “LIXTE’s proprietary compound, LB-100, combined with GSK’s anti PD1 drug Dostarlimab, has shown an acceptable safety profile. All 21 planned participants in the trial have been enrolled, and 20 were evaluated for efficacy in this interim analysis. Based on those favorable results, an additional cohort of 21 patients with a higher exposure to LB-100 is in the process of enrolling.”

Trial Results

At a median follow-up length of 12 months (range 1.4-22), median OS has not been reached. However, OS probability was 0.84 (95%CI 0.64-0.94) at 6 months and 0.69 (95% CI 0.44-0.84) at 12 months. The Disease Control Rate was 40% (8/20, 95% CI 19.1-63.9%).

The trial is based on the observation by the lead clinical investigator Amir Jazaeri MD, Professor of Gynecologic Oncology at The University of Texas MD Anderson Cancer Center, that a genetically acquired reduction in PP2A activity may increase responsiveness to immune checkpoint blockade (ICB) in Ovarian Clear Cell Carcinoma (OCCC), particularly in tumors harboring somatic PPP2R1A mutations resulting in loss of protein phosphatase 2A (PP2A) function.

“We are learning more about the molecular features of ovarian clear-cell carcinomas that correlate with benefit from immune checkpoint inhibitors,” said Dr. Jazaeri. “This study investigates how to use immunotherapy combinations such as Dostarlimab and LB-100 to expand the benefit for patients whose tumors do not carry these features.”

Specifically, prior investigation reported markedly prolonged overall survival (OS) with ICB in patients with PPP2R1A-mutant OCCC (66.9 months versus 9.2 months for patients with wild-type tumors). This suggested that reducing PP2A pharmacologically with LB-100 may enhance the anti-tumor effect of the PD-1 blocking monoclonal antibody, dostarlimab-gxly, in patients with Ovarian Clear Cell Carcinoma lacking the genetic reduction in PP2A.

About LIXTE Biotechnology Holdings, Inc.

LIXTE Biotechnology Holdings, Inc. is a clinical-stage pharmaceutical and med-tech company focused on new targets for cancer drug development and developing and commercializing cancer therapies. LIXTE has demonstrated that LB-100, its lead compound and first-in-class lead clinical PP2A inhibitor, is well-tolerated in cancer patients at doses associated with anti-cancer activity. Based on published preclinical data, LB-100 has the potential to significantly enhance chemotherapies and immunotherapies and improve outcomes for patients with cancer. It 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 novel approach is covered by a comprehensive patent portfolio, with proof-of-concept clinical trials currently in progress for Ovarian Clear Cell Carcinoma, Metastatic Colon Cancer and Advanced Soft Tissue Sarcoma. Additional information can be found at www.lixte.com.

Through LIXTE’s wholly owned subsidiary, Liora Technologies Europe Ltd., the Company also is pioneering the development of electronically controlled proton therapy systems for treating tumors in various types of cancers. Liora’s proprietary flagship technology, LiGHT System, is believed to provide significant advantages over currently available technologies for treating tumors with proton therapy. Additional information about Liora Technologies can be found at www.lioratechnologies.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, are all forward-looking statements. These statements 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 interim results did LIXT (LIXT) present for LB-100 plus dostarlimab on April 13, 2026?

The interim analysis showed a 40% Disease Control Rate (8/20) with median OS not reached. According to LIXT, 6-month OS probability was 0.84 and 12-month OS probability was 0.69 at median 12-month follow-up.

How many patients were enrolled in the LIXT LB-100 and dostarlimab ovarian cancer trial (LIXT)?

All 21 planned patients were enrolled and 20 were evaluable for efficacy in the interim analysis. According to LIXT, an additional 21-patient cohort with higher LB-100 exposure is now enrolling.

What does a 40% Disease Control Rate mean for LIXT's ovarian cancer study (LIXT)?

A 40% DCR means 8 of 20 patients had disease control (stable disease or better) at assessment. According to LIXT, this interim signal supported enrolling an additional higher-exposure cohort for further evaluation.

Are there safety concerns reported for LB-100 with dostarlimab in the LIXT study (LIXT)?

The combination demonstrated an acceptable safety profile in the reported interim results. According to LIXT, investigators described the safety as acceptable while expanding enrollment to a higher-exposure cohort.

What is the next step after LIXT's April 2026 interim ovarian cancer results (LIXT)?

LIXT is enrolling an additional 21-patient cohort with higher LB-100 exposure to further assess efficacy and safety. According to LIXT, this follows favorable interim results from the initial 21-patient cohort.