Lixte expands ovarian cancer trial to 42 patients; expects initial data in H1 2026

LIXTE BIOTECHNOLOGY HOLDINGS, INC.

Amendment No.2 to collaborative study doubles enrollment from 21 to 42 patients for LB-100 + dostarlimab trial in ovarian clear cell carcinoma.
Lixte enters new Collaborative Research Agreement with MD Anderson; pays milestone payments up to $1.5M ($500k per event) plus 3.75% royalty on net profit.
GSK and Lixte provide drugs at no cost to institution for expanded 42-patient study; no additional GSK payments beyond original 21 subjects.
Initial data from first 21 patients expected in first half of 2026; trial led by MD Anderson includes Northwestern as second site.

Key facts

Extracted from this filing and checked against the source text.

Material Agreements SEC 8-K Item 1.01/1.02 confidence 0.9

LIXTE BIOTECHNOLOGY HOLDINGS, INC. entered into Collaborative Research Agreement with The University of Texas M.D. Anderson Cancer Center (effective 2025-12-17).

Action: entry
Agreement: collaboration
Counterparty: The University of Texas M.D. Anderson Cancer Center
Effective: 2025-12-17

Exact text from the filing

On December 17, the Company entered into a Collaborative Research Agreement with the Anderson Cancer Center (the “Research Agreement”).

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Material Agreements SEC 8-K Item 1.01/1.02 confidence 0.9

LIXTE BIOTECHNOLOGY HOLDINGS, INC. amended Amendment No.2 with GlaxoSmithKline LLC and The University of Texas M.D. Anderson Cancer Center (effective 2025-12-17).

Action: amendment
Agreement: collaboration
Counterparty: GlaxoSmithKline LLC and The University of Texas M.D. Anderson Cancer Center
Effective: 2025-12-17

Exact text from the filing

On December 17, 2025, Lixte Biotechnology Holdings, Inc., a Delaware corporation (the “Company”), entered into Amendment No.2 (“Amendment No.2”) to the GSK & LIXTE Supported Collaborative Study (the “Collaborative Study”) by and between the Company, GlaxoSmithKline LLC (“GSK”) and the University of Texas M.D. Anderson Cancer Center

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Source: SEC EDGAR

accession 0001493152-25-028999

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