LIXTE BIOTECHNOLOGY HOLDINGS, INC. 8-K

What Happened
LIXTE Biotechnology Holdings, Inc. announced (8-K filed Dec 23, 2025) Amendment No. 2 to its collaborative study with GlaxoSmithKline LLC (GSK) and The University of Texas M.D. Anderson Cancer Center that expands the ongoing ovarian clear cell carcinoma trial (Protocol 219582) from 21 to 42 patients. The amendment (dated Dec 17, 2025) increases study drug supply commitments (GSK vials increased from 400 to 800; LIXTE to supply ~3x its original LB-100 amount to support 42 patients) and updates enrollment expectations. Concurrently, LIXTE entered a separate Collaborative Research Agreement with MD Anderson detailing milestone payments and a royalty arrangement tied to the expanded study.

Key Details

• Study size: increased from 21 to 42 study subjects (includes Northwestern patients); enrollment target ≈ 2 subjects/month.
• Drug supply: GSK vials increased from 400 to 800; LIXTE will provide sufficient LB-100 to support 42 subjects at 2 time points per cycle (approx. 3× original amount).
• Payments to MD Anderson: three milestone payments of $500,000 each (total $1.5M) tied to (i) start of first pivotal trial, (ii) Breakthrough Therapy or Accelerated Approval, and (iii) FDA approval in clear cell ovarian cancer.
• Royalties: 3.75% royalty on annual Net Profit, product-by-product and country-by-country, beginning upon FDA approval and continuing until expiration of PCT/US2017/065270 or December 8, 2037.
• GSK funding: GSK’s cash payments remain based on the original 21-subject budget—GSK will not make additional payments for subjects 22–42, though it will supply drug at no cost.

Why It Matters
For investors, the amendment signals an increased clinical commitment to advancing LB-100 in ovarian clear cell carcinoma and could accelerate data generation by roughly doubling the trial population. The Research Agreement creates contingent financial obligations (up to $1.5M in milestone payments plus ongoing 3.75% royalties if approved) that would only be payable upon achievement of specified regulatory or commercial milestones. Importantly, GSK will not increase its cash payments for the larger enrollment (though it will provide drug supply), so some incremental study costs fall to the institution and ultimately to LIXTE under the Research Agreement. These are material operational and potential future financial events to monitor as the trial progresses.