New Risk • May 17
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -US$4.5m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$4.5m free cash flow). Shareholders have been substantially diluted in the past year (333% increase in shares outstanding). Revenue is less than US$1m. Minor Risks Share price has been volatile over the past 3 months (15% average weekly change). Market cap is less than US$100m (US$59.9m market cap). Announcement • Apr 14
LIXTE Biotechnology Holdings, Inc. Presents Favorable Results For LB-100 And Dostarlimab Combination In Ovarian Cancer Study LIXTE Biotechnology Holdings, Inc. 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. 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. 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. 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. New Risk • Feb 12
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of American stocks, typically moving 11% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risks Shareholders have been substantially diluted in the past year (287% increase in shares outstanding). Revenue is less than US$1m. Minor Risks Share price has been volatile over the past 3 months (11% average weekly change). Market cap is less than US$100m (US$23.4m market cap).