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). Duyuru • 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). Duyuru • Dec 19
Lixte Biotechnology Holdings, Inc. has filed a Follow-on Equity Offering in the amount of $4.299989 million. Lixte Biotechnology Holdings, Inc. has filed a Follow-on Equity Offering in the amount of $4.299989 million.
Security Name: Common Units
Security Type: Equity/Derivative Unit
Securities Offered: 1,051,342
Price\Range: $4.09
Transaction Features: Registered Direct Offering New Risk • Nov 14
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$2.6m 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$2.6m free cash flow). Shareholders have been substantially diluted in the past year (103% increase in shares outstanding). Revenue is less than US$1m. Minor Risks Share price has been volatile over the past 3 months (13% average weekly change). Market cap is less than US$100m (US$19.6m market cap). Duyuru • Oct 18
Lixte Biotechnology Holdings, Inc., Annual General Meeting, Dec 08, 2025 Lixte Biotechnology Holdings, Inc., Annual General Meeting, Dec 08, 2025. Board Change • Sep 04
Less than half of directors are independent There are 6 new directors who have joined the board in the last 3 years. Of these new board members, 2 were independent directors. The company's board is composed of: 6 new directors. 1 experienced director. No highly experienced directors. 2 independent directors (4 non-independent directors). President, Chief Scientific Officer & Director Bas van der Baan is the most experienced director on the board, commencing their role in 2022. Independent Director Jason Sawyer was the last independent director to join the board, commencing their role in 2025. The following issues are considered to be risks according to the Simply Wall St Risk Model: Minority of independent directors. Lack of board continuity. Lack of experienced directors. Duyuru • Aug 26
LIXTE Biotechnology Holdings, Inc. Targets Large, Unmet Oncology Markets LIXTE Biotechnology Holdings, Inc. is advancing its clinical strategy by focusing on high-need, high-value cancer indications that currently offer limited treatment options. The company's lead compound, LB-100, is being evaluated in several investigator-led clinical studies aimed at enhancing the effectiveness of both chemotherapy and immunotherapy in treatment-resistant cancers. Colorectal cancer is among the most prevalent cancers globally, with the colorectal cancer drug market projected to surpass $18 billion by 2028. A significant challenge in the field is that approximately 85% of colorectal cancer cases are microsatellite-stable (MSS) and typically do not respond to existing immunotherapies such as checkpoint inhibitors. At the Netherlands Cancer Institute, LB-100 is being studied in combination with atezolizumab, Roche's anti-PD-L1 immunotherapy, in a clinical trial focused specifically on patients with MSS colorectal cancer. The trial is designed to assess whether inhibition of PP2A with LB-100 can improve immune response in these tumors, which are generally considered immunologically "cold." Ovarian Clear-Cell Carcinoma (OCCC) OCCC is a rare but aggressive subtype of ovarian cancer, accounting for about 5-10% of cases. The current standard treatments have limited efficacy, and patients often have poor long-term outcomes. The global market for ovarian cancer therapies was valued at over $2 billion in 2023, with growth expected due to rising incidence and expanded treatment approaches. Interim data from this trial are expected in fourth quarter 2025. Soft-tissue sarcomas are a diverse group of rare cancers with limited treatment advances in recent decades. Doxorubicin remains a frontline standard, despite modest response rates and long-standing resistance challenges. The global market for soft-tissue sarcoma therapies is projected to reach $1.5 to $2 billion by 2030. In collaboration with the Spanish Sarcoma Group (GEIS), LIXTE is supporting a Phase 1b clinical study evaluating LB-100 in combination with doxorubicin. The trial is designed to evaluate whether LB-100 can enhance the effectiveness of chemotherapy by disrupting tumor cell stress-response and DNA repair pathways. Initial clinical results are anticipated later this year. Ongoing Development Strategy: LIXTE's clinical programs are aligned with indications that represent significant commercial opportunities and unmet therapeutic needs, particularly in tumors with poor responses to current immunotherapies.LB-100 is a first-in-class inhibitor of PP2A, a master regulatory enzyme involved in multiple oncogenic signaling pathways. Its novel mechanism of action is designed to sensitize tumors to other treatments, including both immune checkpoint blockade and standard chemotherapy. The company's development strategy is focused on combination approaches that aim to improve outcomes in indications with historically poor response rates, thereby addressing both clinical and commercial gaps in the oncology market. Duyuru • Aug 19
Lixte Biotechnology Holdings, Inc. announced that it has received $5 million in funding On August 18, 2025, Lixte Biotechnology Holdings, Inc. closed the transaction. The company raised remaining $1,000,000 in its second tranche. New Risk • Jul 16
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 138% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (35% average weekly change). Earnings have declined by 3.3% per year over the past 5 years. Shareholders have been substantially diluted in the past year (138% increase in shares outstanding). Revenue is less than US$1m. Minor Risk Market cap is less than US$100m (US$19.8m market cap). Duyuru • Jul 10
New Clinical Findings Published in Scientific Journal Nature Validate LIXTE's Ongoing Ovarian and Colorectal Cancer Trials LIXTE Biotechnology Holdings, Inc. announced that the medical journal Nature has published findings by a team of physician-scientists that validate LIXTE's ongoing clinical trials with its proprietary compound LB100 for Ovarian and Colorectal cancers. A team led by principal investigator Amir Jazaeri, MD, professor of Gynecologic Oncology and Reproductive Medicine at The University of Texas MD Anderson Cancer Center, studied survival outcomes of Ovarian Clear Cell Carcinoma (OCCC) patients treated with immune checkpoint blockade therapy (clinicaltrials.gov identifier: NCT03026062). The; study showed that patients having tumors with inactivating mutations in PPP2R1A - the major scaffold subunit of protein phosphatase 2A (PP2A) - had significantly better overall survival, compared with patients who did not have this mutation in their tumors. Inactivating mutations in PPP 2R1A are known to reduce the enzymatic activity of PP2A, which is the target of LIXTE's lead compound LB-100. Tumors with mutations in PPP2R 1A were found to have increased the interferon gamma response pathway, which is known to be associated with improved immune checkpoint responses. LIXTE is currently investigating the activity of LB-100 in combination with checkpoint immunotherapy in two clinical trials. The first is enrolling patients with OCCC, led by Dr. Jazaeri at MD Anderson Cancer Center, and also is open at Northwester University. In this trial, LIXTE is collaborating with GSK to test LB-100 in combination with dostarlimab (anti PD1). In the second trial, at the Netherlands Cancer Institute, LIXTE is collaborating With Roche to test LB-100 in collaboration with atezolizumab (anti PDL1) in colon cancer patients. Duyuru • Jul 02
Lixte Biotechnology Holdings, Inc. announced that it expects to receive $5 million in funding Lixte Biotechnology Holdings, Inc announced entered into a definitive agreement with accredited investors on the purchase and sale of approximately $5,000,000 of shares of Common Stock (or Pre-Funded Warrants), Series B Convertible Preferred Stock and Common Warrants on July 1, 2025. The offering consists of the sale of an aggregate of 2,382,084 shares of Common Stock (or Pre-funded Warrants in lieu thereof), 3,573,130 shares of Series B Convertible Preferred Stock and 6,355,214 Common Warrants. The Pre-Funded Warrants will be immediately exercisable at an exercise price of $0.00001 and may be exercised at any time until exercised in full. The initial exercise price of each Common Warrant is $1.00 per share of Common Stock. The Common Warrants are exercisable immediately and expire 60 months after the resale registration statement registering the underlying shares is declared effective. Aggregate gross proceeds to the Company are expected to be approximately $5,000,000, $4,000,000 of which will be paid at closing and $1,000,000of which will be paid when the resale registration statement registering Common Stock and the underlying shares is declared effective. The transaction is expected to close on or about July 2, 2025, subject to the satisfaction of customary closing conditions. The securities described above are being sold in a private placement transaction not involving a public offering and have not been registered under the Securities Act of 1933, as amended (the “Securities Act”), or applicable state securities laws. Accordingly, the securities may not be reoffered or resold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws. The securities were offered only to accredited investors. Pursuant to a registration rights agreement with the investors, the Company has agreed to file one or more registration statements with the SEC covering the resale of the Common Stock and the Shares issuable upon exercise of the pre-funded warrants and warrants. Duyuru • Jun 18
Lixte Biotechnology Holdings, Inc. has filed a Follow-on Equity Offering. Lixte Biotechnology Holdings, Inc. has filed a Follow-on Equity Offering.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 5,263,158
Price\Range: $1.14
Security Name: Pre-Funded Warrants
Security Type: Equity Warrant
Securities Offered: 5,263,158 New Risk • May 13
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$2.9m 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$2.9m free cash flow). Earnings have declined by 3.3% per year over the past 5 years. Revenue is less than US$1m. Market cap is less than US$10m (US$3.44m market cap). Minor Risk Shareholders have been diluted in the past year (19% increase in shares outstanding). Duyuru • Apr 19
Nasdaq Hearings Panel Grants Lixte Biotechnology Holdings an Extension to Regain Compliance with All Continued Listing Rules of the Nasdaq Capital Market by July 3, 2025 As previously reported, Lixte Biotechnology Holdings, Inc. (the ‘Company’) received a letter from the Listing Qualifications Department (the ‘Staff’) of the Nasdaq Stock Market LLC (‘Nasdaq’) indicating that the Company was not in compliance with the minimum stockholders’ equity requirement of $2,500,000 for continued listing on the Nasdaq Capital Market under Listing Rule 5550(b)(1) (the ‘Equity Rule’). On April 17, 2025, the Company received notice that the Nasdaq Hearings Panel (the ‘Panel’) had granted the Company an extension in which to regain compliance with all continued listing rules of the Nasdaq Capital Market. The Panel’s determination follows a hearing on April 3, 2025, at which the Panel considered the Company’s plan to regain compliance with the Equity Rule. As a result of the extension, the Panel granted the Company’s request for continued listing on the Nasdaq Capital Market, provided that the Company demonstrates compliance with the Equity Rule and all other continued listing requirements for the Nasdaq Capital Market by July 3, 2025. During the extension period, the Company’s common shares and warrants will continue to trade on the Nasdaq Capital Market under the symbols ‘LIXT’ and ‘LIXTW’, respectively. The Company is undertaking measures to regain compliance under Nasdaq’s continued listing requirements within the extension period and to remain listed on the Nasdaq Capital Market. However, there can be no assurances that the Company will ultimately regain compliance with the Equity Rule, or be able to maintain compliance with all other applicable requirements for continued listing on the Nasdaq Capital Market. The Company’s failure to meet these requirements would result in the Company’s securities being delisted from the Nasdaq Capital Market. Duyuru • Mar 31
LIXTE Biotechnology Holdings, Inc. Launches New Study to Determine If Certain Pre-Cancerous Cells Found in an Aging Population Can Be Eliminated by LB-100 LIXTE Biotechnology Holdings, Inc. announced it will conduct a new pre-clinical study in collaboration with Netherlands Cancer Institute (NKI) to test whether "initiated" cells that carry mutations found in cancer cells can be eliminated by treatment with LIXTE's proprietary compound LB-100. Increasing evidence indicates that as individuals age, certain mutations accumulate that are found in cancer cells. While these "initiated" cells behave essentially normally, they can propagate to form reservoirs of pre-malignant cells from which malignant cells may eventually emerge. Recent data from LIXTE's ongoing clinical collaboration with NKI shows that LB-100 activates oncogenic signaling and that this is detrimental to cancer cells. The new study in animal models will investigate whether "initiated" cell, harboring a mutant RAS oncogene, can be eliminated with LB-100. If successful, LB-100 could have a significant role in the elimination of initiated cells in aged individuals and could reduce the risk of developing a wide range of cancers as a person ages. The study will be led by Rene Bernards, Ph.D., a global leader in the field of molecular carcinogenesis and Senior Staff Scientist at NKI, one of the comprehensive cancer centers. Dr. Bernards also is a member of LIXTE's Board of Directors. Duyuru • Mar 28
Lixte Biotechnology Holdings, Inc. Provides Update on Progress with Proprietary Compound, Lb-100, to Treat Ovarian and Colorectal Cancer LIXTE Biotechnology Holdings, Inc. provided an update on its recent activities. Recent LIXTE Highlights Include: The first patient dosing in a Phase 1b/2 trial combining LIXTE's LB-100 with GSK's immunotherapy, dostarlimab-gxly, targeting ovarian clear cell carcinoma. Dosing of the first patient in a new clinical trial in collaboration with the Netherlands Cancer Institute (NKI) and supported by F. Hoffmann-La Roche Ltd. ("Roche") for treatment of unresponsive (MSI Low) metastatic colorectal cancer. Further bolstering of LIXTE's intellectual property portfolio, with receipt of a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for U.S. Patent application number 16/467,721, titled, "Oxabicycloheptanes for Modulation of Immune Response," for combining the Company's LB-100 compound with various innovative cancer immunotherapies. Completion of a registered direct offering, raising aggregate gross proceeds of approximately $1,050,000 to be used for working capital and other general corporate purposes. Study published in Cancer Discovery, revealing that LB-100 can force cancer cells to relinquish their malignant properties, suggesting a novel therapeutic approach. Study published in EMBO, highlighting how LB-100 forces cancer cells to create neo antigens and make them more vulnerable for immunotherapy. New Risk • Mar 26
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 19% This is considered a minor risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Earnings have declined by 7.8% per year over the past 5 years. Revenue is less than US$1m. Market cap is less than US$10m (US$3.62m market cap). Minor Risks Share price has been volatile over the past 3 months (15% average weekly change). Shareholders have been diluted in the past year (19% increase in shares outstanding). Duyuru • Mar 11
LIXTE Biotechnology Holdings, Inc. Announces Online Publication of New Pre-Clinical Data in BioXriv and International Journal of Pharmaceutics LIXTE Biotechnology Holdings, Inc. announced online publication of new pre-clinical data in BioXriv and International Journal of Pharmaceutics demonstrating how the Company's lead clinical compound, LB-100, is converted into its active form, endothall, a protein phosphatase (PP2A) inhibitor that has been found to be effective in cancer treatment in combination with immunotherapy. As published in BioXriv, scientists at the Netherlands Cancer Institute have discovered an enzyme that mediates the conversion of LB-100 into the active metabolite endothall. Accordingly, this protein represents a potential biomarker to identify patients who are most likely to respond to LB-100. The biomarker discovery study was performed in the laboratories of Professor Rene Bernards, group leader at the Netherlands Cancer Institute and LIXTE board member. As published in the International Journal of Pharmaceutics, Dr. Hans Rollema and colleagues, medicinal chemists and biochemists at BioPharmaWorks LLC, a consultant to LIXTE, studied how LB-100 can spontaneously convert into the active metabolite endthall by hydrolysis. Their data indicate that this conversion is slow under physiological conditions. The enzymatic conversion of LB-100 identified by the Bernards laboratory expedites the activation of LB-100 inside the cell. Duyuru • Feb 22
Lixte Biotechnology Holdings Receives Nasdaq Staff Determination Letter As previously reported in a Current Report on Form 8-K filed with the Securities and Exchange Commission (the SEC") on August 23, 2024, Lixte Biotechnology Holdings, Inc. (the Company") received a letter from the Listing Qualifications Department (the Staff") of the Nasdaq Stock Market LLC (Nasdaq") on August 19, 2024 indicating that the Company was not in compliance with the minimum stockholders' equity requirement of $2,500,000 for continued listing on the Nasdaq Capital Market under Listing Rule 5550(b) (the Stockholders' Equity Requirement"). On October 3, 2024, the Company submitted a plan to the Staff to regain compliance with the Stockholders' Equity Requirement, which outlined the Company's proposed initiatives to regain compliance by raising equity capital through various registered equity offerings. On October 21, 2024, the Staff provided notice (the Notice") to the Company that it had granted an extension through February 18, 2025 to regain compliance with the Stockholders' Equity Requirement, which required that the Company complete its capital raising initiatives and evidence compliance with the Stockholders' Equity Requirement through filing a Current Report on Form 8-K with the SEC providing certain required information. As of February 18, 2025, the Company had not gained compliance with the Stockholders' Equity Requirement. Accordingly, on February 19, 2025, the Company received a Staff determination letter from the Staff stating that the Company did not meet the terms of the extension because it did not complete its proposed financing initiatives to regain compliance. The Company intends to timely file an appeal and request a Hearing before a Nasdaq Hearings Panel (the Panel"). The Hearing request will automatically stay Nasdaq's delisting of the Company's common shares and warrants pending the Panel's decision. Pursuant to the Nasdaq Listing Rules, the Panel has the discretion to grant the Company an additional extension through no later than August 18, 2025. At the hearing, the Company will present its plan for regaining and sustaining compliance with the Stockholders' Equity Requirement for continued listing. However, there can be no assurance that the Hearings Panel will grant the Company an extension of time to regain compliance, or that the Company will be able to regain compliance during any extension period. During the appeal process the Company's common shares and warrants will continue to trade on The Nasdaq Capital Market under the symbols LIXT" and LIXTW", respectively. If the Company is not able to regain compliance with Nasdaq's continued listing requirements within the time period permitted by Nasdaq, then the Company's securities will be delisted from Nasdaq. Duyuru • Feb 14
Lixte Biotechnology Holdings, Inc. has completed a Follow-on Equity Offering in the amount of $1.050003 million. Lixte Biotechnology Holdings, Inc. has completed a Follow-on Equity Offering in the amount of $1.050003 million.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 434,784
Price\Range: $2.415
Discount Per Security: $0.205
Transaction Features: Registered Direct Offering Duyuru • Feb 13
Lixte Biotechnology Holdings, Inc. has filed a Follow-on Equity Offering in the amount of $1.050003 million. Lixte Biotechnology Holdings, Inc. has filed a Follow-on Equity Offering in the amount of $1.050003 million.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 434,784
Price\Range: $2.415
Discount Per Security: $0.205
Transaction Features: Registered Direct Offering Duyuru • Jan 07
Lixte Biotechnology Holdings, Inc. has filed a Follow-on Equity Offering in the amount of $1.7 million. Lixte Biotechnology Holdings, Inc. has filed a Follow-on Equity Offering in the amount of $1.7 million.
Security Name: Common Stock
Security Type: Common Stock
Transaction Features: At the Market Offering Duyuru • Oct 25
Lixte Biotechnology Holdings, Inc., Annual General Meeting, Dec 19, 2024 Lixte Biotechnology Holdings, Inc., Annual General Meeting, Dec 19, 2024. Duyuru • Oct 23
Lixte Biotechnology Holdings Receives an Extension Through February 18, 2025 to Regain Compliance with the Stockholders’ Equity Requirement As previously reported in a Current Report on Form 8-K filed with the Securities and Exchange Commission on August 23, 2024, Lixte Biotechnology Holdings, Inc. received a letter from the Listing Qualifications Department of the Nasdaq Stock Market LLC on August 19, 2024 indicating that the Company was not in compliance with the minimum stockholders’ equity requirement of $2,500,000 for continued listing on the Nasdaq Capital Market under Listing Rule 5550(b). On October 3, 2024, the Company submitted a plan to the Staff to regain compliance with the Stockholders’ Equity Requirement, which outlined the Company’s proposed initiatives to regain compliance by raising equity capital through various registered equity offerings. In that regard, the Company filed a Registration Statement on Form S-1 with the SEC on October 22, 2024 to raise up to $4,000,000 of equity capital. On October 21, 2024, the Staff provided notice (the “Notice”) to the Company that it has granted an extension through February 18, 2025 to regain compliance with the Stockholders’ Equity Requirement. By February 18, 2025, the Notice requires that the Company must complete its capital raising initiatives and evidence compliance with the Stockholders’ Equity Requirement through filing a Current Report on Form 8-K with the SEC providing certain required information. If the Company fails to evidence compliance with the Stockholders’ Equity Requirement upon filing its periodic report for the quarter ending March 31, 2025 with the SEC, it may be subject to delisting. If the Staff determines to delist the Company’s common stock, the Company will have the right to appeal to a Nasdaq hearings panel. There can be no assurances that the Company will be able to regain compliance with the Stockholders’ Equity Requirement during the extension period. The Notice has no immediate effect on the listing of the Company’s common shares and warrants, which will continue to trade on The Nasdaq Capital Market under the symbols “LIXT” and “LIXTW”, respectively. Duyuru • Jun 08
Lixte Biotechnology Holdings, Inc. Reports Findings Show LIXTE's Lead Clinical Compound, LB-100, Increases Recognition of Colon Cancer Cells by the Immune System LIXTE Biotechnology Holdings, Inc. announced online publication of new pre-clinical data in the journal EMBO Reports, showing that its lead compound, LB-100, can turn immunologically " cold" tumors "hot," potentially enhancing the benefit of immunotherapy. In a paper titled, "The Phosphatase Inhibitor LB-100 Creates Neoantigens in Colon Cancer Cells through Perturbation of mRNA Splicing," LIXTE's collaborators from the Netherlands Cancer Institute have demonstrated that treatment of cancer cells with LB-100 disrupts the normal processing of the mRNA that encodes proteins, thereby generating neo-antigens that are presented to the host immune system. This new mechanism adds to several previous discoveries showing that LB-100 sensitizes cancer cells to immune checkpoint blockade. The bioactivity of LB-100 shown in this new study turns the large group of immunologically cold microsatellite stable colon cancer cells into tumors that are recognized by the immune system. This development has the potential to significantly expand the number of colon cancer patients who respond to immunotherapy. In the currently published manuscript, the authors provide direct evidence that LB-100 generates neo-antigens that are presented in the context of MHC class I antigens to the immune system. Duyuru • Jun 05
LIXTE Biotechnology Holdings, Inc. Announces Executive Changes LIXTE Biotechnology Holdings, Inc. announced the appointment of Jan Schellens, M.D., Ph.D., as Chief Medical Officer (CMO). Dr. Schellens brings to LIXTE more than 25 years of clinical experience as a medical oncologist, pharmacologist and clinical pharmacologist, including more than two decades developing and bringing new drugs to market. He assumes the CMO role at LIXTE effective August 1, 2024, succeeding James S. Miser, M.D., who is leaving the Company after serving in this capacity since 2020. Co-author of more 900 publications in peer-reviewed scientific journals, Dr. Schellens has held leadership positions at the Netherlands Cancer Institute in Amsterdam and the Dr. Daniel den Hoed Clinic-Erasmus University in Rotterdam. He was professor of clinical pharmacology at Utrecht University in the Netherlands, where he earned his M.D. degree, and he served as a board member and Chief Medical Officer of Byondis B.V. in Nijmegen, Netherlands through September 2023. Dr. Schellens also earned a Ph.D. degree in Pharmaceutical Sciences from Leiden University in Leiden, Netherlands. Dr. Schellens served for 17 years as a board member of the Dutch Medicines Evaluation Board, and for 12 years as a member and chairperson of the Scientific Advisory Board Oncology of the EMA. He also is a part-time CMO of Modra Pharmaceuticals B.V., an Amsterdam-based clinical stage biopharmaceutical company that successfully completed a Phase 2b clinical study of ModraDoc006/r, a boosted oral taxane therapeutic, in contrast to the standard-of-care IV chemotherapy docetaxel, in patients with prostate cancer. New Risk • Mar 28
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of American stocks, typically moving 21% a week. This is considered a major risk. Share price volatility 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. It may also indicate 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. 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$4.3m free cash flow). Share price has been highly volatile over the past 3 months (21% average weekly change). Earnings have declined by 23% per year over the past 5 years. Revenue is less than US$1m. Market cap is less than US$10m (US$7.92m market cap). Minor Risk Shareholders have been diluted in the past year (35% increase in shares outstanding). Duyuru • Mar 27
Lixte Biotechnology Holdings, Inc. Announces Publication of Pre-Clinical Data in the Online Journal LIXTE Biotechnology Holdings, Inc. announced publication of pre-clinical data in the online journal, Cancer Discovery, showing that its lead clinical compound, LB-100, can force cancer cells to give up their cancer-causing properties in a paper entitled “Paradoxical activation of oncogenic signaling as a cancer treatment strategy.” The finding opens a potentially new treatment strategy in addition to LIXTE’s current three clinical trials. As will be published in the July 2024 issue and posted online today, LB-100 was shown to trigger hyper-activation of the signals that are responsible for the deregulated proliferation of cancer cells, which is the opposite of most of the current generation of cancer therapies. The deliberate hyper-activation of cancer signals becomes lethal when combined with an inhibitor of the WEE1 kinase. This well-tolerated combination proved to be highly effective in killing colon cancer cells in animal models of cancer and in cell culture. Resistance to therapy is the leading cause of death due to cancer. Resistance to LB-100 therapy, however, has been shown to be associated with cancer cells becoming less malignant. Specifically, colon cancer cells that developed resistance to LB-100 had lost many of the features that make the cells cancerous in the first place and were unable to form tumors in experimental animal models. This “tumor suppressive drug resistance” stems from the unique features of LB-100. Although cancer-causing signals force cancer cells to become more cancerous, the hyper-activation of these signals by LB-100 forces cancer cells to suppress these signals and thus become less cancerous. The team of scientists reporting these findings was headed by Professor René Bernards at the Netherlands Cancer Institute and Oncode Institute, Amsterdam. Professor Bernards is a a leader in the field of molecular carcinogenesis and is a member of the Board of Directors of LIXTE. Duyuru • Mar 23
LIXTE Biotechnology Holdings, Inc. Provides Update on Progress with LB-100 as a PP2A Inhibitor to Enhance Chemotherapy and Immunotherapy Cancer Treatments LIXTE Biotechnology Holdings, Inc. provided an update on the Company’s progress with its proprietary compound, LB-100. Clinical trials are taking place at the University of Texas MD Anderson Cancer (ovarian clear cell carcinoma); City of Hope Cancer Center and the Sarah Cannon Research Institute (small cell lung cancer); and the Spanish Sarcoma Group (advanced soft tissue sarcoma). LIXTE recently announced the following significant developments: The dosing of the first patient in a Phase 1b/2 clinical trial to assess whether adding LB-100 to GSK’s dostarlimab-gxly will enhance the effectiveness of immunotherapy in the treatment of ovarian clear cell carcinoma (OCCC). The clinical trial was initiated by, and is being conducted at, the University of Texas MD Anderson Cancer Center. LIXTE is providing LB-100, and GSK is providing dostarlimab-gxly and financial support. The signing of an exclusive patent license agreement with the National Institute of Neurological Disorders and Stroke and the National Cancer Institute, each an Institute of the National Institutes of Health (NIH). LIXTE has licensed NIH’s intellectual property rights under a Cooperative Research and Development Agreement that, focused on LB-100 promoting anti-cancer activity alone and in combination with immune checkpoint inhibitors. On February 28, 2024, René Bernards, PhD, a leader in the field of molecular carcinogenesis and Senior Staff Scientist at the Netherlands Cancer Institute, presented new pre-clinical data at the Joint Conference of European and American Associations for Cancer Research in Dublin, Ireland on how stress imposed onto colon cancer cells by LB-100 drives cancer cells to evolve to less cancerous behavior, underscoring a unique mechanism of action of LB-100. Dr. Bernards is a member of the Board of Directors of LIXTE. Duyuru • Jan 30
Lixte Biotechnology Holdings, Inc. Announces Dosing of the First Patient in A Phase 1B/2 Clinical Trial to Assess Whether Adding Lixte’S Lb-100 to Gsk’S Programmed Death Receptor-1 (Pd-1)-Blocking Monoclonal Antibody, Dostarlimab-Gxly, May Enhance the Effectiveness of Immunotherapy in the Treatment of Ovarian Clear Cell Carcinoma LIXTE Biotechnology Holdings, Inc. announced the dosing of the first patient in a Phase 1b/2 clinical trial to assess whether adding LIXTE’s LB-100 to GSK’s programmed death receptor-1 (PD-1)-blocking monoclonal antibody, dostarlimab-gxly, may enhance the effectiveness of immunotherapy in the treatment of ovarian clear cell carcinoma (OCCC). The clinical trial was initiated by and is being conducted at The University of Texas MD Anderson Cancer Center. LIXTE is providing LB-100; GSK is providing dostarlimab-gxly and financial support for the clinical trial. The clinical trial (NCT06065462) is based on the observation by the lead clinical investigator of the trial, Amir Jazaeri MD, Professor of Gynecologic Oncology at MD Anderson, that a genetically acquired reduction in PP2A may enhance sensitivity to immunotherapy. This raises the possibility 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 OCCC lacking the genetic reduction in PP2A. Duyuru • Oct 11
Lixte Biotechnology Holdings, Inc., Annual General Meeting, Nov 27, 2023 Lixte Biotechnology Holdings, Inc., Annual General Meeting, Nov 27, 2023, at 10:00 Pacific Standard Time. Agenda: To elect the five nominees for director named herein; To ratify the appointment of Weinberg & Company, P.A. as the Company’s independent registered public accounting firm for the fiscal year ending December 31, 2023; To approve a proposal to amend the Company’s 2020 Stock Incentive Plan (the “2020 Plan”) to increase the number of shares issuable thereunder by 336,667 shares, to a total of 750,000 shares; and To authorize the adjournment of the Annual Meeting, if necessary, to solicit additional proxies if there are not sufficient votes in favor of one or more of the Proposals; To transact other business that may properly come before the meeting and any postponement(s) or adjournment(s) thereof. Duyuru • Sep 21
LIXTE Biotechnology Holdings, Inc. Announces Supported Collaborative Trial to Study LIXTE’s First-in-Class PP2A Inhibitor, LB-100, Plus GSK’s Immunotherapy, Dostarlimab, in Clear-Cell Ovarian Cancer LIXTE Biotechnology Holdings, Inc. announced a Phase 1b collaborative clinical trial to assess whether adding Lixte's LB-100 to GSK's programmed death receptor-1 (PD-1)-blocking monoclonal antibody, dostarlimab, may enhance the effectiveness of immunotherapy in the treatment of ovarian clear cell carcinoma (OCCC). The clinical trial is sponsored by The University of Texas - MD Anderson Cancer Center and will be conducted at MD Anderson and will also be open at Northwestern University's Robert H. Lurie Comprehensive Cancer Center. LIXTE will provide LB-100; GSK will provide dostarlimab and financial support for the clinical trial. The clinical trial is based on the observation of longer survival of patients with OCCC treated with immunotherapy whose cancer cells have an acquired gene mutation resulting in a reduction in PP2A. This finding was reported by the lead clinical investigators of this new trial1: Amir Jazaeri MD, Professor of Gynecologic Oncology at MD Anderson, and Emily Hinchcliff, MD, MPH, Assistant Professor of Obstetrics and Gynecology at Northwestern University Feinberg School of Medicine. The observation by Drs. Jazaeri and Hinchcliff, that a genetically acquired reduction in PP2A enhances sensitivity to immunotherapy, raises the possibility that reducing PP2A pharmacologically with LB-100 will enhance the anti-tumor effect of the PD-1 blocking monoclonal antibody dostarlimab in patients with OCCC lacking the genetic reduction in PP2A. New Risk • Jul 24
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 35% This is considered a minor risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. 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$4.8m free cash flow). Share price has been highly volatile over the past 3 months (19% average weekly change). Earnings have declined by 30% per year over the past 5 years. Revenue is less than US$1m. Market cap is less than US$10m (US$9.45m market cap). Minor Risk Shareholders have been diluted in the past year (35% increase in shares outstanding). New Risk • Jul 18
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of American stocks, typically moving 17% a week. This is considered a major risk. Share price volatility 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. It may also indicate 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. 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$4.8m free cash flow). Share price has been highly volatile over the past 3 months (17% average weekly change). Earnings have declined by 30% per year over the past 5 years. Revenue is less than US$1m. Duyuru • Jun 08
LIXTE Biotechnology Holdings, Inc. Announces the Enrollment of the First Patient in the Phase 1b Portion of the Phase 1b/2 Protocol LIXTE Biotechnology Holdings, Inc. announced the enrollment of the first patient in the Phase 1b portion of the Phase 1b/2 protocol (NCT05809830) to determine the appropriate dose of LB-100 given with a standard dose of doxorubicin. Once the dose is determined, a randomized Phase 2 study will be initiated seeking to gain evidence that the inclusion of doxorubicin increases time to a progression and/or overall survival of patients with advanced soft tissue sarcomas (ASTS). Duyuru • Jun 03
LIXTE Biotechnology Announces 1-for-10 Reverse Stock Split to Bring it into Compliance with Nasdaq’s Minimum Bid Price Requirement for Continued Listing on the Nasdaq Capital Market On June 2, 2023, LIXTE Biotechnology Holdings, Inc. announced that it will effect a 1-for-10 reverse stock split of its issued and outstanding common stock effective on June 2, 2023. Commencing with the opening of trading on the Nasdaq Capital Market on June 5, 2023, the company’s common stock will trade on a post-split basis under the same symbol LIXT. The reverse stock split was approved by the company’s stockholders at a special meeting of stockholders held on May 26, 2023, with the final ratio being determined by the company’s Board of Directors. As a result of the reverse stock split, every 10 shares of issued and outstanding common stock will be exchanged for 1 share of common stock, with any fractional shares being rounded up to the next higher whole share. Immediately after the reverse stock split becomes effective, the company will have approximately 1,665,909 shares of common stock issued and outstanding. The reverse stock split is primarily intended to increase the per share trading price of LIXTE’s common stock to bring the company into compliance with Nasdaq’s minimum bid price requirement for continued listing on the Nasdaq Capital Market. However, there can be no assurances that the company will be able to remain in compliance with the minimum bid price requirement over time, or that it will be successful in maintaining compliance with any of the other Nasdaq continued listing requirements. Duyuru • May 31
Lixte Biotechnology Holdings, Inc. Announces Recently Published Independent Research Reveals New Mechanisms LIXTE Biotechnology Holdings, Inc. announced that a recently published article in the journal Cancer Research showed that PP2A, the pharmacologic target of LIXTE's lead clinical compound, LB-100, when inactivated in pre-clinical models of glioma, activates a complex intracellular signaling system, the cGAS-STING pathway. This leads to an activation of interferon signaling, an increase in MHC class I expression on tumor cells, an increase in CD8(+) killer T cell proliferation, while at the same time reducing immunosuppressive tumor associated macrophages. Consequently, as shown in the article, PP2A inactivation sensitized the immunologically "cold" glioblastoma cells to immune checkpoint blockade therapy in vitro. The May 23, 2023 article in the journal Cancer Research, entitled "PP2Ac Deficiency Enhances Tumor Immunogenicity by Activating STING-Type I Interferon Signaling in Glioblastoma," by Mondal et al. from the Department of Neurological Surgery, University of California, San Francisco. Executive Departure • Apr 17
Independent Director has left the company On the 9th of April, Sze Ho's tenure as Independent Director ended after 2.7 years in the role. We don't have any record of a personal shareholding under Sze's name. Sze is the only executive to leave the company over the last 12 months. Duyuru • Mar 05
Lixte Biotechnology Holdings, Inc. to Showcase Its Anti-Cancer Therapy Enhancer LB-100 At the Virtual Annual Roth Capital Conference Lixte Biotechnology Holdings, Inc. announced that it will participate in the virtual Annual Roth Conference, being held March 15-17, 2021. During the corporate presentation and in one-on-one and small group investor meetings, Dr. Kovach will discuss the Company’s proprietary clinical stage compound LB-100, a first in-class protein phosphatase (PP2A) inhibitor that increases the anti-tumor activity of standard chemotherapy, radiotherapy, and immunotherapy without increasing toxicity. LB-100 is initially being evaluated in three clinical treatment studies (phase 1b/2 for Myelodysplastic Syndromes, Advanced Soft Tissue Sarcoma, and Small Cell Lung Cancer and in a phase 0 (human pharmacodynamic/pharmacokinetic study) in recurrent gliomas. LB-100 is also being tested for potential benefit in a rodent model of Angelman Syndrome, a severe neurodevelopmental disorder. There are no direct competitors of LB-100 known to Lixte in the clinic at present. Is New 90 Day High Low • Feb 27
New 90-day high: US$5.58 The company is up 53% from its price of US$3.65 on 27 November 2020. The American market is up 2.0% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Biotechs industry, which is up 6.0% over the same period. Is New 90 Day High Low • Jan 30
New 90-day low: US$3.05 The company is down 55% from its price of US$6.72 on 27 October 2020. The American market is up 17% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is up 25% over the same period. Duyuru • Jan 20
Lixte Biotechnology Holdings, Inc. and City of Hope to Initiate Phase 1b Clinical Trial of Lixte’S Lead Compound Lb-100 to Treat Small Cell Lung Cancer Lixte Biotechnology Holdings, Inc. announced an agreement on a Phase 1b clinical trial with City of Hope. The trial will assess the combination of Lixte’s first-in-class protein phosphatase inhibitor LB-100 with a standard regimen for untreated, extensive stage-disease small cell lung cancer (ED-SCLC). LB-100 will be given in combination with carboplatin, etoposide and atezolizumab, an FDA approved but marginally effective regimen, in previously untreated ED-SCLC. The dose of LB-100 will be escalated with fixed doses of the 3-drug regimen to reach a recommended Phase 2 dose (RP2D). Patient entry will then be expanded so that a total of 12 patients will be evaluable at the RP2D to confirm its safety and to look for objective evidence of potential therapeutic activity as assessed by objective response rate, duration of overall response, progression-free-survival and overall survival. Is New 90 Day High Low • Dec 30
New 90-day low: US$3.14 The company is down 55% from its price of US$7.02 on 29 September 2020. The American market is up 15% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is up 16% over the same period. Is New 90 Day High Low • Dec 11
New 90-day low: US$3.59 The company is down 49% from its price of US$7.08 on 11 September 2020. The American market is up 13% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is up 22% over the same period. Is New 90 Day High Low • Dec 03
New 90-day low: US$3.60 The company is down 49% from its price of US$7.08 on 27 August 2020. The American market is up 4.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is up 11% over the same period. Is New 90 Day High Low • Nov 28
New 90-day low: US$3.65 The company is down 48% from its price of US$7.08 on 27 August 2020. The American market is up 6.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is up 7.0% over the same period. Duyuru • Nov 27
Lixte Biotechnology Holdings Deleted from Other OTC Lixte Biotechnology Holdings, Inc.’s Common Stock has been deleted from Other OTC effective November 25, 2020. The deletion was due to Market Center Change Listed on NASDAQ. Is New 90 Day High Low • Nov 27
New 90-day low: US$3.74 The company is down 47% from its price of US$7.08 on 27 August 2020. The American market is up 7.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is up 7.0% over the same period. Duyuru • Nov 26
Lixte Biotechnology Holdings, Inc. has completed an IPO in the amount of $5.7 million. Lixte Biotechnology Holdings, Inc. has completed an IPO in the amount of $5.7 million.
Security Name: Units
Security Type: Equity/Derivative Unit
Securities Offered: 1,200,000
Price\Range: $4.75
Discount Per Security: $0.35625
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 1,200,000 Duyuru • Sep 04
Lixte Biotechnology Holdings, Inc. has filed an IPO in the amount of $10.668 million. Lixte Biotechnology Holdings, Inc. has filed an IPO in the amount of $10.668 million.
Security Name: Common Stock
Security Type: Common Stock 