LIXTE BIOTECHNOLOGY HOLDINGS INC
For the period ended Jun 30, 2024. Filed Aug 8, 2024.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Jun 30, 2024 · Filed Aug 8, 2024
NMAD$3.60+3.2%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2024-03-31; filed 2024-05-09.
0001493152-24-018337
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2024-06-30; filed 2024-08-08.
0001493152-24-030757
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 151 previous paragraphs and 169 current paragraphs.
80 unchanged; 52 reworded; 28 added; 14 removed; 5 previous and 9 current paragraphs rearranged.
Tables are not compared: 4 previous and 4 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (28)
Current report
On May 24, 2024, the Company provided notice to Dr. James Miser that it had elected not to renew the employment agreement between the Company and Dr. Miser pursuant to which Dr. Miser has served as the Company’s Chief Medical Officer since August 1, 2020. Accordingly, such employment expired on July 31, 2024.
Current report
On May 31, 2024, the Company entered into a Consulting Agreement (the “Schellens Agreement”) with Dr. Jan H.M. Schellens, M.D., Ph.D. Pursuant to the Schellens Agreement, effective July 1, 2024, the Company engaged Dr. Schellens as a consultant, and, effective August 1, 2024, as the Company’s Chief Medical Officer. The term of the Schellens Agreement will be in effect from July 1, 2024 until the earliest of (i) termination by either party upon sixty days’ notice, (ii) Dr. Schellens’ death or disability, or (iii) termination by the Company for breach as provided in the Schellens Agreement. Under the Schellens Agreement, Dr. Schellens will provide his services for two days per week with the specific days in each week to be based on arrangements agreed to from time to time between Dr. Schellens and the Company’s Chief Executive Officer. The Company will pay Dr. Schellens 104,000 Euros on an annual basis.
Current report
Dr. Schellens will play a leadership role in the planning, implementation and oversight of clinical trials and be responsible for assisting in the development of strategic clinical goals and the implementation and safety monitoring of investigational studies. Dr. Schellens will be the primary medical monitor for all clinical investigational studies, and for the oversight of third party CRO monitors. He will be responsible for the regulatory strategy and implementation of the strategy and the primary contact for regulators. Dr. Schellens will work closely with the Company’s Chief Executive Officer on the development of strategic goals needed to insure the timely implementation of appropriate clinical studies needed for the successful registration of therapeutics products. Dr. Schellens services will be principally rendered in the Netherlands.
Current report
Dr. Schellens, age 67, has 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. Co-author of more than 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. from January 2019 through September 2023. He 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. From 2016 to the present, he has served as a part-time Chief Medical Officer of Modra Pharmaceuticals B.V., an Amsterdam-based 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.
Current report
**Cybersecurity Risks.**The Company has established policies and processes for assessing, identifying and managing material risk from cybersecurity threats, and has integrated these processes into its overall risk management systems and processes. The Company routinely assesses material risks from cybersecurity threats, including any potential unauthorized occurrence on or conducted through its information and email systems that may result in adverse effects on the confidentiality, integrity, or availability of the Company’s information and email systems or any information residing therein. The Company conducts periodic risk assessments to identify cybersecurity threats, as well as assessments in the event of a material change in the Company’s business practices that may affect information systems that are vulnerable to such cybersecurity threats. These risk assessments include identification of reasonably foreseeable internal and external risks, the likelihood and potential damage that could result from such risks, and the sufficiency of existing policies, procedures, systems and safeguards in place to manage such risks. The Company has not encountered any cybersecurity challenges that have materially impaired its operations or financial condition. Additional information regarding risks from cybersecurity threats is provided in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023.
Current report
For the three months ended June 30, 2023, general and administrative costs were $1,242,541, which consisted of the fair value of vested stock options issued to directors and officers of $280,060, patent and licensing legal and filing fees and costs of $340,010, other consulting and professional fees of $159,361, insurance expense of $104,151, officer salaries and related costs of $216,248, cash-based director and board committee fees of $42,501, licensing and royalties of $6,233, shareholder reporting costs of $57,350, listing fees of $15,500, filing fees of $3,470, taxes and licenses of $3,769, investor relations of $9,372, rent of $1,530, conference fees of $0 and other operating costs of $2,986.
Current report
Research and Development Costs. For the three months ended June 30, 2024, research and development costs were $210,708, which consisted of clinical and related oversight costs of $97,947, regulatory service costs of $1,956, and preclinical research focused on development of additional novel anti-cancer compounds to add to the Company’s clinical pipeline of $110,805.
Current report
For the three months ended June 30, 2023, research and development costs were $427,457, which consisted of clinical and related oversight costs of $297,763, regulatory service costs of $1,740, and preclinical research focused on development of additional novel anti-cancer compounds to add to the Company’s clinical pipeline of $127,954.
Current report
Effective June 10, 2024, the Company entered into a Clinical Trial Agreement with the Netherlands Cancer Institute (“NKI”) to conduct a Phase 1b/2 clinical trial of the Company’s protein phosphatase inhibitor, LB-100, combined with atezolizumab, a PD-L1 inhibitor, the proprietary molecule of F. Hoffman-La Roche Ltd. (“Roche”), for patients with metastatic colon cancer. NKI employs Dr. René Bernards, a director of the Company since June 15, 2022. As of June 30, 2024, no costs have been incurred pursuant to this clinical trial agreement.
Current report
Six Months Ended June 30, 2024 and 2023
Current report
General and Administrative Costs. For the six months ended June 30, 2024, general and administrative costs were $1,646,263, which consisted of the fair value of vested stock options issued to directors and officers of $233,618 (including quarterly director and board committee fees of $27,500), patent and licensing legal and filing fees and costs of $146,823, other consulting and professional fees of $363,972, insurance expense of $253,727, officer salaries and related costs of $387,589, cash-based director and board committee fees of $38,819, licensing and royalties of $60,569, shareholder reporting costs of $12,749, listing fees of $24,750, filing fees of $19,053, taxes and licenses of $30,813, investor relations of $34,794, rent of $9,881, conference fees of $14,475 and other operating costs of $14,631.
Current report
For the six months ended June 30, 2023, general and administrative costs were $2,423,603, which consisted of the fair value of vested stock options issued to directors and officers of $557,040, patent and licensing legal and filing fees and costs of $657,350, other consulting and professional fees of $329,946, insurance expense of $208,305, officer salaries and related costs of $432,603, cash-based director and board committee fees of $85,001, licensing and royalties of $12,398, shareholder reporting costs of $60,896, listing fees of $31,000, filing fees of $10,195, taxes and licenses of $7,538, investor relations of $22,344, rent of $4,113, conference fees of $0 and other operating costs of $4,874.
Current report
General and administrative costs decreased by $777,340, or 32.1%, in 2024 as compared to 2023, primarily as a result of a decrease in the fair value of vested stock options issued to directors and officers of $323,422, a decrease in patent and licensing legal and filing fees and costs of $510,527, a decrease in shareholder reporting costs of $48,147, a decrease in officer salaries and related costs of $45,014, and a decrease in cash-based director and board committee fees of $46,182, offset by increases in other consulting and professional fees of $34,026, licensing and royalties of $48,171, taxes and licenses of $23,275, investor relations of $12,450, conference fees of $14,475, and an increase in insurance expense of $45,422.
Current report
Research and Development Costs. For the six months ended June 30, 2024, research and development costs were $329,772, which consisted of clinical and related oversight costs of $107,976, regulatory service costs of $2,616, and preclinical research focused on development of additional novel anti-cancer compounds to add to the Company’s clinical pipeline of $219,180.
Current report
For the six months ended June 30, 2023, research and development costs were $616,542, which consisted of clinical and related oversight costs of $393,892, regulatory service costs of $7,819, and preclinical research focused on development of additional novel anti-cancer compounds to add to the Company’s clinical pipeline of $214,831.
Current report
Effective June 10, 2024, the Company entered into a Clinical Trial Agreement with the Netherlands Cancer Institute (“NKI”) to conduct a Phase 1b/2 clinical trial of the Company’s protein phosphatase inhibitor, LB-100, combined with atezolizumab, a PD-L1 inhibitor, the proprietary molecule of F. Hoffman-La Roche Ltd. (“Roche”), for patients with metastatic colon cancer. NKI employs Dr. René Bernards, a director of the Company since June 15, 2022. As of June 30, 2024, no costs have been incurred pursuant to this clinical trial agreement.
Current report
Research and development costs decreased by $286,770, or 46.5%, in 2024 as compared to 2023, primarily as a result of a decrease in clinical and related oversight costs of $285,916.
Current report
Interest Income. For the six months ended June 30, 2024, the Company had interest income of $5,092, as compared to interest income of $7,729 for the six months ended June 30, 2023, related to the investment of the Company’s cash resources.
Current report
Net Loss. For the six months ended June 30, 2024, the Company incurred a net loss of $1,982,241, as compared to a net loss of $3,036,014 for the six months ended June 30, 2023.
Current report
**Netherlands Cancer Institute.**Effective June 10, 2024, the Company entered into a Clinical Trial Agreement with the Netherlands Cancer Institute (“NKI”) to conduct a Phase 1b clinical trial of the Company’s protein phosphatase inhibitor, LB-100, combined with atezolizumab, a PD-L1 inhibitor, the proprietary molecule of F. Hoffman-La Roche Ltd. (“Roche”), for patients with microsatellite stable metastatic colon cancer. Under the agreement, the Company will provide its lead compound, LB-100, and under a separate agreement between NKI and Roche, Roche will provide atezolizumab and financial support for the clinical trial. The Company has no obligation to and will not provide any reimbursement of clinical trial costs. Pursuant to the agreement and the protocol set forth in the agreement, the clinical trial will be conducted by NKI at NKI’s site in Amsterdam by principal investigator Neeltje Steeghs, MD, PhD, and NKI will be responsible for the recruitment of patients. The agreement provides for the protection of the respective intellectual property rights of each of the Company, NKI and Roche.
Current report
This Phase 1b clinical trial will evaluate safety, optimal dose and preliminary efficacy of LB-100 combined with atezolizumab for the treatment of patients with metastatic microsatellite stable colorectal cancer. Immunotherapy using monoclonal antibodies like atezolizumab can enhance the body’s immune response against cancer and hinder tumor growth and spread. LB-100 has been found to improve the effectiveness of anticancer drugs in killing cancer cells by inhibiting a protein called PP2A on cell surfaces. Blocking PP2A increases stress signals in tumor cells expressing the PP2A protein. Accordingly, combining atezolizumab with LB-100 may enhance treatment efficacy for metastatic colorectal cancer, as cancer cells with heightened stress signals are more vulnerable to immunotherapy.
Current report
This study comprises a dose escalation phase and a dose expansion phase. The objective of the dose escalation phase is to determine the recommended Phase 2 dose (RP2D) of LB-100 when combined with the standard dosage of atezolizumab. The dose expansion phase will further investigate the preliminary efficacy, safety, tolerability, and pharmacokinetics/dynamics of the LB-100 and atezolizumab combination. The clinical trial is scheduled to open by September 30, 2024. Patient accrual is expected to take up to 24 months, with a maximum of 37 patients with advanced colorectal cancer to be enrolled in this study.
Current report
As of June 30, 2024, no costs have been incurred pursuant to this agreement.
Current report
After evaluating patient accrual through June 30, 2024, the Company and City of Hope agreed to close the clinical trial. Pursuant to the terms of the Agreement, the Company provided notice to City of Hope of the Company’s intent to terminate the Agreement effective as of July 8, 2024. The Company is exploring alternative sites, including international locations, for the conduct of a small cell lung cancer clinical trial.
Current report
The Company’s aggregate commitment pursuant to this letter of intent, less amounts previously paid to date, totaled approximately $18,000 as of June 30, 2024, which is expected to be incurred through December 31, 2027.
Current report
This letter of intent is designed to serve as a statement of the intent to retain the oversight services of Theradex with respect to the MD Andersen clinical trial at an additional cost of approximately $72,000.
Current report
As a result of the closure of the Agreement with City of Hope effective July 8, 2024 (see “Clinical Trial Agreements – City of Hope” above), the work order agreement with Theradex to monitor this clinical trial was concurrently terminated, although nominal oversight trailing costs subsequent to June 30, 2024 are expected to be incurred relating to the closure of this study.
Current report
**Netherlands Cancer Institute.**The Company is in the process of finalizing a new work order agreement with Theradex to monitor the NKI Phase 1b clinical trial of LB-100 combined with atezolizumab, a PD-L1 inhibitor, for patients with microsatellite stable metastatic colon cancer.
Removed paragraphs (14)
Previous report
President and Chief Executive Officer
Previous report
Effective September 26, 2023, Bas van der Baan, a director of the Company since June 17, 2022, replaced the Company’s founder, Dr. John S. Kovach, as President and Chief Executive Officer. Dr. Kovach passed away on October 5, 2023. Effective October 6, 2023, Mr. van der Baan was appointed as Chairman of the Board of Directors. Dr. Kovach was also the Company’s Chief Scientific Officer.
Previous report
Enhancing immunotherapy with LB-100 is a primary strategy of the Company that could generate significant clinical and business prospects, subject to the availability of adequate financing to pursue this opportunity.
Previous report
For the three months ended March 31, 2023, general and administrative costs were $1,181,062, which consisted of the fair value of vested stock options issued to directors and officers of $276,980, patent and licensing legal and filing fees and costs of $317,340, other consulting and professional fees of $170,585, insurance expense of $104,153, officer salaries and related costs of $216,355, cash-based director and board committee fees of $42,500, licensing and royalties of $6,165, shareholder reporting costs of $3,546, listing fees of $15,500, filing fees of $6,725, taxes and licenses of $3,769, investor relations of $12,972, rent of $2,583 and other operating costs of $1,889.
Previous report
Research and Development Costs. For the three months ended March 31, 2024, research and development costs were $119,064, which consisted of clinical and related oversight costs of $10,029, regulatory service costs of $660, and preclinical research focused on development of additional novel anti-cancer compounds to add to the Company’s clinical pipeline of $108,375.
Previous report
For the three months ended March 31, 2023, research and development costs were $189,085, which consisted of clinical and related oversight costs of $96,129, regulatory service costs of $6,079, and preclinical research focused on development of additional novel anti-cancer compounds to add to the Company’s clinical pipeline of $86,877.
Previous report
The Company’s aggregate commitment pursuant to this agreement, less amounts previously paid to date, totaled approximately $2,433,000 as of March 31, 2024, which is expected to be incurred through March 31, 2026. If a significant number of patients fail during the dose-escalation process, an increase of up to 12 patients would likely be necessary, at an estimated additional cost of approximately $800,000.
Previous report
The Company currently expects that enrollment in this clinical trial will range from approximately 18 to 30 enrollees, with 24 enrollees as the most likely number. Should fewer than 42 enrollees be required, the Company has agreed to compensate City of Hope on a per enrollee basis. If a significant improvement in outcome is seen with the addition of LB-100, this would be an important advance in the treatment of a very aggressive disease.
Previous report
Primary malignant brain tumors (gliomas) are very challenging to treat. Radiation combined with the chemotherapeutic drug temozolomide has been the mainstay of therapy of the most aggressive gliomas (glioblastoma multiforme or GBM) for decades, with little further benefit gained by the addition of one or more anti-cancer drugs, but without major advances in overall survival for the majority of patients. In animal models of GBM, the Company’s novel protein phosphatase inhibitor, LB-100, has been found to enhance the effectiveness of radiation, temozolomide chemotherapy treatments and immunotherapy, raising the possibility that LB-100 may improve outcomes of standard GBM treatment in the clinic. Although LB-100 has proven safe in patients at doses associated with apparent anti-tumor activity against several human cancers arising outside the brain, the ability of LB-100 to penetrate tumor tissue arising in the brain was not known. Many drugs potentially useful for GBM treatment do not enter the brain in amounts necessary for anti-cancer action.
Previous report
During July and August 2020, the Company entered into one-year employment agreements with each of its executive officers at that time, consisting of Dr. John S. Kovach, Eric J. Forman, Dr. James S. Miser, and Robert N. Weingarten, which provided for aggregate annual cash compensation of $640,000, payable monthly. These employment agreements were automatically renewable for additional one-year periods unless terminated by either party upon 60 days written notice prior to the end of the applicable one-year period, or by death, or by termination for cause. These employment agreements were automatically renewed for additional one-year periods in July and August 2021, 2022 and 2023.
Previous report
On April 9, 2021, the Board of Directors increased the annual cash compensation of Eric J. Forman, Dr. James S. Miser, and Robert N. Weingarten under the employment agreements, such that the aggregate annual compensation for all officers increased to $775,000, effective May 1, 2021.
Previous report
Effective November 6, 2022, Mr. Forman was promoted to Vice President and Chief Operating Officer, and his annual salary was increased to $200,000.
Previous report
On September 26, 2023, the Company entered into an employment agreement with Bastiaan van der Baan to act as the Company’s President and Chief Executive Officer and as Vice Chairman of the Board of Directors, with an annual salary of $150,000. The term of the employment agreement is for three years and is automatically renewable for additional one-year periods unless terminated by either party, subject to early termination as described in the employment agreement. Under the employment agreement, Mr. van der Baan’s annual salary may be increased from time to time at the sole discretion of the Board of Directors. In addition, Mr. van der Baan will be eligible to receive an annual bonus as determined at the sole discretion of the Board of Directors. Mr. van der Baan was appointed as Chairman of the Board of Directors upon the death of Dr. Kovach, who died on October 5, 2023.
Previous report
The aggregate annual cash compensation for all officers was $700,000 as of March 31, 2024.
Reworded paragraphs (52)
Previous wording
The Company is a clinical-stage biopharmaceutical company dedicated to improving patients’ lives by developing a drug class called Protein Phosphatase 2A inhibitors. The Company’s corporate office is located in Pasadena, California.
Current wording
The Company is a clinical-stage biopharmaceutical company focused on identifying new targets for cancer drug development and developing and commercializing cancer therapies. The Company’s corporate office is located in Pasadena, California.
Previous wording
The Company’s product pipeline is primarily focused on inhibitors of Protein Phosphatase 2A, used to enhance cytotoxic agents, radiation, immune checkpoint blockers and other cancer therapies. The Company believes that inhibitors of protein phosphatases have significant therapeutic potential for a broad range of cancers. The Company is focusing on the clinical development of a specific protein phosphatase inhibitor, referred to as LB-100, which has been shown to have clinical anti-cancer activity at doses that produce little or no toxicity.
Current wording
The Company’s product pipeline is primarily focused on inhibitors of Protein Phosphatase 2A, which is used to enhance cytotoxic agents, radiation, immune checkpoint blockers and other cancer therapies. The Company believes that inhibitors of protein phosphatases have significant therapeutic potential for a broad range of cancers. The Company is focusing on the clinical development of a specific protein phosphatase inhibitor, referred to as LB-100, which has been shown to have clinical anti-cancer activity at doses that produce little or no toxicity.
Previous wording
For the three months ended March 31, 2024, the Company recorded a net loss of $971,322 and used cash in operations of $789,225. At March 31, 2024, the Company had cash of $3,414,263 available to fund its operations. Because the Company is currently engaged in various early-stage clinical trials, it is expected that it will take a significant amount of time and resources to develop any product or intellectual property capable of generating sustainable revenues. Accordingly, the Company’s business is unlikely to generate any sustainable operating revenues in the next several years and may never do so. Even if the Company is able to generate revenues through licensing its technology, product sales or other commercial activities, there can be no assurance that the Company will be able to achieve and maintain positive earnings and operating cash flows. At March 31, 2024, the Company’s remaining financial contractual commitments pursuant to clinical trial agreements and clinical trial monitoring agreements not yet incurred aggregated approximately $6,317,000, which are currently scheduled to be incurred through approximately December 31, 2027.
Current wording
For the six months ended June 30, 2024, the Company recorded a net loss of $1,982,241 and used cash in operations of $1,608,266. At June 30, 2024, the Company had cash of $2,595,222 available to fund its operations. Because the Company is currently engaged in various early-stage clinical trials, it is expected that it will take a significant amount of time and resources to develop any product or intellectual property capable of generating sustainable revenues. Accordingly, the Company’s business is unlikely to generate any sustainable operating revenues in the next several years and may never do so. Even if the Company is able to generate revenues through licensing its technology, product sales or other commercial activities, there can be no assurance that the Company will be able to achieve and maintain positive earnings and operating cash flows. At June 30, 2024, the Company’s remaining financial contractual commitments pursuant to clinical trial agreements and clinical trial monitoring agreements not yet incurred aggregated approximately $3,614,000, which are currently scheduled to be incurred through approximately December 31, 2027.
Previous wording
The Company’s consolidated financial statements have been presented on the basis that it will continue as a going concern, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. The Company has no recurring source of revenue and has experienced negative operating cash flows since inception. The Company has financed its working capital requirements through the recurring sale of its equity securities.
Current wording
The Company’s consolidated financial statements have been presented on the basis that it will continue as a going concern, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. The consolidated financial statements also do not reflect any adjustments relating to the recoverability of assets and liabilities that might be necessary if the Company is unable to continue as a going concern. The Company has no recurring source of revenues and has experienced negative operating cash flows since inception. The Company has financed its working capital requirements through the recurring sale of its equity securities.
Previous wording
Based on current operating plans, the Company estimates that its existing cash resources at March 31, 2024 will provide sufficient working capital to fund the current clinical trial program with respect to the development of the Company’s lead anti-cancer clinical compound LB-100 through approximately December 31, 2024. However, existing cash resources will not be sufficient to complete the clinical development of, and obtain regulatory approval for, the Company’s product candidate, which will require that the Company raise significant additional capital. The Company estimates that it will need to raise additional capital to fund its operations in one or more tranches by approximately September 30, 2024 in order to be able to effectively manage its current business plan during the remainder of 2024, the full year 2025, and thereafter. In addition, the Company’s operating plans may change as a result of many factors that are currently unknown and/or outside of the control of the Company, and additional funds may be needed sooner than planned. The Company is considering various strategies and alternatives to obtain the required additional capital.
Current wording
Based on current operating plans, the Company estimates that its existing cash resources at June 30, 2024 will provide sufficient working capital to fund the current clinical trial program with respect to the development of the Company’s lead anti-cancer clinical compound, LB-100, through approximately December 31, 2024. As existing cash resources will not be sufficient to complete the clinical development of, and obtain regulatory approval for, the Company’s product candidate, the Company will need to raise additional capital in one or more tranches to fund its operations in the near-term in order to be able to effectively manage its current business plan during the remainder of 2024, the full year 2025, and thereafter. In addition, the Company’s operating plans and capital requirements may change as a result of many factors that are currently unknown and/or outside of the control of the Company. The Company is considering various strategies and alternatives to obtain the required additional capital.
Previous wording
If cash resources are insufficient to satisfy the Company’s ongoing cash requirements, the Company would be required to scale back or discontinue its clinical trial program, as well as its licensing and patent prosecution efforts and its technology and product development efforts, or obtain funds, if available, through strategic alliances or joint ventures that could require the Company to relinquish rights to and/or control of LB-100, or to discontinue operations entirely.
Current wording
If cash resources are insufficient to satisfy the Company’s ongoing cash requirements, the Company would be required to scale back or discontinue its clinical trial program, or obtain funds, if available, through strategic alliances or joint ventures that could require the Company to relinquish rights to and/or control of LB-100, or to discontinue operations entirely.
Previous wording
The Company’s common stock and the warrants are traded on the Nasdaq Capital Market (“Nasdaq”) under the symbols “LIXT” and “LIXTW”, respectively. On June 2, 2023, the Company effected a 1-for-10 reverse split of its outstanding shares of common stock in order to remain in compliance with the $1.00 minimum closing bid price requirement of Nasdaq. However, there can be no assurances that the Company will be able to remain in compliance with the $1.00 minimum closing bid price requirement of Nasdaq over time, or that it will be successful in maintaining compliance with any of the other continued listing requirements of Nasdaq.
Current wording
The Company’s common stock and the warrants are traded on the Nasdaq Capital Market (“Nasdaq”) under the symbols “LIXT” and “LIXTW”, respectively. On June 2, 2023, the Company effected a 1-for-10 reverse split of its outstanding shares of common stock in order to remain in compliance with the $1.00 minimum closing bid price requirement of Nasdaq. However, there can be no assurances that the Company will be able to remain in compliance with the $1.00 minimum closing bid price requirement of Nasdaq over time. In addition, Nasdaq has other continued listing requirements, one of which is maintaining a minimum net stockholders’ equity of $2,500,000. At June 30, 2024, the Company’s net stockholders equity was $2,246,139.
Previous wording
Information with respect to recent accounting pronouncements is provided at Note 2 to the condensed consolidated financial statements for the three months ended March 31, 2024 and 2023 included elsewhere in this document.
Current wording
Information with respect to recent accounting pronouncements is provided at Note 2 to the condensed consolidated financial statements for the three months and six months ended June 30, 2024 and 2023 included elsewhere in this document.
Previous wording
Information with respect to concentration of risk is provided at Note 2 to the condensed consolidated financial statements for the three months ended March 31, 2024 and 2023 included elsewhere in this document.
Current wording
Information with respect to concentration of risk is provided at Note 2 to the condensed consolidated financial statements for the three months and six months ended June 30, 2024 and 2023 included elsewhere in this document.
Previous wording
During the three months ended March 31, 2024 and 2023, patent and licensing legal and filing fees and costs related to the development and protection of its intellectual property were $83,211 and $317,340, respectively, a decrease of $234,129, or 73.8%, in 2024 as compared to 2023.
Current wording
During the three months ended June 30, 2024 and 2023, patent and licensing legal and filing fees and costs related to the development and protection of its intellectual property were $63,612 and $340,010, respectively, a decrease of $276,398, or 81.3%, in 2024 as compared to 2023.
Previous wording
In September 2023, the Company appointed a new President and Chief Executive Officer, who, with the assistance of the Company’s management, Board of Directors and patent legal counsel, conducted a comprehensive analysis of the Company’s extensive patent portfolio in order to implement a program to balance patent prosecution costs with intellectual property protection benefits. As a result, the Company identified certain patent filings that it does not intend to continue to support in 2024 and thereafter. The Company expects that patent and licensing legal and filing fees and costs will continue to be a significant continuing cost in 2024 and thereafter as the Company continues to develop and expand its patent portfolio related to the clinical development of LB-100.
Current wording
In September 2023, the Company appointed a new President and Chief Executive Officer, who, with the assistance of the Company’s management, Board of Directors and patent legal counsel, conducted a comprehensive analysis of the Company’s extensive patent portfolio in order to implement a program to balance patent prosecution costs with intellectual property protection benefits. As a result, the Company identified certain patent filings that it does not intend to continue to support in 2024 and thereafter. In addition, effective July 1, 2024, the Company changed its intellectual property law firm. The Company expects that patent and licensing legal and filing fees and costs will continue to be a significant continuing cost in 2024 and thereafter as the Company continues to develop and expand its patent portfolio related to the clinical development of LB-100.
Previous wording
The Company accounts for warrants as either equity-classified or liability-classified instruments based on an assessment of the warrant’s specific terms and applicable authoritative guidance in Accounting Standards Codification (“ASC”) 480, Distinguishing Liabilities from Equity (“ASC 480”), and ASC 815, Derivatives and Hedging (“ASC 815”). The assessment considers whether the warrants are freestanding financial instruments pursuant to ASC 480, meet the definition of a liability pursuant to ASC 480, and whether the warrants meet all of the requirements for equity classification under ASC 815, including whether the warrants are indexed to the Company’s own common stock and whether the warrant holders could potentially require “net cash settlement” in a circumstance outside of the Company’s control, among other conditions for equity classification. The Company has determined that the warrants issued in the July 20, 2023 equity financing meet the requirements for equity classification. This assessment, which requires the use of professional judgment, is conducted when the warrants are issued and at the end each subsequent quarterly period while the warrants are outstanding. For issued or modified warrants that meet all of the criteria for equity classification, the warrants are required to be recorded as a component of additional paid-in capital at the time of issuance. For issued or modified warrants that do not meet all of the criteria for equity classification, the warrants are required to be liability classified and recorded at their initial fair value on the date of issuance and remeasured at fair value at each balance sheet date thereafter. Changes in the estimated fair value of the warrants are recognized as a non-cash gain or loss on the statements of operations.
Current wording
The Company accounts for warrants as either equity-classified or liability-classified instruments based on an assessment of the warrant’s specific terms and applicable authoritative guidance in Accounting Standards Codification (“ASC”) 480, Distinguishing Liabilities from Equity (“ASC 480”), and ASC 815, Derivatives and Hedging (“ASC 815”). The assessment considers whether the warrants are freestanding financial instruments pursuant to ASC 480, meet the definition of a liability pursuant to ASC 480, and whether the warrants meet all of the requirements for equity classification under ASC 815, including whether the warrants are indexed to the Company’s own common stock and whether the warrant holders could potentially require “net cash settlement” in a circumstance outside of the Company’s control, among other conditions for equity classification. The Company has determined that the warrants issued in the July 20, 2023 equity financing meet the requirements for equity classification. This assessment, which requires the use of professional judgment, is conducted when the warrants are issued and at the end each subsequent quarterly period while the warrants are outstanding. For issued or modified warrants that meet all of the criteria for equity classification, the warrants are required to be recorded as a component of additional paid-in capital at the time of issuance. For issued or modified warrants that do not meet all of the criteria for equity classification, the warrants are required to be liability classified and recorded at their initial fair value on the date of issuance and remeasured at fair value at each balance sheet date thereafter. Changes in the estimated fair value of the warrants that are liability classified are recognized as a non-cash gain or loss in the statement of operations.
Previous wording
General and Administrative Costs. For the three months ended March 31, 2024, general and administrative costs were $847,815, which consisted of the fair value of vested stock options issued to directors and officers of $102,927, patent and licensing legal and filing fees and costs of $83,211, other consulting and professional fees of $172,443, insurance expense of $126,854, officer salaries and related costs of $195,618, cash-based director and board committee fees of $38,819, licensing and royalties of $53,113, shareholder reporting costs of $8,938, listing fees of $12,375, filing fees of $7,734, taxes and licenses of $15,406, investor relations of $17,397, rent of $5,651 and other operating costs of $7,329.
Current wording
General and Administrative Costs. For the three months ended June 30, 2024, general and administrative costs were $798,448, which consisted of the fair value of vested stock options issued to directors and officers of $130,691 (including quarterly director and board committee fees of $27,500), patent and licensing legal and filing fees and costs of $63,612, other consulting and professional fees of $191,529, insurance expense of $126,873, officer salaries and related costs of $191,971, cash-based director and board committee fees of $0, licensing and royalties of $7,455, shareholder reporting costs of $3,811, listing fees of $12,375, filing fees of $11,319, taxes and licenses of $15,406, investor relations of $17,397, rent of $4,230, conference fees of $14,475 and other operating costs of $7,304.
Previous wording
General and administrative costs decreased by $333,247, or 28.2%, in 2024 as compared to 2023, primarily as a result of a decrease in the fair value of vested stock options issued to directors and officers of $174,053, a decrease in patent and licensing legal and filing fees and costs of $234,129, a decrease in officer salaries and related costs of $20,737, offset by increases in licensing and royalties of $46,948, an increase in insurance of $22,701, and an increase in taxes and licenses of $11,637.
Current wording
General and administrative costs decreased by $444,093, or 35.7%, in 2024 as compared to 2023, primarily as a result of a decrease in the fair value of vested stock options issued to directors and officers of $149,369, a decrease in patent and licensing legal and filing fees and costs of $276,398, a decrease in shareholder reporting of $53,539, a decrease in officer salaries and related costs of $24,277, and a decrease in cash-based director and board committee fees of $42,501, offset by increases in other consulting and professional fees of $32,168, and an increase in insurance expense of $22,722.
Previous wording
Included in preclinical research costs for the three months ended March 31, 2024 and 2023 were $66,965 and $52,203, respectively, of costs paid to the Netherlands Cancer Institute, which employs Dr. René Bernards, a director of the Company since June 15, 2022. On October 8, 2021, the Company entered into a Development Collaboration Agreement with the Netherlands Cancer Institute, Amsterdam, one of the world’s leading comprehensive cancer centers, and Oncode Institute, Utrecht, a major independent cancer research center, to identify the most promising drugs to be combined with LB-100, and potential LB-100 analogues, to be used to treat a range of cancers, as well as to identify the specific molecular mechanisms underlying the identified combinations.
Current wording
Included in preclinical research costs for the three months ended June 30, 2024 and 2023 were $67,119 and $53,178, respectively, of costs paid to the Netherlands Cancer Institute, On October 8, 2021, the Company entered into a Development Collaboration Agreement with the Netherlands Cancer Institute, Amsterdam, one of the world’s leading comprehensive cancer centers, and Oncode Institute, Utrecht, a major independent cancer research center, to identify the most promising drugs to be combined with LB-100, and potential LB-100 analogues, to be used to treat a range of cancers, as well as to identify the specific molecular mechanisms underlying the identified combinations.
Previous wording
Research and development costs decreased by $70,021, or 37.0%, in 2024 as compared to 2023, as a result of a decrease in clinical and related oversight costs of $86,100, and a decrease in regulatory service costs of $5,419, offset by an increase in preclinical research focused on development of additional novel anti-cancer compounds to add to the Company’s clinical pipeline of $21,498.
Current wording
Research and development costs decreased by $216,749, or 50.7%, in 2024 as compared to 2023, as a result of a decrease in clinical and related oversight costs of $199,816, and a decrease in preclinical research focused on development of additional novel anti-cancer compounds to add to the Company’s clinical pipeline of $17,149.
Previous wording
Interest Income. For the three months ended March 31, 2024, the Company had interest income of $2,859, as compared to interest income of $5,015 for the three months ended March 31, 2023, related to the investment of funds generated by the Company’s financing activities.
Current wording
Interest Income. For the three months ended June 30, 2024, the Company had interest income of $2,233, as compared to interest income of $2,714 for the three months ended June 30, 2023, related to the investment of the Company’s cash resources.
Previous wording
Interest Expense. For the three months ended March 31, 2024, the Company had interest expense of $7,186, as compared to interest expense of $3,861 for the three months ended March 31, 2023, related to the financing of the premium for the Company’s directors and officers liability insurance policy.
Current wording
Interest Expense. For the three months ended June 30, 2024, the Company had interest expense of $4,154, as compared to interest expense of $1,948 for the three months ended June 30, 2023, related to the financing of the premium for the Company’s directors and officers liability insurance policy.
Previous wording
Foreign Currency Gain (Loss). For the three months ended March 31, 2024, the Company had a foreign currency loss of $116, as compared to a foreign currency gain of $1,334 for the three months ended March 31, 2023, from foreign currency transactions.
Current wording
Foreign Currency Gain. For the three months ended June 30, 2024, the Company had a foreign currency gain of $158, as compared to a foreign currency gain of $877 for the three months ended June 30, 2023, from foreign currency transactions.
Previous wording
Net Loss. For the three months ended March 31, 2024, the Company incurred a net loss of $971,322, as compared to a net loss of $1,367,659 for the three months ended March 31, 2023.
Current wording
Net Loss. For the three months ended June 30, 2024, the Company incurred a net loss of $1,010,919, as compared to a net loss of $1,668,355 for the three months ended June 30, 2023.
Previous wording
At March 31, 2024, the Company had working capital of $3,126,367, as compared to working capital of $3,994,762 at December 31, 2023, reflecting a decrease in working capital of $868,395 for the three months ended March 31, 2024. The decrease in working capital during the three months ended March 31, 2024 was primarily the result of the funding of the Company’s ongoing research and development activities and other ongoing operating expenses, including maintaining and developing the Company’s patent portfolio. At March 31, 2024, the Company had cash of $3,414,263 available to fund its operations.
Current wording
At June 30, 2024, the Company had working capital of $2,246,139, as compared to working capital of $3,994,762 at December 31, 2023, reflecting a decrease in working capital of $1,748,623 for the six months ended June 30, 2024. The decrease in working capital during the six months ended June 30, 2024 was primarily the result of the funding of the Company’s ongoing research and development activities and other ongoing operating expenses, including maintaining and developing the Company’s patent portfolio. At June 30, 2024, the Company had cash of $2,595,222 available to fund its operations.
Previous wording
Based on current operating plans, the Company estimates that its existing cash resources at March 31, 2024 will provide sufficient working capital to fund the current clinical trial program with respect to the development of the Company’s lead anti-cancer clinical compound LB-100 through approximately December 31, 2024. However, existing cash resources will not be sufficient to complete the clinical development of, and obtain regulatory approval for, the Company’s product candidate, which will require that the Company raise significant additional capital. The Company estimates that it will need to raise additional capital to fund its operations in one or more tranches by approximately September 30, 2024 in order to be able to effectively manage its current business plan during the remainder of 2024, the full year 2025, and thereafter. In addition, the Company’s operating plans may change as a result of many factors that are currently unknown and/or outside of the control of the Company, and additional funds may be needed sooner than planned. The Company is considering various strategies and alternatives to obtain the required additional capital.
Current wording
Based on current operating plans, the Company estimates that its existing cash resources at June 30, 2024 will provide sufficient working capital to fund the current clinical trial program with respect to the development of the Company’s lead anti-cancer clinical compound, LB-100, through approximately December 31, 2024. As existing cash resources will not be sufficient to complete the clinical development of, and obtain regulatory approval for, the Company’s product candidate, the Company will need to raise additional capital in one or more tranches to fund its operations in the near-term in order to be able to effectively manage its current business plan during the remainder of 2024, the full year 2025, and thereafter. In addition, the Company’s operating plans and capital requirements may change as a result of many factors that are currently unknown and/or outside of the control of the Company. The Company is considering various strategies and alternatives to obtain the required additional capital.
Previous wording
At March 31, 2024, the Company’s remaining financial contractual commitments pursuant to clinical trial agreements and clinical trial monitoring agreements not yet incurred aggregated $6,317,000, which are currently scheduled to be incurred through approximately December 31, 2027.
Current wording
At June 30, 2024, the Company’s remaining financial contractual commitments pursuant to clinical trial agreements and clinical trial monitoring agreements not yet incurred aggregated $3,614,000, which are currently scheduled to be incurred through approximately December 31, 2027.
Previous wording
Operating Activities. For the three months ended March 31, 2024, operating activities utilized cash of $789,225, as compared to utilizing cash of $1,271,369 for the three months ended March 31, 2023, to fund the Company’s ongoing research and development activities and to fund its other ongoing operating expenses, including maintaining and developing its patent portfolio.
Current wording
Operating Activities. For the six months ended June 30, 2024, operating activities utilized cash of $1,608,266, as compared to utilizing cash of $2,446,753 for the six months ended June 30, 2023, to fund the Company’s ongoing research and development activities and to fund its other ongoing operating expenses, including maintaining and developing its patent portfolio.
Previous wording
Investing Activities. For the three months ended March 31, 2024 and 2023, the Company had no investing activities.
Current wording
Investing Activities. For the six months ended June 30, 2024 and 2023, the Company had no investing activities.
Previous wording
Financing Activities. For the three months ended March 31, 2024, the Company had no financing activities. For the three months ended March 31, 2023, financing activities consisted of $6,281 from the exercise of common stock options.
Current wording
Financing Activities. For the six months ended June 30, 2024, the Company had no financing activities. For the six months ended June 30, 2023, financing activities consisted of $6,281 from the exercise of common stock options.
Previous wording
At March 31, 2024, the Company’s remaining financial contractual commitments pursuant to clinical trial agreements and clinical trial monitoring agreements not yet incurred, as described below, aggregated $6,317,000, including clinical trial agreements of $5,930,000 and clinical trial monitoring agreements of $387,000, which, based on current estimates, are currently scheduled to be incurred through approximately December 31, 2027. The Company’s ability to conduct and fund these contractual commitments is subject to the timely availability of sufficient capital to fund such expenditures, as well as any changes in the allocation or reallocation of such funds to the Company’s current or future clinical trial programs. The Company expects that the full amount of these expenditures will be incurred only if such clinical trial programs are conducted as originally designed and their respective enrollments and duration are not modified or reduced. Clinical trial programs, such as the types that the Company is engaged in, can be highly variable and can frequently involve a series of changes and modifications over time as clinical data are obtained and analyzed, and are frequently modified, suspended or terminated before the clinical trial endpoint is reached. Accordingly, such contractual commitments as discussed herein should be considered as estimates only based on current clinical assumptions and conditions and are typically subject to significant modifications and revisions over time.
Current wording
At June 30, 2024, the Company’s remaining financial contractual commitments pursuant to clinical trial agreements and clinical trial monitoring agreements not yet incurred, as described below, aggregated $3,614,000, including clinical trial agreements of $3,467,000 and clinical trial monitoring agreements of $147,000, which, based on current estimates, are currently scheduled to be incurred through approximately December 31, 2027. The Company’s ability to conduct and fund these contractual commitments is subject to the timely availability of sufficient capital to fund such expenditures, as well as any changes in the allocation or reallocation of such funds to the Company’s current or future clinical trial programs. The Company expects that the full amount of these expenditures will be incurred only if such clinical trial programs are conducted as originally designed and their respective enrollments and duration are not modified or reduced. Clinical trial programs, such as the types that the Company is engaged in, can be highly variable and can frequently involve a series of changes and modifications over time as clinical data is obtained and analyzed, and is frequently modified, suspended or terminated, in part based on receipt or lack of receipt of an indication of clinical benefit or activity, before the clinical trial endpoint is reached. Accordingly, such contractual commitments as discussed herein should be considered as estimates only based on current clinical assumptions and conditions and are typically subject to significant modifications and revisions over time.
Previous wording
The following is a summary of the contractual clinical trials discussed below as of March 31, 2024:
Current wording
The following is a summary of the Company’s ongoing contractual clinical trials described below as of June 30, 2024:
Previous wording
**City of Hope.**Effective January 18, 2021, the Company executed a Clinical Research Support Agreement with the City of Hope National Medical Center, an NCI-designated comprehensive cancer center, and City of Hope Medical Foundation (collectively, “City of Hope”), to carry out a Phase 1b clinical trial of LB-100, the Company’s first-in-class protein phosphatase inhibitor, combined with an FDA-approved standard regimen for treatment of 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 standard of care regimen, to previously untreated ED-SCLC patients. The dose of LB-100 will be escalated with the standard fixed doses of the 3-drug regimen to reach a recommended Phase 2 dose (“RP2D”). Patient entry will be expanded so that a total of 12 patients will be evaluable at the RP2D to confirm the safety of the LB-100 combination and to look for potential therapeutic activity as assessed by objective response rate, duration of overall response, progression-free survival, and overall survival.
Current wording
**City of Hope.**Effective January 18, 2021, the Company executed a Clinical Research Support Agreement (the “Agreement”) with the City of Hope National Medical Center, an NCI-designated comprehensive cancer center, and City of Hope Medical Foundation (collectively, “City of Hope”), to carry out a Phase 1b clinical trial of LB-100, the Company’s first-in-class protein phosphatase inhibitor, combined with an FDA-approved standard regimen for treatment of untreated extensive-stage disease small cell lung cancer (“ED-SCLC”). LB-100 was given in combination with carboplatin, etoposide and atezolizumab, an FDA-approved standard of care regimen, to previously untreated ED-SCLC patients. The LB-100 dose was to be escalated with the standard fixed doses of the 3-drug regimen to reach a recommended Phase 2 dose (“RP2D”). Patient entry was to be expanded so that a total of 12 patients would be evaluable at the RP2D to confirm the safety of the LB-100 combination and to look for potential therapeutic activity as assessed by objective response rate, duration of overall response, progression-free survival, and overall survival.
Previous wording
The clinical trial was initiated on March 9, 2021, with patient accrual expected to take approximately two years to complete. Because patient accrual was slower than expected, effective March 6, 2023, the Company and City of Hope added the Sarah Cannon Research Institute (“SCRI”), Nashville, Tennessee, to the ongoing Phase 1b clinical trial. The Company and City of Hope are continuing efforts to increase patient accrual by adding additional sites and by modifying the protocol to increase the number of patients eligible for the clinical trial. The impact of these efforts to increase patient accrual and to decrease time to completion will be evaluated over the next two quarters.
Current wording
The clinical trial was initiated on March 9, 2021, with patient accrual expected to take approximately two years to complete. Because patient accrual was slower than expected, effective March 6, 2023, the Company and City of Hope added the Sarah Cannon Research Institute (“SCRI”), Nashville, Tennessee, to the ongoing Phase 1b clinical trial. The Company and City of Hope continued efforts to increase patient accrual by adding additional sites and by modifying the protocol to increase the number of patients eligible for the clinical trial. The impact of these efforts to increase patient accrual and to decrease time to completion was evaluated in subsequent quarters.
Previous wording
During the three months ended March 31, 2024 and 2023, the Company did not incur any costs pursuant to this agreement. As of March 31, 2024, total costs of $447,512 have been incurred pursuant to this agreement.
Current wording
During the three months ended June 30, 2024 and 2023, the Company incurred costs of $78,015 and $0, respectively, pursuant to this Agreement. During the six months ended June 30, 2024 and 2023, the Company incurred costs of $78,015 and $69,001, respectively, pursuant to this Agreement. As of June 30, 2024, total costs of $525,528 had been incurred pursuant to this Agreement.
Previous wording
In order to manufacture a new inventory supply of LB-100 for the GEIS clinical trial, the Company engaged a number of vendors to carry out the multiple tasks needed to make and gain approval of a new clinical product for investigational study in Spain. These tasks included the synthesis under good manufacturing practices (GMP) of the active pharmacologic ingredient (API), with documentation of each of the steps involved by an independent auditor. The API was then transferred to a vendor that prepares the clinical drug product, also under GMP conditions documented by an independent auditor. The clinical drug product was then sent to a vendor to test for purity and sterility, provide appropriate labels, store the drug, and distribute the drug to the clinical centers for use in the clinical trials. A formal application documenting all steps taken to prepare the clinical drug product for clinical use was submitted to the appropriate regulatory authorities for review and approval before being used in a clinical trial.
Current wording
In order to manufacture a new inventory supply of LB-100 for the GEIS clinical trial, the Company engaged a number of vendors to carry out the multiple tasks needed to make and gain approval of a new clinical product for investigational study in Spain. These tasks included the synthesis under good manufacturing practice (GMP) of the active pharmaceutical ingredient (API), with documentation of each of the steps involved by an independent auditor. The API was then transferred to a vendor that prepares the clinical drug product, also under GMP conditions documented by an independent auditor. The clinical drug product was then sent to a vendor to test for purity and sterility, provide appropriate labels, store the drug, and distribute the drug to the clinical centers for use in the clinical trials. A formal application documenting all steps taken to prepare the clinical drug product for clinical use was submitted to the appropriate regulatory authorities for review and approval before being used in a clinical trial.
Previous wording
As of December 31, 2023, this program to provide new inventory of the clinical drug product for the Spanish Sarcoma Group study, and potentially for subsequent multiple trials within the European Union, had cost approximately $1,144,000. Although the production of new inventory has been completed, nominal trailing costs subsequent to March 31, 2024 may be incurred.
Current wording
As of December 31, 2023, this program to provide new inventory of the clinical drug product for the Spanish Sarcoma Group study, and potentially for subsequent multiple trials within the European Union, had cost approximately $1,144,000.
Previous wording
On October 13, 2022, the Company announced that the Spanish Agency for Medicines and Health Products (Agencia Española de Medicamentos y Productos Sanitarios or “AEMPS”) had authorized a Phase 1b/randomized Phase 2 study of LB-100, the Company’s lead clinical compound, plus doxorubicin, versus doxorubicin alone, the global standard for initial treatment of advanced soft tissue sarcomas (ASTS). Consequently, this clinical trial commenced during the quarter ended June 30, 2023 and is expected to be completed and a report prepared by December 31, 2026. In April 2023, GEIS completed its first site initiation visit in preparation for the clinical trial at Fundación Jiménez Díaz University Hospital (Madrid). Up to 170 patents will be entered into the clinical trial. The Phase 1b portion of the protocol is expected to be completed by June 30, 2024, at which time the Company expects to have data on toxicity from this portion of the clinical trial, and subject to clinical results, anticipates that it will be able to proceed to the related Phase 2 portion of the study.
Current wording
On October 13, 2022, the Company announced that the Spanish Agency for Medicines and Health Products (Agencia Española de Medicamentos y Productos Sanitarios or “AEMPS”) had authorized a Phase 1b/randomized Phase 2 study of LB-100, the Company’s lead clinical compound, plus doxorubicin, versus doxorubicin alone, the global standard for initial treatment of ASTS. Consequently, this clinical trial commenced during the quarter ended June 30, 2023 and is expected to be completed and a report prepared by December 31, 2026. In April 2023, GEIS completed its first site initiation visit in preparation for the clinical trial at Fundación Jiménez Díaz University Hospital (Madrid). Up to 170 patents will be entered into the clinical trial. The recruitment for the Phase 1b portion of the protocol was completed during the quarter ended June 30, 2024. The Company expects to have data on toxicity and preliminary efficacy from this portion of the clinical trial in the quarter ending December 31, 2024, and subject to clinical results and the availability of working capital resources, anticipates that it will then be in a position to decide whether to proceed to the related Phase 2 portion of the study.
Previous wording
The interim analysis of this clinical trial will be done before full accrual of patients is completed to determine whether the study has the possibility of showing superiority of the combination of LB-100 plus doxorubicin compared to doxorubicin alone. A positive study would have the potential to change the standard therapy for this disease after four decades of failure to improve the marginal benefit of doxorubicin alone.
Current wording
The interim analysis of the Phase 2 portion of this clinical trial will be done before full accrual of patients is completed to determine whether the study has the possibility of showing superiority of the combination of LB-100 plus doxorubicin compared to doxorubicin alone. A positive study would have the potential to change the standard therapy for this disease after four decades of failure to improve the marginal benefit of doxorubicin alone.
Previous wording
The Company’s agreement with GEIS provides for various payments based on achieving specific milestones over the term of the agreement. During the three months ended March 31, 2024 and 2023, the Company did not incur any costs pursuant to this agreement. Such costs, when incurred, are included in research and development costs in the Company’s consolidated statements of operations. Through March 31, 2024, the Company has paid GEIS an aggregate of $684,652 for work done under this agreement through the fourth milestone.
Current wording
The Company’s agreement with GEIS provides for various payments based on achieving specific milestones over the term of the agreement. During the three months ended June 30, 2024 and 2023, the Company incurred costs of $0 and $268,829, respectively, pursuant to this agreement. During the six months ended June 30, 2024 and 2023, the Company incurred costs of $0 and $268,829, respectively, pursuant to this agreement. Through June 30, 2024, the Company has incurred charges of $684,652 for work done under this agreement through the fourth milestone.
Previous wording
The Company’s aggregate commitment pursuant to this agreement, less amounts previously paid to date, totaled approximately $3,497,000 as of March 31, 2024, which is expected to be incurred through December 31, 2027. As the work is being conducted in Europe and is paid for in Euros, final costs are subject to foreign currency fluctuations between the United States Dollar and the Euro. Such fluctuations are recorded in the consolidated statements of operations as foreign currency gain or loss, as appropriate.
Current wording
The Company’s aggregate commitment pursuant to this agreement, less amounts previously paid to date, totaled approximately $3,467,000 (consisting of $267,000 for the Phase 1b portion and $3,200,000 for the Phase 2 portion) as of June 30, 2024, which is scheduled to be incurred through December 31, 2027. As the work is being conducted in Europe and is paid for in Euros, final costs are subject to foreign currency fluctuations between the United States Dollar and the Euro. Such fluctuations are recorded in the consolidated statements of operations as foreign currency gain or loss, as appropriate, and have not been significant.
Previous wording
MD Anderson Cancer Center Clinical Trial. On September 20, 2023, the Company announced an investigator-initiated Phase 1b/2 collaborative clinical trial to assess whether adding LB-100 to a human programmed death receptor-1 (“PD-1”) blocking antibody of GSK plc (“GSK”), dostarlimab-gxly, may enhance the effectiveness of immunotherapy in the treatment of ovarian clear cell carcinoma (“OCCC”). The clinical trial is being sponsored by The University of Texas MD Anderson Cancer Center (“MD Anderson”) and is being conducted at The University of Texas - MD Anderson Cancer Center. The Company is providing LB-100 and GSK is providing dostarlimab-gxly and financial support for the clinical trial. On January 29, 2024, the Company announced the entry of the first patient into this clinical trial. The Company currently expects that this clinical trial will be completed by December 31, 2025.
Current wording
MD Anderson Cancer Center Clinical Trial. On September 20, 2023, the Company announced an investigator-initiated Phase 1b/2 collaborative clinical trial to assess whether adding LB-100 to a human programmed death receptor-1 (“PD-1”) blocking antibody of GSK plc (“GSK”), dostarlimab-gxly, may enhance the effectiveness of immunotherapy in the treatment of ovarian clear cell carcinoma (“OCCC”). The study objective is to determine the overall survival (“OS”) of patients with OCCC. The clinical trial is being sponsored by The University of Texas MD Anderson Cancer Center (“MD Anderson”) and is being conducted at The University of Texas - MD Anderson Cancer Center. The Company is providing LB-100 and GSK is providing dostarlimab-gxly and financial support for the clinical trial. On January 29, 2024, the Company announced the entry of the first patient into this clinical trial. The Company currently expects that this clinical trial will be completed by December 31, 2027.
Previous wording
During the three months ended March 31, 2024 and 2023, the Company incurred costs of $0 and $6,000, respectively, pursuant to this agreement, which have been included in research and development costs in the Company’s consolidated statements of operations. As of March 31, 2024, total costs of $147,239 have been incurred pursuant to this agreement.
Current wording
During the three months ended June 30, 2024 and 2023, the Company incurred costs of $0 and $6,000, respectively, pursuant to this agreement. During the six months ended June 30, 2024 and 2023, the Company incurred costs of $0 and $12,000, respectively, pursuant to this agreement. As of June 30, 2024, total costs of $147,239 had been incurred pursuant to this agreement.
Previous wording
The NCI study was designed to determine the extent to which LB-100 enters recurrent malignant gliomas. Patients having surgery to remove one or more tumors received one dose of LB-100 prior to surgery and had blood and tumor tissue analyzed to determine the amount of LB-100 present and to determine whether the cells in the tumors showed the biochemical changes expected to be present if LB-100 reached its molecular target. As a result of the innovative design of the NCI study, it was believed that data from a few patients would be sufficient to provide a sound rationale for conducting a larger clinical trial to determine the effectiveness of adding LB-100 to the standard treatment regimen for GBMs. Blood and brain tumor tissue were analyzed from seven patients after intravenous infusion of a single dose of LB-100. Results of the investigation demonstrated that there was virtually no entry of LB-100 into the brain tumor tissue. Accordingly, alternative methods of drug delivery will be required to determine if LB-100 has meaningful clinical anti-cancer activity against glioblastoma multiforme and other aggressive brain tumors.
Current wording
**National Cancer Institute Pharmacologic Clinical Trial.**In May 2019, the National Cancer Institute (“NCI”) initiated a glioblastoma (“GBM”) pharmacologic clinical trial. This study was being conducted and funded by the NCI under a Cooperative Research and Development Agreement, with the Company responsible for providing the LB-100 clinical compound. The NCI study was designed to determine the extent to which LB-100 enters recurrent malignant gliomas. Patients having surgery to remove one or more tumors received one dose of LB-100 prior to surgery and had blood and tumor tissue analyzed to determine the amount of LB-100 present and to determine whether the cells in the tumors showed the biochemical changes expected to be present if LB-100 reached its molecular target. As a result of the innovative design of the NCI study, it was believed that data from a few patients would be sufficient to provide a sound rationale for conducting a larger clinical trial to determine the effectiveness of adding LB-100 to the standard treatment regimen for GBMs. Blood and brain tumor tissue were analyzed from seven patients after intravenous infusion of a single dose of LB-100. Results of the investigation demonstrated that there was virtually no entry of LB-100 into the brain tumor tissue. Accordingly, alternative methods of drug delivery will be required to determine if LB-100 has meaningful clinical anti-cancer activity against glioblastoma multiforme and other aggressive brain tumors. The Company is considering an additional clinical study to address the delivery of LB-100 to the brain.
Showing the first 40 of 52 pairs. Open the source sections for the rest.
Rearranged current paragraphs (9)
Current report — wording carried from elsewhere
During the six months ended June 30, 2024 and 2023, patent and licensing legal and filing fees and costs related to the development and protection of its intellectual property were $146,823 and $657,350, respectively, a decrease of $510,527, or 77.7%, in 2024 as compared to 2023.
Current report — wording carried from elsewhere
Three Months Ended June 30, 2024 and 2023
Current report — wording carried from elsewhere
Revenues. The Company did not have any revenues for the six months ended June 30, 2024 and 2023.
Current report — wording carried from elsewhere
Included in preclinical research costs for the six months ended June 30, 2024 and 2023 were $134,084 and $105,382, respectively, of costs paid to the Netherlands Cancer Institute, On October 8, 2021, the Company entered into a Development Collaboration Agreement with the Netherlands Cancer Institute, Amsterdam, one of the world’s leading comprehensive cancer centers, and Oncode Institute, Utrecht, a major independent cancer research center, to identify the most promising drugs to be combined with LB-100, and potential LB-100 analogues, to be used to treat a range of cancers, as well as to identify the specific molecular mechanisms underlying the identified combinations.
Current report — wording carried from elsewhere
On October 3, 2023, the Company entered into Amendment No. 2 to the Development Collaboration Agreement with the Netherlands Cancer Institute, which provides for additional research activities, extends the termination date of the Development Collaboration Agreement by two years to October 8, 2026, and added 500,000 Euros to the operating budget being funded by the Company (see “Principal Commitments – Other Significant Agreements and Contracts – Netherlands Cancer Institute” below).
Current report — wording carried from elsewhere
Interest Expense. For the six months ended June 30, 2024, the Company had interest expense of $11,340, as compared to interest expense of $5,809 for the six months ended June 30, 2023, related to the financing of the premium for the Company’s directors and officers liability insurance policy.
Current report — wording carried from elsewhere
Foreign Currency Gain. For the six months ended June 30, 2024, the Company had a foreign currency gain of $42, as compared to a foreign currency gain of $2,211 for the six months ended June 30, 2023, from foreign currency transactions.
Current report — wording carried from elsewhere
MD Anderson Cancer Center Clinical Trial. On May 15, 2024, the Company signed a letter of intent with Theradex to monitor the MD Andersen investigator-initiated Phase 1b/2 collaborative clinical trial to assess whether adding LB-100 to a human programmed death receptor-1 (“PD-1”) blocking antibody of GSK plc (“GSK”), dostarlimab-gxly, may enhance the effectiveness of immunotherapy in the treatment of ovarian clear cell carcinoma (“OCCC”). Costs under this letter of intent are estimated to be approximately $23,000. During the three months and six months ended June 30, 2024, the Company incurred costs of $8,228 pursuant to this letter of intent. As of June 30, 2024, total costs of $8,228 have been incurred pursuant to this letter of intent.
Current report — wording carried from elsewhere
The Company recorded charges to operations pursuant to this Collaboration Agreement of $7,200 and $30,000 during the three months ended June 30, 2024 and 2023, respectively, which were included in research and development costs in the consolidated statements of operations. The Company recorded charges to operations pursuant to this Collaboration Agreement of $27,200 and $60,000 during the six months ended June 30, 2024 and 2023, respectively, which were included in research and development costs in the consolidated statements of operations.
Rearranged previous paragraphs (5)
Previous report — wording carried elsewhere
Effective February 23, 2024, the Company entered into a Patent License Agreement (the “License Agreement”) with the National Institute of Neurological Disorders and Stroke (“NINDS”) and the National Cancer Institute (“NCI”), each an institute or center of the National Institute of Health (“NIH”). Pursuant to the License Agreement, the Company has licensed on an exclusive basis the NIH’s intellectual property rights claimed for a Cooperative Research and Development Agreement (“CRADA”) subject invention co-developed with the Company, and the licensed field of use, which focuses on promoting anti-cancer activity alone, or in combination with standard anti-cancer drugs. The scope of this clinical research extends to checkpoint inhibitors, immunotherapy, and radiation for the treatment of cancer. The License Agreement is effective, and shall extend, on a licensed product, licensed process, and country basis, until the expiration of the last-to-expire valid claim of the jointly owned licensed patent rights in each such country in the licensed territory, estimated at twenty years, unless sooner terminated. See “Principal Commitments – Patent and Licensing Agreements – National Institute of Health” below for additional information on this License Agreement.
Previous report — wording carried elsewhere
The Company is a clinical-stage biopharmaceutical company dedicated to improving patients’ lives by developing a drug class called Protein Phosphatase 2A inhibitors. The Company’s corporate office is located in Pasadena, California.
Previous report — wording carried elsewhere
The Company’s product pipeline is primarily focused on inhibitors of protein phosphatase 2A, used in combination with cytotoxic agents and/or x-ray, immune checkpoint blockers and other cancer therapies. The Company believes that inhibitors of protein phosphatases have significant therapeutic potential to enhance a broad range of anti-cancer therapies. The Company is focusing on the clinical development of a specific protein phosphatase inhibitor, referred to as LB-100, which has been shown to have clinical anti-cancer activity at doses that produce little or no toxicity.
Previous report — wording carried elsewhere
**National Cancer Institute Pharmacologic Clinical Trial.**In May 2019, the National Cancer Institute (“NCI”) initiated a glioblastoma (“GBM”) pharmacologic clinical trial. This study was being conducted and funded by the NCI under a Cooperative Research and Development Agreement, with the Company responsible for providing the LB-100 clinical compound.
Previous report — wording carried elsewhere
The Company’s aggregate commitment pursuant to this clinical trial monitoring agreement, less amounts previously paid to date, totaled approximately $134,000 as of March 31, 2024, which is expected to be incurred through June 30, 2026.