NOMAD POWER SOLUTIONS, INC.
For the period ended Mar 31, 2025. Filed May 12, 2025.
View on SEC.govAbout this filing
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.
Mar 31, 2025 · Filed May 12, 2025
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 2024-09-30; filed 2024-11-12.
0001493152-24-044810
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-03-31; filed 2025-05-12.
0001641172-25-009575
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 189 previous paragraphs and 173 current paragraphs.
67 unchanged; 72 reworded; 29 added; 42 removed; 8 previous and 5 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 (29)
Current report
Recent Significant Developments
Current report
Summaries of News Releases
Current report
The Company announced online publication of new preclinical 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.
Current report
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 LB100. The biomarker discovery study was performed in the laboratories of Dr. René Bernards, Ph.D., group leader at the Netherlands Cancer Institute and a member of the Company’s Board of Directors.
Current report
As published in the International Journal of Pharmaceutics, Dr. Hans Rollema and colleagues, medicinal chemists and biochemists at BioPharmaWorks LLC, a consultant to the Company, studied how LB-100 can spontaneously convert into the active metabolite endothall 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.
Current report
The Company announced it will conduct a new preclinical study in collaboration with the Netherlands Cancer Institute to test whether “initiated” cells that carry mutations found in cancer cells can be eliminated by treatment with the Company’s proprietary compound LB-100.
Current report
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 the Company’s ongoing clinical collaboration with the Netherlands Cancer Institute shows that LB-100 activates oncogenic signaling and that this is detrimental to cancer cells.
Current report
The new study in animal models will investigate whether “initiated” cells, 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.
Current report
The study will be led by Dr. René Bernards, Ph.D., a global leader in the field of molecular carcinogenesis and group leader at the Netherlands Cancer Institute, one of the world’s leading comprehensive cancer centers. Dr. Bernards also is a member of the Company’s Board of Directors. This study will not require any additional funding commitment from the Company and is expected to be completed by June 30, 2025.
Current report
As of February 18, 2025, the Company had not gained compliance with the Stockholders’ Equity Requirement. On February 19, 2025, the Company received a Staff determination letter 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 timely requested a Hearing before a Nasdaq Hearings Panel (the “Panel”).
Current report
On April 17, 2025, the Company received notice that 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 followed a hearing on April 3, 2025, at which the Panel considered the Company’s plan to regain compliance with the Stockholders’ Equity Requirement. 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 Stockholders’ Equity Requirement and all other continued listing requirements for the Nasdaq Capital Market by July 3, 2025.
Current report
The Company’s President and Chief Executive Officer is the Company’s Chief Operating Decision Maker (“CODM”) and evaluates performance and makes operating decisions about allocating resources based on internal financial data presented on a consolidated basis. Because the CODM evaluates financial performance on a consolidated basis, the Company has determined that it operates in a single reportable segment, which consists of the development of a drug class called Protein Phosphatase 2A inhibitors, and is comprised of the consolidated financial results of the Company. The CODM uses consolidated net income (loss) as the sole measure of segment profit or loss.
Current report
In November 2023, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosure. ASU 2023-07 amends the FASB Accounting Standards Codification to require additional reportable segment disclosures of a public entity by requiring disclosure of significant segment expenses that are regularly provided to the chief operating decision maker, requiring other new disclosures, and requiring enhanced interim disclosures. ASU 2023-07 requires public entities with a single reportable segment to provide all the disclosures required by ASU 2023-07 and all existing segment disclosures in Topic 280 on an interim and annual basis. The Company adopted ASU 2023-07 effective January 1, 2024 for the 2024 annual period, including quarterly periods, on a retrospective basis.
Current report
Given the identified adverse events in the two patients in the clinical trial, the IRB requested from the principal investigator of the study at the NKI information as to whether the adverse events could have been caused by the combination of LB-100 and atezolizumab and information about the mode of action of the combination of LB-100 and atezolizumab. The principal investigator is preparing a response to the IRB detailing the safety experience with LB-100 given alone and in combination with other cancer drugs, especially doxorubicin and dostarlimab. Doxorubicin is a well-known chemotherapy, and dostarlimab is a well-known immunotherapy of which the mode of action is closely related to that of atezolizumab.
Current report
The reported adverse events in the colorectal cancer study have not been seen in any other patients thus far treated with LB-100 alone or in combination with other cancer drugs. Through March 2025, a total of 78 patients have received or are receiving experimental treatment with LB-100. It is expected that it will take at least two months to prepare a detailed response to the IRB, during which time the Company intends to update the safety overview of LB-100.
Current report
External Risks Associated with the Company’s Business Activities
Current report
Research and Development Costs. For the three months ended March 31, 2025, research and development costs were $91,457, which consisted of clinical and related oversight costs of $15,868, compound maintenance costs of $32,819, and preclinical research focused on development of additional novel anti-cancer compounds to add to the Company’s clinical pipeline of $42,770.
Current report
For the year three months ended March 31, 2024, research and development costs were $119,064, which consisted of clinical and related oversight costs of $10,030, compound maintenance costs of $3,894, 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 $104,480.
Current report
On October 3, 2023, the Company entered into Amendment No. 2 to the Development Collaboration Agreement with the Netherlands Cancer Institute, which provided for additional research activities, extended 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.
Current report
Research and development costs decreased by $27,607, or 23.2%, in 2025 as compared to 2024, primarily as a result of a decrease in preclinical research focused on development of additional novel anti-cancer compounds to add to the Company’s clinical pipeline of $61,710, offset by an increase in compound maintenance costs of $28,925.
Current report
General and Administrative Costs. For the three months ended March 31, 2025, general and administrative costs were $615,483, which consisted of the fair value of vested stock options issued to directors and officers of $99,738 (including quarterly director and board committee fees of $27,500), patent and licensing legal and filing fees and costs of $56,084, other consulting and professional fees of $205,315, insurance expense of $64,277, officer compensation and related costs of $118,268, cash-based director and board committee fees of $0, licensing and royalties of $7,397, shareholder reporting costs of $4,811, listing fees of $33,250, filing fees of $9,750, investor relations of $11,397, taxes and licenses of $5,056, and other operating costs of $2,998, offset by a rent refund of $2,858.
Current report
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 compensation 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, investor relations of $17,397, taxes and licenses of $15,406, rent of $5,651, and other operating costs of $7,329.
Current report
General and administrative costs decreased by $232,332, or 27.4%, in 2025 as compared to 2024, primarily as a result of decreases in patent and licensing legal and filing fees and costs of $27,127, insurance expense of $62,577, officer compensation and related costs of $77,350, cash-based director and board committee fees of $38,819, licensing and royalties of $45,716, investor relations of $6,000, taxes and licenses of $10,350, and rent of $8,509, offset by increases in other consulting and professional fees of $32,872 and listing fees of $20,875.
Current report
Going Concern
Current report
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, joint ventures or other transaction structures that could require the Company to relinquish rights to and/or control of LB-100, or to curtail or discontinue operations entirely.
Current report
Investing Activities. For the three months ended March 31, 2025 and 2024, the Company did not have any investing activities.
Current report
Given the focus on the combination of LB-100 with immunotherapy in ovarian clear cell carcinoma and colorectal cancer and the availability of capital resources, the Company entered into Amendment No. 1 to the Collaboration Agreement effective March 11, 2025 that relieved the Company of the financial obligation to support the randomized Phase 2 portion of the clinical trial contemplated in the Collaboration Agreement of approximately $3,095,000. As a result, it is uncertain as to whether the Phase 2 portion of this clinical trial will proceed.
Current report
On February 25, 2025, the Company announced that it has added the Robert H. Lurie Comprehensive Cancer Center (Lurie Cancer Center) of Northwestern University as a second site in a clinical trial combining the Company’s proprietary compound LB-100 with GSK’s dostarlimab to treat ovarian clear cell cancer. Patient recruitment is underway, and the first patient has been dosed.
Current report
On October 4, 2024, the Company entered into Amendment No. 3 to the Development Collaboration Agreement with NKI, which suspended Amendment No. 2 and provided for a new study term of one year and starts upon the dosing of the first patient in the trial at a project cost of 100,000 Euros.
Removed paragraphs (42)
Previous report
Recent Developments
Previous report
On September 4, 2024, the Company announced it had received 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 lead compound, LB-100, with various innovative cancer immunotherapies.
Previous report
If the Company fails to evidence compliance with the Stockholders’ Equity Rule upon filing its periodic report for the quarter ending March 31, 2025 with the SEC, the Company may be subject to delisting. If Nasdaq determines to delist the Company’s common stock, the Company will have the right to appeal to a Nasdaq hearings panel. The hearing request would stay any suspension or delisting action pending the conclusion of the hearing process.
Previous report
The Company operates and reports in one segment, which consisted of the development of a drug class called Protein Phosphatase 2A inhibitors. The Company’s operating segment is reported in a manner consistent with the internal reporting provided to the Company’s Chief Operating Decision Maker, which is the Company’s President and Chief Executive Officer.
Previous report
During the nine months ended September 30, 2024 and 2023, patent and licensing legal and filing fees and costs related to the development and protection of its intellectual property were $192,239 and $835,362, respectively, a decrease of $643,123, or 77.0%, in 2024 as compared to 2023.
Previous report
Intellectual Property
Previous report
The Company’s intellectual property includes proprietary know-how, proprietary methodologies and extensive clinical validation data and publications. To provide legal protection of the Company’s intellectual property, the Company relies on a combination of patents, licenses, trade secrets, trademarks, confidentiality and non-disclosure clauses and agreements, and other forms of intellectual property protection to define and protect our rights to the Company’s product candidates.
Previous report
The Company’s product candidates are expected to be covered by its patents. These patents now cover sole rights to the composition and synthesis of the Company’s LB-100 series of drugs, which is the Company’s lead clinical compound in development. The Company has filed patent applications covering the treatment of cancer with LB-100. The Company has also filed joint patent applications with the NIH and the Netherlands Cancer Institute for the treatment of cancer using LB-100 in combination with other drugs such as an immune checkpoint inhibitor and a WEE1 inhibitor.
Previous report
Patent applications for the LB-100 series (oxabicycloheptanes and oxabicycloheptenes) have been filed in the United States and internationally under the Patent Cooperation Treaty. Patents for composition of matter and for several uses of the LB-100 series have been issued in the United States, Mexico, Australia, Japan, China, Hong Kong, Canada, and by the European Patent Office
Previous report
The Company strives to protect and enhance the proprietary technology, inventions, and improvements that are commercially important to the development of its business, including seeking, maintaining, and defending its patent rights, which are owned solely by the Company’s wholly-owned Delaware subsidiary, Lixte Biotechnology, Inc., except in several instances jointly with one of the Company’s many collaborators. The Company also relies on trade secrets relating to its proprietary pipeline of product candidates and on know-how and continuing technological innovation to develop and strengthen its pipeline. The Company intend to rely on regulatory protection afforded by regulatory agencies through data exclusivity, market exclusivity, and patent term extensions, where available.
Previous report
The Company’s success will depend in large part on its ability to obtain and maintain patent and other proprietary protection for commercially important technology, inventions and know-how related to its business; defend and enforce its patents; preserve the confidentiality of its trade secrets; and operate without infringing valid and enforceable patents or proprietary rights of third parties. The Company’s ability to stop third parties from making, using, selling, offering to sell, or importing its technology may depend on the extent to which the Company has rights under valid and enforceable licenses, patents, or trade secrets that cover these activities. In some cases, enforcement of these rights may depend on cooperation of the joint owners of the Company’s jointly owned patents and patent applications.
Previous report
With respect to both the Company’s solely and jointly owned intellectual property, the Company cannot be sure that patents will be granted on any of its pending patent applications or on any patent applications filed solely or jointly by the Company in the future; the Company cannot be sure that any of its existing patents or any patents that may be granted to the Company in the future will be commercially useful in protecting the Company’s intended commercial products or therapeutic methods; and the Company cannot be sure that an agency or court would determine that its solely or jointly owned patents are valid and enforceable.
Previous report
Other Business Risks
Previous report
General and Administrative Costs. For the three months ended September 30, 2024, general and administrative costs were $621,627, which consisted of the fair value of vested stock options issued to directors and officers of $106,827 (including quarterly director and board committee fees of $27,500), patent and licensing legal and filing fees and costs of $45,416, other consulting and professional fees of $146,610, insurance expense of $116,440, officer salaries and related costs of $161,728, cash-based director and board committee fees of $0, licensing and royalties of $7,537, shareholder reporting costs of $2,941, listing fees of $12,375, filing fees of $2,864, taxes and licenses of $56, investor relations of $13,397, rent of $3,218, and other operating costs of $2,218.
Previous report
For the three months ended September 30, 2023, general and administrative costs were $891,694, which consisted of the fair value of vested stock options issued to directors and officers of $112,106 (including quarterly director and board committee fees of $0), patent and licensing legal and filing fees and costs of $178,012, other consulting and professional fees of $199,884, insurance expense of $107,910, officer salaries and related costs of $216,880, cash-based director and board committee fees of $42,228, shareholder reporting costs of $3,887, listing fees of $15,500, filing fees of $4,439, taxes and licenses of $3,946, investor relations of $14,172, rent of $7,323, and other operating costs of $6,914, offset by a credit to licensing and royalties of $21,507 relating to the termination of the Moffitt agreement.
Previous report
General and administrative costs decreased by $270,067, or 30.3%, 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 $5,279, a decrease in patent and licensing legal and filing fees and costs of $132,596, a decrease in officer salaries and related costs of $55,152, a decrease in cash-based director and board committee fees of $42,228, and a decrease in other consulting and professional fees of $53,274, offset by an increase in licensing and royalties of $29,044.
Previous report
Research and Development Costs. For the three months ended September 30, 2024, research and development costs were $361,630, which consisted of clinical and related oversight costs of $250,342, regulatory service costs of $11,405, and preclinical research focused on development of additional novel anti-cancer compounds to add to the Company’s clinical pipeline of $99,883.
Previous report
Included in clinical and related oversight costs for the three months ended September 30, 2024 is $207,004 for the cost of patients enrolled in the City of Hope clinical trial prior to its termination on July 8, 2024.
Previous report
For the three months ended September 30, 2023, research and development costs were $132,487, which consisted of clinical and related oversight costs of $8,816, regulatory service costs of $10,919, and pre-clinical research focused on development of additional novel anti-cancer compounds to add to the Company’s clinical pipeline of $124,752, offset by a credit of $12,000 relating to the termination of the Moffitt agreement.
Previous 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. The Company has no financial contractual commitment associated with this clinical trial.
Previous report
Research and development costs increased by $229,143, or 173.0%, in 2024 as compared to 2023, primarily as a result of a charge of $207,004 for the cost of patients enrolled in the City of Hope clinical trial prior to its termination on July 8, 2024.
Previous report
Nine Months Ended September 30, 2024 and 2023
Previous report
General and Administrative Costs. For the nine months ended September 30, 2024, general and administrative costs were $2,267,890, which consisted of the fair value of vested stock options issued to directors and officers of $340,445 (including quarterly director and board committee fees of $55,000), patent and licensing legal and filing fees and costs of $192,239, other consulting and professional fees of $510,582, insurance expense of $370,167, officer salaries and related costs of $549,317, cash-based director and board committee fees of $38,819, licensing and royalties of $68,106, shareholder reporting costs of $15,690, listing fees of $37,125, filing fees of $21,917, taxes and licenses of $30,869, investor relations of $48,191, rent of $13,099, conference fees of $14,475 and other operating costs of $16,849.
Previous report
For the nine months ended September 30, 2023, general and administrative costs were $3,315,297, which consisted of the fair value of vested stock options issued to directors and officers of $669,146, patent and licensing legal and filing fees and costs of $835,362, other consulting and professional fees of $529,830, insurance expense of $316,214, officer salaries and related costs of $649,483, cash-based director and board committee fees of $127,229, shareholder reporting costs of $64,783, listing fees of $46,500, filing fees of $14,634, taxes and licenses of $11,483, investor relations of $36,516, rent of $11,436, conference fees of $0 and other operating costs of $11,790, offset by a credit to licensing fees of $9,109 relating to the termination of the Moffitt agreement.
Previous report
General and administrative costs decreased by $1,047,407, or 31.6%, 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 $328,701, a decrease in patent and licensing legal and filing fees and costs of $643,123, a decrease in shareholder reporting costs of $49,093, a decrease in officer salaries and related costs of $100,166, and a decrease in cash-based director and board committee fees of $88,410, offset by increases in licensing and royalties of $77,215, taxes and licenses of $19,386, and in insurance expense of $53,953.
Previous report
Research and Development Costs. For the nine months ended September 30, 2024, research and development costs were $691,402, which consisted of clinical and related oversight costs of $358,318, regulatory service costs of $14,021, and preclinical research focused on development of additional novel anti-cancer compounds to add to the Company’s clinical pipeline of $319,063.
Previous report
Included in clinical and related oversight costs for the nine months ended September 30, 2024 is $207,004 for the cost of patients enrolled in the City of Hope clinical trial prior to its termination on July 8, 2024.
Previous report
For the nine months ended September 30, 2023, research and development costs were $749,029, which consisted of clinical and related oversight costs of $390,708, regulatory service costs of $18,738, and preclinical research focused on development of additional novel anti-cancer compounds to add to the Company’s clinical pipeline of $339,583.
Previous 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. The Company has no financial contractual commitment associated with this clinical trial.
Previous report
Research and development costs decreased by $57,627, or 7.7%, in 2024 as compared to 2023, primarily as a result of a decrease in clinical and related oversight costs of $32,390.
Previous report
Net Loss. For the nine months ended September 30, 2024, the Company incurred a net loss of $2,968,271, as compared to a net loss of $4,054,774 for the nine months ended September 30, 2023.
Previous report
Investing Activities. For the nine months ended September 30, 2024 and 2023, the Company had no investing activities.
Previous report
During the three months ended September 30, 2024 and 2023, the Company incurred costs of $207,004 and $0, respectively, pursuant to this Agreement. During the nine months ended September 30, 2024 and 2023, the Company incurred costs of $285,019 and $69,001, respectively, pursuant to this Agreement. As of September 30, 2024, total costs of $732,532 had been incurred pursuant to this Agreement.
Previous report
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 report
**Moffitt.**Effective August 20, 2018, the Company entered into a Clinical Trial Research Agreement with the Moffitt Cancer Center and Research Institute Hospital Inc., Tampa, Florida (“Moffitt”), effective for a term of five years. Pursuant to the Clinical Trial Research Agreement, Moffitt agreed to conduct and manage a Phase 1b/2 clinical trial to evaluate the toxicity and therapeutic benefit of the Company’s lead anti-cancer clinical compound LB-100 to be administered intravenously in patients with low or intermediate-1 risk myelodysplastic syndrome (“MDS”).
Previous report
In November 2018, the Company received approval from the U.S. Food and Drug Administration for its Investigational New Drug (“IND”) Application to conduct a Phase 1b/2 clinical trial to evaluate the toxicity and therapeutic benefit of LB-100 in patients with low and intermediate-1 risk MDS who had failed or were intolerant of standard treatment. This Phase 1b/2 clinical trial utilized LB-100 as a single agent in the treatment of patients with low and intermediate-1 risk MDS.
Previous report
The clinical trial began at a single site in April 2019 and the first patient was entered into the clinical trial in July 2019. During the year ended December 31, 2023, the clinical trial was closed. Although the maximum tolerated dose (“MTD”) was not achieved, there was no dose-limiting toxicity noted.
Previous report
During September 2023, the Company decided not to pursue further studies in MDS, as other, more promising, opportunities had become available (see “Patent and License Agreements - Moffitt” below).
Previous report
**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.
Previous report
**Moffitt.**Effective August 20, 2018, the Company entered into an Exclusive License Agreement with Moffitt. Pursuant to the License Agreement, Moffitt granted the Company an exclusive license under certain patents owned by Moffitt (the “Licensed Patents”) relating to the treatment of MDS and a non-exclusive license under inventions, concepts, processes, information, data, know-how, research results, clinical data, and the like (other than the Licensed Patents) necessary or useful for the practice of any claim under the Licensed Patents or the use, development, manufacture or sale of any product for the treatment of MDS which would otherwise infringe a valid claim under the Licensed Patents.
Showing the first 40 of 42 passages. Open the source sections for the rest.
Reworded paragraphs (72)
Previous 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.
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.
Previous wording
The Company’s activities are subject to significant risks and uncertainties, including the need for additional capital. The Company has not yet commenced any revenue-generating operations, does not have positive cash flows from operations, relies on stock-based compensation for a substantial portion of employee and consultant compensation, and is dependent on periodic infusions of equity capital to fund its operating requirements.
Current wording
The Company’s activities are subject to significant risks and uncertainties, including the need for additional capital. The Company has not yet commenced any revenue-generating operations, does not have positive cash flows from operations, relies on stock-based compensation for a substantial portion of employee and consultant compensation, and is dependent on periodic access to equity capital to fund its operating requirements.
Previous wording
For the nine months ended September 30, 2024, the Company recorded a net loss of $2,968,271 and used cash in operations of $2,565,861. At September 30, 2024, the Company had cash of $1,637,627 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 September 30, 2024, the Company’s remaining financial contractual commitments pursuant to clinical trial agreements and clinical trial monitoring agreements not yet incurred aggregated approximately $3,918,000, which are currently scheduled to be incurred through approximately December 31, 2027.
Current wording
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, 2025, the Company’s remaining financial contractual commitments pursuant to clinical trial agreements and clinical trial monitoring agreements not yet incurred aggregated approximately $514,000, which are currently scheduled to be incurred through approximately December 31, 2027.
Previous wording
Based on the foregoing, management has concluded that there is substantial doubt about the Company’s ability to continue as a going concern within one year after the date that the consolidated financial statements are being issued. In addition, our independent registered public accounting firm has included an explanatory paragraph in their report with respect to this uncertainty that accompanies our audited consolidated financial statements as of and for the year ended December 31, 2023. The Company’s consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.
Current wording
Based on the foregoing, management has concluded that there is substantial doubt about the Company’s ability to continue as a going concern within one year after the date that the consolidated financial statements are being issued. In addition, the Company’s independent registered public accounting firm included an explanatory paragraph in their report with respect to this uncertainty that accompanied the Company’s audited consolidated financial statements as of and for the year ended December 31, 2024, in which they expressed substantial doubt about the Company’s ability to continue as a going concern. The Company’s consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.
Previous wording
The Company’s ability to continue as a going concern is dependent upon its ability to raise additional equity capital to fund its research and development activities and to ultimately achieve sustainable operating revenues and profitability. The amount and timing of future cash requirements depends on the pace, design, and results of the Company’s clinical trial program, which, in turn, depends on the availability of operating capital to fund such activities.
Current wording
The Company’s ability to continue as a going concern is dependent upon its ability to raise additional equity capital to fund its research and development activities , including its ongoing clinical trials. The amount and timing of future cash requirements depends in substantial part on the pace, design and results of the Company’s clinical trial program, which, in turn, depends on the availability of operating capital to fund such activities.
Previous wording
Based on current operating plans, the Company estimates that its existing cash resources at September 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 the first quarter of 2025. 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 during the next few months in order to be able to effectively manage its current business plan during 2025 and thereafter, as well as to maintain its listing on Nasdaq. Furthermore, 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.
Current wording
Based on current operating plans, the Company estimates that its existing cash resources at March 31, 2025 will provide sufficient working capital to fund the Company’s operations, including its current clinical trial program with respect to the development of the Company’s lead anti-cancer clinical compound LB-100, through no later than September 30, 2025. Existing cash resources will not be sufficient to complete the development of and to 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 by mid-2025 to be able to proactively manage its current business plan during the remainder of 2025 and during 2026. 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. However, as market conditions present uncertainty as to the Company’s ability to secure additional funds, there can be no assurances that the Company will be able to secure additional financing on acceptable terms, as and when necessary, to continue to conduct operations.
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, 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, as well as its licensing and patent prosecution efforts and its technology and product development efforts, or obtain funds, if available, through strategic alliances, joint ventures or other transaction structures that could require the Company to relinquish rights to and/or control of LB-100, or to curtail or 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. In addition, Nasdaq has other continued listing requirements, one of which is maintaining a minimum net stockholders’ equity of $2,500,000.
Current wording
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.
Previous wording
On August 19, 2024, the Company received a deficiency letter from the Listing Qualifications Department of Nasdaq indicating that it was not in compliance with Nasdaq Listing Rule 5550(b)(1) (the “Stockholders’ Equity Rule”), which requires the Company to maintain a minimum stockholders’ equity of $2,500,000. This notice of non-compliance has no immediate impact on the continued listing or trading of the Company’s securities on Nasdaq, which will continue to be listed and traded on Nasdaq, subject to the Company’s compliance with the other Nasdaq continued listing requirements.
Current wording
On August 19, 2024, 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 “Stockholders’ Equity Requirement”).
Previous wording
On October 3, 2024, the Company submitted a letter to Nasdaq with its plan to regain compliance with the Stockholders’ Equity Rule, which outlined the Company’s proposed initiatives to regain compliance by raising equity capital through various registered equity offerings.
Current wording
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.
Previous wording
On October 21, 2024, Nasdaq provided the Company notice that it had granted an extension through February 18, 2025 for the Company to regain compliance with the Stockholders’ Equity Rule. The Company must complete its capital raising initiatives and evidence compliance with the Stockholders’ Equity Rule through filing a Current Report on Form 8-K with the SEC providing certain required information by February 18, 2025.
Current wording
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.
Previous wording
The Company intends to take reasonable measures available to regain compliance under Nasdaq’s listing rules and to remain listed on Nasdaq. However, there can be no assurances that the Company will ultimately regain compliance with the Stockholders’ Equity Rule, or be able to maintain compliance with all other applicable requirements for continued listing on Nasdaq. If the Company does not regain compliance with Nasdaq’s listing rules within the time period permitted by Nasdaq, then the Company’s securities will be delisted from Nasdaq.
Current wording
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 be able to regain compliance with the Stockholders’ Equity Requirement, 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.
Previous wording
Information with respect to recent accounting pronouncements is provided at Note 2 to the condensed consolidated financial statements for the three months and nine months ended September 30, 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 ended March 31, 2025 and 2024 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 and nine months ended September 30, 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 ended March 31, 2025 and 2024 included elsewhere in this document.
Previous wording
Due to the significant uncertainty associated with the successful development of one or more commercially viable products based on the Company’s research efforts and related patent applications, all patent and licensing legal and filing fees and costs are charged to operations as incurred. Patent and licensing legal and filing fees and costs are included in general and administrative costs in the Company’s consolidated statements of operations.
Current wording
Due to the significant uncertainty associated with the successful development of commercially viable products based on the Company’s research efforts and related patent applications, all patent and licensing legal and filing fees and costs related to the development and protection of the Company’s intellectual property are charged to operations as incurred. Patent and licensing legal and filing fees and costs are included in general and administrative costs in the Company’s consolidated statement of operations.
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. 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.
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 review and analysis of the Company’s patent portfolio in order to implement a program to balance patent prosecution costs with intellectual property protection benefits. As a result of such review and analysis, the Company identified certain patent filings that it decided not to continue to support in 2024 and thereafter. In addition, the Company changed patent legal counsel in mid-2024. The Company expects that patent and licensing legal and filing fees and costs will continue to be a significant continuing cost in 2025 and thereafter as the Company continues to manage its patent portfolio related to the clinical development of LB-100.
Previous wording
During the three months ended September 30, 2024 and 2023, patent and licensing legal and filing fees and costs related to the development and protection of its intellectual property were $45,416 and $178,012, respectively, a decrease of $132,596, or 74.5%, in 2024 as compared to 2023.
Current wording
As a result of such review and analysis, patent and licensing legal and filing fees and costs related to the development and protection of the Company’s intellectual property, primarily related to LB-100, decreased to $56,084 for the three months ended March 31, 2025, as compared to $83,211 for the three months ended March 31, 2024, a decrease of $27,127, or 32.6%.
Previous wording
The Company periodically issues common stock and stock options to officers, directors, employees, Scientific Advisory Committee members, contractors and consultants for services rendered. Options vest and expire according to terms established at the issuance date of each grant. Stock grants, which are generally time vested, are measured at the grant date fair value and charged to operations ratably over the vesting period.
Current wording
The Company periodically issues common stock and stock options to officers, directors, employees, contractors and consultants for services rendered. Options vest and expire according to terms established at the issuance date of each grant. Stock grants, which are generally time vested, are measured at the grant date fair value and charged to operations ratably over the vesting period.
Previous wording
The Company accounts for stock-based payments to officers, directors, employees, Scientific Advisory Committee members, contractors, and consultants by measuring the cost of services received in exchange for equity awards utilizing the grant date fair value of the awards, with the cost recognized as compensation expense on the straight-line basis in the Company’s financial statements over the vesting period of the awards. Recognition of compensation expense for non-employees is in the same period and manner as if the Company had paid cash for the services.
Current wording
The Company accounts for stock-based payments to officers, directors, employees, contractors, and consultants by measuring the cost of services received in exchange for equity awards utilizing the grant date fair value of the awards, with the cost recognized as compensation expense on the straight-line basis in the Company’s financial statements over the vesting period of the awards. Recognition of compensation expense for non-employees is in the same period and manner as if the Company had paid cash for the services.
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 that are liability classified are recognized as a non-cash gain or loss in the statement 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 and in the February 2025 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 at each balance sheet date. At March 31, 2025 and December 31, 2024, the Company did not have any liability-classified warrants.
Previous wording
The Company is focusing its development activities on its lead compound LB-100. The Company believes that the mechanism by which LB-100 affects cancer cell growth is different from cancer agents currently approved for clinical use. LB-100 is currently being tested in clinical trials in Ovarian Clear Cell Carcinoma, Metastatic Micro Satellite Stable (MSS) Colon Cancer and Advanced Soft Tissue Sarcoma. LB-100 has shown anti-cancer activity in animal models of glioblastoma multiforme, neuroblastoma, and medulloblastoma, all cancers of neural tissue. LB-100 enhances the effectiveness of commonly used anti-cancer drugs in melanoma, breast cancer and sarcoma animal models. The enhancement of anti-cancer activity of these anti-cancer drugs occurs at doses of LB-100 that do not significantly increase toxicity in animals. It is therefore hoped that, when combined with standard anti-cancer regimens against many tumor types, LB-100 will improve therapeutic benefit.
Current wording
The Company believes that the mechanism by which LB-100 affects cancer cell growth is different from cancer agents currently approved for clinical use. LB-100 is currently being tested in clinical trials in Ovarian Clear Cell Carcinoma, Metastatic Micro Satellite Stable (MSS) Colon Cancer, and Advanced Soft Tissue Sarcoma. LB-100 has shown anti-cancer activity in animal models of glioblastoma multiforme, neuroblastoma, and medulloblastoma, all cancers of neural tissue. LB-100 has also been shown to enhance the effectiveness of commonly used anti-cancer drugs in animal models of melanoma, breast cancer and sarcoma. The enhancement of anti-cancer activity of these anti-cancer drugs occurs at doses of LB-100 that do not significantly increase toxicity in animals. It is therefore hoped that, when combined with standard anti-cancer regimens against many tumor types, LB-100 will improve therapeutic benefit.
Previous wording
As a compound moves through the FDA-approval process, it becomes an increasingly valuable property, but at a cost of additional investment at each stage. As the potential effectiveness of LB-100 has been documented at the clinical trial level, the Company has allocated resources to expand the breadth and depth of its patent portfolio. The Company’s approach has been to operate with a minimum of overhead, moving compounds forward as efficiently and inexpensively as possible, and to raise funds to support each of these stages as certain milestones are reached. The Company’s longer-term objective is to secure one or more strategic partnerships or licensing agreements with pharmaceutical companies with major programs in cancer.
Current wording
As a compound moves through the FDA-approval process, it becomes an increasingly valuable property, but at a cost of additional investment at each stage. As the potential effectiveness of LB-100 has been documented at the clinical trial level, the Company has allocated resources to manage its patent portfolio. The Company’s approach has been to operate with a minimum of overhead, moving compounds forward as efficiently and inexpensively as possible, and to raise funds to support each of these stages as certain milestones are reached. The Company’s longer-term objective is to secure one or more strategic partnerships or licensing agreements with pharmaceutical companies with major programs in cancer.
Previous wording
The Company’s lead drug candidate, LB-100, is currently undergoing various clinical trials, and there is a risk that one or more of these trials could be placed on hold by regulatory authorities due to serious adverse events (SAEs) related to our drug candidate or to another company’s drug used in combination in one of our clinical trials. It is possible that the SAEs could be attributable to our drug candidate and could include, but not be limited to, unexpected severe side effects, treatment-related deaths, or long-term health complications. A dose given could result in non-tolerable adverse events defined as dose-limiting toxicity (DLT). When two DLTs occur at the same dose-level that dose-level is considered too high and unsafe. Further treatment is only allowed at lower dose-levels that have previously been found safe.
Current wording
The Company’s lead drug candidate, LB-100, is currently undergoing various clinical trials, and there is a risk that one or more of these trials could be placed on hold by regulatory authorities due to serious adverse events (SAEs) related to the Company’s drug candidate or to another company’s drug used in combination in one of the Company’s clinical trials. It is possible that the SAEs could be attributable to the Company’s drug candidate and could include, but not be limited to, unexpected severe side effects, treatment-related deaths, or long-term health complications. A dose given could result in non-tolerable adverse events defined as dose-limiting toxicity (DLT). When two DLTs occur at the same dose-level, that dose-level is considered too high and unsafe. Further treatment is only allowed at lower dose-levels that have previously been found safe.
Previous wording
If an SAE or a pattern of SAEs is observed during the course of a clinical trial involving our drug candidate, the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), or other regulatory authorities may issue a clinical hold, requiring us to pause or discontinue further enrollment and dosing in our clinical trial. It is also possible that the clinical trial could be terminated. Any of these actions could delay or halt the development of our drug candidate, increase development costs, and negatively impact our ability to ultimately achieve regulatory approval. Additionally, if an SAE is confirmed to be drug-related, we may be required to conduct additional studies, modify the study design, or abandon further development of the drug candidate altogether, which could materially impact our business, financial condition, and prospects.
Current wording
If an SAE or a pattern of SAEs is observed during the course of a clinical trial involving the Company’s drug candidate, the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), or other regulatory authorities may issue a clinical hold, requiring the Company to pause or discontinue further enrollment and dosing in its clinical trial. It is also possible that the clinical trial could be terminated. Any of these actions could delay or halt the development of the Company’s drug candidate, increase development costs, and negatively impact the Company’s ability to ultimately achieve regulatory approval. Additionally, if an SAE is confirmed to be drug-related, the Company may be required to conduct additional studies, modify the study design, or abandon further development of the drug candidate altogether, which could materially impact the Company’s business, financial condition, and prospects.
Previous wording
The occurrence of an SAE and any resulting clinical hold could also harm our reputation with patients, physicians, health institutions, and investors, diminish our ability to attract clinical trial participants, and damage our ability to interest investors and obtain financing in the future. There can be no assurance that we will not experience such SAEs in the future or that any related clinical hold will be lifted in a timely manner, or at all.
Current wording
The occurrence of an SAE and any resulting clinical hold could also harm the Company’s reputation with patients, physicians, health institutions, and investors, diminish its ability to attract clinical trial participants, and damage its ability to interest investors and obtain financing in the future. There can be no assurance that the Company will not experience such SAEs in the future or that any related clinical hold will be lifted in a timely manner, or at all.
Previous wording
The principal investigator of the colorectal study testing LB-100 in combination with atezolizumab (Roche PD-L1 inhibitor) is currently investigating two SAEs observed in the clinical trial that was launched in August 2024. Evaluation is underway to determine next steps.
Current wording
The principal investigator of the colorectal study testing LB-100 in combination with atezolizumab (Roche PD-L1 inhibitor) is currently investigating two SAEs observed in the clinical trial that was launched in August 2024. The Institutional Review Board (the “IRB”) of the Netherlands Cancer Institute (“NKI”) has put the colorectal cancer study on hold. The adverse reactions that developed in the two patients were dyspnea (shortness of breath) due to lung toxicity possibly or probably related to the combination of LB-100 and atezolizumab in one patient and fever and aphasia possibly or probably related to the combination of LB-100 and atezolizumab in the second patient. The patient who developed lung toxicity deceased due to the combination of lung metastases of colorectal cancer and dyspnea. The patient with fever and aphasia fully recovered from the adverse events with supportive medication.
Previous wording
Covid-19 Virus. The global outbreak of the novel coronavirus (Covid-19) in early 2020 led to disruptions in general economic activities throughout the world as businesses and governments implemented broad actions to mitigate this public health crisis. Although Covid-19 outbreak has subsided, the extent to which the coronavirus or any other pandemics may reappear and impact the Company’s clinical trial programs and capital raising efforts in the future is uncertain and cannot be predicted.
Current wording
Covid-19 Virus. The global outbreak of the novel coronavirus (Covid-19) in early 2020 led to disruptions in general economic activities throughout the world as businesses and governments implemented broad actions to mitigate this public health crisis. Although Covid-19 outbreak has subsided, the extent to which the coronavirus pandemic may reappear and impact the Company’s clinical trial programs and capital raising efforts in the future is uncertain and cannot be predicted.
Previous wording
**Inflation and Interest Rate Risk.**The Company does not believe that inflation or increasing interest rates has had a material effect on its operations to date, other than its impact on the general economy. However, there is a risk that the Company’s operating costs could become subject to inflationary and interest rate pressures in the future, which would have the effect of increasing the Company’s operating costs (including, specifically, clinical trial costs), and which would put additional stress on the Company’s working capital resources.
Current wording
**Inflation and Interest Rate Risk.**The Company does not believe that inflation or increasing interest rates have had a material effect on its operations to date, other than their impact on the general economy. However, there is a risk that the Company’s operating costs could become subject to inflationary and interest rate pressures in the future, which would have the effect of increasing the Company’s operating costs, and which would put additional stress on the Company’s working capital resources.
Previous wording
Geopolitical Risk. The geopolitical landscape poses inherent risks that could significantly impact the operations and financial performance of the Company. In the event of a military conflict, supply chain disruptions, geopolitical uncertainties, and economic repercussions may adversely affect the Company’s ability to conduct research, develop, test and manufacture products, and distribute them globally. This could lead to delays in product development, interruptions in the supply of critical materials, and delays in clinical trials, thereby impeding the Company’s clinical development and commercialization plans. Furthermore, the impact of a conflict on global financial markets may result in increased volatility and uncertainty in the capital markets, thereby affecting the valuation of the Company’s publicly-traded shares. Investor confidence, market sentiment, and access to capital may all be negatively influenced. Such geopolitical risks are outside the control of the Company, and the actual effects on the Company’s business, financial condition and results of operations may differ from current estimates.
Current wording
Geopolitical Risk. The geopolitical landscape poses inherent risks that could significantly impact the operations and financial performance of the Company. In the event of a military conflict, supply chain disruptions, geopolitical uncertainties, and economic repercussions may adversely affect the Company’s ability to conduct research, develop, test and manufacture products, and distribute them globally. This could lead to delays in product development, interruptions in the supply of critical materials, and delays in clinical trials, thereby impeding the Company’s clinical development and commercialization plans. Furthermore, the impact of a conflict on global financial markets may result in increased volatility and uncertainty in the capital markets, thereby affecting the valuation of the Company’s publicly-traded shares. Investor confidence, market sentiment, and access to capital could all be negatively influenced. Such geopolitical risks are outside the control of the Company, and the actual effects on the Company’s business, financial condition and results of operations may differ from current estimates.
Previous wording
**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 wording
**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 to date that have materially impaired its operations or financial condition.
Previous wording
The Company is continuing to monitor these matters and will adjust its current business and financing plans as more information and guidance become available.
Current wording
The Company is continuing to monitor these matters and will adjust its current business and financing plans as more information becomes available.
Previous wording
Included in preclinical research costs for the three months ended September 30, 2024 and 2023 were $76,278 and $51,568, 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 wording
Included in preclinical research costs for the three months ended March 31, 2025 and 2024 were $0 and $66,965, 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
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 wording
On October 4, 2024, the Company entered into Amendment No. 3 to the Development Collaboration Agreement with NKI, which suspended Amendment No. 2 and provided for a new study term of one year commencing upon the dosing of the first patient in the clinical trial at a project cost of 100,000 Euros (see “Principal Commitments – Other Significant Agreements and Contracts – Netherlands Cancer Institute” below).
Previous wording
Interest Income. For the three months ended September 30, 2024, the Company had interest income of $1,437, as compared to interest income of $5,809 for the three months ended September 30, 2023, related to the investment of the Company’s cash resources.
Current wording
Interest Income. For the three months ended March 31, 2025, the Company had interest income of $441, as compared to interest income of $2,859 for the three months ended March 31, 2024, related to the investment of the Company’s cash resources.
Previous wording
Interest Expense. For the three months ended September 30, 2024, the Company had interest expense of $1,049, as compared to interest expense of $279 for the three months ended September 30, 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 March 31, 2025, the Company had interest expense of $3,135, as compared to interest expense of $7,186 for the three months ended March 31, 2024, related to the financing of the premium for the Company’s directors and officers liability insurance policy.
Previous wording
Foreign Currency Loss. For the three months ended September 30, 2024, the Company had a foreign currency loss of $3,161, as compared to a foreign currency loss of $109 for the three months ended September 30, 2023, from foreign currency transactions.
Current wording
Foreign Currency Gain (Loss). For the three months ended March 31, 2025, the Company had a foreign currency gain of $79, as compared to a foreign currency loss of $116 for the three months ended March 31, 2024, from foreign currency transactions.
Previous wording
Net Loss. For the three months ended September 30, 2024, the Company incurred a net loss of $986,030, as compared to a net loss of $1,018,760 for the three months ended September 30, 2023.
Current wording
Net Loss. For the three months ended March 31, 2025, the Company incurred a net loss of $709,555, as compared to a net loss of $971,322 for the three months ended March 31, 2024.
Previous wording
The Company’s consolidated statements of cash flows as discussed herein are as follows:
Current wording
The Company’s condensed consolidated statements of cash flows as discussed herein are as follows:
Previous wording
At September 30, 2024, the Company had working capital of $1,360,008, as compared to working capital of $3,994,762 at December 31, 2023, reflecting a decrease in working capital of $2,634,754 for the nine months ended September 30, 2024. The decrease in working capital during the nine months ended September 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 September 30, 2024, the Company had cash of $1,637,627 available to fund its operations.
Current wording
At March 31, 2025, the Company had working capital of $1,159,130, as compared to working capital of $827,219 at December 31, 2024, reflecting a net increase in working capital of $331,911 for the three months ended March 31, 2025. The increase in working capital during the three months ended March 31, 2025 was primarily the result of the net proceeds of $914,228 from the sale of securities in a registered direct offering and concurrent private placement that closed on February 13, 2025, the proceeds from which are being used to fund the Company’s ongoing research and development activities and other operating expenses. At March 31, 2025, the Company had cash of $1,384,697 available to fund its operations.
Previous wording
Based on current operating plans, the Company estimates that its existing cash resources at September 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 the first quarter of 2025. 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 during the next few months in order to be able to effectively manage its current business plan during 2025 and thereafter, as well as to maintain its listing on Nasdaq. Furthermore, 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.
Current wording
Based on current operating plans, the Company estimates that its existing cash resources at March 31, 2025 will provide sufficient working capital to fund the Company’s operations, including its current clinical trial program with respect to the development of the Company’s lead anti-cancer clinical compound LB-100, through no later than September 30, 2025. Existing cash resources will not be sufficient to complete the 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 by mid-2025 to be able to proactively manage its current business plan during the remainder of 2025 and during 2026. 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. However, as market conditions present uncertainty as to the Company’s ability to secure additional funds, there can be no assurance that the Company will be able to secure additional financing on acceptable terms, as and when necessary, to continue to conduct operations.
Showing the first 40 of 72 pairs. Open the source sections for the rest.
Rearranged current paragraphs (5)
Current report — wording carried from elsewhere
For the three months ended March 31, 2025, the Company recorded a net loss of $709,555 and used cash in operations of $568,483. At March 31, 2025, the Company had cash of $1,384,697 available to fund its operations.
Current report — wording carried from elsewhere
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 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.
Current report — wording carried from elsewhere
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.
Current report — wording carried from elsewhere
Based on the foregoing, management has concluded that there is substantial doubt about the Company’s ability to continue as a going concern within one year after the date that the consolidated financial statements are being issued. In addition, the Company’s independent registered public accounting firm included an explanatory paragraph in their report with respect to this uncertainty that accompanied the Company’s audited consolidated financial statements as of and for the year ended December 31, 2024, in which they expressed substantial doubt about the Company’s ability to continue as a going concern. The Company’s consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.
Current report — wording carried from elsewhere
Netherlands Cancer Institute. On October 8, 2021, the Company entered into a Development Collaboration Agreement with the Netherlands Cancer Institute, Amsterdam (“NKI”), one of the world’s leading comprehensive cancer centers, and Oncode Institute, Utrecht, a major independent cancer research center, for a term of three years. The Development Collaboration Agreement was subsequently modified by Amendment No. 1 thereto.
Rearranged previous paragraphs (8)
Previous report — wording carried elsewhere
As market conditions present uncertainty as to the Company’s ability to secure additional funds, there can be no assurance that the Company will be able to secure additional financing on acceptable terms, as and when necessary, to continue to conduct operations.
Previous report — wording carried elsewhere
Three Months Ended September 30, 2024 and 2023
Previous report — wording carried elsewhere
Revenues. The Company did not have any revenues for the nine months ended September 30, 2024 and 2023.
Previous report — wording carried elsewhere
Included in preclinical research costs for the nine months ended September 30, 2024 and 2023 were $210,362 and $156,950, 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 report — wording carried 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).
Previous report — wording carried elsewhere
Interest Income. For the nine months ended September 30, 2024, the Company had interest income of $6,529, as compared to interest income of $13,538 for the nine months ended September 30, 2023, related to the investment of the Company’s cash resources.
Previous report — wording carried elsewhere
Interest Expense. For the nine months ended September 30, 2024, the Company had interest expense of $12,389, as compared to interest expense of $6,088 for the nine months ended September 30, 2023, related to the financing of the premium for the Company’s directors and officers liability insurance policy.
Previous report — wording carried elsewhere
Foreign Currency Gain (Loss). For the nine months ended September 30, 2024, the Company had a foreign currency loss of $3,119, as compared to a foreign currency gain of $2,102 for the nine months ended September 30, 2023, from foreign currency transactions.