LIXTE BIOTECHNOLOGY HOLDINGS, INC.
For the period ended Jun 30, 2025. Filed Aug 7, 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.
Jun 30, 2025 · Filed Aug 7, 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 2025-03-31; filed 2025-05-12.
0001641172-25-009575
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-06-30; filed 2025-08-07.
0001641172-25-022517
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 173 previous paragraphs and 204 current paragraphs.
97 unchanged; 64 reworded; 35 added; 11 removed; 1 previous and 8 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 (35)
Current report
Sale of Common Stock, Preferred Stock, Pre-Funded Common Stock Purchase Warrants, and Common Stock Purchase Warrants
Current report
On July 2, 2025, the Company closed a private placement for gross proceeds of $5,050,000, consisting of shares of common stock, pre-funded warrants to purchase shares of common stock, warrants to purchase shares of common stock, and shares of Series B Convertible Preferred Stock.
Current report
On July 8, 2025, the Company closed a registered direct offering for gross proceeds of $1,500,000, consisting of shares of common stock and pre-funded warrants to purchase shares of common stock.
Current report
Information with respect to these equity financings is provided at Note 9 to the condensed consolidated financial statements for the three months and six months ended June 30, 2025 and 2024 included elsewhere in this document.
Current report
Resignation of Certain Directors and Officers; Appointment of New Directors
Current report
As described above, the Company entered into a Securities Purchase Agreement with certain purchasers named therein pursuant to which, among other things, the Company issued to the purchasers 3,573,190 shares of the Company’s Series B Preferred Stock (the “Preferred Shares”). The Certificate of Designation for the Preferred Shares grants to the holders the right to designate two members to the Company’s Board of Directors (the “Board”), and the holders designated Jason Sawyer and Dr. Michael Holloway as members of the Board. At a meeting of the Board on July 18, 2025, Mr. Sawyer and Dr. Holloway were appointed as independent members of the Board.
Current report
In connection with such appointment, Dr. Stephen Forman and Dr. Yun Yen resigned from the Board and were contemporaneously appointed to serve as members of the Company’s Scientific Advisory Committee. Mr. Sawyer will replace Dr. Yen as Chairman of the Compensation Committee and as a member of the Audit Committee. The compensation of Mr. Sawyer and Dr. Holloway will be determined by the Compensation Committee of the Board as part of an overall review of the Company’s compensation program for its independent directors.
Current report
Effective as of July 31, 2025, the Company agreed to accept the resignation of Dr. Jan Schellens, the Company’s Chief Medical Officer, and to terminate his related consulting agreement dated as of May 31, 2024, to allow Dr. Schellens to pursue other employment opportunities.
Current report
Summary of News Release
Current report
The Company issued a news release announcing that the Medical JournalNature published findings by a team of physician scientists that validate the scientific premise underlying the Company’s ongoing clinical trials for Ovarian and Colorectal cancers
Current report
The team led by principal investigator Amir Jazaeri, MD, professor of Gynecologic Oncology and Reproductive Medicine at The University of Texas MD Anderson Cancer Center, studied survival outcomes of Ovarian Clear Cell Carcinoma (OCCC) patients treated with immune checkpoint blockade therapy (clinicaltrials.gov identifier: NCT03026062). The study showed that patients having tumors with inactivating mutations in PPP2R1A — the major scaffold subunit of protein phosphatase 2A (PP2A) — had significantly better overall survival, compared with patients who did not have this mutation in their tumors.
Current report
Inactivating mutations in PPP2R1A are known to reduce the enzymatic activity of PP2A, which is the target of the Company’s lead compound LB-100. Tumors with mutations in PPP2R1A were found to have increased the interferon gamma response pathway, which is known to be associated with improved immune checkpoint responses.
Current report
The Company is currently investigating the activity of LB-100 in combination with checkpoint immunotherapy in two clinical trials. The first is enrolling patients with OCCC, led by Dr. Jazaeri at MD Anderson Cancer Center, and also is open at Northwestern University. In this trial, the Company is collaborating with GSK to test LB-100 in combination with dostarlimab (anti PD1). In the second trial, at the Netherlands Cancer Institute, the Company is collaborating with Roche to test LB-100 in combination with atezolizumab (anti PDL1) in colon cancer patients.
Current report
In addition, as a result of the appointment of a new Chairman and Chief Executive Officer in June 2025, the completion of the July 2025 equity financings, and other changes in senior management and the Board of Directors in July 2025, the Company’s operating strategies and business plans may change, including the incurrence of additional personnel and operating costs, which may require that the Company raise additional capital to fund operations. 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 fund its operations.
Current report
The Company’s common stock and public warrants are traded on the Nasdaq Capital Market under the symbols “LIXT” and “LIXTW”, respectively.
Current report
On July 2, 2025, the Company closed a private placement for $5,050,000, consisting of shares of common stock, pre-funded warrants to purchase shares of common stock, warrants to purchase shares of common stock, and shares of Series B Convertible Preferred Stock, and on July 8, 2025, the Company closed a registered direct offering for $1,500,000, consisting of shares of common stock and pre-funded warrants to purchase shares of common stock.
Current report
On July 15, 2025, the Company received notice from Nasdaq that the Panel found that the Company was in compliance with the Stockholders’ Equity Requirement. The Company was also notified that it will remain subject to a “Panel Monitor”, as that term is defined in Nasdaq Listing Rule 5815(d)(4)(B), for a period of one year from the date of the Nasdaq notice, through July 15, 2026. If, during the term of the Panel Monitor, the Company does not continue to remain in compliance with the Stockholders’ Equity Requirement, the Company will not be provided with the opportunity to submit a compliance plan for review by the Listing Qualifications Staff and must instead request a hearing before the Panel to address the deficiency, with such request staying any further action with respect to the Company’s listing on Nasdaq pending completion of the hearing process.
Current report
Serious Adverse Events
Current report
In May 2025, the Company updated the safety overview of LB-100 and delivered the updated version 5.0 of the Investigator’s Brochure (the “IB”), which contains all of the relevant preclinical, clinical and pharmacologic data with respect to the study of the LB-100 clinical compound in humans, to the investigators of all ongoing clinical trials. The investigators of the study in colorectal cancer (NCT06012734) submitted a detailed response to the IRB, including the updated IB. The Company is currently awaiting the outcome of the IRB review.
Current report
Research and Development Costs. For the three months ended June 30, 2025, research and development costs were $60,648, which consisted of clinical and related oversight costs of $11,601, compound maintenance costs of $20,265, regulatory service costs of $1,190, and preclinical research focused on development of additional novel anti-cancer compounds to add to the Company’s clinical pipeline of $27,592.
Current report
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, compound maintenance costs of $5,976, 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 $104,829.
Current report
General and administrative costs decreased by $84,287, or 10.6%, in 2025 as compared to 2024, primarily as a result of decreases in patent and licensing legal and filing fees and costs of $46,309, insurance expense of $62,596, officer compensation and related costs of $87,024, investor relations of $6,000, taxes and licenses of $10,350, filing fees of $5,899, rent of $3,855, and conference fees of $14,475, offset by increases in fair value of vested stock options issued to directors and officers of $137,308, other consulting and professional fees of $14,833 and shareholder reporting of $3,542.
Current report
Six Months Ended June 30, 2025 and 2024
Current report
Research and Development Costs. For the six months ended June 30, 2025, research and development costs were $152,105, which consisted of clinical and related oversight costs of $27,470, compound maintenance costs of $53,083, regulatory service costs of $1,190, and preclinical research focused on development of additional novel anti-cancer compounds to add to the Company’s clinical pipeline of $70,362.
Current report
For the six months ended June 30, 2024, research and development costs were $329,772, which consisted of clinical and related oversight costs of $107,977, compound maintenance costs of $9,870, 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 $209,309.
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 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). The Company was recently notified that the preparations for this clinical trial were suspended and the clinical trial is not expected commence. Accordingly, the Company expects that this agreement will be terminated and the Company will have no further financial commitment or cost.
Current report
Research and development costs decreased by $177,667, or 53.9%, in 2025 as compared to 2024, primarily as a result of a decrease in clinical and related oversight costs of $80,507 and preclinical research focused on development of additional novel anti-cancer compounds to add to the Company’s clinical pipeline of $138,947, offset by an increase in compound maintenance costs of $43,213.
Current report
General and Administrative Costs. For the six months ended June 30, 2025, general and administrative costs were $1,329,644, which consisted of the fair value of vested stock options issued to directors and officers of $367,737 (including quarterly director and board committee fees of $55,000 and the acceleration of the vesting of stock options held by Bas van der Baan of $167,460 as a result of the amendment of his employment contract), patent and licensing legal and filing fees and costs of $73,386, other consulting and professional fees of $439,182, insurance expense of $128,553, officer compensation and related costs of $195,711, cash-based director and board committee fees of $0, licensing and royalties of $14,795, shareholder reporting costs of $12,164, listing fees of $46,500, filing fees of $15,170, investor relations of $22,794, taxes and licenses of $10,113, travel and entertainment of $435, and other operating costs of $5,587, offset by a rent refund of $2,483.
Current report
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 compensation 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, investor relations of $34,794, taxes and licenses of $30,813, rent of $9,881, conference fees of $14,475, travel and entertainment of $9,725, and other operating costs of $4,906.
Current report
Net Loss. For the six months ended June 30, 2025, the Company incurred a net loss of $1,485,228, as compared to a net loss of $1,982,241 for the six months ended June 30, 2024.
Current report
In addition, as a result of the appointment of a new Chairman and Chief Executive Officer in June 2025, the completion of the July 2025 equity financings, and other changes in senior management and the Board of Directors in July 2025, the Company’s operating strategies and business plans may change, including the incurrence of additional personnel and operating costs, which may require that the Company raise additional capital to fund operations. 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 fund its operations.
Current report
The Company was recently notified that the preparations for this clinical trial were suspended and the clinical trial is not expected commence. Accordingly, the Company expects that this agreement will be terminated and the Company will have no further financial commitment or cost.
Current report
The Company was recently notified that the preparations for this clinical trial were suspended and the clinical trial is not expected commence. Accordingly, the Company expects that this agreement will be terminated and the Company will have no further financial commitment or cost.
Current report
Consideration of Strategic Alternatives
Current report
The Company will continue to evaluate various alternatives to be able to obtain the capital required to fund its operations and business development activities, and to maintain its listing on the Nasdaq Capital Market, including merger or acquisition opportunities (including reverse mergers and acquisitions) and funding transactions which could result in a change in control of the Company. There can be no assurances that the evaluation process will result in the identification of an appropriate transaction, the negotiation and execution of a definitive agreement to effect such a transaction, or that any such transaction will ultimately be approved by the Company’s stockholders and then be consummated. Even if such a strategic transaction is consummated, there can be no assurances that it would enhance stockholder value, and it may result in substantial dilution to existing stockholders. Any potential transaction would be dependent on a number of factors that may be outside of the control of the Company, including, among other things, market conditions, industry trends, the interest of third parties in a potential transaction with the Company, and the availability of appropriate financing for such a transaction.
Removed paragraphs (11)
Previous report
Summaries of News Releases
Previous 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.
Previous 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.
Previous 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.
Previous 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.
Previous 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.
Previous 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.
Previous 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.
Previous 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.
Previous 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.
Previous report
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.
Reworded paragraphs (64)
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.
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.
Previous wording
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 wording
For the six months ended June 30, 2025, the Company recorded a net loss of $1,485,228 and used cash in operations of $1,055,968. At June 30, 2025, the Company had cash of $887,212 available to fund its operations.
Previous 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.
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 June 30, 2025, the Company’s remaining financial contractual commitments pursuant to clinical trial agreements and clinical trial monitoring agreements not yet incurred aggregated approximately $524,000, 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 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 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 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. These factors raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date the consolidated financial statements are issued. 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
Previous 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.
Current wording
Based on current operating plans, the Company estimates that its existing cash resources at June 30, 2025, together with the net proceeds from the July 2, 2025 private placement, and the July 8, 2025 registered direct offering, will provide sufficient working capital to fund the Company’s operations as currently configured, including its ongoing clinical trial program with respect to the development of the Company’s lead anti-cancer clinical compound LB-100, for at least the next 12 months. However, existing cash resources will not be sufficient to complete the development of and to obtain regulatory approval for the Company’s product candidate, which would require significant additional operating capital.
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, 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 wording
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
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 the Nasdaq Stock Market LLC (“Nasdaq”).
Previous 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”).
Current wording
On August 19, 2024, the Company received a letter from the Listing Qualifications Department (the “Staff”) of 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
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 wording
As of February 18, 2025, the Company had not regained 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”), which automatically stayed Nasdaq’s suspension or delisting of the Company’s common stock and public warrants pending the Panel’s decision.
Previous 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.
Current wording
The Company is undertaking measures to maintain compliance under Nasdaq’s continued listing requirements and to remain listed on the Nasdaq Capital Market. However, there can be no assurances that the Company will ultimately be able to maintain 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 ended March 31, 2025 and 2024 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, 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 ended March 31, 2025 and 2024 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, 2025 and 2024 included elsewhere in this document.
Previous wording
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 wording
The Company’s 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.
Previous 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%.
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 $17,303 for the three months ended June 30, 2025, as compared to $63,612 for the three months ended June 30, 2024, a decrease of $46,309, or 72.8%. 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 $73,386 for the six months ended June 30, 2025, as compared to $146,823 for the six months ended June 30, 2024, a decrease of $73,437, or 50.0%.
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 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.
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 2023 equity financing, the February 2025 equity financing, and the July 2025 equity financings 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 June 30, 2025 and December 31, 2024, the Company did not have any liability-classified warrants.
Previous 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 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 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 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.
Previous 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.
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 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
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.
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 the Company’s 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 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.
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 the Company’s ability to attract clinical trial participants, and damage the Company’s ability to interest investors and obtain financing in the future. There can be no assurances 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
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 wording
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 prepared 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.
Previous wording
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 wording
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 early July 2025, the Company has been informed that a total of 82 patients had received or were receiving experimental treatment with LB-100.
Previous wording
**Potential Recession.**There are some indications that the United States economy may be at risk of entering a recessionary period. Although unclear at this time, an economic recession would likely impact the general business environment and the capital markets, which could, in turn, affect the Company.
Current wording
**Potential Recession.**There have been some indications that the United States economy may be at risk of entering a recessionary period. Although it does not appear likely at this time, an economic recession could impact the general business environment and the capital markets, which could, in turn, affect the Company.
Previous 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.
Current wording
Included in preclinical research costs for the three months ended June 30, 2025 and 2024 were $0 and $67,119, 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 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).
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). The Company was recently notified that the preparations for this clinical trial were suspended and the clinical trial is not expected commence. Accordingly, the Company expects that this agreement will be terminated and the Company will have no further financial commitment or cost.
Previous wording
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 wording
Research and development costs decreased by $150,060, or 71.2%, in 2025 as compared to 2024, primarily as a result of a decrease in clinical and related oversight costs of $86,346 and preclinical research focused on development of additional novel anti-cancer compounds to add to the Company’s clinical pipeline of $77,237, offset by an increase in compound maintenance costs of $14,289.
Previous wording
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 wording
General and Administrative Costs. For the three months ended June 30, 2025, general and administrative costs were $714,161, which consisted of the fair value of vested stock options issued to directors and officers of $267,999 (including quarterly director and board committee fees of $27,500 and the acceleration of the vesting of stock options held by Bas van der Baan of $167,460 as a result of the amendment of his employment contract), patent and licensing legal and filing fees and costs of $17,303, other consulting and professional fees of $206,362, insurance expense of $64,277, officer compensation and related costs of $104,947, licensing and royalties of $7,397, shareholder reporting costs of $7,353, listing fees of $13,250, filing fees of $5,420, investor relations of $11,397, taxes and licenses of $5,056, and other operating costs of $3,400.
Previous wording
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 wording
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 compensation and related costs of $191,971, licensing and royalties of $7,455, shareholder reporting costs of $3,811, listing fees of $12,375, filing fees of $11,319, investor relations of $17,397, taxes and licenses of $15,406, rent of $4,230, conference fees of $14,475, and other operating costs of $7,304.
Previous 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.
Current wording
Interest Income. For the three months ended June 30, 2025, the Company had interest income of $365, as compared to interest income of $2,233 for the three months ended June 30, 2024, related to the investment of the Company’s cash resources.
Previous 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.
Current wording
Interest Expense. For the three months ended June 30, 2025, the Company had interest expense of $1,810, as compared to interest expense of $4,154 for the three months ended June 30, 2024, 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, 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.
Current wording
Foreign Currency Gain. For the three months ended June 30, 2025, the Company had a foreign currency gain of $581, as compared to a foreign currency gain of $158 for the three months ended June 30, 2024, from foreign currency transactions.
Previous 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.
Current wording
Net Loss. For the three months ended June 30, 2025, the Company incurred a net loss of $775,673, as compared to a net loss of $1,010,919 for the three months ended June 30, 2024.
Previous wording
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 wording
General and administrative costs decreased by $316,619, or 19.2%, in 2025 as compared to 2024, primarily as a result of decreases in patent and licensing legal and filing fees and costs of $73,437, insurance expense of $125,174, officer compensation and related costs of $191,878, cash-based director and board committee fees of $38,819, licensing and royalties of $45,774, investor relations of $12,000, taxes and licenses of $20,700, rent of $12,364, conference fees of $14,475, and travel and entertainment of $9,290, offset by increases in the fair value of vested stock options issued to directors and officers of $134,119, other consulting and professional fees of $75,210 and listing fees of $21,750.
Previous 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.
Current wording
At June 30, 2025, the Company had working capital of $452,630, as compared to working capital of $827,219 at December 31, 2024, reflecting a net decrease in working capital of $374,589 for the six months ended June 30, 2025. The decrease in working capital during the six months ended June 30, 2025 was primarily the result of the level of continuing expenditures related to the Company’s ongoing operations, offset in part by 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. At June 30, 2025, the Company had cash of $887,212 available to fund its operations.
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 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 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 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. These factors raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date the consolidated financial statements are issued. 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.
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
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 $514,000, which are currently scheduled to be incurred through approximately December 31, 2027.
Current wording
At June 30, 2025, the Company’s remaining financial contractual commitments pursuant to clinical trial agreements and clinical trial monitoring agreements not yet incurred aggregated $524,000, which are currently scheduled to be incurred through approximately December 31, 2027.
Previous wording
Operating Activities. For the three months ended March 31, 2025, operating activities utilized cash of $568,483, as compared to utilizing cash of $789,225 for the three months ended March 31, 2024, to fund the Company’s ongoing research and development activities and other operating expenses.
Current wording
Operating Activities. For the six months ended June 30, 2025, operating activities utilized cash of $1,055,968, as compared to utilizing cash of $1,608,266 for the six months ended June 30, 2024, to fund the Company’s ongoing research and development activities and other operating expenses.
Previous wording
Investing Activities. For the three months ended March 31, 2025 and 2024, the Company did not have any investing activities.
Current wording
Investing Activities. For the six months ended June 30, 2025 and 2024, the Company did not have any investing activities.
Previous wording
Financing Activities. For the three months ended March 31, 2025, financing activities consisted of the gross proceeds from the sale of securities in the Company’s registered direct offering of $1,050,003, reduced by offering costs of $135,775. For the three months ended March 31, 2024, the Company had no financing activities.
Current wording
Financing Activities. For the six months ended June 30, 2025, financing activities consisted of the gross proceeds from the sale of securities in the Company’s registered direct offering of $1,050,003, reduced by offering costs of $135,775, and the payment of deferred offering costs of $10,000. For the six months ended June 30, 2024, the Company had no financing activities.
Previous wording
At March 31, 2025, the Company’s remaining financial contractual commitments pursuant to clinical trial agreements and clinical trial monitoring agreements not yet incurred, as described below, aggregated $514,000, including clinical trial agreements of $269,000 and clinical trial monitoring agreements of $245,000, 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.
Current wording
At June 30, 2025, the Company’s remaining financial contractual commitments pursuant to clinical trial agreements and clinical trial monitoring agreements not yet incurred, as described below, aggregated $524,000, including clinical trial agreements of $293,000 and clinical trial monitoring agreements of $231,000, 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.
Showing the first 40 of 64 pairs. Open the source sections for the rest.
Rearranged current paragraphs (8)
Current report — wording carried from elsewhere
Three Months Ended June 30, 2025 and 2024
Current report — wording carried from elsewhere
Revenues. The Company did not have any revenues for the six months ended June 30, 2025 and 2024.
Current report — wording carried from elsewhere
Included in preclinical research costs for the six months ended June 30, 2025 and 2024 were $0 and $134,084, 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 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 — wording carried from elsewhere
Interest Income. For the six months ended June 30, 2025, the Company had interest income of $806, as compared to interest income of $5,092 for the six months ended June 30, 2024, related to the investment of the Company’s cash resources.
Current report — wording carried from elsewhere
Interest Expense. For the six months ended June 30, 2025, the Company had interest expense of $4,945, as compared to interest expense of $11,340 for the six months ended June 30, 2024, 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, 2025, the Company had a foreign currency gain of $660, as compared to a foreign currency gain of $42 for the six months ended June 30, 2024, from foreign currency transactions.
Current report — wording carried from elsewhere
Based on current operating plans, the Company estimates that its existing cash resources at June 30, 2025, together with the net proceeds from the July 2, 2025 private placement, and the July 8, 2025 registered direct offering, will provide sufficient working capital to fund the Company’s operations as currently configured, including its ongoing clinical trial program with respect to the development of the Company’s lead anti-cancer clinical compound LB-100, for at least the next 12 months. However, existing cash resources will not be sufficient to complete the development of and to obtain regulatory approval for the Company’s product candidate, which would require significant additional operating capital.
Rearranged previous paragraphs (1)
Previous report — wording carried 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.