LIXTE BIOTECHNOLOGY HOLDINGS, INC.
For the period ended Sep 30, 2025. Filed Nov 12, 2025.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Sep 30, 2025 · Filed Nov 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 2025-06-30; filed 2025-08-07.
0001641172-25-022517
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-09-30; filed 2025-11-12.
0001493152-25-021941
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 204 previous paragraphs and 209 current paragraphs.
120 unchanged; 48 reworded; 29 added; 33 removed; 3 previous and 12 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
The Company is focusing on a disciplined approach to strategic expansion and is focused on advancing LB-100 in high-need cancer indications, while pursuing acquisitions of complementary oncology assets that could enhance the Company’s pipeline, accelerate development and create durable value for patients and shareholders. The Company has announced that it is in advanced negotiations regarding potential transactions consistent with its strategy, although there can be no assurance that any transaction will be completed.
Current report
On October 3, 2024, the Company submitted a compliance plan, outlining proposed equity financings. On October 21, 2024, Nasdaq granted the Company an extension through February 18, 2025 to complete its plan and evidence compliance via Form 8-K.
Current report
Following an April 3, 2025 hearing, the Panel granted the Company a further extension through July 3, 2025 to regain compliance.
Current report
On July 2, 2025, the Company closed a $5.05 million private placement and, on July 8, 2025, completed a $1.5 million registered direct offering (see Note 5). On July 15, 2025, Nasdaq notified the Company that it had regained compliance with the stockholders’ equity requirement.
Current report
The Company remains subject to a Panel Monitor under Nasdaq Listing Rule 5815(d)(4)(B) through July 15, 2026. During this period, any future deficiency in stockholders’ equity would require the Company to request a hearing before the Panel rather than submit a new compliance plan.
Current report
Digital Assets
Current report
The Company holds certain digital assets, consisting of Bitcoin and Ethereum cryptocurrencies. Digital assets are initially recorded at cost and if the fair value of a digital asset is other than its carrying amount, an unrealized gain or loss is recognized equal to the difference between the carrying amount and the fair value at the measurement date. Realized gains and losses on the sale of digital assets are included in other income (expense) in the Company’s consolidated statements of operations. The Company’s digital assets are reasonably expected to be realized in cash or sold or consumed during the Company’s normal operating cycle and as such have been classified as current assets in the Company’s consolidated balance sheets.
Current report
The Company uses a combination of third-party custodial arrangements and cold storage solutions to secure its digital assets. While management believes these arrangements provide appropriate safeguards, digital assets are subject to unique risks, including technological failures, cybersecurity threats, loss of private keys, market volatility, and evolving legal and regulatory environments.
Current report
Management monitors developments in accounting and regulatory guidance related to digital assets. Any future updates may require changes in the Company’s accounting policies, disclosures, or internal controls.
Current report
Research and Development Costs. For the three months ended September 30, 2025, research and development costs were $50,696 which consisted of clinical and related oversight costs of $13,424, compound maintenance costs of $7,480, regulatory service costs of $7,581, and preclinical research focused on development of additional novel anti-cancer compounds to add to the Company’s clinical pipeline of $22,211.
Current report
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, compound maintenance costs of $9,062, 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 $90,821.
Current report
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 $45,415, other consulting and professional fees of $117,893, insurance expense of $116,440, officer compensation and related costs of $190,445, licensing and royalties of $7,537, shareholder reporting costs of $2,941, listing fees of $12,375, filing fees of $2,864, investor relations of $13,397, rent of $3,218, and other operating costs of $2,275.
Current report
General and administrative costs increased by $1,129,031 or 181.6%, in 2025 as compared to 2024, primarily as a result of increases in the fair value of vested stock options issued to directors and officers of $669,784 (including the vested portion of stock options granted to Geordan Pursglove, the Company’s CEO, on July 3, 2025 of $546,499, the vested portion of stock options granted to Peter Stazzone, the Company’s CFO, on September 1, 2025 of $55,732, and the vested portion of stock options granted to two new directors on August 15, 2025 of $76,010), other consulting and professional fees of $420,325 (including public relation fees of $184,711 paid to MicroCap Advisory LLC and $150,000 paid to IR Agency LLC), officer compensation and related costs of $16,932, travel expenses of $40,320, director fees paid in cash of $27,500, shareholder reporting of $24,645, taxes and licenses of $5,056, offset by decreases in patent and licensing legal and filing fees and costs of $28,562, and insurance expense of $52,163.
Current report
Effective August 4, 2025, the Company entered into a Market Awareness Agreement (the “Agreement”) with MicroCap Advisory, LLC for a term of six months to develop a clear, impactful, and marketable corporate strategy to identify, reach and engage with potential investors. Following the initial 30 day term of the Agreement, either party may terminate it without cause by providing the other party with at least 15 days prior written notice. This corporate strategy was intended to serve as the foundation for a comprehensive investor communications program for the Company. The Agreement provided for a one-time account set-up fee of $15,000 and a cash fee of $125,000 per month over a period of six months, subject to increase, depending on news, events, or other opportunities to amplify public awareness, which will be reviewed and approved by both parties. In addition, the Agreement provided for the issuance of 48,000 shares of the Company’s common stock to MicroCap Advisory, LLC. upon its signing. The Company also agreed to reimburse MicroCap Advisory, LLC for any pre-approved expenses incurred, including analyst reports and travel expenses. Effective September 5, 2025, the Company terminated this Agreement and issued 9,181 shares of common stock, valued at $44,711, under the Agreement as settlement of the original 48,000 common share obligation.
Current report
Unrealized Gain (Loss) in Fair Value of Digital Assets, Net. For the three months ended September 30, 2025, the Company had aa unrealized net loss from a decrease in the fair value of digital assets of $182,887.
Current report
Series B Convertible Preferred Stock 8% Cumulative Dividend. For the three months ended September 30, 2025, the Company recorded a Series B Convertible Preferred Stock dividend of $50,367.
Current report
Net Loss Attributable to Common Stockholders. For the three months ended September 30, 2025, the Company incurred a net loss attributed to common stockholders of $2,030,765, as compared to a net loss attributed to common stockholders of $986,030 for the three months ended September 30, 2024.
Current report
Nine Months Ended September 30, 2025 and 2024
Current report
Research and Development Costs. For the nine months ended September 30, 2025, research and development costs were $202,801 which consisted of clinical and related oversight costs of $40,894, compound maintenance costs of $60,563, regulatory service costs of $8,771, and preclinical research focused on development of additional novel anti-cancer compounds to add to the Company’s clinical pipeline of $92,573.
Current report
For the nine months ended September 30, 2024, research and development costs were $691,402, which consisted of clinical and related oversight costs of $358,319, compound maintenance costs of $18,932, 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 300,130.
Current report
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 $192,238, other consulting and professional fees of $481,865, insurance expense of $370,167, officer compensation and related costs of $578,034, director fees paid in cash 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, investor relations of $48,191, rent of $13,099, conference fees of $14,475, travel of $9,725, taxes and licenses of $30,869, and other operating costs of $7,125.
Current report
General and administrative costs increased by $812,412 or 35.8%, in 2025 as compared to 2024, primarily as a result of increases in the fair value of vested stock options issued to directors and officers of $803,903 ((including quarterly director and board committee fees of $55,000, 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 on June 16, 2025, the vested portion of stock options granted to Geordan Pursglove, the Company’s CEO, on July 3, 2025 of $546,499, the vested portion of stock options granted to Peter Stazzone, the Company’s CFO, on September 1, 2025 of $55,732, and the vested portion of stock options granted to two new directors on August 15, 2025 of $76,010), other consulting and professional fees of $438,219 (including public relation fees of $184,711 paid to MicroCap Advisory LLC and $150,000 paid to IR Agency LLC), travel expenses of $31,029, director fees paid in cash of $27,500, shareholder reporting of $24,041, listing fees of $22,625, , offset by decreases in patent and licensing legal and filing fees and costs of $101,999, officer compensation and related costs of $117,631, licensing and royalties of $45,914, taxes and licenses of $15,700, investor relations of $12,000, director fees paid in cash of $11,319, rent of $13,099, conference fees of $14,475, and insurance expense of $177,337.
Current report
Effective August 4, 2025, the Company entered into a Market Awareness Agreement (the “Agreement”) with MicroCap Advisory, LLC for a term of six months to develop a clear, impactful, and marketable corporate strategy to identify, reach and engage with potential investors. Following the initial 30 day term of the Agreement, either party may terminate it without cause by providing the other party with at least 15 days prior written notice. This corporate strategy was intended to serve as the foundation for a comprehensive investor communications program for the Company. The Agreement provided for a one-time account set-up fee of $15,000 and a cash fee of $125,000 per month over a period of six months, subject to increase, depending on news, events, or other opportunities to amplify public awareness, which will be reviewed and approved by both parties. In addition, the Agreement provided for the issuance of 48,000 shares of the Company’s common stock to MicroCap Advisory, LLC. upon its signing. The Company also agreed to reimburse MicroCap Advisory, LLC for any pre-approved expenses incurred, including analyst reports and travel expenses. Effective September 5, 2025, the Company terminated this Agreement and issued 9,181 shares of common stock, valued at $44,711, under the Agreement as settlement of the original 48,000 common share obligation.
Current report
Unrealized Gain (Loss) in Fair Value of Digital Assets, Net. For the nine months ended September 30, 2025, the Company had aa unrealized net loss from a decrease in the fair value of digital assets of $182,887.
Current report
Series B Convertible Preferred Stock 8% Cumulative Dividend. For the nine months ended September 30, 2025, the Company recorded a Series B Convertible Preferred Stock dividend of $50,367.
Current report
Net Loss Attributable to Common Stockholders. For the nine months ended September 30, 2025, the Company incurred a net loss attributed to common stockholders of $3,515,993, as compared to a net loss attributed to common stockholders of $2,968,271 for the nine months ended September 30, 2024.
Current report
The Company is focusing on a disciplined approach to strategic expansion and is focused on advancing LB-100 in high-need cancer indications, while pursuing acquisitions of complementary oncology assets that could enhance the Company’s pipeline, accelerate development and create durable value for patients and shareholders. The Company has announced that it is in advanced negotiations regarding potential transactions consistent with its strategy, although there can be no assurance that any transaction will be completed.
Current report
Other Business Risks
Current report
The Company is focusing on a disciplined approach to strategic expansion and is focused on advancing LB-100 in high-need cancer indications, while pursuing acquisitions of complementary oncology assets that could enhance the Company’s pipeline, accelerate development and create durable value for patients and shareholders. The Company has announced that it is in advanced negotiations regarding potential transactions consistent with its strategy, although there can be no assurance that any transaction will be completed.
Removed paragraphs (33)
Previous report
Recent Significant Developments
Previous report
Sale of Common Stock, Preferred Stock, Pre-Funded Common Stock Purchase Warrants, and Common Stock Purchase Warrants
Previous 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.
Previous 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.
Previous 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.
Previous report
Resignation of Certain Directors and Officers; Appointment of New Directors
Previous 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.
Previous 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.
Previous 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.
Previous report
Summary of News Release
Previous 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
Previous 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.
Previous 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.
Previous 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.
Previous report
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 report
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 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.
Previous 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.
Previous 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.
Previous report
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 report
Serious Adverse Events
Previous report
**Supply Chain Issues.**The Company does not currently expect that supply chain issues will have a significant impact on its business activities, including its ongoing clinical trials.
Previous report
The Company is continuing to monitor these matters and will adjust its current business and financing plans as more information becomes available.
Previous 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.
Previous 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.
Previous report
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 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.
Previous report
Six Months Ended June 30, 2025 and 2024
Previous 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.
Previous 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.
Previous 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.
Previous report
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 report
Other Significant Agreements and Contracts
Reworded paragraphs (48)
Previous 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.
Current wording
For the nine months ended September 30, 2025, the Company recorded a net loss of $3,465,626 and used cash in operations of $1,982,720. At September 30, 2025, the Company had cash of $2,887,874 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 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.
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 September 30, 2025, the Company’s remaining financial contractual commitments pursuant to clinical trial agreements and clinical trial monitoring agreements not yet incurred aggregated approximately $510,000, which are currently scheduled to be incurred through approximately December 31, 2027.
Previous 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.
Current wording
Based on current operating plans, the Company estimates that its existing cash resources at September 30, 2025 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
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 wording
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 recent changes in senior management and the Board of Directors, the Company’s operating strategies that may include the addition of personnel and/or the incurrence of additional 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.
Previous 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”).
Current wording
On August 19, 2024, the Company received a letter from the Nasdaq Listing Qualifications Staff notifying the Company of its noncompliance with the minimum $2.5 million stockholders’ equity requirement for continued listing on the Nasdaq Capital Market under Rule 5550(b)(1).
Previous 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.
Current wording
The Company did not meet the terms of the extension and, on February 19, 2025, received a Staff determination letter. The Company timely requested a hearing before the Nasdaq Hearings Panel, staying any suspension or delisting pending the Panel’s decision.
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 six months ended June 30, 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 nine months ended September 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 and six months ended June 30, 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 nine months ended September 30, 2025 and 2024 included elsewhere in this document.
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 $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%.
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 $16,853 for the three months ended September 30, 2025, as compared to $45,415 for the three months ended September 30, 2024, a decrease of $28,562, or 62.9%. 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 $90,239 for the nine months ended September 30, 2025, as compared to $192,238 for the nine months ended September 30, 2024, a decrease of $101,999, or 53.1%.
Previous 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.
Current wording
Included in preclinical research costs for the three months ended September 30, 2025 and 2024 were $0 and $76,278, respectively, of costs paid to the Netherlands Cancer Institute. On October 8, 2021, the Company entered into a Development Collaboration Agreement with the Netherlands Cancer Institute, Amsterdam, one of the world’s leading comprehensive cancer centers, and Oncode Institute, Utrecht, a major independent cancer research center, to identify the most promising drugs to be combined with LB-100, and potential LB-100 analogues, to be used to treat a range of cancers, as well as to identify the specific molecular mechanisms underlying the identified combinations.
Previous wording
Research and development costs decreased by $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 wording
Research and development costs decreased by $310,934, or 86.0%, in 2025 as compared to 2024, primarily as a result of a decrease in clinical and related oversight costs of $236,918 and preclinical research focused on development of additional novel anti-cancer compounds to add to the Company’s clinical pipeline of $68,610.
Previous 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.
Current wording
General and Administrative Costs. For the three months ended September 30, 2025, general and administrative costs were $1,750,658, which consisted of the fair value of vested stock options issued to directors and officers of $776,611 (including the vested portion of stock options granted to Geordan Pursglove, the Company’s CEO, on July 3, 2025 of $546,499, the vested portion of stock options granted to Peter Stazzone, the Company’s CFO, on September 1, 2025 of $55,732, and the vested portion of stock options granted to two new directors on August 15, 2025 of $76,010), patent and licensing legal and filing fees and costs of $16,853, other consulting and professional fees of $538,218 (including public relation fees of $184,711 paid to MicroCap Advisory LLC and $150,000 paid to IR Agency LLC), insurance expense of $64,277, travel expense of $40,320, officer compensation and related costs of $207,377, director fees paid in cash of $27,500, licensing and royalties of $7,397, shareholder reporting costs of $27,566, listing fees of $13,250, filing fees of $6,211, investor relations of $13,397, taxes and licenses of $5,056, and other operating costs of $6,625.
Previous 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.
Current wording
Interest Income. For the three months ended September 30, 2025, the Company had interest income of $4,430, as compared to interest income of $1,437 for the three months ended September 30, 2024, related to the investment of the Company’s cash resources.
Previous 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.
Current wording
Interest Expense. For the three months ended September 30, 2025, the Company had interest expense of $457, as compared to interest expense of $1,049 for the three months ended September 30, 2024, related to the financing of the premium for the Company’s directors and officers liability insurance policy.
Previous 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.
Current wording
Realized Gain (Loss) on Foreign Currency Transactions. For the three months ended September 30, 2025, the Company had a realized foreign currency loss of $130, as compared to a foreign currency loss of $3,161 for the three months ended September 30, 2024, from foreign currency transactions.
Previous 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.
Current wording
Net Loss. For the three months ended September 30, 2025, the Company incurred a net loss of $1,980,398, as compared to a net loss of $986,030 for the three months ended September 30, 2024.
Previous wording
Revenues. The Company did not have any revenues for the six months ended June 30, 2025 and 2024.
Current wording
Revenues. The Company did not have any revenues for the nine months ended September 30, 2025 and 2024.
Previous wording
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 wording
Included in preclinical research costs for the nine months ended September 30, 2025 and 2024 were $0 and $210,362, respectively, of costs paid to the Netherlands Cancer Institute. On October 8, 2021, the Company entered into a Development Collaboration Agreement with the Netherlands Cancer Institute, Amsterdam, one of the world’s leading comprehensive cancer centers, and Oncode Institute, Utrecht, a major independent cancer research center, to identify the most promising drugs to be combined with LB-100, and potential LB-100 analogues, to be used to treat a range of cancers, as well as to identify the specific molecular mechanisms underlying the identified combinations.
Previous wording
Research and development costs decreased by $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.
Current wording
Research and development costs decreased by $488,601, or 70.7%, in 2025 as compared to 2024, primarily as a result of a decrease in clinical and related oversight costs of $317,425 and preclinical research focused on development of additional novel anti-cancer compounds to add to the Company’s clinical pipeline of $207,557, offset by an increase in compound maintenance of $41,631.
Previous wording
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 wording
General and Administrative Costs. For the nine months ended September 30, 2025, general and administrative costs were $3,080,302, which consisted of the fair value of vested stock options issued to directors and officers of $1,144,348 (including quarterly director and board committee fees of $55,000, 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 on June 16, 2025, the vested portion of stock options granted to Geordan Pursglove, the Company’s CEO, on July 3, 2025 of $546,499, the vested portion of stock options granted to Peter Stazzone, the Company’s CFO, on September 1, 2025 of $55,732, and the vested portion of stock options granted to two new directors on August 15, 2025 of $76,010), patent and licensing legal and filing fees and costs of $90,239, other consulting and professional fees of $920,084 (including public relation fees of $184,711 paid to MicroCap Advisory LLC and $150,000 paid to IR Agency LLC), insurance expense of $192,830, travel expense of $40,754, officer compensation and related costs of $460,403, director fees paid in cash of $27,500, licensing and royalties of $22,192, shareholder reporting costs of $39,731, listing fees of $59,750, filing fees of $21,381, investor relations of $36,191, taxes and licenses of $15,169, and other operating costs of $9,729.
Previous wording
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 wording
Interest Income. For the nine months ended September 30, 2025, the Company had interest income of $5,236, as compared to interest income of $6,529 for the nine months ended September 30, 2024, related to the investment of the Company’s cash resources.
Previous wording
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 wording
Interest Expense. For the nine months ended September 30, 2025, the Company had interest expense of $5.402, as compared to interest expense of $12,389 for the nine months ended September 30, 2024, related to the financing of the premium for the Company’s directors and officers liability insurance policy.
Previous wording
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 wording
Realized Gain (Loss) on Foreign Currency Transactions. For the nine months ended September 30, 2025, the Company had a realized foreign currency gain of $530, as compared to a foreign currency loss of $3,119 for the nine months ended September 30, 2024, from foreign currency transactions.
Previous wording
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 wording
Net Loss. For the nine months ended September 30, 2025, the Company incurred a net loss of $3,465,626, as compared to a net loss of $2,968,271 for the three months ended September 30, 2024.
Previous 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.
Current wording
At September 30, 2025, the Company had working capital of $4,912,254, as compared to working capital of $827,219 at December 31, 2024, reflecting a net increase in working capital of $4,085,035 for the nine months ended September 30, 2025. The increase in working capital during the nine months ended September 30, 2025 was primarily the result net proceeds of $4,178,162 from the sale of securities in a registered private placement that closed on July 2, 2025, and the net proceeds from the sale of securities in registered direct offerings of $914,228, that closed on February 13, 2025, and $1,330,812, that closed on July 8, 2025, offset by the level of continuing expenditures related to the Company’s ongoing operations. At September 30, 2025, the Company had cash of $2,887,874 available to fund its operations.
Previous 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.
Current wording
Based on current operating plans, the Company estimates that its existing cash resources at September 30, 2025 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
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 wording
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 recent changes in senior management and the Board of Directors, the Company’s operating strategies that may include the addition of personnel and/or the incurrence of additional 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.
Previous 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.
Current wording
At September 30, 2025, the Company’s remaining financial contractual commitments pursuant to clinical trial agreements and clinical trial monitoring agreements not yet incurred aggregated $510,000, which are currently scheduled to be incurred through approximately December 31, 2027.
Previous 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.
Current wording
Operating Activities. For the nine months ended September 30, 2025, operating activities utilized cash of $1,982,720, as compared to utilizing cash of $2,565,861 for the nine months ended September 30, 2024, to fund the Company’s ongoing research and development activities and other operating expenses.
Previous wording
Investing Activities. For the six months ended June 30, 2025 and 2024, the Company did not have any investing activities.
Current wording
Investing Activities. For the nine months ended September 30, 2025, investing activities utilized cash of $2,637,360 for the purchase of digital assets, For the nine months ended September 30, 2024 the Company did not have any investing activities.
Previous 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.
Current wording
Financing Activities. For the nine months ended September 30, 2025, financing activities consisted of the gross proceeds from the sale of securities in the Company’s registered direct offerings of $2,550,003, reduced by offering costs of $304,963, gross proceeds from the sale of securities in the Company’s registered private placement of $5,050,000, reduced by offering costs of $871,838, and proceeds from the sale of common stock warrant of $45,800. For the nine months ended September 30, 2024, the Company had no financing activities.
Previous 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.
Current wording
At September 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 $510,000, including clinical trial agreements of $292,000 and clinical trial monitoring agreements of $218,000, which, based on current estimates, are currently scheduled to be incurred through approximately December 31, 2027. The Company’s ability to conduct and fund these contractual commitments is subject to the timely availability of sufficient capital to fund such expenditures, as well as any changes in the allocation or reallocation of such funds to the Company’s current or future clinical trial programs. The Company expects that the full amount of these expenditures will be incurred only if such clinical trial programs are conducted as originally designed and their respective enrollments and duration are not modified or reduced. Clinical trial programs, such as the types that the Company is engaged in, can be highly variable and can frequently involve a series of changes and modifications over time as clinical data is obtained and analyzed, and is frequently modified, suspended or terminated, in part based on receipt or lack of receipt of an indication of clinical benefit or activity, before the clinical trial endpoint is reached. Accordingly, such contractual commitments as discussed herein should be considered as estimates only based on current clinical assumptions and conditions and are typically subject to significant modifications and revisions over time.
Previous wording
During the three months ended June 30, 2025 and 2024, the Company incurred costs of $0 and $78,015, respectively, pursuant to this Agreement. During the six months ended June 30, 2025 and 2024, the Company incurred costs of $0 and $78,015, respectively, pursuant to this Agreement. As of June 30, 2025, total costs of $732,532 had been incurred pursuant to this Agreement.
Current wording
During the three months ended September 30, 2025 and 2024, the Company did not incur any costs pursuant to this Agreement. During the nine months ended September 30, 2025 and 2024, the Company incurred costs of $0 and $78,015, respectively, pursuant to this Agreement. As of September 30, 2025, total costs of $732,532 had been incurred pursuant to this Agreement.
Previous wording
The Company’s agreement with GEIS provided for various payments based on achieving specific milestones over the term of the agreement. During the three months ended June 30, 2025 and 2024, the Company did not incur any costs pursuant to this agreement. During the six months ended June 30, 2025 and 2024, the Company did not incur any costs pursuant to this agreement. Through June 30, 2025, the Company has incurred charges of $685,107 for work done under this agreement through the fourth milestone.
Current wording
The Company’s agreement with GEIS provided for various payments based on achieving specific milestones over the term of the agreement. During the three months ended September 30, 2025 and 2024, the Company did not incur any costs pursuant to this agreement. During the nine months ended September 30, 2025 and 2024, the Company did not incur any costs pursuant to this agreement. Through September 30, 2025, the Company has incurred charges of $685,107 for work done under this agreement through the fourth milestone.
Previous wording
The Company’s aggregate commitment pursuant to this agreement, less amounts previously paid to date, totaled approximately $293,000 for the Phase 1b portion of this clinical trial as of June 30, 2025, which is scheduled to be incurred through December 31, 2025. As the work is being conducted in Europe and is paid for in Euros, final costs are subject to foreign currency fluctuations between the United States Dollar and the Euro. Such fluctuations are recorded in the consolidated statements of operations as foreign currency gain or loss, as appropriate, and have not been significant.
Current wording
The Company’s aggregate commitment pursuant to this agreement, less amounts previously paid to date, totaled approximately $292,000 for the Phase 1b portion of this clinical trial as of September 30, 2025, which is currently scheduled to be incurred through December 31, 2025. As the work is being conducted in Europe and is paid for in Euros, final costs are subject to foreign currency fluctuations between the United States Dollar and the Euro. Such fluctuations are recorded in the consolidated statements of operations as foreign currency gain or loss, as appropriate, and have not been significant.
Previous wording
Costs under this letter of intent and related work order agreement are estimated to be approximately $95,000. During the three months ended June 30, 2025 and 2024, the Company incurred costs of $4,614 and $8,228 pursuant to this letter of intent and subsequent work order. During the six months ended June 30, 2025 and 2024, the Company incurred costs of $11,892 and $8,228 pursuant to this letter of intent and subsequent work order. As of June 30, 2025, total costs of $38,655 have been incurred pursuant to this letter of intent and subsequent work order.
Current wording
Costs under this letter of intent and related work order agreement are estimated to be approximately $95,000. During the three months ended September 30, 2025 and 2024, the Company incurred costs of $4,942 and $12,610 pursuant to this letter of intent and subsequent work order. During the nine months ended September 30, 2025 and 2024, the Company incurred costs of $16,834 and $20,838 pursuant to this letter of intent and subsequent work order. As of September 30, 2025, total costs of $43,597 have been incurred pursuant to this letter of intent and subsequent work order.
Previous wording
The Company’s aggregate commitment pursuant to this letter of intent, less amounts previously paid to date, totaled approximately $57,000 as of June 30, 2025, which is expected to be incurred through December 31, 2027.
Current wording
The Company’s aggregate commitment pursuant to this letter of intent, less amounts previously paid to date, totaled approximately $53,000 as of September 30, 2025, which is expected to be incurred through December 31, 2027.
Previous wording
**City of Hope.**On February 5, 2021, the Company signed a new work order agreement with Theradex to monitor the City of Hope investigator-initiated clinical trial in small cell lung cancer in accordance with FDA requirements for oversight by the sponsoring party. Costs under this work order agreement were estimated to be approximately $335,000. During the three months ended June 30, 2025 and 2024, the Company incurred costs of $0 and $4,500, respectively, pursuant to this work order. During the six months ended June 30, 2025 and 2024, the Company incurred costs of $0 and $9,000, respectively, pursuant to this work order. As of June 30, 2025, total costs of $87,823 had been incurred pursuant to this work order agreement.
Current wording
**City of Hope.**On February 5, 2021, the Company signed a new work order agreement with Theradex to monitor the City of Hope investigator-initiated clinical trial in small cell lung cancer in accordance with FDA requirements for oversight by the sponsoring party. Costs under this work order agreement were estimated to be approximately $335,000. During the three months ended September 30, 2025 and 2024, the Company incurred costs of $0 and $1,603, respectively, pursuant to this work order. During the nine months ended September 30, 2025 and 2024, the Company incurred costs of $0 and $10,603, respectively, pursuant to this work order. As of September 30, 2025, total costs of $87,823 had been incurred pursuant to this work order agreement.
Previous wording
Costs under this work order agreement are estimated to be approximately $153,000, with such payments expected to be allocated approximately 72% to Theradex for services and approximately 28% for payments for pass-through software costs. During the three months ended June 30, 2025 and 2024, the Company incurred costs of $3,750 and $7,203, respectively, pursuant to this work order. During the six months ended June 30, 2025 and 2024, the Company incurred costs of $7,622 and $12,732, respectively, pursuant to this work order. As of June 30, 2025, total costs of $57,077 have been incurred pursuant to this work order agreement.
Current wording
Costs under this work order agreement are estimated to be approximately $153,000, with such payments expected to be allocated approximately 72% to Theradex for services and approximately 28% for payments for pass-through software costs. During the three months ended September 30, 2025 and 2024, the Company incurred costs of $3,981 and $13,475, respectively, pursuant to this work order. During the nine months ended September 30, 2025 and 2024, the Company incurred costs of $11,603 and $26,207, respectively, pursuant to this work order. As of September 30, 2025, total costs of $61,058 have been incurred pursuant to this work order agreement.
Previous wording
The Company’s aggregate commitment pursuant to this clinical trial monitoring agreement, less amounts previously paid to date, totaled approximately $95,000 as of June 30, 2025, which is expected to be incurred through December 31, 2026.
Current wording
The Company’s aggregate commitment pursuant to this clinical trial monitoring agreement, less amounts previously paid to date, totaled approximately $91,000 as of September 30, 2025, which is expected to be incurred through December 31, 2026.
Showing the first 40 of 48 pairs. Open the source sections for the rest.
Rearranged current paragraphs (12)
Current report — wording carried from elsewhere
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.
Current report — wording carried from elsewhere
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.
Current report — wording carried from elsewhere
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.
Current report — wording carried from elsewhere
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.
Current report — wording carried from elsewhere
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.
Current report — wording carried from elsewhere
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 September 30,2025, the Company has been informed that a total of 86 patients had received or were receiving experimental treatment with LB-100.
Current report — wording carried from elsewhere
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 — wording carried from elsewhere
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 the 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 report — wording carried from elsewhere
**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.
Current report — wording carried from elsewhere
**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.
Current report — wording carried from elsewhere
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.
Current report — wording carried from elsewhere
**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.
Rearranged previous paragraphs (3)
Previous report — wording carried elsewhere
Specific Risks Associated with the Company’s Business Activities
Previous report — wording carried elsewhere
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 report — wording carried elsewhere
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.