| Commitments and Contingencies | 8.
Commitments and Contingencies Legal
Claims The
Company may be subject to legal claims and actions from time to time as part of its business activities. As of September 30, 2024 and
December 31, 2023, the Company was not subject to any threatened or pending lawsuits, legal claims or legal proceedings. Principal
Commitments Clinical
Trial Agreements At
September 30, 2024, the Company’s remaining financial contractual commitments pursuant to clinical trial agreements and clinical
trial monitoring agreements not yet incurred, as described below, aggregated $ 3,918,000 3,616,000 302,000 The
following is a summary of the Company’s ongoing contractual clinical trials described below as of September 30, 2024: Schedule
of Contractual Clinical Trials
Description of Clinical Trial Institution Start Date Projected End Date Number of Patients in Trial Study Objective Clinical Update Expected Date of Preliminary Efficacy Signal NCT No. Remaining Financial Contractual Commitment
LB-100 combined with atezolizumab in microsatellite stable metastatic colon cancer Netherlands Cancer Institute (NKI) August 2024 December 2026 37 Determine RP2D with atezolizumab First patient entered August 2024 June 2026 NCT06012734 - (1)
LB-100 combined with doxorubicin in advanced soft tissue sarcoma GEIS June 2023 Recruitment completed September 2024 9 18 Determine MTD and RP2D Fourteen patients entered March 2025 NCT05809830 $ 284,000
Doxorubicin with or without LB-100 in advanced soft tissue sarcoma (Randomized GEIS TBD TBD 150 Determine efficacy: PFS Clinical trial not yet begun (subject to completion of Phase 1b GEIS clinical trial) December 2026 NCT05809830 $ 3,332,000
LB-100 combined with dostarlimab in ovarian clear cell carcinoma MD Anderson January 2024 December 2027 21 Determine the OS of patients with recurrent ovarian clear cell carcinoma Seven patients entered December 2026 NCT06065462 - (1)
Total $ 3,616,000
(1) The
Company has no financial contractual commitment associated with this clinical trial at September 30, 2024. Netherlands
Cancer Institute. This
Phase 1b clinical trial will evaluate safety, optimal dose and preliminary efficacy of LB-100 combined with atezolizumab for the treatment
of patients with metastatic microsatellite stable colorectal cancer. Immunotherapy using monoclonal antibodies like atezolizumab can
enhance the body’s immune response against cancer and hinder tumor growth and spread. LB-100 has been found to improve the effectiveness
of anticancer drugs in killing cancer cells by inhibiting a protein called PP2A on cell surfaces. Blocking PP2A increases stress signals
in tumor cells expressing the PP2A protein. Accordingly, combining atezolizumab with LB-100 may enhance treatment efficacy for metastatic
colorectal cancer, as cancer cells with heightened stress signals are more vulnerable to immunotherapy. This
study comprises a dose escalation phase and a dose expansion phase. The objective of the dose escalation phase is to determine the recommended
Phase 2 dose (RP2D) of LB-100 when combined with the standard dosage of atezolizumab. The dose expansion phase will further investigate
the preliminary efficacy, safety, tolerability, and pharmacokinetics/dynamics of the LB-100 and atezolizumab combination. The clinical
trial opened in August 2024 with the enrollment of the first patient. Patient accrual is expected to take up to 24 months, with a maximum
of 37 patients with advanced colorectal cancer to be enrolled in this study. The
principal investigator of the colorectal study testing LB-100 in combination with atezolizumab is currently investigating two Serious
Adverse Events (“SAEs”) observed in the clinical trial. Evaluation is underway to determine next steps (see “Serious
Adverse Events” below for additional information). The
Company has no financial contractual commitment associated with this clinical trial. City
of Hope. The
clinical trial was initiated on March 9, 2021, with patient accrual expected to take approximately two years to complete. Because patient
accrual was slower than expected, effective March 6, 2023, the Company and City of Hope added the Sarah Cannon Research Institute (“SCRI”),
Nashville, Tennessee, to the ongoing Phase 1b clinical trial. The Company and City of Hope continued efforts to increase patient accrual
by adding additional sites and by modifying the protocol to increase the number of patients eligible for the clinical trial. The impact
of these efforts to increase patient accrual and to decrease time to completion was evaluated in subsequent quarters. After
evaluating patient accrual through June 30, 2024, the Company and City of Hope agreed to close the clinical trial. Pursuant to the terms
of the Agreement, the Company provided notice to City of Hope of the Company’s intent to terminate the Agreement effective as of
July 8, 2024. Upon closure, the Company incurred a prorated charge of $ 207,004 During
the three months ended September 30, 2024 and 2023, the Company incurred costs of $ 207,004 0 285,019 69,001 732,532 GEIS.
GEIS
has a network of referral centers in Spain and across Europe that have an impressive track record of efficiently conducting innovative
studies in ASTS. The Company agreed to provide GEIS with a supply of LB-100 to be utilized in the conduct of this clinical trial, as
well as to provide funding for the clinical trial. The goal is to enter approximately 150 to 170 patients in this clinical trial over
a period of two to four years. The Phase 1 portion of the study began in the quarter ended June 30, 2023 to determine the recommended
Phase 2 dose of the combination of doxorubicin and LB-100. As advanced sarcoma is a very aggressive disease, the design of the Phase
2 portion of the study assumes a median progression-free survival (“PFS”), no evidence of disease progression or death from
any cause, of 4.5 months in the doxorubicin arm and an alternative median PFS of 7.5 months in the doxorubicin plus LB-100 arm to demonstrate
a statistically significant decrease in relative risk of progression or death by adding LB-100. There is a planned interim analysis of
the primary endpoint when approximately 50% of the 102 events required for final analysis is reached. The
Company had previously expected that this clinical trial would commence during the quarter ended June 30, 2020. However, during July
2020, the Spanish regulatory authority advised the Company that although it had approved the scientific and ethical basis of the protocol,
it required that the Company manufacture new inventory of LB-100 under current Spanish pharmaceutical manufacturing standards. These
standards were adopted subsequent to the production of the Company’s existing LB-100 inventory. In
order to manufacture a new inventory supply of LB-100 for the GEIS clinical trial, the Company engaged a number of vendors to carry out
the multiple tasks needed to make and gain approval of a new clinical product for investigational study in Spain. These tasks included
the synthesis under good manufacturing practice (GMP) of the active pharmaceutical ingredient (API), with documentation of each of the
steps involved by an independent auditor. The API was then transferred to a vendor that prepares the clinical drug product, also under
GMP conditions documented by an independent auditor. The clinical drug product was then sent to a vendor to test for purity and sterility,
provide appropriate labels, store the drug, and distribute the drug to the clinical centers for use in the clinical trials. A formal
application documenting all steps taken to prepare the clinical drug product for clinical use was submitted to the appropriate regulatory
authorities for review and approval before being used in a clinical trial. As
of December 31, 2023, this program to provide new inventory of the clinical drug product for the Spanish Sarcoma Group study, and potentially
for subsequent multiple trials within the European Union, had cost approximately $ 1,144,000 On
October 13, 2022, the Company announced that the Spanish Agency for Medicines and Health Products (Agencia Española de Medicamentos
y Productos Sanitarios or “AEMPS”) had authorized a Phase 1b/randomized Phase 2 study of LB-100, the Company’s lead
clinical compound, plus doxorubicin, versus doxorubicin alone, the global standard for initial treatment of ASTS. Consequently, this
clinical trial commenced during the quarter ended June 30, 2023 and is expected to be completed and a report prepared by December 31,
2026. In April 2023, GEIS completed its first site initiation visit in preparation for the clinical trial at Fundación Jiménez
Díaz University Hospital (Madrid). Up to 170 patents will be entered into the clinical trial. The recruitment for the Phase 1b
portion of the protocol was extended with two patients and was completed during the quarter ended September 30, 2024. The Company expects
to have data on toxicity and preliminary efficacy from this portion of the clinical trial by December 31, 2024, and a full report by
June 30, 2025. Subject to clinical results and the availability of sufficient working capital resources, the Company anticipates that
it will then be in a position to decide whether to proceed to the related Phase 2 portion of the study. The
interim analysis of the Phase 2 portion of this clinical trial will be done before full accrual of patients is completed to determine
whether the study has the possibility of showing superiority of the combination of LB-100 plus doxorubicin compared to doxorubicin alone.
A positive study would have the potential to change the standard therapy for this disease after four decades of failure to improve the
marginal benefit of doxorubicin alone. The
Company’s agreement with GEIS provides for various payments based on achieving specific milestones over the term of the agreement.
During the three months ended September 30, 2024 and 2023, the Company did not incur any costs pursuant to this agreement. During the
nine months ended September 30, 2024 and 2023, the Company incurred costs of $ 0 268,829 684,652 The
Company’s aggregate commitment pursuant to this agreement, less amounts previously paid to date, totaled approximately $ 3,616,000 284,000 3,332,000 MD
Anderson Cancer Center Clinical Trial Moffitt.
In
November 2018, the Company received approval from the U.S. Food and Drug Administration for its Investigational New Drug (“IND”)
Application to conduct a Phase 1b/2 clinical trial to evaluate the toxicity and therapeutic benefit of LB-100 in patients with low and
intermediate-1 risk MDS who had failed or were intolerant of standard treatment. This Phase 1b/2 clinical trial utilized LB-100 as a
single agent in the treatment of patients with low and intermediate-1 risk MDS. The
clinical trial began at a single site in April 2019 and the first patient was entered into the clinical trial in July 2019. During the
year ended December 31, 2023, the clinical trial was closed. Although the maximum tolerated dose (“MTD”) was not achieved,
there was no dose-limiting toxicity noted. During
the three months and nine months ended September 30, 2024 and 2023, the Company did not incur any costs pursuant to this agreement. As
of September 30, 2024, total costs of $ 147,239 During
September 2023, the Company decided not to pursue further studies in MDS, as other, more promising, opportunities had become available
(see “Patent and License Agreements - Moffitt” below). National
Cancer Institute Pharmacologic Clinical Trial. Clinical
Trial Monitoring Agreements MD
Anderson Cancer Center Clinical Trial Costs
under this letter of intent and related work order agreement are estimated to be approximately $ 95,000 12,610 20,838 20,838 The
Company’s aggregate commitment pursuant to this letter of intent, less amounts previously paid to date, totaled approximately $ 78,000 City
of Hope. 335,000 1,603 4,500 10,603 15,740 89,284 As
a result of the closure of the Agreement with City of Hope effective July 8, 2024 (see “Clinical Trial Agreements – City
of Hope” above), the work order agreement with Theradex to monitor this clinical trial was concurrently terminated, although nominal
oversight trailing costs subsequent to July 8, 2024 are expected to be incurred relating to the closure of this study. GEIS.
Costs
under this work order agreement are estimated to be approximately $ 153,000 72 28 13,475 3,750 26,208 10,000 41,070 The
Company’s aggregate commitment pursuant to this clinical trial monitoring agreement, less amounts previously paid to date, totaled
approximately $ 118,000 Netherlands
Cancer Institute. Costs
under this work order agreement are estimated to be approximately $ 106,380 47 53 14,900 14,900 The
Company’s aggregate commitment pursuant to this clinical trial monitoring agreement, less amounts previously paid to date, totaled
approximately $ 106,380 Patent
and License Agreements National
Institute of Health. The
License Agreement contemplates that the Company will seek to work with pharmaceutical companies and clinical trial sites (including comprehensive
cancer centers) to initiate clinical trials within timeframes that will meet certain benchmarks. Data from the clinical trials will be
the subject of various regulatory filings for marketing approval in applicable countries in the licensed territories. Subject to the
receipt of marketing approval, the Company would be expected to commercialize the licensed products in markets where regulatory approval
has been obtained. The
Company is obligated to pay the NIH a non-creditable, non-refundable license issue royalty of $ 50,000 25,643 30,000 50,000 25,643 The
Company is obligated to pay the NIH, on a country-by-country basis, earned royalties of 2% on net sales of each royalty-bearing product
and process, subject to reduction by 50% under certain circumstances relating to royalties paid by the Company to third parties, but
not less than 1%. The Company’s obligation to pay earned royalties under the License Agreement commences on the date of the first
commercial sale of a royalty-bearing product or process and expires on the date on which the last valid claim of the licensed product
or licensed process expires in such country. The
Company is obligated to pay the NIH benchmark royalties, on a one-time basis, within sixty days from the first achievement of each such
benchmark. The License Agreement defines four such benchmarks, which the Company is required to pursue based on “commercially reasonable
efforts” as defined in the License Agreement, with deadlines of October 1, 2024, 2027, 2029 and 2031, respectively, each with a
different specified benchmark payment amount payable within thirty days of achieving such benchmark. The October 1, 2024 benchmark of
$ 100,000 1,225,000 The
Company is obligated to provide annual reports to the NIH on its progress toward the development and commercialization of products under
the licensed patents. These reports, due within sixty days following the end of each calendar year, must include updates on research
and development activities, regulatory submissions, manufacturing efforts, sublicensing, and sales initiatives. If any deviations from
the established commercial development plan or agreed-upon benchmarks occur, the Company is obligated to provide explanation and may
amend the commercial development plan and the benchmarks, which, subject to certain conditions, the NIH shall not unreasonably withhold,
condition, or delay approval of any request of the Company to amend the commercial development plan and/or the benchmarks and to extend
the time periods of the benchmarks. The
Company is obligated to pay the NIH sublicensing royalties of 5 During
the three months ended September 30, 2024, the Company incurred costs of $ 7,537 68,106 68,106 1,795,000 Moffitt.
On
October 4, 2023, the Company received a counter-signed termination letter dated September 29, 2023 with respect to the Exclusive License
Agreement dated August 20, 2018 between the Company and Moffitt, effective September 30, 2023. The Company and Moffitt agreed that no
termination fee was due or payable by the Company, and Moffitt acknowledged that no payments are owed by the Company under the Agreement. During
the three months and nine months ended September 30, 2023, the Company recorded credits to operations of $ 21,507 9,109 Other
Significant Agreements and Contracts NDA
Consulting Corp. 4,000 4,000 4,000 12,000 12,000 BioPharmaWorks BioPharmaWorks
was founded in 2015 by former Pfizer scientists with extensive multi-disciplinary research and development and drug development experience.
The Collaboration Agreement was for an initial term of two years and automatically renews for subsequent annual periods unless terminated
by a party not less than 60 days prior to the expiration of the applicable period. In connection with the Collaboration Agreement, the
Company agreed to pay BioPharmaWorks a monthly fee of $ 10,000 The
Company recorded charges to operations pursuant to this Collaboration Agreement of $ 8,000 30,000 35,200 90,000 Netherlands
Cancer Institute 391,000 On
October 3, 2023, the Company entered into Amendment No. 2 to the Development Collaboration Agreement with NKI, which provides for additional
research activities, extends the termination date of the Development Collaboration Agreement by two years to October 8, 2026, and added
500,000 During
the three months ended September 30, 2024 and 2023, the Company incurred charges in the amount of $ 76,278 51,568 210,362 156,950 695,918 279,000 MRI
Global. 9,062 21,045 18,932 30,628 334,147 The
Company’s aggregate commitment pursuant to this contract, less amounts previously paid to date, totaled approximately $ 124,000 Specific
Risks Associated with the Company’s Business Activities Serious
Adverse Events The
Company’s lead drug candidate, LB-100, is currently undergoing various clinical trials, and there is a risk that one or more of
these trials could be placed on hold by regulatory authorities due to serious adverse events (SAEs) related to our drug candidate or
to another company’s drug used in combination in one of our clinical trials. It is possible that the SAEs could be attributable
to our drug candidate and could include, but not be limited to, unexpected severe side effects, treatment-related deaths, or long-term
health complications. A dose given could result in non-tolerable adverse events defined as dose-limiting toxicity (DLT). When two DLTs
occur at the same dose-level that dose-level is considered too high and unsafe. Further treatment is only allowed at lower dose-levels
that have previously been found safe. If
an SAE or a pattern of SAEs is observed during the course of a clinical trial involving our drug candidate, the U.S. Food and Drug Administration
(FDA), European Medicines Agency (EMA), or other regulatory authorities may issue a clinical hold, requiring us to pause or discontinue
further enrollment and dosing in our clinical trial. It is also possible that the clinical trial could be terminated. Any of these actions
could delay or halt the development of our drug candidate, increase development costs, and negatively impact our ability to ultimately
achieve regulatory approval. Additionally, if an SAE is confirmed to be drug-related, we may be required to conduct additional studies,
modify the study design, or abandon further development of the drug candidate altogether, which could materially impact our business,
financial condition, and prospects. The
occurrence of an SAE and any resulting clinical hold could also harm our reputation with patients, physicians, health institutions, and
investors, diminish our ability to attract clinical trial participants, and damage our ability to interest investors and obtain financing
in the future. There can be no assurance that we will not experience such SAEs in the future or that any related clinical hold will be
lifted in a timely manner, or at all. The
principal investigator of the colorectal study testing LB-100 in combination with atezolizumab (Roche PD-L1 inhibitor) is currently investigating
two SAEs observed in the clinical trial that was launched in August 2024. Evaluation is underway to determine next steps. Other
Business Risks Covid-19
Virus Inflation
and Interest Rate Risk. Supply
Chain Issues. Potential
Recession. Geopolitical
Risk. Cybersecurity
Risks. The
Company is continuing to monitor these matters and will adjust its current business and financing plans as more information and guidance
become available. |
