Commitments and Contingencies

6 Months Ended

Jun. 30, 2026

Commitments and Contingencies Disclosure [Abstract]

Commitments and Contingencies

9. Commitments and Contingencies

Legal Proceedings

From time to time, the Company may become involved in legal proceedings arising in the ordinary course of business. As of June 30, 2026 and December 31, 2025, the Company was not subject to any material pending or threatened legal proceedings.

Clinical Trial and Monitoring Agreements

As of June 30, 2026, the Company had remaining contractual commitments of approximately $463,000 under clinical trial and monitoring agreements, consisting of approximately $293,000 related to the GEIS clinical trial and approximately $170,000 related to clinical trial monitoring agreements. These commitments are expected to be incurred through December 31, 2027. Actual expenditures may vary based on patient enrollment, trial duration, protocol modifications, foreign currency fluctuations and the continuation, suspension or termination of the applicable clinical trials.

The Company’s principal ongoing clinical trials include the following:

	●	Netherlands Cancer Institute. A Phase 1b clinical trial evaluating LB-100 in combination with atezolizumab in patients with microsatellite-stable metastatic colorectal cancer began in August 2024. Two patients have been enrolled. The Company has no obligation to fund the clinical trial costs but provides LB-100 and separately funds certain monitoring activities. The trial is currently on enrollment hold pending review by the Netherlands Cancer Institute Institutional Review Board, as discussed below.

	●	Spanish Sarcoma Group (“GEIS”). The Phase 1b portion of a clinical trial evaluating LB-100 in combination with doxorubicin in advanced soft tissue sarcoma enrolled 14 patients. In March 2025, the agreement was amended to eliminate the Company’s approximately $3.1 million funding obligation for the randomized Phase 2 portion of the trial. In February 2026, GEIS informed the Company that participating sites had been closed and the trial was being closed out. As of June 30, 2026, the Company’s remaining commitment under the agreement was approximately $293,000, which is expected to be incurred through December 31, 2026.

	●	MD Anderson Cancer Center. An investigator-initiated Phase 1b/2 clinical trial is evaluating LB-100 in combination with dostarlimab in patients with ovarian clear cell carcinoma. Twenty-one patients have been enrolled, and the trial is expected to be completed by December 31, 2027. The Company provides LB-100 but has no contractual obligation to fund the clinical trial costs.

The Company has monitoring agreements with Theradex covering the MD Anderson, GEIS and Netherlands Cancer Institute trials. As of June 30, 2026, the remaining commitments under these agreements were approximately $33,000, $81,500 and $55,800, respectively.

Patent License Agreement

In February 2024, the Company entered into an exclusive patent license agreement with institutes of the National Institutes of Health (“NIH”) covering certain jointly developed intellectual property related to the use of LB-100 in cancer treatment. The license generally continues on a country-by-country basis until expiration of the last valid licensed patent claim, unless earlier terminated.

The Company is required to pay the NIH an annual minimum royalty of $30,000, royalties of 2% of net sales, subject to certain reductions but not below 1%, and 5% of sublicensing revenue. The agreement also provides for contingent milestone payments aggregating $1.225 million upon achievement of specified development benchmarks.

Expense under the license agreement was $7,500 and $7,397 for the three months ended June 30, 2026 and 2025, respectively, and $15,000 and $14,794 for the six months ended June 30, 2026 and 2025, respectively. As of June 30, 2026, the Company’s estimated remaining commitment under the agreement was approximately $1.735 million, expected to be incurred over approximately 19 years.

Other Agreements

Under a development collaboration agreement with the Netherlands Cancer Institute and Oncode Institute, the Company is funding certain preclinical research involving LB-100. As of June 30, 2026, the remaining commitment under the agreement was approximately $116,000, expected to be incurred through October 2026.

The Company incurred expenses under its agreement with BioPharmaWorks of $17,600 and $10,800 for the three months ended June 30, 2026 and 2025, respectively, and $30,800 and $24,800 for the six months ended June 30, 2026 and 2025, respectively.

The Company also contracts with MRI Global for stability testing, storage and distribution of LB-100. Related expense was $7,245 and $6,765 for the three months ended June 30, 2026 and 2025, respectively, and $12,296 and $34,857 for the six months ended June 30, 2026 and 2025, respectively.

Serious Adverse Events

The principal investigator of the Netherlands Cancer Institute colorectal cancer trial is investigating two serious adverse events observed in the first two enrolled patients. One patient experienced dyspnea associated with lung toxicity considered possibly or probably related to the combination of LB-100 and atezolizumab and subsequently died in the context of metastatic colorectal cancer and dyspnea. The second patient experienced fever and aphasia considered possibly or probably related to the combination and fully recovered following supportive treatment.

The Institutional Review Board placed the trial on enrollment hold and requested additional information regarding the events and the potential effects of the drug combination. The investigator submitted a response that included updated safety information for LB-100, and the Company is awaiting completion of the review. The Company cannot predict when or whether the enrollment hold will be lifted. A continued hold or termination of the trial could delay development of LB-100 and increase the Company’s development costs.