Company: BFRG
Filing Date: 2025-11-14
Form Type: 10-Q
Source: 0001493152-25-023496
Chunk: 66

Company: BullFrog AI Holdings, Inc.
Filing Date: 2025-11-14
Form: 10-Q
Item: Item 8
Chunk 66
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 models with different types of cancer and has been evaluated in a Phase I clinical trial in patients with high-grade
glioma (NCT01729260). The trial, an open-label dose-escalation study, assessed the safety and efficacy of the improved formulation with
adjuvant temozolomide in 24 patients with newly diagnosed gliomas. Investigators observed no dose-limiting toxicity in patients receiving
all but the highest tested dose (200mg/kg/day). Four of the 15 patients receiving the maximum tested dose of 200mg/kg/day experienced
dose-limiting toxicity, all of which were reversed by decreasing or eliminating the dose given. There were no serious adverse events
attributed to Mebendazole at any dose during the trial. 41.7% of patients who received Mebendazole were alive at two years after enrollment,
and 25% were alive at four years (Gallia et al., 2021).

The
license covers six (6) issued patents and one (1) pending application. In consideration of the rights granted to the Company under the
license agreement, JHU received a staggered upfront license fee of $250,000, with $50,000 paid in 2022 and the remaining balance of $200,000
paid in 2023. The Company will also reimburse JHU for previously incurred and ongoing patent costs. Under the terms of the license agreement,
JHU will be entitled to three and one-half percent (3.5%) royalty on net sales by the Company in which the JHU license was utilized.
In addition, the Company is required to pay JHU minimum annual royalty payments of $5,000 for 2022, $10,000 for 2023, $20,000 for 2024,
$30,000 for 2025 and $50,000 for 2026 and each year after until the first commercial sale, after which the annual minimum royalty shall
be $250,000. The license agreement also contains milestone payments for clinical development steps through the approval of an NDA and
commercialization. As of September 30, 2025, the Company has accrued $22,500 of the $30,000 annual minimum royalty for 2025. The Company
assessed whether the license should be capitalized and determined that the licensed program is in the early stage and therefore may not
be recoverable. The Company expensed the license fee and will expense development costs until commercial viability is likely.