Company: BFRG
Filing Date: 2025-11-14
Form Type: 10-Q
Source: 0001493152-25-023496
Chunk: 26

Company: BullFrog AI Holdings, Inc.
Filing Date: 2025-11-14
Form: 10-Q
Item: Item 1
Chunk 26
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 sublicense and assignment fees decline as the Company advances the clinical development of the licensed technology. The license
agreement also contains milestone payments for clinical development through the approval of a new drug application (“NDA”)
by the U.S. Food and Drug Administration and commercialization. As of September 30, 2025, there has been no accrual for royalties since
the Company has not begun to generate applicable revenue; however, the Company has accrued $15,000 of the $20,000 license maintenance
fees 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.

    16

Johns
Hopkins University – Mebendazole License 

In
February 2022, the Company entered into an exclusive, world-wide, royalty-bearing license from Johns Hopkins University (“JHU”)
for the use of an improved formulation of Mebendazole for the treatment of any human cancer or neoplastic disease. This formulation shows
potent activity in animal 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