Company: BFRG
Filing Date: 2025-03-14
Form Type: 10-K
Source: 0001493152-25-010367
Chunk: 825

Company: BullFrog AI Holdings, Inc.
Filing Date: 2025-03-14
Form: 10-K
Item: Item 7A
Chunk 825
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 generate applicable revenue. 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.

     F-17 

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 will receive a staggered upfront license fee of $250,000. The Company initially paid $50,000 and the remaining
balance of $200,000 was 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