Company: BFRG
Filing Date: 2025-03-14
Form Type: 10-K
Source: 0001493152-25-010367
Chunk: 76

Company: BullFrog AI Holdings, Inc.
Filing Date: 2025-03-14
Form: 10-K
Item: Item 1
Chunk 76
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oplastic 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 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.
The Company is currently formulating a strategy to conduct additional clinical trials with this asset to enable evaluation of safety
in humans.

 15 

The
license covers six (6) issued patents and one (1) pending application, with the term of the agreement beginning on February 22, 2022
and ending on the date of expiration of the last to expire patent. The license can be terminated by the licensee upon 90 days’
written notice, or by the licensor in the event of any material breach of the license that is not cured within 30 days. In consideration
of the rights granted to the Company under the license agreement, JHU received a staggered upfront license fee of $250,000, with the
first $50,000 paid in 2022 and the remaining balance of $200,000 paid in 2023. The Company also reimbursed 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. Aggregate future milestone costs could reach $1