Company: BFRG
Filing Date: 2025-03-14
Form Type: 10-K
Source: 0001493152-25-010367
Chunk: 75

Company: BullFrog AI Holdings, Inc.
Filing Date: 2025-03-14
Form: 10-K
Item: Item 1
Chunk 75
---
 condition in which excess lipids, or fat, build up in the liver. This condition, which
is more common in people who have obesity and related metabolic diseases including type 2 diabetes, affects as many as 24% of adults
in the United States and is associated with risk of progression to more serious conditions, including non-alcoholic steatohepatitis (“NASH”),
with associated liver inflammation and fibrosis, and hepatocellular carcinoma (“HCC”). Evidence in animal models of obesity
suggest that a protein called β2-spectrin may play a key role in lipid accumulation, tissue fibrosis, and liver damage, and targeting
expression or activity of this protein may be a useful approach in treating NASH and liver cancer (Rao et al., 2021).

In
consideration of the rights granted to the Company under the license agreement, GWU received a $20,000 license initiation fee. Under
the terms of the license agreement, GWU will be entitled to a three percent (3%) royalty on net sales subject to quarterly minimums once
the first sale has occurred subsequent to regulatory approval, as well sublicense or assignment fees in the event the Company sublicenses
or assigns their rights to use the technology. The Company will also reimburse GWU for previously incurred and ongoing patent costs.
The sublicense and assignment fee amounts 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”) and commercialization.

Aggregate
future milestone costs could reach $860,000 if the drug successfully completes clinical trials and is the subject of an NDA to the U.S.
FDA. Future milestones on sales revenue are limited to $1 million on the first $20 million in net sales.

As
of December 31, 2024 and 2023, there has been no accrual for royalties since we have not begun to 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.

Johns
Hopkins University – Mebendazole License 

On
February 22, 2022, the Company entered into an exclusive, worldwide, royalty-bearing license with JHU for the use of an improved formulation
of Mebendazole for the treatment of any human cancer or ne