Company: BFRG
Filing Date: 2025-03-14
Form Type: 10-K
Source: 0001493152-25-010367
Chunk: 78

Company: BullFrog AI Holdings, Inc.
Filing Date: 2025-03-14
Form: 10-K
Item: Item 1
Chunk 78
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 assigns their rights to use the technology. The sublicense fee amount declines
as the Company advances the clinical development of licensed technology. The Company is required to pay minimum annual royalties beginning
in year 4 of the agreement. The minimum annual royalty for year 4 will be $5,000 (2026), increasing to $10,000 in year 5 (2027), $20,000
in year 6 (2028), $30,000 in year 7 (2029), and $50,000 in year 8 and subsequent years (2030 and beyond). The Company will be responsible
for milestone payments for patent issuance of up to $50,000 and clinical development milestones up to and including approval of an NDA
totaling up to $2.3 million. The Company will be required to pay a commercial milestone of $1 million once sales reach $20 million in
the United States, $2 million when sales in the United States reach $100 million, $10 million when United States sales reach $500 million,
and $20 million when United States sales exceed $1 billion.

As
of December 31, 2024 and 2023, the balance of accrued expense related to this license agreement was $0. 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.

On
September 26, 2023, the Company announced positive data in a preclinical study investigating the anti-cancer activity of a novel prodrug
of mebendazole for the treatment of glioblastoma. The study assessed the relative efficacy of BF-222, a novel formulation of mebendazole
that has been evaluated in clinical trials, and BF-223, a novel prodrug of mebendazole with improved solubility and bioavailability relative
to BF-222, compared with placebo in mice that had been implanted with tumor cells as a model for human glioblastoma. Animals treated
with BF-223 had an average survival time of 27.9 days compared with 27.3 days for mice treated with BF-222 and 23.4 days for mice given
placebo. Mice treated with BF-223 were administered 80% of the dose that mice treated with BF-222 received, and improved outcomes for
both treatment groups were statistically significant compared to placebo.