Company: BFRG
Filing Date: 2025-03-14
Form Type: 10-K
Source: 0001493152-25-010367
Chunk: 65

Company: BullFrog AI Holdings, Inc.
Filing Date: 2025-03-14
Form: 10-K
Item: Item 1
Chunk 65
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 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 MASH and liver cancer (Rao et al., 2021).

In
February 2022, the Company entered into an exclusive, worldwide, royalty-bearing license with 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 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 find a partner to conduct additional clinical trials
with this asset to enable evaluation of safety in humans.

In
October 2022, the Company entered into an exclusive, world-wide, royalty-bearing license with JHU and the Institute of Organic Chemistry
and Biochemistry (“IOCB”) of the Czech Academy of Sciences for rights to commercialize N-substituted prodrugs of mebendazole
that demonstrate improved solubility and bioavailability. The license covers prodrug compositions and use for treating disease as claimed
in multiple United States and worldwide patent applications. Patents have since been issued in the United States and Australia and are
still in the prosecution phase in other territories. In September 2023, the Company announced results from a preclinical study demonstrating
the effectiveness of BF-223, a compound chosen from this class, in an animal model for glioblastoma. The Company is currently formulating
a strategy for initiating IND-enabling studies on BF-223 and is conducting outreach to identify partners that may want to license or
partner in the development of BF-223.

Our
bfLEAP™ Analytics Platform

We
are able to pursue our drug rescue business by leveraging a