Company: ANIX
Filing Date: 2025-09-10
Form Type: 10-Q
Source: 0001493152-25-013000
Chunk: 10

Company: Anixa Biosciences Inc
Filing Date: 2025-09-10
Form: 10-Q
Item: Part I, Item 1
Chunk 10
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 (iii) a vaccine discovery program utilizing the same mechanism as our breast and ovarian cancer
vaccines, to develop additional cancer vaccines to address many intractable cancers, including high incidence malignancies in lung, colon
and prostate.

Our
subsidiary, Certainty, is developing immuno-therapy drugs against cancer. Certainty holds an exclusive worldwide, royalty-bearing license
to use certain intellectual property owned or controlled by The Wistar Institute (“Wistar”), the nation’s first independent
biomedical research institute and a leading National Cancer Institute (“NCI”) designated cancer research center, relating
to Wistar’s chimeric endocrine receptor targeted therapy technology. We have initially focused on the development of a treatment
for ovarian cancer, but we also may pursue applications of the technology for the development of treatments for additional solid tumors.
The license agreement requires Certainty to make certain cash and equity payments to Wistar upon achievement of specific development
milestones. With respect to Certainty’s equity obligations to Wistar, Certainty issued to Wistar shares of its common stock equal
to five percent (5%) of the common stock of Certainty, such equity stake subject to dilution by further funding of Certainty’s
activities by the Company. Due to such Company funding, Wistar’s equity stake in Certainty was 4.1% as of July 31, 2025.

Certainty,
in collaboration with the H. Lee Moffitt Cancer Center and Research Institute, Inc. (“Moffitt”), has begun human clinical
testing of the CAR-T technology licensed by Certainty from Wistar aimed initially at treating ovarian cancer. After receiving authorization
from the U.S. Food and Drug Administration (“FDA”), we commenced enrollment of patients in a Phase 1 clinical trial and treated
the first patient in August 2022. Further, in May 2023 and August 2023, we treated the second and third patients in the trial, respectively,
at the same dose level as the first patient, and the treatment was well-tolerated by the patients. Between February and June 2024, we
treated the three patients of the second dose cohort, where the patients were administered a three-times higher dose of cells than the
patients in the first cohort. The treatment at this dose level was also well-tolerated by the patients. From November 2024 to February
2025, we treated three patients in the third dose cohort, where they were administered a ten-times higher dose of cells