Company: ANIX
Filing Date: 2025-01-10
Form Type: S-8
Source: 0001493152-25-001798
Chunk: 29

Company: Anixa Biosciences Inc
Filing Date: 2025-01-10
Form: S-8
Chunk 29
---
 costs could increase and our ability to generate revenue could be delayed.

| 16 |

Switching or adding third parties to conduct our clinical trials involves substantial cost and requires extensive management time and focus. In addition, there is a natural transition period when a new third party commences work. As a result, delays occur, which can materially impact our ability to meet our desired clinical development timelines.

If we encounter difficulties enrolling patients in our clinical trials, our clinical development activities could be delayed or otherwise adversely affected.

We may experience difficulties in patient enrollment in our clinical trials for a variety of reasons. The timely completion of clinical trials in accordance with their protocols depends, among other things, on our ability to enroll a sufficient number of patients who remain in the study until its conclusion. The enrollment of patients depends on many factors, including:

| ● | the                                                                                                        
 patient eligibility criteria defined in the clinical trial protocol;                                       |
| ● | the                                                                                                        
 size of the patient population required for analysis of the trial’s primary endpoints;                     |
| ● | the                                                                                                        
 proximity of patients to the study site;                                                                   |
| ● | the                                                                                                        
 design of the clinical trial;                                                                              |
| ● | our                                                                                                        
 ability to retain clinical trial investigators with the appropriate competencies and experience;           |
| ● | our                                                                                                        
 ability to obtain and maintain patient consents;                                                           |
| ● | the                                                                                                        
 risk that patients enrolled in clinical trials will drop out of the clinical trials before completion; and |
| ● | competing                                                                                                  
 clinical trials and approved therapies available for patients.                                             |

In particular, our Phase 1 CAR-T ovarian cancer clinical trial is enrolling patients with late-stage ovarian cancer who have failed conventional treatment, and are willing and able to be treated at Moffitt. Our Phase 1a breast cancer vaccine clinical trial is enrolling patients who have undergone standard of care treatment for TNBC. Our Phase 1b breast cancer vaccine clinical trial is enrolling healthy women who, as a result of, among other things, testing positive for the BRCA1, BRCA2 or PALB2 gene mutations which are leading predictors of future incidence of breast cancer, have elected to have prophylactic mastectomies. Our Phase 1c breast cancer vaccine clinical trial is enrolling post-operative TNBC patients who have residual disease following neoadjuvant chemo-immunotherapy and are being treated with pembrolizumab (Keytruda®). These potential trial participants must be willing and able to undergo treatment at the