Company: NCEL
Filing Date: 2025-06-09
Form Type: F-4/A
Source: 0001213900-25-052354
Chunk: 703

Company: NewcelX Ltd.
Filing Date: 2025-06-09
Form: F-4/A
Chunk 703
---
 |     |     84.6 | % |

As can be seen, the success rates of clinical trials differ according to the disease area and according to the phase. The average success rates are represented by “All Indication” in which the probability of success of Phase I is 52% and those of Phase II and Phase III are 28.9% and 57.8% respectively. For the IsletRx (diabetes) development we used the Endocrine success rates from the above table.

| Moore Financial Consulting |

____________ 5Clinical Development Success rates and Contributing factors 2011–2020/BIO, February 2021 Annex E-25

Another one of the BIO research results is the rates of success of clinical trials for rare diseases. In this context the BIO research reads “ …rare diseases can be identified based on meeting either or both of the following standard criteria: affecting fewer than 200,000 people in the US, or prevalence of 1 in 2,000 people in the EU. As 43% of the Oncology transitions are for rare indications, all Oncology indications were removed to make this rare disease analysis more concentrated on inborn genetic disorders. For chronic diseases, we first obtained a list of conditions from the CMS Chronic Conditions Data Warehouse (CCW). We removed any cancer indications, then identified those diseases with greater than 1 million patients affected in the United States.” The success rates of clinical trials included in the Rare Disease segment are as follows:

| Disease Area  |     | From 
 To   |     |  Phase I 
 Phase II |   |     |  Phase II 
 Phase III |   |     | Phase III 
   NDA/BLA |   |     |  NDA/BLA 
 Approval |   |
| Rare Diseases |     |      |     |    67.40 | % |     |     44.60 | % |     |     60.40 | % |     |    93.60 | % |

These success rates were used in the current valuation as the success rates of the AstroRx ®(ALS). The rates of success used in the current valuation are as follows:

| Phase     |     | AstroRx |   |     | IsletRx |   |
| Phase I   |     |     N/R |   |     |   43.30 | % |
| Phase II  |     |   44.60 | % |     |   26.60