Company: NCEL
Filing Date: 2025-09-03
Form Type: F-4/A
Source: 0001213900-25-084157
Chunk: 746

Company: NewcelX Ltd.
Filing Date: 2025-09-03
Form: F-4/A
Chunk 746
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) 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 | % |
| Phase III |     |   60.40 | % |     |   66.20 | % |
| NDA       |     |   93.60 | % |     |   86.30 | % |
| TOTAL     |     |   25.21 | % |     |    6.58 | % |

Cash Flows Following are the cash flows based on the assumptions describe