Company: MDCXW
Filing Date: 2025-05-01
Form Type: DRS
Source: 0001062993-25-008292
Chunk: 98

Company: Medicus Pharma Ltd.
Filing Date: 2025-05-01
Form: DRS
Chunk 98
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 B, et al, 2017). Survival advantage persisted with 40% of MNA-Doxorubicin-treated mice alive at 40 days post-inoculation. As a result, we believe BCC is a rational target for chemo-immunotherapy using D-MNAs.

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| CONFIDENTIAL TREATMENT REQUESTED BY MEDICUS PHARMA LTD. 
 PURSUANT TO 17 C.F.R. SECTION 200.83                    |

The University of Pittsburgh research under IND #122448 was conducted on mice in groups ranging in size from six mice to 45 mice using the same D-MNAs that we are developing. These studies were not powered to demonstrate statistical significance.

Manufacturing Processes and Critical to Quality Parameters

Overview

For BCC, the principal mode of action of the D-MNA depends on doxorubicin being delivered to this basal layer space, disrupting the affected basal cells, and recruiting immune cells to eradicate the lesion. The 400 microneedles in the D-MNA must therefore be durable enough to penetrate the stratum corneum and upper layers of the epidermis, but also dissolve quickly enough to deliver sufficient doxorubicin to the site during the 30 minute application. Other more traditional parameters of biopharmaceutics also apply, such as consistency of dose between arrays, made more complex than oral or other dosage forms, by the molding and centrifugation process for the arrays. The important biopharmaceutic considerations for the efficacy of the array therefore include the following:

•Fidelity of dose to label claim

•Needle strength/hardness

•Homogeneous distribution of drug throughout the array

•Consistency of dose between arrays

•Dissolution of the microneedles sufficient to deliver the drug payload

These factors can affect the ability of a dissolvable, tip-loaded microneedle array to perform as expected in human clinical studies. We have taken the following steps to ensure these factors are properly controlled during manufacturing.

Factors Affecting Ability of MNA to Perform Clinically

| Factor                                                                                                                          |     | Measurement                                                                                                                   |
| Fidelity of dose to label claim                                                                                                 |     | Quantitative testing of the array samples by a validated HPLC method                                                          |
| Homogeneous distribution of drug throughout the array                                                                           |     | Visual inspection for "hot spots"                                                                                             |
| Consistency of dose between arrays                                                                                              |     | Quant