Company: MDCXW
Filing Date: 2025-09-11
Form Type: DRS
Source: 0001062993-25-015568
Chunk: 125

Company: Medicus Pharma Ltd.
Filing Date: 2025-09-11
Form: DRS
Chunk 125
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| CONFIDENTIAL TREATMENT REQUESTED BY MEDICUS PHARMA LTD. 
 PURSUANT TO 17 C.F.R. SECTION 200.83                    |

While Intertek is performing this testing, Nelson Laboratories is performing the following work to assess microbiological safety:

Endotoxin testing: The Bacterial Endotoxin Test, or Lumulus Amebocyte Lysate ("LAL") Test, quantifies endotoxins that are part of the cell wall of gram-negative bacteria. LAL testing is performed on samples at T0 and subsequent stability timepoints.

Sterility/bioburden: The arrays are also dissolved and the contents are cultured to determine if the sterilization eradicated all bacteria and yeasts from the samples. This test is performed on samples at T0 and subsequent stability timepoints.

All of the results of these tests and others such as moisture content and physical assessment are then collated and appended to a certificate of analysis ("COA"), which, when signed by qualified persons, allows the release of the product by Clinigen Clinical Services, who has stored the product under quarantine until they receive the signed COA authorizing release to the clinical site.

Preclinical Development of D-MNA

Preclinical Test Material

GMP-quality doxorubicin was used for all preclinical studies (murine local lymph node assay, rabbit irritation and pyrogenicity study, and Yucatan minipig local tolerance study). The nonclinical arrays were produced under non-GMP conditions; GMP conditions were not required for these studies. The manufacturing methods used to make the arrays for the non-clinical studies are identical to the methods used to make the GMP-quality arrays.

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

Preclinical PK and Safety Studies

The results of the preclinical studies indicate a reliable lack of systemic exposure when doxorubicin is delivered via MNA. Furthermore, minipig studies using doses of up to 200 µg per MNA showed no detectable levels of doxorubicin, measured by LC-MS/MS. Given these data, no systemic effects are anticipated from D-MNA application.

All preclinical studies of D-MNA were conducted by the University of Pittsburgh at the laboratory of Dr. Louis Falo.

University of