Company: MDCXW
Filing Date: 2025-11-19
Form Type: S-1
Source: 0001062993-25-016962
Chunk: 120

Company: Medicus Pharma Ltd.
Filing Date: 2025-11-19
Form: S-1
Chunk 120
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                            |                                                                  |
| Sample Preparation                                          | Protein Precipitation            |                                                                  |
| Assay Range                                                 | 0.250 - 50.0 ng/ml               |                                                                  |
| Regression                                                  | Linear (1/x2)                    |                                                                  |
| Selectivity                                                 | 6 of 6 lots within acceptance    | ≤ 20% of mean LLOQ, ≥90% of individual lots free of interference |
| Injector Carryover                                          | Not Significant                  | ≤20% of mean LLOQ                                                |
| Validation Batch Acceptance (Acceptable/Total Primary Runs) | 4/4                              |                                                                  |

The toxicity of doxorubicin hydrochloride has previously been evaluated and reported in standard preclinical toxicology models. More important, the toxicity profile of parenteral doxorubicin in humans at doses cytotoxic to cancers has been well established and recounted in the Investigator Brochure for D-MNA Patch (September 4, 2018).

We have not conducted any formal safety pharmacology studies. However, selected parameters that are typically collected in CNS and respiratory safety pharmacology were collected in the form of clinical observations in the below-listed toxicology studies. In addition, electrocardiograms were recorded in a pivotal toxicology study in minipigs and were evaluated by a board-certified veterinary cardiologist.

We have completed three GLP-compliant toxicology studies:

1.D-MNA toxicity, local tolerance and toxicokinetics study in Yucatan minipigs (Study No. S15055)

2.Local lymph node immunotoxicology assay ("LLNA") in CBA/J mice (Study No. BRT Study 20170724)

3.Pyrogenicity/skin irritation study in New Zealand White ("NZW") rabbits (Study No. Study No. S15054), each of which was preceded by a pilot study using the same species and strain of animal.

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The D-MNA was designed to penetrate human skin and dissolve into a skin cancer. Given the inherent differences in skin types between mammalian species, the pilot studies were necessary to ensure that the GLP study would provide for a valid safety assessment.

In total, three pilot studies were performed. For the GLP minipig study (SRC Study No. S15055), a pilot study demonstrated that it was technically feasible to administer D-MNA to Yucatan minipigs (SRC Study No. S15200). For the LLNA (BRT Study