Company: LIMN
Filing Date: 2025-06-24
Form Type: S-1
Source: 0001410578-25-001432
Chunk: 131

Company: Liminatus Pharma, Inc.
Filing Date: 2025-06-24
Form: S-1
Chunk 131
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   |          3 |   |       3 |   |              2 |   |       2 |
| 2         |   |                 |   |          10 |   |              2 |   |             5 |   |          3 |   |       3 |   |              — |   |       — |
| 3         |   | IBA101          |   |          30 |   |                |   |            15 |   |          3 |   |       3 |   |              — |   |       — |
| 4         |   |                 |   |         100 |   |                |   |            50 |   |          3 |   |       3 |   |              2 |   |       2 |

| ● | Study design and standards |

| ● | The 4-week toxicity study of IBA101 in Cynomolgus monkeys, conducted by Charles River Laboratories, was designed and analyzed according to GLP (Good Laboratory Practice) standards. This ensured the reliability and reproducibility of the data, adhering to rigorous quality standards throughout the study. |

| ● | Parameters and endpoints of evaluation |

Based on the most recent body weight measurement, the following parameters and endpoints were evaluated:

| ● | Mortality, clinical signs, body weight, ophthalmology, electrocardiographic examinations |

| ● | Clinical pathology parameters (hematology, coagulation, clinical chemistry, and urinalysis) |

| ● | Anti-drug antibody analysis, toxicokinetic parameters, organ weights, and macroscopic and microscopic examinations. |

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| ● | Conclusion:   Toxicokinetic Analysis |

Following once-weekly (Days 1, 8, 15, 22, and 29) intravenous dosing of IBA101 to Cynomolgus monkeys at 0, 10, 30, or 100 mg/kg/dose:

| ● | No significant IBA101-related effects were noted at any dose level, indicating that 100 mg/kg/dose was well-tolerated. |

| ● | All study parameters, including body weight, clinical pathology results, and toxicokinetic measurements, were analyzed for statistical significance using standard statistical methods. At the highest dose tested (100 mg/kg), no statistically significant differences were observed in any parameter compared to the vehicle control group, supporting the determination of the No Observed Adverse Effect Level (NOAEL