Notice of Completion of Patient Enrollment in a Phase 3 Trial of Nivolumab in Combination with the PAI-1 Inhibitor RS5614 for Unresectable Malignant Melanoma | Renascience Inc. (4889) timely disclosure

Worth reading

47Recurring

Scored from 4 of 5 sections

Direction

Neutral

Direction inferred from the company’s description.

Scale

124

cases

Wording

Conditional

How definitive the wording is.

Completion of patient enrollment in a Phase III trial of nivolumab in combination with PAI-1 inhibitor RS5614 for unresectable malignant melanoma

Subject Entity

Renascience Inc. (the Company), Tohoku University Hospital and 16 other medical institutions in Japan

Target Locations / Products

18 medical institutions in Japan, nivolumab, PAI-1 inhibitor RS5614, and unresectable malignant melanoma

Occurrence5 October 2026 (patient enrollment completion date)

This disclosure10/05/2026

Impact on Earnings Forecast

There is currently no particular impact on results for the fiscal year ending March 2027.

Outlook

Following an observation period for the subjects of up to 3 years, the primary endpoint will be evaluated and the results of the data analysis are scheduled to be compiled into a clinical study report.

Planned follow-up disclosure

Following the observation period for the subjects of up to 3 years and data analysis, the results are scheduled to be compiled into a clinical study report. The specific disclosure timing is Not disclosed

Event that occurred
Item	Details
Event name	Completion of patient enrollment in a Phase III trial of nivolumab in combination with PAI-1 inhibitor RS5614 for unresectable malignant melanoma
Date of occurrence	5 October 2026 (patient enrollment completion date)
Subject Entity	Renascience Inc. (the Company), Tohoku University Hospital and 16 other medical institutions in Japan
Target Locations / Products	18 medical institutions in Japan, nivolumab, PAI-1 inhibitor RS5614, and unresectable malignant melanoma
Impact on Earnings Forecast	There is currently no particular impact on results for the fiscal year ending March 2027.
Outlook	Following an observation period for the subjects of up to 3 years, the primary endpoint will be evaluated and the results of the data analysis are scheduled to be compiled into a clinical study report.
Planned follow-up disclosure	Following the observation period for the subjects of up to 3 years and data analysis, the results are scheduled to be compiled into a clinical study report. The specific disclosure timing is Not disclosed

Items this document does not state (18)

Date recognized / date notice receivedCauseAmount of Impact on Business PerformanceAccounting period in which recognizedType of litigation or proceedingCourt or authorityPlaintiffDefendantDate of filing / date of actionClaim amount / surcharge amountAmount of receivables at risk of non-collection or delayed collectionSuspended operationsScheduled resumption dateInvestigation structureMeasures to prevent recurrenceDirectors' and officers' liabilityVoting rights ownership percentage before the changeVoting rights ownership percentage after the change

These are items the company does not state in this document. We do not leave them blank, nor fill them in from other sources or by inference.

The reasons the company gives

The company's own explanation, not something inferred from the numbers.

Because enrollment of the target 124 patients was completed.

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