Regentis Biomaterials Ltd Dossier
Outlook & Key Dates
Estimates, guidance, catalysts, and upcoming events
Analyst Estimates Learn more →
Analyst Coverage
1analyst covering
FY EPS (est.)
-$0.68next fiscal year
Monitoring Framework
Key Performance Indicators
Pivotal Phase III FDA Trial Patient Enrollment Quarterly58.8Target: 100% (80 patients for initial PMA submission)
Cash Runway Duration QuarterlyTarget: Sufficient runway to complete Phase III enrollment and support European commercial launch
European Clinical Site Network Expansion Annually6.0Target: Establishment of Centers of Excellence in key European markets to support commercial launch
Watch Items
- PMA Submission Timeline for GelrinC in the U.S.Trigger: Delay beyond the target window of late 2027Action: Re-evaluate clinical site enrollment rates, expand clinical trial sites, and assess cash burn impact.
- European Commercial Launch and Distribution PartnershipTrigger: Failure to secure a strategic commercial partner in Europe by late 2026Action: Assess direct sales force feasibility or adjust European market entry timeline and budget.
- Going Concern Qualification and Capital SufficiencyTrigger: Cash balance falling below $3.0 million without additional non-dilutive or equity financingAction: Execute further private placements, secure strategic licensing upfront payments, or implement cost-reduction measures.
Research as of 20 Jun 2026