Strategic Execution and Clinical Validation

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• Initiated a rolling NDA submission for D-PLEX100 in abdominal colorectal surgery, completing CMC and nonclinical modules with clinical components expected imminently.

• Advanced U.S. commercial partnership discussions to late-stage negotiations, shifting focus from due diligence to finalizing definitive agreement terms.

• Strengthened the clinical value proposition with new SHIELD II data showing a 64% relative risk reduction in clinically significant wound infection severity.

• Positioned D-PLEX100 to align with Medicare’s new TEAM reimbursement model, which holds hospitals financially accountable for complications within a 30-day post-surgery window.

• Leveraged Breakthrough Therapy Designation to maintain frequent communication with the FDA regarding CMC processes and development reports prior to formal submission.

• Maintained operational continuity and manufacturing readiness despite regional conflict, noting that the FDA has recently inspected other Israeli facilities.

Regulatory Milestones and Launch Preparation

• Anticipates a potential 6-month priority review period if granted by the FDA, which would shorten the standard 10-month review timeline.

• Plans to submit a Marketing Authorization Application (MAA) to the EMA in Q3 2026 following alignment meetings with European regulators.

• Targets a formal U.S. commercial launch in the first quarter of 2027, supported by a strategic partner with established hospital sales infrastructure.

• Expects current cash resources to fund operations into the second half of 2026, covering several significant upcoming milestones.

• Prepares for a critical FDA pre-approval inspection of the internal manufacturing facility, supported by multiple successful mock audits and external consultants.

Financial and Structural Developments

• Received a $4.3 million PDUFA fee waiver from the FDA under small business provisions, preserving capital for commercialization activities.

• Achieved a debt-free balance sheet following the full repayment of the remaining 2022 loan facility in early May 2026.

• Reported a narrowed net loss of $7.7 million for Q1 2026, down from $8.3 million in the prior year period, reflecting the completion of Phase III trials.

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Confidence in CMC module and manufacturing inspection readiness

• Management emphasized that owning their manufacturing facility provides full control over QA and processes, unlike relying on a CMO.

• Mock inspections identified only minor comments that have already been addressed or are currently being implemented.

• The company utilized Breakthrough Therapy status to align with the FDA on risky CMC aspects well before the actual filing.