PolyNovo

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Q: PolyNovo is in the process of hiring a Vice President of Global Marketing. Should this be interpreted as a shift in commercial strategy or emphasis following the earlier strategic review?

A: The Company continues to evaluate the commercial structure to support growth across markets. The decision to appoint a Vice President of Global Marketing reflects the investment in marketing capability across regions and will play a critical role in continuing to shape our commercial strategy as we drive velocity in the NovoSorb® pipeline.

This position has been accompanied by the further resourcing of key levers for growth in the U.S. and globally, including appointments supporting reimbursement, upstream marketing, and outpatient presence.

Alongside this, some changes have been made to the Commercial Leadership team in the U.S., with Andrew Addonizio appointed Vice President Sales, East and Matthew Stubbs appointed Vice President Sales, West. With Ed Graubart’s leadership, this organisational structure enables us to continue to scale and grow market share.

Q: Will PolyNovo release quarterly sales figures for Q1 FY26?

A: The question of providing quarterly sales updates has been given careful consideration. While we understand the interest in more frequent disclosures, preparing and releasing quarterly sales information carries a meaningful time, cost and operational burden for the Company, requiring additional management and finance resources that would otherwise be focused on executing the business and progressing key strategic priorities.

On balance, having considered the benefits against this cost and distraction, the Company does not believe that introducing quarterly sales reporting is justified at this time. Consistent with our current disclosure approach, we will continue to provide market updates where they are material and appropriate, and to release our audited full‑year financial results for FY26 in August, in line with our reporting obligations.

Q: Will the results of the BARDA-funded Pivotal Trial be made available at the time of the PMA submission?

A: The results of the BARDA study are submitted to the FDA as part of the Premarket Approval (PMA) process in the form of a Clinical Study Report (CSR). The CSR is a detailed regulatory document prepared specifically for FDA review, but it is not a publication‑ready manuscript and is not intended for public release.

Public disclosure of clinical results typically occurs through peer‑reviewed journal publication. Converting the CSR into a manuscript suitable for submission to a journal is a separate and time‑intensive process, requiring additional analysis, drafting, and review by the primary investigators and participating surgeons. As a result, journal submission is currently expected to occur approximately 6–12 months after CSR submission, noting that this timing can vary depending on investigator availability and review cycles.

Once submitted, the journal peer‑review and editorial process itself generally takes several months before publication.

This approach is consistent with standard regulatory and scientific practice, ensuring the data are presented appropriately and independently through the peer‑review process.

Q: Is PolyNovo actively engaging with Brokers and Analysts to drive engagement and interest in the Company?

A: The Company has had long‑standing, active engagement with a number of brokers, and this activity has been further increased in recent months. That engagement sits alongside our broader focus on improving the cadence and quality of communications with the market, as noted during the first‑half results call.

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