8/14/2025

speaker
Operator
Conference Operator

Good day and welcome to Mediwound Second Quarter 2025 Earnings Conference Call. All participants will be in the listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star then 1 on your touch-tone phone. To withdraw your questions, please press star then 2. Please note, this event is being recorded. I would now like to turn the conference over to Dan Ferry of LifeSciAdvisors. Please go ahead.

speaker
Dan Ferry
Managing Partner, LifeSci Advisors

Thank you, Operator, and welcome, everyone. Earlier today, pre-market open, MedWound issued a press release announcing financial results for the second quarter ended June 30, 2025. You may access this press release on the company's website under the Investors tab. It would ask you to review the full text of our forward-looking statements within this morning's press release. Before we begin, I would like to remind everyone that statements made during this call, including the Q&A session, relating to anyone's expected future performance, future business prospects, or future events or plans are forward-looking statements as defined under the Private Securities Litigation Reform Act of 1995. These statements may involve risks and uncertainties that could cause actual results to differ materially from expectations that are described more fully in our filings with the SEC. In addition, All forward-looking statements represent our views only as of today, and MetaWound assumes no obligation to update or supplement any forward-looking statements, whether a result of new information, future events, or otherwise. This conference call is the property of MetaWound, and any recording or rebroadcast is expressly prohibited without the written consent of MetaWound. With us today are Ofer Gonen, Chief Executive Officer of MetaWound, and Hani Luxemburg, Chief Financial Officer. Barry Wolfesson, EVP of Strategy and Corporate Development, is also participating in today's call. Following our prepared remarks, we will open the call for Q&A. Now, I would like to turn the call over to Ofer Gonin, Chief Executive Officer of MedWound. Ofer?

speaker
Ofer Gonen
Chief Executive Officer, Mediwound

Hi, thank you, Dan, and good morning, everyone. In the second quarter, we continue to execute across our clinical, commercial, and operational objectives. The SCRx value phase three trial is actively enrolling patients, and with new collaboration established with Convatec and SCT, all the relevant global wound care leaders are now engaged in our clinical programs. At the same time, NexoBrit continues to gain traction in the US market, and the commissioning of our manufacturing scale-up remains on track for completion by year end. As a result of these activities, We are in a strong position to achieve several key milestones over the next 12 months that are expected to advance our strategic and financial objectives. Now let's begin with an update on Escarex, our late-stage enzymatic debridement therapy for chronic wounds. Enrollment in the Value Phase III study for venous leg ulcers is actively progressing. This global trial aims to enroll 216 patients across 40 sites in the United States and Europe. Once 65% of those patients have completed treatment in the value trial, we will perform an interim sample size assessment. We expect this readout to take place by mid-2026. During this quarter, we further strengthened our network of research partners. We established new collaborations with SCT and Convatec, to support both the ongoing VLU trial and the planned DFU trial. Specifically, Essity's Job's medical compression therapy products are now included in the value trial protocol, and Convatec's AquaCell dressings will support the DFU study. Both of these category-leading partnerships complement our current relationships with Solventum, Molniki, Keresis, and Mimetics, and reinforced the broad validation of Escarex within the wound care ecosystem. In addition, a new post-hoc analysis from our earlier Phase II study was published yesterday in Advances in New Wound Care. It's a leading peer-reviewed journal. The analysis confirms that wound bed preparation is a key predictor of healing in venous leg ulcers. and that without it, chronic wounds rarely heal. Wounds that failed to achieve wound bed preparation had a 90% probability of not healing in the study, while those that achieved it were four times more likely to close. P-value was 0.0004. This data validate SCRx potential to improve healing outcomes by accelerating wound bed preparation, which is the primary endpoint of our phase three study. While wound bed preparation has been recognized for nearly two decades as a core principle in chronic wound healing, this is the first time that this concept has been confirmed with robust clinical evidence. Now let's turn our attention to Nexobrid, our innovative enzymatic therapy for severe burns. In the United States, adoption continues to expand. Our partner, VeriCell, reported 52% year-over-year revenue growth for NexoBridge in the second quarter, driven by increases in both hospital unit orders and number of ordering centers. Operationally, the commissioning of our new manufacturing facility remains on track towards completion by year-end. with regulatory authority review and approval, determining the timing of enabling the commercial output. Capacity expansion is critical for us in order to support our global growth. We also continued planning for future US-based manufacturing as part of our collaboration with BARDA. In parallel, we were awarded an additional $3.6 million in non-dilutive funding from the U.S. Department of Defense to support the development of a room temperature stable formulation for NexoBREED, bringing the total program funding to $18.2 million. This supplementing funding will enable expansion of our CMC activities, enhancement of in-house manufacturing capabilities, and initial preparations for the clinical trial. Now, I'd like to turn the call over to Hani to review our financial performance in more detail. Hani?

Disclaimer

This conference call transcript was computer generated and almost certianly contains errors. This transcript is provided for information purposes only.EarningsCall, LLC makes no representation about the accuracy of the aforementioned transcript, and you are cautioned not to place undue reliance on the information provided by the transcript.

-

-