MediWound Ltd. - MDWD STOCK NEWS

MediWound (Nasdaq: MDWD) has announced the initiation of a Phase II clinical study comparing EscharEx® to collagenase ointment for treating venous leg ulcers (VLUs). The study, set to begin in 2025, will run alongside the company's Phase III trial and aims to support the Biologics License Application (BLA) for EscharEx while strengthening MediWound's commercialization strategy.

The randomized study will enroll 45 patients across multiple sites in the U.S. and Europe, evaluating safety endpoints and exploratory efficacy measures. MediWound has secured R&D collaborations with Solventum and Mölnlycke Health Care to provide compression systems and wound care products, ensuring consistency and optimal patient outcomes across study arms.

MediWound (Nasdaq: MDWD), a leader in enzymatic therapeutics for tissue repair, has announced its participation in the 2024 Maxim Healthcare Virtual Summit. CEO Ofer Gonen will engage in a fireside chat on Wednesday, October 16, 2024, at 9:30 a.m. ET. The discussion will be hosted by Michael Okunewitch, Senior Biotechnology Analyst at Maxim.

Interested parties can register to attend the virtual fireside chat through the provided link. Additionally, the MediWound management team will be available for one-on-one meetings during the summit. Investors wishing to schedule a meeting are advised to contact their Maxim representative.

MediWound (Nasdaq: MDWD), a leader in enzymatic therapeutics for tissue repair, has announced its participation in the H.C. Wainwright 26th Annual Global Investment Conference. CEO Ofer Gonen will engage in a fireside chat on September 10, 2024, at 3:30 p.m. ET.

The discussion, hosted by Swayampakula Ramakanth, Managing Director, Senior Equity Research, will be available via live webcast. Investors and interested parties can access the webcast through a provided link or on MediWound's website under the Events & Presentations page in the Investors section.

This presentation offers an opportunity for investors to gain insights into MediWound's latest developments and future prospects in the field of next-generation enzymatic therapeutics for tissue repair.

MediWound (Nasdaq: MDWD) has announced that the U.S. Food and Drug Administration (FDA) has approved NexoBrid® (anacaulase-bcdb) for use in pediatric patients aged newborn through eighteen with deep partial- and/or full-thickness thermal burns. This approval expands NexoBrid's use to all age groups in the U.S., aligning with its approvals in the European Union and Japan.

The approval was supported by the results of the global Phase III Children Innovation Debridement Study (CIDS), funded by BARDA, as well as additional pediatric data from Phase III and Phase II studies. This milestone is significant as pediatric burn victims represent over 30% of the total burn population, and NexoBrid offers a non-surgical alternative to the current traumatic standard of care.

MediWound (MDWD) reported Q2 2024 financial results and provided a company update. Key highlights include:

1. Completed construction of new NexoBrid® manufacturing facility, increasing capacity sixfold.

2. Secured €16.25 million EIC funding to expand EscharEx® development for diabetic foot ulcers.

3. Raised $25 million in strategic investment led by Mölnlycke Health Care.

4. Q2 revenue increased to $5.1 million, up from $4.8 million in Q2 2023.

5. Net loss of $6.3 million in Q2 2024, compared to net profit of $0.9 million in Q2 2023.

6. Cash position of $29.7 million as of June 30, 2024.

7. NexoBrid U.S. launch gaining momentum with 70+ burn centers submitting to P&T committees.

8. EscharEx Phase III study for venous leg ulcers to begin in H2 2024.

MediWound (Nasdaq: MDWD) announced positive results from the U.S. NexoBrid® Expanded Access Protocol (NEXT). The study, conducted at 29 burn centers, involved 239 patients with deep partial and full-thickness thermal burns. Key findings include:

- 94.9% of adults and 100% of children achieved complete debridement
- Only 4.2% of adults required surgical excision after NexoBrid treatment
- Time to complete eschar removal was less than one day for all patients
- Median time to wound closure was 22 days for adults and 28 days for children
- Median hospitalization duration was 10 days for both adults and children

The results confirm NexoBrid's safety and efficacy in eschar removal, significantly reducing surgical procedures for burn patients. The safety data was consistent with NexoBrid's established profile, with no new concerns identified.

MediWound (Nasdaq: MDWD), a leader in enzymatic therapeutics for tissue repair, has announced it will release its Q2 2024 financial results on August 14, 2024. The company will host a conference call and webcast at 8:30 am Eastern Time on the same day to discuss the results and provide corporate updates.

Investors and interested parties can join the call using the following details:

• Toll-Free: 1-833-630-1956
• Israel: 1-80-921-2373
• International: 1-412-317-1837

MediWound (Nasdaq: MDWD) has announced the publication of its Phase II ChronEx study results for EscharEx® in treating Venous Leg Ulcers (VLU) in THE LANCET's eClinicalMedicine. The study, conducted across 20 medical centers in the US, Europe, and Israel, demonstrated EscharEx's superiority over non-surgical standard of care in debridement and promoting healthy granulation tissue.

Key findings include:

• 63.0% complete debridement rate for EscharEx vs. 30.2% for placebo and 13.3% for non-surgical standard of care
• Median time to complete debridement: 9 days for EscharEx vs. 63 days for placebo
• 50.0% incidence of complete cover with healthy granulation tissue for EscharEx vs. 25.6% for placebo
• Comparable safety profile to placebo and non-surgical standard of care

MediWound (Nasdaq: MDWD) has been awarded €16.25 million in blended funding from the European Innovation Council (EIC) Accelerator program. This funding will significantly advance the development of EscharEx, MediWound's innovative treatment for diabetic foot ulcers (DFUs). The package includes a €2.5 million grant and an investment with terms to be finalized.

This support will enable MediWound to expedite the market introduction of EscharEx by four years, addressing a substantial market of up to 34 million diabetic patients in the US and Europe who are at risk of developing DFUs. The funding not only recognizes EscharEx's potential impact on patients but also allows MediWound to develop it for DFUs in parallel with their advanced program for venous leg ulcers (VLUs).