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MediWound Ltd. (Nasdaq: MDWD) is an integrated biopharmaceutical company focused on developing, manufacturing, and commercializing novel therapeutic products. The company's mission is to address unmet medical needs in the fields of severe burns, chronic and other hard-to-heal wounds, connective tissue disorders, and other medical conditions. MediWound leverages its patented proteolytic enzyme technology to create innovative and effective treatments.
NexoBrid®, MediWound's flagship product, has received marketing authorization from multiple health agencies, including the European Medicines Agency, as well as health ministries in Israel and Argentina. This innovative biopharmaceutical product is designed for the non-surgical removal of dead or damaged tissue, known as eschar, in adults with deep partial and full-thickness thermal burns. Clinical trials have demonstrated NexoBrid's capability to rapidly and effectively debride eschar without harming viable tissue.
MediWound's pipeline includes several promising products. EscharEx®, another key product, is a topical biological drug being developed for debridement of chronic wounds. This product has shown significant potential in clinical trials, suggesting it can outperform traditional enzymatic debridement methods and improve patient outcomes. Additionally, MW005 is under development for the treatment of non-melanoma skin cancers, offering a new hope for patients with basal cell carcinoma.
The company has established valuable partnerships and research collaborations with industry leaders such as 3M, Mölnlycke, and MIMEDX. These collaborations aim to further validate and enhance MediWound's product pipeline. Recent achievements include substantial governmental grants, expanded indications for NexoBrid, and successful market entries in new regions.
Financially, MediWound is on solid ground. As of December 31, 2023, the company reported a cash, restricted cash, and investments balance of $42.1 million, compared to $34.1 million at the end of 2022. In the first quarter of 2023, MediWound raised $27.5 million through a registered direct offering, using $17.1 million to support its activities. The company expects its existing financial resources to be sufficient to reach profitability.
MediWound's commitment to improving patient care through innovative enzymatic therapeutics positions it as a significant player in the biopharmaceutical industry. With a strong pipeline and robust financial health, the company aims to continue delivering life-saving treatments and expanding its market presence.
For more information, visit www.mediwound.com and follow the company on LinkedIn and X.
MediWound Ltd. (Nasdaq: MDWD) announced plans for an underwritten public offering of its ordinary shares, all offered by the company itself, with underwriters receiving a 30-day option to buy an additional 15%. The offering will proceed under a previously filed shelf registration statement and is contingent on market conditions. Oppenheimer & Co. Inc. will manage the offering. Interested investors are advised to review the forthcoming preliminary prospectus supplement for comprehensive details regarding the securities offered.
MediWound Ltd. (Nasdaq: MDWD) announced its participation in two investor conferences in March 2022. The first event is Cowen’s 42nd Annual Health Care Conference on March 9 at 9:10 am ET, followed by Oppenheimer on March 17 at 11:20 am ET. Both presentations will emphasize MediWound’s focus on biotherapeutic solutions for tissue repair. NexoBrid®, their commercial product, treats severe burns efficiently, while EscharEx® is in development for chronic wound care. Replays of the events will be available on the MediWound Investor Relations website.
MediWound Ltd. (Nasdaq: MDWD) has been awarded a $1.7 million research project by the U.S. Department of Defense (DoD) through the Medical Technology Enterprise Consortium (MTEC) to develop NexoBrid as a non-surgical solution for burn treatment in field care. This funding recognizes NexoBrid's effectiveness for eschar removal and aims to improve treatment outcomes for U.S. Army service members suffering from traumatic burn injuries. The project is set to span 24 months and focuses on ensuring optimal care close to the point of injury.
MediWound Ltd. (Nasdaq: MDWD) announced its participation in two investor conferences in February 2022. The first is the BTIG MedTech, Digital Health, Life Science & Diagnostic Tools Conference on February 16, 2022, at 8:30 am ET, featuring a fireside chat. The second is the Aegis Virtual Investor Conference on February 24, 2022, at 3:00 pm ET. Investors can access replays on the company’s Events page. MediWound focuses on bio-therapeutic solutions for tissue repair and offers products like NexoBrid® and EscharEx®.
MediWound Ltd. (Nasdaq: MDWD) announced an expansion of its contract with the Biomedical Advanced Research and Development Authority (BARDA), receiving an additional $9 million for NexoBrid's BLA resubmission and expanded access treatment protocol. This funding raises the total non-dilutive funding from BARDA to $211 million. NexoBrid, a product designed for burn treatment, has been under BARDA's support since 2015. The company anticipates further collaboration with BARDA and plans to submit its BLA mid-2022 to enhance U.S. healthcare preparedness.
MediWound announced positive topline results from its U.S. Phase 2 clinical study of EscharEx for treating venous leg ulcers. The study included 120 patients and met its primary endpoint, showing a statistically significant higher incidence of complete debridement with EscharEx (63%) compared to the gel vehicle (30%) with a p-value of 0.004. Safety reviews indicated no concerns. The company plans to submit for an end-of-Phase 2 meeting with the FDA in late 2022, aiming for Phase 3 trials. This highlights EscharEx's potential in a billion-dollar chronic wound care market.
MediWound Ltd. (Nasdaq: MDWD) announced positive initial data from its phase 2 study of EscharEx, a novel enzymatic debridement therapy for chronic wounds. The study involved seven patients and demonstrated safety and effective debridement of diabetic foot ulcers and venous leg ulcers. Results indicated a significant reduction in wound biofilm and bacterial burden. The full data set is expected to be shared in the first half of 2022. EscharEx aims to improve current wound care treatments with its efficient bioactive approach.
MediWound Ltd. (Nasdaq: MDWD) announced the completion of patient enrollment in its U.S. Phase 2 clinical study for EscharEx®, a treatment for venous leg ulcers (VLUs). The trial, involving 120 patients across 20 sites, compares EscharEx to a gel vehicle and non-surgical standard-of-care treatments. Following a positive interim assessment, topline data is expected in Q1 2022. This represents a significant step in addressing the chronic wound care market, valued over $1 billion annually.
MediWound Ltd. (Nasdaq: MDWD) announced receiving positive scientific advice from the EMA's CHMP regarding the pediatric label extension for NexoBrid, anticipated for submission in the first half of 2022. This follows significant outcomes from the pivotal Phase 3 CIDS study, which demonstrated effective treatment for thermal burns in children, achieving its primary endpoints with a strong safety profile. NexoBrid aims to provide a non-surgical treatment option, expanding its market presence in Europe, and potentially improving treatment standards for pediatric patients.
MediWound Ltd. (Nasdaq: MDWD) reported Q3 2021 revenues of $6.4 million, a 4% decline from Q3 2020. Year-to-date revenues rose by 21% to $18.3 million. The company maintains $13.9 million in cash and short-term investments as of September 30, 2021. A regulatory path for the resubmission of NexoBrid's Biologics License Application (BLA) is established, targeted for mid-2022. The EscharEx Phase 2 program's top-line results are now expected in Q1 2022. Notably, net loss for Q3 2021 was $3.3 million, or $0.12 per share.
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