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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 the completion of the patient enrollment target for its U.S. Phase 2 study of EscharEx, a treatment for venous leg ulcers (VLUs). An interim assessment for futility analysis is expected by the end of July 2021, with a total of 120 patients to be enrolled by year-end. The company noted a significant market opportunity exceeding a billion dollars annually for EscharEx. Additionally, a separate Phase 2 open-label study is underway, focusing on diabetic foot ulcers and the pharmacological effects of EscharEx.
MediWound Ltd. (Nasdaq: MDWD) announced a peer-reviewed publication demonstrating preliminary proof-of-concept for MW005, a treatment for basal cell carcinoma (BCC). The study reported successful destruction of six BCC tumors using proteolytic enzymes enriched in bromelain. MediWound plans to initiate a Phase I/II clinical study for MW005 in June 2021, with data expected by year's end. BCC is the most common skin cancer type, with about 4.3 million cases diagnosed annually in the U.S. The company views MW005 as a potential solution for an unmet medical need in non-melanoma skin cancers.
MediWound Ltd. (Nasdaq: MDWD) reported first-quarter revenues of $5.8 million, marking a 32% increase year-over-year, primarily due to NexoBrid® procurement by BARDA. Cash and short-term investments totaled $17.9 million as of March 31, 2021, down from $21.6 million at year-end 2020. Operating loss improved to $1.9 million, while net loss was $2.9 million or $0.10 per share. The company initiated a phase 2 study of EscharEx and submitted a protocol for a clinical study of MWPC005. The management expects 2021 cash usage between $5.0 to $7.0 million.
MediWound Ltd. (Nasdaq: MDWD) announced it will release its financial results for Q1 2021 on May 5, 2021, at 7:00 AM ET. A conference call and webcast will follow at 8:30 AM ET to discuss results and provide corporate updates. The company specializes in biopharmaceuticals for tissue repair and regeneration. Its product NexoBrid has been marketed in the EU and submitted for FDA review, with a PDUFA date set for June 29, 2021. Also in development are EscharEx for chronic wound treatment and MWPC005 for non-melanoma skin cancer.
MediWound Ltd. (Nasdaq: MDWD) announced patient enrollment in a phase 2 pharmacology study for EscharEx, an innovative enzymatic agent for chronic wound treatment. The trial will assess its effectiveness in debridement for lower leg ulcers with results anticipated in the second half of 2021. This study aims to evaluate safety and clinical performance, focusing on biofilm and inflammation impact. CEO Sharon Malka emphasized EscharEx's potential to improve chronic wound management, having shown positive safety and efficacy in prior trials.
MediWound Ltd. (Nasdaq: MDWD) announced an upcoming analyst day webinar on March 30, 2021, to highlight EscharEx, its enzymatic agent for chronic wound debridement. Esteemed experts will discuss U.S. chronic wound care practices and EscharEx's potential impact. The product showed promising results in Phase 2 studies, demonstrating safety and a higher incidence of complete debridement compared to hydrogel vehicles. The company’s existing product, NexoBrid, is under FDA evaluation, with a decision expected by June 29, 2021.
MediWound Ltd. (Nasdaq: MDWD) has announced its participation in two upcoming virtual investor conferences in March 2021. The company will present at the Cowen 41st Annual Health Care Conference on March 2 at 9:10 am ET, and at the Oppenheimer 31st Annual Healthcare Conference on March 16 at 1:10 pm ET. Investors can access live webcasts of both events on the company's website, along with replays available for 30 days. MediWound focuses on innovative bio-therapeutic solutions for tissue repair, highlighted by its product NexoBrid, currently marketed in the EU and a BLA submitted for the U.S.
MediWound Ltd. (MDWD) reported a strong financial performance for Q4 and full-year 2020. Q4 revenues surged 23% to $6.7 million, fueled by BARDA's emergency stockpile procurement. Full-year revenues totaled $21.8 million, with product revenues up 117% to $7.8 million. The company achieved a gross margin from product sales of 60% for the full year. MediWound's cash and short-term investments totaled $21.6 million as of December 31, 2020. The FDA has accepted the Biologics License Application for NexoBrid, with a target review date set for June 29, 2021.
MediWound Ltd. (MDWD) announced the initiation of a phase I/II clinical study for MWPC005 aimed at treating basal cell carcinoma (BCC). The study is set to begin in the second quarter of 2021, with results expected by the end of the year. MWPC005, utilizing bromelain, aims for non-invasive treatment without the side effects of current therapies. BCC is the most common skin cancer in the U.S., with approximately 4.3 million cases diagnosed annually. The clinical program includes trials in the U.S. and Israel, focusing on safety, tolerability, and preliminary efficacy.
MediWound Ltd. (Nasdaq: MDWD) will release its financial results for Q4 and the year ended December 31, 2020, on February 25, 2021, at 7:00 am ET. This will be followed by a conference call at 8:30 am ET for management to discuss results and address questions. MediWound is a biopharmaceutical company focused on innovative therapies for severe burns and chronic wounds. Its products, NexoBrid and EscharEx, utilize patented enzyme technology for effective treatment. NexoBrid has been authorized in various countries, while EscharEx is currently under a U.S. phase 2 study.
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