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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) has appointed Tzvi Palash as Chief Operating Officer (COO), effective June 30, 2022. Palash brings over 35 years of operational experience from prominent pharmaceutical companies. His previous roles include COO at Enlivex and Gamida Cell, where he oversaw critical BLA submissions. His expertise will support MediWound's development of EscharEx and the resubmission of the NexoBrid BLA. NexoBrid is a bromelain-based product for burn care marketed in the EU and at the registration stage in the U.S., backed by BARDA.
MediWound Ltd. (Nasdaq: MDWD) has appointed Ofer Gonen as its new Chief Executive Officer, effective June 30, 2022, succeeding Sharon Malka, who will transition to the Board of Directors. Gonen brings over 20 years of experience in life sciences and business development, previously serving as CEO of Clal Biotechnology Industries, MediWound's largest shareholder. The leadership change aims to position the company for long-term growth and enhance its capabilities in treating burns and wound care.
MediWound Ltd. (NASDAQ: MDWD) announced its Q1 2022 financial results, reporting revenues of $4.4 million, a 24% decline from $5.8 million in Q1 2021. The company faced a 56% drop in product revenue, primarily due to decreased emergency stockpile procurement by BARDA. Despite a net loss of $3.6 million or $0.12 per share, MediWound highlighted the positive results from its U.S. Phase 2 trial of EscharEx®, achieving primary and secondary endpoints with no safety issues. The company has raised $10 million through equity offerings and is on track for NexoBrid BLA resubmission by mid-year.
MediWound Ltd. (Nasdaq: MDWD) has announced positive results from its U.S. Phase 2 clinical study of EscharEx® for treating venous leg ulcers (VLUs). The study met its primary and key secondary endpoints with statistically significant improvements, including a 63% complete debridement rate in 14 days versus 30% for the control. EscharEx demonstrated a median time to complete debridement of 9 days compared to 59 days for standard care. The FDA meeting is anticipated in the second half of 2022 to discuss advancing to Phase 3 trials. No safety issues were observed, reinforcing EscharEx's therapeutic potential.
MediWound Ltd. (Nasdaq: MDWD) will announce its first-quarter financial results on May 17, 2022. The release will be followed by a conference call at 8:30 AM ET for management to discuss these results and provide corporate updates. MediWound specializes in bio-therapeutic solutions for tissue repair, notably its product NexoBrid for thermal burns, which has received support from BARDA. The company is also developing EscharEx for chronic wounds and MW005 for non-melanoma skin cancers. The webcast will be accessible for 90 days following the call.
MediWound Ltd. (Nasdaq: MDWD) announced that its EscharEx® phase 2 clinical study results were featured at the SAWC Spring Conference. The poster highlighting the pharmacology study was among ten selected from 235 presented. The data indicated EscharEx effectively debrided wounds and reduced biofilm while being safe for patients with diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs). CEO Sharon Malka expressed optimism about EscharEx's potential in the over billion-dollar wound care market, emphasizing the urgent need for new debridement solutions.
MediWound Ltd. (Nasdaq: MDWD) announced the presentation of its EscharEx® clinical data at the 35th SAWC Spring Conference in April 2022. The oral presentation will cover results from clinical studies on the safety and efficacy of EscharEx for the debridement of hard-to-heal wounds, including venous leg ulcers and diabetic foot ulcers. The data showed that EscharEx was well-tolerated and effectively reduced biofilm and bacterial loads. The ongoing Phase 2 study aims to evaluate its clinical performance, positioning EscharEx as a potential non-surgical treatment for chronic wounds.
MediWound Ltd. (Nasdaq: MDWD) announced the partial exercise of an over-allotment option from its recent public offering, closing on March 22, 2022. The underwriter purchased an additional 623,082 ordinary shares, raising approximately $1.2 million. This brings the total funds raised in the offering to $11.2 million. MediWound plans to utilize the proceeds for working capital and corporate purposes. The offering was conducted under a previously filed shelf registration statement with the SEC.
MediWound Ltd. (Nasdaq: MDWD) has completed its U.S. Phase 2 clinical study of EscharEx for treating venous leg ulcers (VLUs). The study met its primary endpoint, showing a significant improvement in complete debridement rates: 63% for EscharEx versus 30% for the gel vehicle (p=0.004). Final results, including secondary safety measurements, are expected in Q2 2022. CEO Sharon Malka emphasized EscharEx's potential as a leading solution for chronic wound care, aiming to advance to pivotal Phase 3 trials.
MediWound Ltd. (MDWD) reported total revenues of $23.8 million for 2021, reflecting a 9% increase from 2020, with product revenues soaring 46% to $11.4 million. The company achieved profitability for its NexoBrid product but faced an 18% decline in Q4 revenues to $5.5 million. A public equity offering garnered an additional $10 million. Positive results from the Phase 2 EscharEx trial support its potential for chronic wound treatment, and FDA guidance indicates a path for the NexoBrid Biologics License Application resubmission in mid-2022.
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