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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 (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).
Mölnlycke Health Care, a leading MedTech company, has announced a $15 million investment in MediWound (Nasdaq: MDWD) through a private investment in public equity (PIPE). MediWound specializes in next-generation enzymatic therapeutics for non-surgical wound debridement. The investment aligns with Mölnlycke's strategy to bring radical innovations to wound care and improve clinical outcomes.
As part of the collaboration agreement, Mölnlycke will have a representative attend MediWound's R&D Committee meetings and participate in potential strategic partnership discussions. This partnership aims to support Mölnlycke's mission to 'help free patients from the burden of wounds' and strengthen MediWound's strategic plans to create long-term value for stakeholders and improve patient care standards.
MediWound (Nasdaq: MDWD) has announced a $25 million strategic private placement financing, led by Mölnlycke Health Care with a $15 million investment. The company will sell 1,453,488 ordinary shares at $17.20 per share. The proceeds will be used to advance EscharEx pre-commercial activities, develop large-scale manufacturing capabilities, and support general corporate purposes.
Alongside the investment, MediWound and Mölnlycke have entered into a collaboration agreement, granting Mölnlycke specific rights, including representation in MediWound's R&D Committee and participation in potential strategic partnerships. The agreement includes a stand-still clause limiting Mölnlycke's ownership to 9.99% of MediWound's outstanding shares.
MediWound reported its Q1 2024 financial results, highlighting $5 million in revenue, compared to $3.8 million in Q1 2023, with a forecast of $24 million for the year. Gross profit decreased to $0.6 million from $0.8 million due to revenue mix changes. MediWound's new manufacturing facility is on track for mid-2024 completion. The EscharEx® Phase III trial will start in H2 2024. Net loss widened to $9.7 million, driven by financial expenses related to warrant revaluation. The company joins the Russell 3000® Index and has $36 million in cash reserves as of March 31, 2024.
The NexoBrid® US launch is progressing, with 30 burn centers placing initial orders. FDA reviews and military contracts are expected to influence future results. R&D and SG&A expenses decreased due to phase completion and operational efficiencies.
MediWound (Nasdaq: MDWD) will release its first quarter 2024 financial results on May 29, 2024. The report will cover the period ending March 31, 2024.
A conference call and live webcast are scheduled for the same day at 8:30 am Eastern Time. The call will discuss financial results, provide corporate updates, and include a Q&A session. Dial-in numbers for various regions and a webcast link are provided. An archived version of the webcast will be available on the MediWound website after the event.
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