MediWound Ltd. - MDWD STOCK NEWS

MediWound Ltd. (NASDAQ: MDWD) has established a Strategic Advisory Board (SAB) comprised of industry leaders to guide its strategic initiatives. The board includes professionals such as John C. Lantis, Samuel Moed, and Eric Shem-Tov, who will bring extensive expertise to the company's efforts, particularly as EscharEx moves into Phase 3 studies and NexoBrid prepares for U.S. approval. This assembly aims to optimize MediWound’s product potential, reflecting the company’s commitment to advancing biotherapeutic solutions for tissue regeneration.

MediWound Ltd. (Nasdaq: MDWD) announced positive clinical outcomes from its EscharEx Phase 2 trials, presented at the SAWC Fall 2022 Conference. The data showed that EscharEx outperformed standard treatments for Venous Leg Ulcers, demonstrating significant improvements in debridement and tissue formation. Presentations highlighted its safety and efficacy, with no adverse effects on wound closure. The company plans to meet with the FDA to discuss the Phase 3 study design by year-end 2022, aiming to capture a share of the lucrative wound care market.

MediWound Ltd. (NASDAQ: MDWD) has successfully closed its registered direct and PIPE offerings, raising $30.5 million in gross proceeds. These funds will primarily support the development of EscharEx®, facility scaling, and general corporate purposes. CEO Ofer Gonen expressed satisfaction with attracting strong new investors and indicated the net proceeds enhance the company's balance sheet and provide an operational runway through 2025. The offerings were facilitated by H.C. Wainwright & Co. and include various warrants that will not be registered under the Securities Act of 1933.

MediWound Ltd. (NASDAQ: MDWD) has entered into a definitive securities purchase agreement for a registered direct offering, selling 7,575,513 ordinary shares at $1.75 each, expecting gross proceeds of approximately $13.26 million. Concurrently, the company will conduct a PIPE offering, selling 9,853,058 pre-funded and ordinary share warrants for expected gross proceeds of about $17.24 million. The total anticipated gross proceeds from both offerings stand at $30.5 million, which will primarily fund the development of EscharEx and general corporate purposes.

MediWound Ltd. (NASDAQ: MDWD) announced that the European Medicines Agency (EMA) is reviewing a Type II Variation to expand NexoBrid usage in children with severe burns. Currently approved for adults, NexoBrid's pediatric application is based on interim results from the Phase 3 CIDS trial, which demonstrated comparable safety and efficacy to standard care. The EMA is expected to deliver a decision in Q1 2023. NexoBrid has previously shown strong results in adult trials and is supported by funding from the U.S. Biomedical Advanced Research and Development Authority (BARDA).

MediWound (Nasdaq: MDWD) recently showcased its product NexoBrid at the European Burns Association Congress 2022 in Turin, Italy. The conference featured 45 presentations highlighting the efficacy of NexoBrid in various burn scenarios, with over 11,000 patients treated. The company's CEO expressed satisfaction with the product's visibility and anticipates a significant regulatory milestone with a target PDUFA date of January 1, 2023, for potential FDA approval. NexoBrid is already approved in the EU and designated as an orphan biologic in the U.S., setting a solid foundation for its commercial prospects.

MediWound Ltd. (NASDAQ: MDWD) announced its Q2 2022 financial results, reporting revenues of $4.7 million, a decrease from $6.1 million in Q2 2021, largely due to a reduction in emergency stockpile procurement and supply chain issues. The company revealed positive Phase 2 trial results for EscharEx, showing significant improvements in ulcer treatment. The FDA accepted NexoBrid's re-submitted BLA with a PDUFA date of January 1, 2023. Despite operational advances, a net loss of $4.4 million was recorded, an increase from $3.2 million year-over-year.

MediWound Ltd. (Nasdaq: MDWD) appoints Nachum Shamir as Chairman of the Board and Dr. Robert Snyder as Chief Medical Officer. Shamir succeeds Stephen T. Wills but remains a board director. Snyder begins his role on January 1, 2023. CEO Ofer Gonen highlights Shamir's extensive experience in launching medical technologies globally, while Snyder is expected to lead the EscharEx clinical development program. MediWound is recognized for its biotherapeutic solutions, including NexoBrid for burn care and EscharEx for chronic wounds, aiming for strategic growth and shareholder value.

MediWound Ltd. (MDWD) announced that the FDA accepted its re-submitted Biologics License Application (BLA) for NexoBrid for eschar removal in adults with severe thermal burns. The FDA has set a PDUFA target date of January 1, 2023. NexoBrid has proven effective in clinical trials, meeting all primary and secondary endpoints, and is already approved in the EU and other regions. The development has received support from BARDA, enhancing its potential for U.S. market introduction. This advancement brings MediWound closer to commercializing NexoBrid in the U.S.