MediWound Ltd. - MDWD STOCK NEWS

MediWound Ltd. (NASDAQ: MDWD) has announced a definitive agreement for a registered direct offering of 1,964,286 shares at $14 per share, expected to close around February 7, 2023. The offering could generate approximately $27.5 million in gross proceeds, which will primarily fund the development of EscharEx®, establish a U.S. commercial presence, and support business activities. H.C. Wainwright & Co. is the exclusive placement agent for the offering. Following this transaction, the total shares outstanding will be 9,204,306. The shares are being offered under a previously filed shelf registration statement with the SEC.

MediWound Ltd. (Nasdaq: MDWD) announced the FDA approval of NexoBrid (anacaulase-bcdb), a non-surgical treatment for eschar removal in adults with deep partial- and full-thickness thermal burns. This approval triggers a $7.5 million milestone payment from Vericel Corporation, which will exclusively commercialize NexoBrid in North America. Anticipated to launch in Q2 2023, NexoBrid is already approved in 43 countries and is expected to become a new standard of care in burn treatment, backed by significant clinical study results demonstrating its efficacy and safety.

MediWound Ltd. (Nasdaq: MDWD) has announced that its partner, Kaken Pharmaceutical Co., Ltd., received marketing approval for NexoBrid in Japan, applicable to both pediatric and adult populations. NexoBrid is a treatment for deep-partial and full-thickness thermal burns, approved under orphan drug designation. Kaken is set to launch NexoBrid in summer 2023, furthering MediWound's global strategy for commercialization. NexoBrid is already approved in 43 countries and has a PDUFA date with the FDA set for January 1, 2023.

MediWound Ltd. (NASDAQ: MDWD) announced marketing approval for NexoBrid in Switzerland, with a launch planned for Q1 2023. The company has partnered with Triskel Integrated Services for distribution, which also covers France, where NexoBrid is expected to launch in Q3 2023. NexoBrid, approved in 42 countries, is designed for non-surgical eschar removal in burn patients. MediWound anticipates reimbursement approval in Switzerland and aims to expand into pediatric use, pending a decision from the European Commission in Q1 2023.

MediWound Ltd. (Nasdaq: MDWD) announced positive results from its Phase I/II study of MW005 for treating low-risk Basal Cell Carcinoma (BCC), showing it to be safe, well-tolerated, and effective. Patients achieved complete clinical and histological clearance of target lesions. The study involved 11 patients receiving seven topical applications of MW005, with follow-ups confirming clearance. MediWound plans to continue patient enrollment and optimize dosing regimens. CEO Ofer Gonen highlighted MW005's potential as a non-surgical solution for BCC amidst rising cases, estimated at 4.3 million annually in the U.S.

MediWound Ltd. (NASDAQ: MDWD) has announced the marketing approval of NexoBrid in India, following an exclusive agreement with Bharat Serums and Vaccines Limited (BSV) to distribute the product for treating severe burns. NexoBrid, which enzymatically removes burn tissue, is expected to be marketed by BSV in the first half of 2023. This approval responds to a significant medical need, as India reports around seven million burn injuries annually, with high mortality rates. NexoBrid is already approved in 42 countries and has pending registration with the FDA.

MediWound Ltd. (Nasdaq: MDWD) announced a 1-for-7 reverse share split, effective December 20, 2022, after receiving shareholder approval on November 28, 2022. The split aims to enhance shareholder value and attract institutional investors by increasing the share price. Following the split, every seven shares will convert into one, with no fractional shares issued. The authorized share count will decrease from 90 million to approximately 12.86 million, while the par value will rise from NIS 0.01 to NIS 0.07. The company continues to develop its therapeutic solutions for tissue repair and regeneration.

MediWound Ltd. (NASDAQ: MDWD) announced significant financial developments, raising $30.5 million in gross proceeds to extend cash runway through 2025. The FDA's review of NexoBrid is progressing with a PDUFA date set for January 1, 2023, anticipated to generate substantial revenues upon approval. The company is also gearing up for a Phase 3 clinical study of EscharEx targeting a billion-dollar market opportunity. Despite a decrease in revenues to $5.8 million in Q3 2022 from $6.4 million in Q3 2021, MediWound holds a strong cash position of $17.6 million.

MediWound Ltd. (NASDAQ: MDWD) announced the publication of a paper in the November 2022 issue of Podiatry Management, detailing the efficacy of its product EscharEx^® for debridement of Diabetic Foot Ulcers (DFUs). The findings indicate that over 50% of patients achieve complete debridement within a week. EscharEx outperformed hydrogel treatments and may represent a shift in wound care management. A meeting with the FDA is planned for Q4 2022 to discuss Phase 3 study design, highlighting the product's potential significance for chronic wound care.