MediWound Ltd. - MDWD STOCK NEWS

MediWound Ltd. (NASDAQ: MDWD), a biopharmaceutical company focused on tissue repair and regeneration, announced it will present at two investor conferences in March 2023. The Cowen 43rd Annual Health Care Conference is scheduled for March 8, 2023, at 10:30 am ET in Boston. The Oppenheimer 33rd Annual Healthcare Conference will take place on March 14, 2023, at 1:20 pm ET virtually. Replay of the Cowen presentation will be available on the company's investor relations webpage. MediWound develops innovative biotherapeutic solutions like NexoBrid for burn care and EscharEx for chronic wound management.

MediWound Ltd. (NASDAQ: MDWD) has successfully closed a registered direct offering, raising $27.5 million in gross proceeds. The funds will primarily accelerate the development of EscharEx®, support U.S. commercial presence, and cover general corporate expenses. MediWound may also consider using a portion of the proceeds for potential acquisitions or licensing of complementary technologies, though no current plans exist. H.C. Wainwright & Co. was the exclusive placement agent for this offering. The company aims to enhance its biotherapeutic solutions for tissue repair and is focused on its products, including NexoBrid®, which has received FDA approval for U.S. marketing.

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.