As a pioneer in addressing severe burn and wound management, the company announced positive top-line results in January from phase 3 Detect study in NexoBrid for eschar removal of severe thermal burns. The results clearly demonstrated the significant beneficial impact NexoBrid has on burn patients as a new paradigm in burn care management.
MediWound intends to file the NexoBrid BLA in the fourth quarter of 2019, subject to the Food and Drug Administration concurrence in a pre-BLA meeting. The company entered into an exclusive license and supply agreements with Vericel in May to commercialize NexoBrid in North America.
During last week, the company appointed Boaz Gur-Lavie as Chief Financial Officer, with expectations of a valuable contribution to the development of EscharEx and the expansion of NexoBrid. Prior to joining MediWound, Gur-Lavie co-founded Center for Digital Innovation (CDI), a non-profit organization that creates innovative new solutions for challenges in the space of healthy aging and digital health, while focusing on senior citizens.
For the first quarter of 2019, the company posted a narrower loss due to a decline in financial expense. For the quarter, the company’s expenses increased due to a one-time management transition costs as well as the investment in the research and development.
Also read: Canopy Growth Q4 2019 earnings preview
As of March 31, 2019, the company’s cash, cash equivalent, and short-term bank deposits fell by 9% to $21.5 million from December 31, 2018. For the ongoing development of EscharEx through BLA filing, MediWound believed that the existing cash combined with the proceeds generated from the collaboration with Vericel would be sufficient to significantly advance.
However, market analysts believed the cash won’t be ample for getting the product to the market. They expect that MediWound might opt for debt in meeting the requirements. The company continues to be optimistic with the assessment of potential strategic opportunities for EscharEx as the development program advances towards regulatory approval.
Shares of MediWound opened lower on Tuesday and is trading in the red territory on the Nasdaq. The stock has fallen over 48% in the past year and over 28% in the past three months.