MediWound Ltd. (MDWD) shares lost 7.99% in after-hours on Thursday, July 15, 2021, and close the trading at $4.26 per share. Earlier in the morning session, MDWD’s stock gained 8.94% to close Thursday’s session at $4.63. MDWD shares have risen 15.17% over the last 12 months, and they have moved up 6.93% in the past week. Over the past three months, the stock has lost 9.92%, while over the past six months, it has slid down 4.34%.
Results publication of phase 2 trial of EscharEx
On July 09, 2021, MediWound Ltd announced that a peer-reviewed publication, detailing the results of the phase 2 randomized control trial of its wound debriding product candidate EscharEx®, has been published in the Wound Repair and Regeneration Journal.
The phase 2 study was carried out in 15 clinical sites in Israel and Europe to evaluate the safety and efficacy of EscharEx compared with a hydrogel vehicle in a variety of chronic and hard-to-heal wounds.
The primary endpoint of this study was achieved by the EscharEx as it achieved a significantly higher incidence of complete debridement compared to the gel vehicle arm.
FDA negative response to NexoBrid approval
On June 29, 2021, MediWound Ltd received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the Biologics License Application (BLA) seeking approval of NexoBrid.
The FDA identified the issues related to the Chemistry, Manufacturing and Controls sections and determined that the application cannot be approved in its present form.
Publication of report of (BCC) destruction by a concentrate of proteolytic enzymes enriched in bromelain
On June 07, 2021, MediWound Ltd announced that a peer-reviewed publication of a case series report of basal cell carcinoma (BCC) destruction by a concentrate of proteolytic enzymes enriched in bromelain has been published in the Open Dermatology Journal. MediWound anticipates initiating a phase I/II clinical study of MW005 for the treatment of BCC this month, with data expected by the end of 2021.
Latest financial results announcement
On May 05, 2021, MediWound Ltd announced financial results for the first quarter ended March 31, 2021.
Q1 2021 financial highlights
MediWound reported revenue of $5.8 million in Q1 2021, compared with $4.4 million for the first quarter of 2020.
Gross profit was $2.4 million in Q1 2021 compared to a gross profit of $1.2 million in Q1 2020.
The Company suffered a net loss of $2.9 million, or $0.10 per share in Q1 2021 compared with a net loss of $2.5 million, or $0.09 per share in Q1 2020.
Adjusted EBITDA was negative $1.3 million in Q1 2021 compared with a loss of $1.8 million for the first quarter of 2020.
MediWound had $17.9 million in cash and short-term investments on March 31, 2021.
Well, we have no news which could justify its gains and loss on Thursday. we hope that MDWD will perform better on Friday.