- Mesoblast (MSB) has ticked off a number of milestones during the March 2020 quarter
- The company submitted an application for its remestemcel drug which was approved by the U.S. FDA earlier this month
- The drug will be used to treat COVID-19 patients who suffer from acute respiratory distress syndrome
- In Japan, Mesoblast’s licensed product dubbed TEMCELL, saw a 99 per cent revenue growth to total US$2.1 million
- Cash on hand at the ended at US$60.1 million, however the next 12 months may see a further US$62.5 million through current financing facilities and strategic partnerships
- Mesoblast is currently down a slight 0.31 per cent and selling shares for $3.23 each
Mesoblast (MSB) has reported on its quarterly operations and cash flow for Q3 FY20.
During this quarter, the company submitted a Biologics License Application (BLA) for RYOCIL (remestemcel-L) which was was accepted by the United States Food and Drug Administration (FDA) earlier this month.
This FDA approval allows Mesoblast to trial its remestemcel-L product on COVID-19 patients.
Mesoblast has since reported an 83 per cent survival rate in ventilator-dependent COVID-19 patients, using remestemcel-L.
The company is in discussions with the U.S. government and potential pharmaceutical partners to commercialise remestemcel-L for COVID-19 patients.
Financial highlights
In Japan, remestemcel-L, under Temcell, sales revenue continued to increase and totalled US$2.1 million for the quarter. This represents a 99 per cent growth over prior corresponding period.
Cash on hand totalled US$60.1 million (A$97.3 million). Mesoblast said in the next 12 months, it could have access to a further US$62.5 million (A$101 million) through existing financing facilities and strategic partnerships.
Total cash payments for operating activities was down 2.8 per cent to US$22 million. Mesoblast’s clinical program expenditure was reduced by US$4.2 million during the period.
Operational highlights
Remestemcel-L for Steroid-Refractory Acute Graft Versus Host Disease (SR-aGVD)
Mesoblast’s remestemcel-L was accepted by the FDA for priority review for the treatment of SR-aGVD in Children. The FDA will be collecting fees from the drug on September 30.
Remestemcel-L for Acute Respiratory Distress Syndrome (ARDS) in COVID-19 patients
ARDS is caused by a cytokine storm in the lungs of patients infected with COVID-19 and is the primary cause of death in these patients.
Earlier this month, the company was granted approval to treat these patients with remestemcel-L.
The trial also saw a 83 per cent (10/12) survival rate in COVID-19 patients with moderate/severe ARDS.
In contrast, one New York hospital network only saw a 12 per cent survival rate using the standard of care within the same period Mesoblast treated its patients.
Revascor for Chronic Heart Failure
In the December quarter, Mesoblast completed its final clinical trial data for its heart disease treatment.
The independent Data Monitoring Committee reviewed data from over 500 participants and gave the go-ahead for final patient visits. Results for the phase three trial are expected by mid-2020.
Mesoblast is down a slight 0.31 per cent and selling shares for $3.23 each at 3:19 pm AEST.