The Mesoblast Limited (ASX: MSB) share price is under the spotlight right now on its FY21 fourth quarter.
Mesoblast says that it’s a global leader in allogeneic cellular medicines for inflammatory diseases.
Mesoblast’s update
The business said it met with the USA FDA on potential pathways to regulatory approval of its product remestemcel-L for steroid refractory acute graft versus host disease (SR-aGVHD) in children, and acute respiratory distress syndrome (ARDS) in adults with COVID-19.
Regarding SR-aGVHD, it said that the FDA’s Center for Biologics Evaluation and Research (CBER) recommended that the next step was to talk with CBER’s review team at the Office of Tissue and Advanced Therapies (OTAT) about Mesoblast’s approach to address certain outstanding chemistry, manufacturing and controls (CMC) items. This is so that it can support a resubmission of the current ‘Biologic License Application’ with a six-month review period.
Regarding COVID-19 ARDS, Mesoblast met with the FDA this week to determine the registration pathway for approval of remestemcel-L, with formal minutes expected in the coming weeks.
It also pointed to a randomised controlled trial of remestemcel-L in 222 ventilator-dependent COVID-19 patients with moderate or severe ARDS. The results were highlighted at a couple of conferences. Mesoblast said the presented data included improved respiratory function in patients treated with remestemcel-L, as well as 90-day survival outcomes showing remestemcel-L “significantly reduced mortality by 48% at 90 days compared to controls in a pre-specified analysis of 123 treated patients under 65 years old.”
Mesoblast has also filed requests and expects to hold meetings with the FDA during the next two quarters to discuss the pathways for US regulatory approval for rexlemestrocel-L after its recently completed phase 3 trial.
Cashflow
The business said it had cash at the end of the quarter of US$136.4 million. Total operating cashflow was a negative US$20.7 million. That included an investment of US$10.8 million associated with remestemcel-L for SR-aGVHD and COVID-19 ARDS.
Management comments
Mesoblast CEO Silviu Itescu said: “During the quarter we made significant progress in both regulatory and clinical outcomes for our lead product candidate, remestemcel-L in the treatment of steroid refractory acute graft versus host disease in children. Additionally, as COVID infections continue to surge, the 90-day survival outcomes from the remestemcel-L trial in adults with COVID ARDS demonstrated the potential for durable benefit of this therapy in certain segments experiencing the most extreme complication of this disease.”
Summary thoughts on the Mesoblast share price
Mesoblast shares are long way down from their previous highs from last year. It’s hard to say if this is a good price or not because it depends on the approval success of it’s products and then the demand. I don’t like to make that kind of investment.
There are other ASX growth shares that I prefer the look of.
