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asx announcement OPERATIONAL HIGHLIGHTS AND FINANCIAL RESULTS FOR THE PERIOD ENDED MARCH 31 , 2021 Melbourne , Australia ; June 3 and New York , USA ; June 2 , 2021 : Mesoblast Limited ( ASX : MSB ; Nasdaq : MESO ) , global leader in allogeneic cellular medicines for inflammatory diseases , today reported operational highlights and financial results for the period ended March 31 , 2021 . mesoblast " We are pleased with the recent clinical outcomes regarding our lead product candidate remestemcel - L and continue to progress our regulatory discussions with the aim of achieving approval . Our focus and top priority remains on successfully bringing remestemcel - L to children with the devastating complication of steroid - refractory acute graft versus host disease and adults fighting COVID - 19 acute respiratory distress syndrome , " said Silviu Itescu , Chief Executive of Mesoblast . Operational Highlights Remestemcel - L in the treatment of steroid - refractory acute graft versus host disease ( SR - aGVHD ) in children : As part of this process , Mesoblast recently met with the FDA's Center for Biologics Evaluation and Research ( CBER ) . Following CBER's recommendation after this meeting , Mesoblast as a next step will discuss with CBER's review team at the Office of Tissue and Advanced Therapies ( OTAT ) our approach to address certain outstanding chemistry , manufacturing and controls ( CMC ) items , including potency assay validation Remestemcel - L in the treatment of COVID - 19 ARDS in adults : ● ● Mesoblast continues to be in discussion with the United States Food & Drug Administration ( FDA ) through a well - established regulatory process that may include a resubmission with a six month review with the aim of achieving approval of remestemcel - L in the treatment of steroid - refractory acute graft versus host disease ( SR - aGVHD ) in children ● Results from the randomized controlled trial of remestemcel - L in ventilator - dependent COVID 19 patients with moderate / severe acute respiratory distress syndrome ( ARDS ) indicated that in the pre - specified population under 65 years old ( n = 123 ) , those who received remestemcel L had a significantly reduced mortality through to 60 days . The trial had been halted after the third interim analysis and 222 enrolled patients since the 30 - day primary endpoint would not be attained . Rexlemestrocel - L in the treatment of chronic low back pain : Results from the trial of rexlemestrocel - L ( MPC - 06 - ID ) in 404 patients with chronic low back pain ( CLBP ) due to degenerative disc disease ( DDD ) indicated that a single injection of rexlemestrocel - L + hyaluronic acid ( HA ) carrier may provide at least two years of pain reduction , with opioid sparing activity in patients using opioids at baseline In patients under 65 years , the benefit was further increased when remestemcel - L was used with dexamethasone as part of standard of care The trial also indicated that the mortality reduction by remestemcel - L in those under 65 years was accompanied by increased days alive off mechanical ventilation and reduced days in hospital Significant and durable reductions in CLBP through 24 months were seen across the entire evaluable study population , and greatest pain reduction was observed in the pre - specified population with CLBP of shorter duration than the study median of 68 months The results indicate that treatment benefit may be greatest when inflammation is high and before irreversible fibrosis has occurred in the intervertebral disc