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Mesoblast (ASX:MSB) - Managing Director & CEO, Silviu Itescu - The Market Herald
Managing Director & CEO, Silviu Itescu
Source: Mesoblast
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  • Mesoblast (MSB) trades in the red following the release of its latest quarterly financial report
  • In the report Mesoblast flagged net cash outflows for the June quarter of just over $20.7 million, taking annual cash outflows to around $107 million
  • Mesoblast CEO Silviu Itescu says the company made "significant progress" over thequarter in gaining regulatory approvals for its remestemcel-L drug
  • Remestemcel-L is currently in phase three trials for acute GVHD in children and for moderate to severe ARDS caused by COVID-19 infection
  • Shares in Mesoblast are down 1.70 per cent and trading at $1.88 each at 11:55 am AEST

Drug developer Mesoblast (MSB) is trading red following the release of its latest quarterly financial report.

In the report, the company flagged net cash outflows of just over $20.7 million, with the bulk of its spending during the three months to the end of June coming from research and development (R&D) work, manufacturing and commercialisation costs.

This takes Mesoblast's annual cash outflows to almost $107 million for the 2021 financial year.

Nevertheless, Mesoblast CEO Silviu Itescu said the company made "significant progress" in both regulatory and clinical towards developing its lead technology platform product remestemcel-L alongside the US Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER).

"FDA's CBER has recently recommended the next steps in the potential approval pathway for remestemcel-L in the treatment of steroid-refractory acute graft versus host disease (GVHD) in children," Mr Itescu said.

"Additionally, as COVID infections continue to surge, the 90-day survival outcomes from the remestemcel-L trial in adults with COVID ARDS (acute respiratory distress syndrome) demonstrated the potential for durable benefit of this therapy in certain segments experiencing the most extreme complication of this issue."

Remestemcel-L is currently in phase three trials for acute GVHD in children and for moderate to severe ARDS caused by COVID-19 infection.

Mesoblast said it met with the FDA during the quarter to discuss potential pathways for the regulatory approval of the drug to treat acute GVHD in children.

Meanwhile, Mesoblast told investors it met with the FDA this week regarding the registration pathway for approval for remestemcel-L to treat COVID-induced ARDS.

Mesoblast is also conducting phase three trials for its REVASCOR product to treat advanced chronic heart failure and its MPC-06-ID product for chronic lower back pain caused by degenerative disc disease.

Shares in Mesoblast were down 1.70 per cent and trading at $1.88 each at 11:55 am AEST. The company has a $1.22 billion market cap.

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