The Mesoblast Ltd (ASX: MSB) share price is under pressure on Tuesday.
At the time of writing, the allogeneic cellular medicines developer's shares are down 4% to $1.04.
Though, shareholders won't be too disheartened given that its shares remain up over 200% since the start of the year.
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Why is the Mesoblast share price falling today?
Investors have been selling the company's shares on Tuesday following the release of two announcements.
The first announcement was its quarterly update, which revealed modest royalty receipts of US$1.7 million for the three months ended 31 March. This brings its year to date royalty receipts to US$5.6 million.
However, this was nowhere near enough to offset its spending during the quarter. As a result, the company recorded an operating cash outflow of US$11.6 million. This led to Mesoblast ending the period with a cash balance of US$76.4 million.
But that shouldn't take away from the many positives that happened during the quarter. This includes some very promising interactions with the US Food and Drugs Administration (FDA).
Mesoblast's chief executive, Silviu Itescu, said:
We are very pleased with the positive interactions we had last quarter with the FDA, having received clarity on the path to licensure for our product candidates in pediatric acute graft versus host disease and in ischemic patients with chronic heart failure. Based on the clear responses and guidance from FDA we intend this quarter to resubmit our Biologics License Application (BLA) for approval of remestemcel-L in children with SR-aGVHD.
In addition, FDA informed us that the results from our pivotal study of rexlemestrocel-L in end-stage heart failure patients may support an accelerated approval, and we intend to have a pre-BLA meeting to discuss the data that will be provided and the timing for an accelerated approval filing.
What else was announced?
In other news, Mesoblast revealed that its chair, Joseph R. Swedish, will be stepping down from the role.
The company's board has been quick to respond. It advised that it has unanimously appointed Jane Bell AM to the role of non-executive chair, effective today.
Mr Swedish commented:
It has been an honour serving on the Board and witnessing first-hand the tremendous dedication and commitment it takes to bring a cutting-edge product to market. I feel we are on the verge of achieving that goal and I am confident that the Board, working with Silviu and the management team will achieve this milestone and capitalize on the building blocks established to date.
The Mesoblast share price is up 21% on a 12-month basis.
