The Mesoblast Ltd (ASX: MSB) share price is charging higher today.
Again.
Shares in the S&P/ASX 300 Index (ASX: XKO) clinical-stage biotechnology company closed yesterday trading for $3.06. In morning trade on Friday, shares are swapping hands for $3.15 apiece, up 2.9%.
This sees the Mesoblast share price up a blistering 1,090% since this time last year.
For some context, the ASX 300 is up 0.8% today and 11.3% over 12 months.
Today's moves come as investors digest Mesoblast's December quarterly report along with a product pipeline update.
Here's what's happening.
Mesoblast share price lifts amid ongoing progress
In the quarter just past, the company – which specialises in allogeneic cellular medicines to treat inflammatory diseases – announced a net operating cash spend of US$10.1 million. While that's still in the red, the net cash spend was down 18% year on year.
Over the three-month period, the Mesoblast share price received a major boost when the company's Ryoncil (remestemcel-L) became the first mesenchymal stromal cell (MSC) therapy approved by the US Food and Drug Administration (FDA) for any indication.
Mesoblast noted that:
FDA approved Ryoncil as the first and only therapy for children aged 2 months and older, including adolescents and teenagers, with steroid-refractory acute graft versus host disease (SR-aGvHD), a life-threatening condition with high mortality rates.
The ASX 300 biotech stock also progressed with its confirmatory Phase 3 trial of rexlemestrocel-L in patients with chronic low back pain, and it reported positive results with its Revascor product for patients with ischemic heart failure and inflammation.
Mesoblast also successfully completed a global private placement, raising US$161 million.
The cash on hand at the end of the quarter was US$38 million, with pro-forma cash after the approximately US$200 million in proceeds raised in January.
What did management say?
Commenting on the results sending the Mesoblast share price higher again today, CEO Silviu Itescu said, "We are committed to making our FDA-approved product Ryoncil available as quickly as possible to the many children with SR-aGVHD in need of life-saving therapy."
Itescu added:
The team has been working relentlessly on finalising product availability, including logistics, regulatory documentation, and contractual arrangements to ensure a successful launch of Ryoncil this quarter.
On the financing front, Itescu said:
The successful financing of US$160 million this month, which provides the company with proforma cash on hand of approximately US$200 million, puts us in a strong position to execute the US commercial launch activities of Ryoncil, to expand the clinical indications of the product, and ensure that commercial manufacturing will meet projected product uptake and demand.
