It's a big day for Mesoblast Ltd (ASX: MSB) shares today.
Not because shares in the clinical-stage biotechnology company are gaining again. In fact, they're headed the other direction on Friday, down 8.1% in early afternoon trade at $1.635 apiece.
There's no need to break out your tiny violin for longer-term stockholders, though. As you can see on the chart below, Mesoblast shares remain up an eye-watering 427% in 2024.
Rather, today is a big day for the company because Mesoblast hosted its annual general meeting (AGM) this morning.
Here's what the company's top management had to say.
Mesoblast shares in focus amid AGM
"This year has seen our company make significant advances as a leading developer of innovative allogeneic cellular medicines," chair Jane Bell said.
She noted:
[Mesoblast has] an extensive clinical-stage pipeline of therapeutic assets validated by clinical data that address serious and life-threatening inflammatory illnesses. Our key areas of focus remain cardiovascular disease, chronic low back pain, and acute life-threatening inflammatory conditions including graft versus host disease (GvHD)…
2024 has been pivotal in our journey toward commercialising our therapies.
Bell said that the company's "positive interactions" with the United States Food and Drug Administration (FDA) enabled Mesoblast to resubmit the Biologics License Application for approval of Ryoncil (remestemcel-L).
The product is intended to help children with steroid-refractory acute GvH.
"As the current review for approval of Ryoncil progresses," Bell added, "our focus has turned to implementing the commercialisation strategies that will allow us to successfully launch Ryoncil, a much-needed treatment for desperately ill children, upon FDA approval."
In addition, the ASX biotech company is working towards filing for accelerated FDA approval of Revascor (rexlemestrocel-L) in end-stage heart failure patients.
As for the balance sheet, Bell noted:
Our balance sheet has been well-managed, including recently securing access to US$50 million to fund our planned commercial launch on approval of Ryoncil, while at the same time maintaining financial discipline through the implementation of cost reduction strategies to maximise our financial runway.
Looking at what might impact Mesoblast shares in the year ahead, Bell said, "As we plan for 2025 and beyond, I am very optimistic about Mesoblast's future."
She added, "The strength of our science, the dedication of our impressive team, and the support of our shareholders position us to achieve our goal of delivering transformative therapies to patients in need."
CEO Silviu Itescu reiterated that Mesoblast "expects to substantially advance its multiple product pipeline" toward FDA approvals over the next six to 12 months.
On the cost reduction front, which has helped support Mesoblast shares, Itescu highlighted the 26% year-on-year decline in the company's net operating cash spend for the September quarter.
