The Mesoblast Limited (ASX: MSB) share price is under the spotlight after revealing its quarterly update to investors.
What’s happening to the Mesoblast share price?
Mesoblast shares are currently up slightly after revealing its news.
The biotech company outlined a number of things regarding its treatments and financials.
Regarding remestemcel-L in the treatment of steroid-refractory acute graft versus host disease in children, it said it’s still in discussions with the US FDA. It’s in a regulatory process that may include a resubmission with a six month review with the aim of achieving approval. Mesoblast is going to discuss with FDA’s Center for Biologics Evaluation and Research (CBER) review team to address certain items.
Looking at using remestemcel-L for the treatment of COVID-19 patients under 65 who are ventilator dependent, a randomised controlled trial showed a significantly reduced mortality through to 60 days. In patients under 65, the benefit was further increased when remestemcel-L was used with dexamethasone as part of standard are. 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. Mesoblast intends to meet with the FDA to discuss the next steps.
Mesoblast also talked about rexlemestrocel-L in the treatment chronic low back pain. The trial of 404 patients with chronic low back pain indicated that a single injection of rexlemestrocel-L and hyaluronic acid carrier may provide at least two years of pain reduction. The results indicate that treatment benefit may be greatest when inflammation is high and before irreversible fibrosis has occurred in the intervertebral disc. Mesoblast also intends to meet with the FDA to discuss with a potential pathway for approval.
Financials
Mesoblast said that sales of TEMCELL in Japan continue to recover from the COVID-19 production shutdown. Revenue for the quarter to 31 March 2021 was US$1.9 million, down from US$2 million a year ago.
The company highlighted that it successfully completed a US$110 million private placement, led by US investor SurgCenter Development, one of the largest private operators of ambulatory surgical centres in the US specialising in spine, orthopaedic and total joint replacement. It had US$158.3 million of cash at the end of 31 March 2021.
Summary thoughts on Mesoblast and the share price
Mesoblast is an interesting business. It’s one of those investments where it’s either effective and approved, or not effective and likely not approved. That’s not the type of binary investment I want to make.
There are other ASX growth shares that are more attractive to me and have a higher chance of success.
