Mesoblast share price spikes amid 'substantial reduction in operational spend'

Mesoblast also completed the resubmission of its Biologics License Application (BLA) for remestemcel-L to the FDA last quarter.

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Shares of Mesoblast Limited (ASX: MSB) spiked 1.52% shortly after the opening bell today. It came amid the release of the company's financial results and operational highlights for the three months ended 31 March 2022.

Mesoblast shares have since retreated and now sit flat at 98.5 cents.

In broad market moves, the S&P/ASX 200 Index (ASX: XJO) has started the day up and is now 22 basis points higher at 7,226 on last check.

Mesoblast grows revenue, reduces net loss

Key financial highlights for the period include:

  • Total revenue increased by 5% from the comparative quarter last year to US$2 million
  • Cash on hand at the end of the quarter US$76.8 million, with up to an additional US$40 million available to be drawn down subject to milestones
  • Net cash usage for operating activities in the quarter reduced by 40% to US$15.5 million
  • Research and development expenses reduced by US$4.2 million or 34%, down to US$8.2 million
  • Finance costs for borrowing arrangements with Oaktree and NovaQuest were US$3.9 million for the third quarter FY2022, compared to US$3.2 million same time last year
  • Loss after tax for the third quarter FY2022 was US$21.3 million compared to US$26.5 million for Q3 FY21

What else happened last quarter for Mesoblast?

The company made two board and executive appointments last quarter to key positions in the company.

Philip Krause MD, former deputy director Office of Vaccines Research and Review at the United States Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER), joined the board in March.

Meanwhile, the company appointed Eric Rose MD as its Chief Medical Officer (CMO). Rose had been a non-executive director of Mesoblast since 2013, the company says.

Mesoblast also completed the resubmission of its Biologics License Application (BLA) for remestemcel-L to the FDA last quarter.

"Mesoblast will provide these new data to FDA and address all chemistry, manufacturing and controls (CMC) outstanding items as required for the planned BLA resubmission in the coming quarter," the company said.

"If the resubmission is accepted, CBER will consider the adequacy of the clinical data in the context of the related CMC issues."

Adding to that, it also progressed through its Phase 2/3 study of remestemcel-L. The aim is to treat acute respiratory distress syndrome in COVID-19.

What's next for Mesoblast?

The company is now working through additional studies for its rexlemestrocel-L compound indicated to manage chronic low back pain from degenerative disc disease.

It is planning an upcoming United States trial set to include at least 20% of subjects from the European Union. This is "to support admissions to both the FDA and the European Medicines Agency (EMA)".

Mesoblast also notes that it is investigating rexlemestrocel-L in patients with chronic heart failure with reduced ejection fraction.

"Mesoblast expects to receive guidance from FDA on a potential approval pathway following detailed review of the outcomes identified in high-risk HFrEF patients with diabetes and/or myocardial ischemia."

The company made no mention of financial guidance in its release today.

Mesoblast share price snapshot

In the last 12 months, the Mesoblast share price has slipped around 48% into the red. Mesoblast shares are down another 29% this year to date.

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