Biotech company specialising in allogeneic cellular medicines, Mesoblast [ASX:MSB], revealed a downsizing of its quarterly losses by US$5.8 million over the three months to September 20 in its financial results for the first quarter of FY23.
The biotech also reported a dip in its quarterly revenue, with the researcher making less than half the sales at the same time last year.
It wasn’t all about financials, MSB also provided an update regarding its remestemcel-L product for children with SR-aGVHD (steroid-refractory graft versus host disease), looking to gain FDA approval.
MSB’s share price was mostly flat this morning and remained down 41.5% across the last 365 days.
Source: tradingview.com
MSB’s latest financial and operational metrics
Wednesday morning, the biotech provided an update on its latest financial highlights for the quarter. For the three-month period ending September 30, Mesoblast reported:
- Total revenue more than halved — decreasing from US$3.59 million in the September period last year to US$1.5 million this quarter.
- Cash used in operating activities was also around half incurred in Q4 FY22, down to US$14.28 million from US$18.19 million, a 22% reduction or US$3.9 million in comparison and a 47% reduction (or US$12.5 million) the same time last year.
- Total loss before income tax was also therefore cut, decreasing from US$22.7 million in September last year to US$16.93 million.
- The company’s cash and equivalents dwindled from US$115.95 million to US$85.5 million.
- Net loss for ordinary shareholders was 2.43 US cents per share, compared with 3.49 US cents per share for the first quarter of FY2022.
Group revenue for the quarter was primarily made up of royalties on sales of TEMCELL in Japan, totalling US$1.4 million.
Over 12 months to September 30, royalties totalled US$7.7 million.
Research and development expenses were reduced by US$3.6 million (from US$9.3 million in the first quarter FY2022 to US$5.7 million for the first quarter FY2023) as clinical trials came to an end and data analysis was completed.
Manufacturing expenses also shrunk by US$2.7 million (from US$7.5 million in Q1 FY23 to US$4.8 million Q1 FY23) as the company focused on re-launch activities.
Mesoblast looks to FDA for remestemcel-L approval
As well as the release of its FY23 highlights, the biotech also sought to validate its remestemcel-L product as a ‘durable long-term survival’ therapy for children with SR-aGVHD.
MSB completed its Phase 3 trial for children over four, with substantial results that now has the company seeking FDA approval to launch.
Mesoblast explained survival outcomes for SR-aGVHD have not improved in 20 years and stated:
‘These new long-term survival data reaffirm the potential significance of remestemcel-L as a life-saving therapy for children with SR-aGVHD and are a cornerstone of the company’s BLA resubmission to the FDA for approval of remestemcel-L in the treatment of children with SR-aGVHD.
‘We are at a pivotal juncture, we believe we have appropriately addressed issues raised by FDA in the complete response, and we are well funded in preparation for a potential first product approval and launch by mid-year.’
Across a four-year-long study provided by the Center for International Blood and Marrow Transplant Research (CIBMTR), Mesoblast revealed remestemcel-L survival rates were ‘63% at 1 year, 51% at 2 years, and 49% at 4 years.’
Mesoblast is working towards a potential US approval for remestemcel-L with first product launch slated for H1 CY2023.
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