Mesoblast burnt $108m in FY20 waiting on key FDA ruling
Health & Biotech
Health & Biotech
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Closely watched biotech Mesoblast (ASX:MSB) has announced it narrowed its cash burn in FY2020 as it awaits a crucial decision by US regulators on whether to approve its stem cell treatment for children suffering from a complication from bone marrow transplants.
Mesoblast said it reduced its full-year loss in the 12 months to June 30 by 13 per cent to US$77.9 million (A$107.6 million), while its revenue rose 92 per cent to US$32.2 million (A$23.3 million).
The company received US$15 million from its strategic partnership with German pharmaceutical company Grünenthal GmbH and $US6.6 million in royalties from its partnership with Japan’s JCR Pharmaceuticals.
The US Food and Drug Administration is due to make a decision by September 30 on whether to approve Mesoblast’s Ryoncil stem cell treatment for children with steroid-refractory graft-versus-host disease (aGVHD), which an advisory committee recommended on August 13.
As many as 14,000 children in the United States suffer from the disease and Mesoblast says it could be ready to launch Ryoncil – which is expected to cost patients hundreds of thousands of dollars – as soon as late this year if FDA approval is granted.
Mesoblast is also enrolling COVID-19 patients in a Phase 3 study in the United States to see if Ryoncil (remestemcel-L) can reduce mortality from inflammatory complications, as well as running clinical trials to test its efficacy as a treatment for chronic advanced heart failure and discogenic low back pain.
It’s a make-or-break period for Mesoblast, which ended FY2020 with $129.3 million ($A188.4) million in cash in hand after a US$90 million (A$138 million) capital raise, although it could have access to up to an additional US$67.5 million in the next year through existing financing facilities and strategic partnerships.
“It’s been a tremendous year, a very important year for Mesoblast, and the next few months are certainly going to be transformational for the company,” Mesoblast CEO Dr Silviu Itescu told analysts in a webcast on Thursday morning.
Mesoblast has industrial-scale manufacturing in place as it prepares for a US launch of Ryoncil during the fourth quarter of 2020, he said.
Elsewhere in the health sector, Medadvisor Limited, which makes an app that lets patients manage their medications, announced a full-year loss of $9.78 million, down 20.4 per cent from FY19.
Its revenue was up 20.4 per cent to $11 million.
Medadvisor (ASX:MDR) said the number of patients actively using its platform grew 42 per cent to 1.7 million, while it grew its pharmacy network by eight per cent to over 3,500.
Invion Limited meanwhile announced its revenue for the year ended June 30 was down 10.4 per cent to $3.48 million.
Melbourne-based Invion (ASX:IVX), which is working on using photosensitising agents to kill cancer cells, also reduced its full-year loss to $953,894.
Also, Antisense Therapeutics (ASX:ANP) announced its revenue was down 20.5 per cent to $60,625 while its net loss doubled to $5.9 million.
The company is working on a potential gene treatment for Duchenne muscular dystrophy and on August 3 asked the US Food and Drug Administration to designate its drug candidate ATL1102 as an “orphan drug,” which would grant it special regulatory privileges.