Globally, there have been more than 4.2 million confirmed cases of COVID-19, including 290,242 deceases, reported to WHO as of 8:35 AM CEST, 14 May 2020.
With more than 4.2 million confirmed cases of COVID-19, including 290,242 deceases reported to WHO as of 8:35 AM CEST, 14 May 2020, the coronavirus pandemic has caused unprecedented levels of damage to the global economy. The growing number of cases has shifted the focus on the healthcare sector’s ability to develop a vaccine for the deadly virus, SARS-CoV-2.
In general, novel vaccines development may take several years. However, in the current scenario, the healthcare industry is competing to reduce this period drastically with the support of government agencies, regulatory authorities and nonprofit organisations.
COVID-19 pandemic has raised a big question for humankind, and humanity is in a fight to save lives along with livelihood. The billion-dollars question, at present, is when the vaccine for the prevention of the coronavirus come in the market?
The healthcare players are working on various developments that could be planned into three different groups: diagnostics, treatments and vaccines. Since it might take at least a year to develop a vaccine, it would not be wise to only focus on this aspect. It would be prudent to put efforts into finding a treatment for saving the already infected individuals and providing treatment as soon as possible.
COVID-19 has already created a domino effect among several companies, as many of them have withdrawn their earnings guidance, and some businesses are shut down. However, one ASX-listed healthcare company, Mesoblast Limited (ASX:MSB) has become a market darling amid the crisis.
Challenging the coronavirus pandemic, Mesoblast has continued its efforts for combating against the virus. With its robust drug pipeline with several drug products under clinical investigation, the Company is well-positioned to progress treatment for COVID-19 patients. The way Mesoblast is progressing towards the goal of finding a COVID-19 treatment through its lead compound Remestemcel-L is commendable, and recently the Company successfully completed the capital raising to scale-up manufacturing of Remestemcel-l for treatment of COVID-19 ARDS.
Let us acquaint you with the success story of Mesoblast:
On 14 March 2020, MSB last quoted at AU$3.670, an increase of 8.26 per cent. The Company has a market cap of AU$1.82 billion and 537.27 million outstanding shares on the ASX. MSB stock has generated a positive return of 87.81 per cent in the last six months and 18.12 per cent in the previous three months.
About Mesoblast Limited (ASX:MSB)
Melbourne-headquartered company Mesoblast Limited is a global leader in developing cellular medicines for inflammatory diseases. MSB has a robust emerging product pipeline with three programs currently in Phase 3 clinical studies. The lead drug candidates of the Company that are under clinical development are- Remestemcel-L, revascor, MPC-06-ID and MPC-300-IV.
MSB Successfully Completes Financing to Fast-track Remestemcel-L Manufacturing
Mesoblast Limited disclosed that the Company has successfully completed a capital raising of AU$138 million via a placement of 43 million shares to its existing and new institutional investors at a per-share price of AU$3.20 per share.
This signifies a discount of 7 per cent to both the closing price of trading on 8 May and the five-day volume-weighted average price (VWAP).
First patient for treatment of COVID-19 induced ARDS dosed in phase 2/3 randomised controlled trial
On 6 May 2020, Mesoblast disclosed that the first patients had been dosed in the placebo-controlled, randomised Phase 2/3 trial in the United States. The investigational drug, Mesoblast’s allogeneic cellular medicine remestemcel-L is being studied in 300 patients having COVID-19 with moderate to severe acute respiratory distress syndrome (ARDS) and were on ventilator support.
Notably, the Company has an IND (or Investigational New Drug) application that is cleared by the US FDA for application of remestemcel-L to treat patients having COVID-19 induced ARDS.
Mesoblast notified that the Phase 2/3 trial clinical protocol is based on initial promising outcomes from the application of remestemcel-L in patients with moderate as well as severe ARDS induced by COVID-19 under an emergency IND application or expanded access protocol at New York’s Mount Sinai Hospital.
Financial and Operational Highlights for the third quarter (ended 31 March 2020)
During the third quarter, MSB accomplished a significant milestone when its Biologics License Application (BLA) for RYONCIL™ (remestemcel-L) was accepted by the US Food and Drug Administration (FDA) for priority review in the treatment of children with steroid-refractory acute graft versus host disease (SR-aGVHD).
Highlights from the financial front-
- The Company recorded revenues from rising TEMCELL® HS Injection sales by its licensee for aGVHD in Japan, which stood at US$2.1 million for the quarter. The sales almost doubled compared to the previous corresponding period (99 per cent growth).
- At the end of this quarter, Mesoblast has cash on hand of US$60.1 million. Over the next one year period, the Company might gain access to an additional US$62.5 million via its existing strategic partnerships and financing facilities.
- For operating activities, the total cash payment was about US$22.0 million, a fall of 2.8 per cent compared to the pcp.
Highlights from the operational front-
- Remestemcel-L Biologics License Application for Steroid-Refractory Acute Graft Versus Host Disease was accepted by the FDA for priority review, and the FDA has set a Prescription Drug User Fee Act (PDUFA) action date of 30 September 2020. MSB notified that if the FDA would approve it, the Company plans to launch RYONCIL in the United States in 2020.
- Mesoblast disclosed that the phase 2/3 randomised trial would be conducted as a public-private partnership in collaboration with CTSN, which was established by the National Institutes of Health’s National Heart, Lung and Blood Institute (NHLBI) of the United States as a flexible platform for performing clinical studies in collaboration.