The equity markets across the world have fallen sharply over the past few weeks. Everyone is caught amid the unprecedented times, as the fear of virus has become the dominating emotion all over the place. While the COVID-19 situation continues to be gloomy in most parts of the world, what comes as a vast solace is a sharp decline in further cases at the very epicenter of the widespread breakout in China, as the country demonstrated the capability of the human beings to conquer any grave condition.
When human beings come across any personal catastrophe, they generally tend to take a less financial, less selfish perspective, and instead, try to adopt a new humanistic worldview and value kindness and generosity.
At the present time of crunch caused by COVID-19, businesses such as travel, hospitality, brick and mortar consumer services, locally operated services that necessitate face-to-face social interaction, and all of the above manufacturing will suffer the highest. Consumers are now buying fewer goods and services apart from essentials as food, medication, and certain sundries due to growing financial insecurity and anxiety bringing enormous loss to the economy.
Conversely, there are certain industries flourishing throughout the COVID-19 turmoil and are most likely to be within the healthcare sector, banking, virtual meeting software, liquor and tobacco sales and streaming entertainment space.
The virus has created a big question on humanity, and human beings are facing huge crisis during this time. Humankind is in the fight to save lives along with livelihood. At this time, the billion-dollar question that pops up is when the vaccine for preventing the spread of this deadly virus will come.
All the healthcare and biopharmaceutical companies are working round the clock to come out with vaccine/treatment for COVID-19 and for the survival benefit of the human beings. It is a moment of disaster, but disasters always create opportunities and one ASX-listed healthcare sector company is working hard to prove this right.
In this article, we are highlighting the Company that is gaining traction by providing survival benefits for COVID-19 patients- MSB
ASX-listed, Melbourne headquartered health care player Mesoblast Limited (ASX:MSB) is a frontrunner in developing innovative cellular medicines across the globe. MSB has a strong emerging drug pipeline with its three programs currently under phase III clinical studies.
The lead drug candidates of Mesoblast remestemcel-L, revascor, MPC-300-IV and MPC-06-ID are under clinical development stage. The Company has a robust and broad worldwide intellectual property portfolio with protection extending through to at least 2040 in all main markets.
Mesoblast to Commence Enrollment for Phase 2/3 trial of Remestemcel-L
After reporting 83% (10 out of 12) survival in the COVID-19 patients who are dependent on ventilator recently, Mesoblast in its latest update disclosed that the Company started enrollment for a Phase 2/3 randomized, placebo-controlled study to accurately check whether remestemcel-L provides a survival benefit in moderate/severe acute respiratory distress syndrome (ARDS) due to COVID-19.
The randomized controlled Phase 2/3 clinical trial of remestemcel-L would be performed in nearly 300 patients having ARDS due to COVID-19 infection.
Moreover, the Company mentioned that more than 20 healthcare centers across the US would take part in this study, which is projected to finalise the enrollment within 3-4 months.
Financial and Operational Highlights for the third quarter (ended March 31, 2020)
During the reporting quarter, Mesoblast achieved a significant milestone when its Biologics License Application (BLA) for RYONCIL™ (remestemcel-L) was accepted by the United States Food and Drug Administration (FDA) for priority review in the treatment of children with steroid-refractory acute graft versus host disease (SR-aGVHD).
The Company has identified a second major inflammatory condition with a high mortality rate, COVID-19 induced ARDS, where its drug remestemcel-L could be of benefit given similar immune stimulation and cytokine surge as happens in aGVHD.
On the operational front, Remestemcel-L is under clinical development for Steroid-Refractory Acute Graft Versus Host Disease (SR-aGVHD) and Acute Respiratory Distress Syndrome in COVID-19 patients.
For the treatment of SR-aGVHD in children, Remestemcel-L was accepted by the FDA for priority review. Moreover, the FDA has decided a PDUFA (Prescription Drug User Fee Act action) date of September 30, 2020. If it receives an approval, the Company plans to launch remestemcel-L (RYONCIL) in the United States in 2020. Moreover, a targeted commercial team is being built, and the product inventory is in place.
Subsequently, for treating patients having COVID-19 induced ARDS with the intravenous (IV) infusions of remestemcel-L, an Investigational New Drug (IND) application was submitted to and approved by the Food and Drug Administration (FDA).
Additionally, Mesoblast highlighted that the Phase 2/3 trial of Remestemcel-L in patients who are dependent on ventilation, with moderate or severe COVID-19 induced ARDS across North America, will be conducted as a partnership (public-private) with the Cardiothoracic Surgical Trials Network (CTSN) that was established as a flexible platform for conducting collaborative trials by the US National Institutes of Health’s National Heart, Lung and Blood Institute (NHLBI).
Revascor® and MPC-06-ID are also under development for Chronic Heart Failure and Chronic Low Back Pain, respectively. For MPC-06-ID, a 404-patient chronic low pain Phase III clinical trial intended to announce in mid-2020.
On the financial front-
- The revenues from sales of TEMCELL® HS Injection by the licensee Mesoblast for aGVHD in Japan remained to rise and were USD 2.1 million for the quarter ended March 31, 2020, reflecting a growth of 99% as compared to the previous corresponding period (pcp).
- Mesoblast exited this quarter with cash on hand of USD 60.1 million at the end of the quarter, and over the next year period, the Company might gain access to an additional USD 62.5 million through its existing financing facilities and strategic partnerships.
- For operating activities, the total cash payment was about USD 22.0 million, a decline of 2.8% relative to the pcp.
Moreover, the Company is in active discussions with respect to its strategies for the ramp-up of commercial manufacturing for remestemcel-L in COVID-19 ARDS with the US, and other government authorities along with potential pharmaceutical partners.
By the end of the trading session, on 1 May 2020, the shares of MSB dwindled by 3.869% from its last close to AUD 3.230. The market cap of the stock was reported at AUD 1.81 billion, with 52-weeks high and low price of AUD 4.450 and AUD 1.020, respectively. MSB stock has delivered a positive return of 88.24% in the last six months and 13.13% in the last three months period.