MSB - Mesoblast Limited

[tech/a]

From MSB website -
Mesoblast is using its proprietary mesenchymal lineage cell technology platform to develop and commercialize innovative allogeneic cellular medicines to treat complex diseases where inflammation plays a central role and are resistant to conventional standard of care.

The Company’s broad portfolio of late-stage product candidates are:

• RYONCIL™ (remestemcel-L) for steroid-refractory acute graft versus host disease (acute GVHD) in children
• REVASCOR® for advanced chronic heart failure
• MPC-06-ID for chronic low back pain due to degenerative disc disease

Mesoblast’s Biologics License Application (BLA) for RYONCIL for the treatment of children with steroid-refractory acute GVHD has been accepted for priority review by the United States Food and Drug Administration (FDA). The FDA has set a Prescription Drug User Fee Act (PDUFA) action date of September 30, 2020, and if approved, Mesoblast will make RYONCIL immediately available in the United States.

Remestemcel-L is also being developed for rare diseases in adults and children. Additionally, Mesoblast has a promising emerging pipeline of Phase 2 product candidates and next generation technologies.

On 24th April 2020 announcement from MSB -
Melbourne, Australia; April 24, 2020; and New York, USA; April 23, 2020: Mesoblast Limited (ASX:MSB; Nasdaq: MESO) today announced 83% survival in ventilator-dependent COVID-19 patients (10/12) with moderate/severe acute respiratory distress syndrome (ARDS) treated during the period March-April 2020 with two intravenous infusions of Mesoblast’s allogeneic mesenchymal stem cell product candidate remestemcel-L within the first five days. 75% (9/12) have successfully come off ventilator support at a median of 10 days. At this time, seven have been discharged from the hospital. Patients received a variety of experimental agents prior to remestemcel-L. All patients were treated under an emergency Investigational New Drug (IND) application or expanded access protocol at New York City’s Mt Sinai hospital. In contrast, only 9% (38/445) of ventilator-dependent COVID-19 patients at a major referral hospital network in New York City were able to come off ventilator support when treated with standard of care during March/April 2020.1 Moreover, there was 88% mortality with only 12% survival (38/320) among ventilator-dependent COVID19 patients at a second major referral hospital network in New York City during the same period.2 These poor outcomes are consistent with earlier published data from China where mortality rates of over 80% were reported in patients with COVID-19 and moderate/severe ARDS.3 Mesoblast Chief Executive Dr Silviu Itescu stated: “The remarkable clinical outcomes in these critically ill patients continue to underscore the potential benefits of remestemcel-L as an anti-inflammatory agent in cytokine release syndromes associated with high mortality, including acute graft versus host disease and COVID-19 ARDS. We intend to rapidly complete the randomized, placebo-controlled Phase 2/3 trial in COVID-19 ARDS patients to rigorously confirm that remestemcel-L improves survival in these critically ill patients.” Mesoblast Chief Medical Officer Dr Fred Grossman said: “There is a significant need to improve the dismal survival outcomes in COVID-19 patients who progress to ARDS and require ventilators. We have implemented robust statistical analyses in our Phase 2/3 trial as recommended by the US Food and Drug Administration (FDA) in order to maximize our ability to evaluate whether remestemcel-L provides a survival benefit in moderate/severe COVID19 ARDS.”

Iggy

People seem to have missed this line.
So which one had the effect?

 

[Knobby22]

People seem to have missed this line.
So which one had the effect?

They didn't work, hence this treatment which appeared to be very effective however the number of people was minimal.
It obviously made the clinicians stand up, hence, now we get a proper study.

There is science behind this treatment, unlike some others.

 

[tech/a]

Interesting.
So the responding time must be super quick for these "Others"
Information is scant. How quick can you tell ANY treatment is a success
or a failure. Supposedly others didn't get it.
From what I understand once on a ventilator its 3-5 days winner
or likely loser.
I dont read it that way Knobby. It doesn't say that they didn't work
how do we know that they weren't synergistic?

 

[Knobby22]

This was a last resort option, heck this is an Aussie company with no Presidential influence.

Though the company knew this may work on the science getting someone to try it when you have little influence is difficult.

I would be surprised to see synergy knowing how it works. They tried a variety of treatments that failed before resorting to this.

This product saves little kids who have resistant to cortosoids. It is a related field with relation to inflammation.

We shall see.

 

[tech/a]

All good.
I hope its a winner.
I may need it!

 

[Joules MM1]

'free' advertising

 

[UMike]

Trading halt.
Better be good news.
??????

 

[Knobby22]

Trading halt.
Better be good news.
??????

Its an equity raising. So no.
We do have two phase 3 trials due to report and of course the coronavirus trial is ongoing but that won't be known till next month. The extra cash needed to fund the trial obviously has created the need for more cash. I was expecting this but thought they would do it later but probably smart to do it now.

 

[UMike]

Not doubting you but I haven't seen the Announcement.

 

[Knobby22]

Not doubting you but I haven't seen the Announcement.

I read it on the Age/ SMH so hopefully they aren't bulldusting.

 

[Knobby22]

Raising at a good price, shows confidence and should remove the need for future raisings.

Decided to buy some more. $3.37. will add about another 14% to my holding at a price well above my average price.

 

[UMike]

I got in really cheap and was sh1tty that I missed getting rid of it around the $4 mark.
Don't really need the cash atm so I guess $3.20 is a bit of a floor.

Might Hang on for a while.

 

[Knobby22]

My pick for next month.
Results out for Covid and I think at least one of the other 3 phase trials.
Raising completed so nothing to stop the rise (if it works).

 

[barney]

My pick for next month.
Results out for Covid and I think at least one of the other 3 phase trials.
Raising completed so nothing to stop the rise (if it works).

Lets hope it works
Lets hope you win the monthly comp and MSB goes to $10 bucks!!

 

[UMike]

Personally got out at $4.1

Still riding the super wave though.

 

[Knobby22]

It's taking off a bit early...leakage of results?

 

[Austwide]

It's taking off a bit early...leakage of results?

I think people are buying on rumour, watch closely on results day.

 

[barney]

It's taking off a bit early...leakage of results?

Certainly interesting to watch … Anything with positive connotations regarding Covid-19 is a possible time bomb price wise.

Based on the chart alone, I'd suggest $5 within a couple of days is a definite possibility …

… we shall see.

 

[Knobby22]

Quarterly out, worth a read. A lot happening over the next 3 months. Very encouraging.

 

[barney]

Quarterly out, worth a read. A lot happening over the next 3 months. Very encouraging.

Its certainly an interesting Stock no doubt ..... i did buy a few last week but ended up selling the remainder today (at a small loss). The recent strong rise is fantastic for longer term holders, but late comers like me will always have to deal with timing the momentum to get any real gain.

Not my normal style to buy in after moves so happy to stand aside ... In saying that, I have every confidence it will prove to be a great stock, so good luck Knobby and others