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97.0¢ mesoblast limited

2024 Here we go again., page-386

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reginaldp

2,657 Posts.

1705

02/04/24

19:30

Post #: 73155256
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Originally posted by dachopper: ↑

Time for my thoughts I think.
Upcoming catalysts - Nexus points if you like .

Pediatric SR a GvHD

BLA resubmission to FDA is targetted over the next three months ( April / May / June ) 2024.

Next will come the FDA acceptance of the resubmission, and the classification into a type 1 ( 2 month review ) or type 2 ( 6 month review ) process.

Following the BLA resubmission acceptance which in my opinion is extremely likely, the advisory comittee meeting and manufacturing inspection already having been completed and effectively both passed, the next peep from MSB we might here is about labelling discussions occurring.

Based on the above, timeline for approval decision will as early as 1 June 24 to 31 Dec 24, dependent mostly on MSB resubmitting this quarter - as they said they intend to do.

Approval I think ( this is not financial advise ) is going to push market cap to at least 5 billion IMO, moreso because approval means it will be easier to label extend the adult GvHD trial, which is already underway. And approval in the adult trial represents a 5x market size, so could be around the 1 billion earnings, justifying a much higher than 5 billion valuation.

CLBP
The trial is registered on clinical trials, and estimated to start recruiting next month ( May 2024 ).
300 person trial, with 12 month primary end point of reduction in pain.
Previous phase 3 and the phase 2 trials both demonstrated a significant redution in pain ( with the average pain reduction approaching a 50% ), which is well above the average pain reduction levels of any other treatments available on the market - and this is the significant point - If approved it would appear to be the best possible treatment available. We have so far no side effects, pain reduction lasting 3 years + , huge reduction in opioid use, and the pricing indications are somewhere in between hardcore opioids, and lubar surgery. Can be administered walk in , walk out of a day surgery.
https://clinicaltrials.gov/study/NCT06325566?term=mesoblast&aggFilters=status:act%20not&rank=2#contacts-and-locations

Based on the forecast, they are estimating up to 2 years 3 months for full completion of the 12 month end point - which would put us in 2026, with BLA filing expected around 2027, for what is easily the biggest market opportunity of all of them. If approved this indication could yield multi billion earnings, which there is not too much point speculating on right now as the trial has not completed, and the market cap now is not even 1 billion US.CHFThis one is interesting.
We have the company saying only 20 days ago, " the FDA supports an accelerated approval pathway for rexlemestrocel-L,
Mesoblast’s allogeneic mesenchymal precursor cell (MPC) product, in patients with end-stage ischemic
heart failure with reduced ejection fraction (HFrEF) and a left ventricular assist device (LVAD)." and

"FDA’s feedback that the presented results from our pivotal study of
rexlemestrocel-L in end-stage HFrEF patients with LVADs may support an accelerated approval,” said
Mesoblast CEO Dr. Silviu Itescu. “We intend to request a pre-Biologics License Application (BLA) meeting
to discuss data presentation, timing and FDA expectations for an accelerated approval filing.”
So this LVAD meeting, was at least the meeting before the meeting before the potential submission.

There are no timelines attached to this ( intention to meet ), but my guess is by the end of 2024 ( 6 - 9 months ), which would support BLA submission in 2025 and possible accelerated approval decision ( or CRL ) by the end of 2025, and that is assuming there are no other meetings jammed in there to try and avoid delays.

Capital RaisesCash reserves were US 77 million as of 31 Dec 24, with Cash burn around 12 million per quarter.
Loan caveats require 6 months cash runway (24 million at 12 million a quarter), but insert your own figures here, leaving around 50 million (or 12 months).
This appears likely enough to see out the FDA approval of Ryoncil for GvHD, since that decision should be somewhere between June and Dec, provided there is no significant incerase in spending.

With this in mind, some form of funds raising is likely to be needed in Q3 onwards. Probably too early for any CLBP or GvHD adult trial DSMB readouts at that stage, but probably after confirmation that the pivotal trials had commenced enrolment. We can see the company has a goal to achieve some kind of partner this year, and I do think, more than likely this is where the funds are going to come from, and in my opinion it will be from the CHF LVAD program.
Remember, once Ryoncil is approved, then loan repayment caveats also kick in, and MSB will also commence paying down those facilities and I think royalty payments to Osiris.

On the other hand.... Terms may not be favourable enough for MSB yet, so there is a chance ( particularly with a high SP ), that MSB perform another round of funding at a much higher SP, that could see them funded out for a longer while. This would make sense the more favourable the DSMB meetings were as the two trials progressed. Ultimately, gaining a partner after approval is from the best position of negotiating power possible, and would give share holders the highest possible value for their money. At that point, partners are zero risk of non approval and the question is more about scale and profit.

... lets see if this is the breakout year for MSB.
Need someone else up there to keep CSL company, and on approval IMO this is the company to do it

Expand

December 31 2023- Company advises they have generated the potency data requested by the FDA. ie we have answered the CRL
February 29 2024- Company advised new potency assay data was with the FDA and a follow up meeting scheduled

March 26th 2024- The FDA responds to the potency data provided , which the company prepared specifically in answer to the CRL.

So the potency data was with the FDA for a month. They checked it to see whether it answered the problems specifically raised in the CRL.

If it didn't answer the CRL then they would have received a negative reply.

Instead the company released a statement saying the FDA NOTIFIES MESOBLAST
THAT AVAILABLE CLINICAL DATA FROM PHASE 3 TRIAL APPEAR SUFFICIENT TO
SUPPORT BLA SUBMISSION FOR REMESTEMCEL-L IN CHILDREN WITH STEROIDREFRACTORY ACUTE GRAFT VERSUS HOST DISEASE (SR-aGVHD)

They don't say the potency data is sufficient- but they may as well have. We are not being told to proceed because the data is crap, rather- spectacularly- it answers the CRL.

This stock is now about dollars not cents.

Safety/Efficacy/Manufacturing and now presumably potency is done and dusted.

The company has never been in a better position

ever

Reg

MSB Price at posting: 95.0¢ Sentiment: Buy Disclosure: Held
86 Upvote

12 Great analysis

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