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Mesoblast Limited (MESO)
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Stanjupiter huge report...2 coffee's length! But well worth it
i am going to make another pending news call. the action today has been building from this morning. if it rallies from here (9.06) into the close something is definitely up.
One of HC's top rated posts today...:
MSB 2.24 = MESO 8.697. No support from down under. We don't really need to follow, do we?
it has been 6 months since the crl and 3 months since the type a meeting that indicated a negative result without an official readout. reml for gvhd is likely dead in the water for some unknown reason that only the fda knows.
the covid data is still a secret 4 months later. that is suspicious only because there is a deal on the table that is dependent upon that data. 4 months later is not very urgent. the nvs deal is in danger and likely because of the fda's reluctance to approve reml for gvhd for moa and product consistency. reml may be finished. that would be a travesty bordering on criminal intent by the fda for not approving a treatment with overwhelming benefit that will knowingly lead to the death of thousands of kids.
the question is whether the same obstacles apply to mpcs.
that brings up the surgcenter investment. they know something that is enough to want a board seat occupied by their m and a guy as the largest shareholder to direct the company to its logical conclusion as a buyout candidate. they made their investment knowing all of the negatives. their investment is the most bullish forecast of them all.
the fda holds the future of MESO in their hands. we will know in a coupla months how the future looks.
As those who have followed me know, I don't make buy or sell recommendations. Rather I post analysis and perspective that some investors may find useful for their particular trading situation and investment goals. I also try to point out erroneous information so that investors who don't follow the stock as closely may avoid being misled. There's been a slew of that since the PIPE involving SurgCenter.
I made a list of the clinical trial-related press releases over the past year to show Mesoblast had a productive, event-filled year, certainly in comparison to the number two company in the industry. There were ample opportunities to make profits – a lot of profits - if that's your short-term goal. All biotechs face hurdles and there's always significant risk. Outlook may change on a dime and the stock may pass through periods where the PPS drops. Most new medicines fail to live up to early promise and many biotechs go out of business or get bought out at a low-ball price. That's why biotechs are often a magnet for short-sellers.
My philosophy is that biotech investing should be fun, always. If you're not having fun, you may have waded in over your head. Maybe you belong in mutual funds instead of trying to time individual stocks. Instead of staying clear-eyed and able to act on opportunities such investors become bitter. They lash out at anyone and anything. They often show an obsession with the short-term PPS (Josephine excepted, she provides a useful service). They call for the CEO to be fired or for the company to be bought out asap. They “downramp” anyone with a positive message and find some ulterior motive in any post. And despite being shown some of their precepts are blatantly false, that such thinking is maybe what got them into trouble in the first place, they persist and undersign. For example, we've heard in recent days, that “SurgCenter now controls the company”, and that “SI has a new boss.” @GroupInvestor endorsed those posts. He's called MESO longs “snakes” and speaks of a “cult”, suggesting a certain paranoia. He has specifically said that writing a put is comparable to selling the stock short, despite the fact that put writing reflects bullish sentiment on the stock, while short-selling reflects bearish sentiment, ie they're the opposite if anything. He seems convinced dark forces and the options market are working against him. And now he's creating a false dichotomy between “science followers” and those interested in “shareholder value” as if the two are somehow diametrically opposed or mutually exclusive. Crazy original, you really can't make this stuff up. Perhaps he needs a dosage adjustment, perhaps just some counseling. And I'm sure some good news from the company won't hurt, though unfortunately it won't prevent recurrence of “in-over-his-head syndrome”.
Meanwhile, for the rest of us, when visiting the zoo best not to engage with or feed the animals.
An open message to @GroupInvestor: It's nearly 8 AM on Wall Street and the financial world is waiting for you to turn in your remedial reading homework assignment. You can find it in the thread below that has over 20 up votes and begins with the words, “As those of you who have followed me know...”. We want to make sure we haven't been wrong about writing cash-secured put options all these years. And there's proof positive in that thread that you, sir, need to issue an apology to the good posters on this board, take down the erroneous and defamatory information you've spewed all over the place, and then stifle yourself unless called upon further. There are no “cults” here and no cult leaders. Just serious investors trying to make sense of the complex world of biotech in general and Mesoblast in particular. Do some introspection, take an options course, learn about how companies structure equity and debt, and re-join us when you have something useful to contribute.
Following some of the amusing posts here on the board. Funny reads at times.
I just want to emphasize that I did not post on the board lately simply since the last period was a silent period, dead money time. I think the last PR by the company was a nice list of all the bits of information we should and would like to hear about in the next few months. Biggest things: ARDS analysis, Novartis deal decision, CHF partner, CLBP partner, FDA regarding GvHD and paths for CHF, CLBP. There are more.
I actually thought at the past the SP will take a deeper hit once financing round is announced, yet it didn't. This is a good sign. Share holders at the moment estimate it is worth waiting for the next batches of news from MESO before making a decision, and seeing the potential.
It will be interesting to see the new post-big-trials burn rate which I think will be much lower. This will mean that with the last round MESO secured almost 2 years into the future. More than enough to get the wheels in motion, and arrive to negotiations with partners from a position of strength without the clock banging at your back. It gives the option to negotiate with several leads and rationally select the best option, rather than just opting for any offer that comes along. Very nicely played by SI.
I hope we get a deeper and wider analysis from the CHF and CLBP trials soon. I'm certain that there are still gems hidden there we have not heard about yet.
Pharmagang second post:ight, I'll continue with paediatric SR-aGvHD.This is an interesting one.According to the Center for International Blood and Marrow Transplant Research, there are approximately 30,0001 allogeneic BMTs globally per year for diseases including hematological cancers (NB:// figures from 2012, will be > than that now)25%2 of all cases in the pediatric population.Nearly 50% of all allogeneic BMT patients develop aGVHD3.Liver or gastrointestinal involvement occur in up to 40%4 of all patients with aGVHD and are associated with the greatest risk of death, with mortality rates of up to 85%5.If we break this down, that 7,500 paediatric patients per year in the US, of which 3,750 will develop aGvHD. 1500 of these patients will develop gastrointestinal/liver complications and have a mortality of 85%.3,750 is an extremely small target population. Why did MSB target it?Probably because it was a strategic decision done by biotech drug development companies to get early validation by getting early revenue from the lowest hanging fruit. Something with such a degree of high unmet medical need in a small population allows for orphan drug designation and an easier regulatory review process (in theory), hopefully generating some revenue early to derisk the company while they go on to develop other indications.Orphan drug status includes various incentives, such as tax credits of up to 50% of R&D costs, R&D grants, waived FDA fees, protocol assistance and may get clinical trial tax incentives.Individuals under the age of 18 incur hospitalization costs of >$173,1446 so the per-therapy-cost could probably be quite highSo where are we?As with all MSB products, we have demonstrated a clean safety profile in a single-arm trial, the same trial design that the standard of care Jakafi was approved on.We met the primary endpoint (mortality), a measure that is generally agreed on by the FDA that 'if you meet X by doing exactly Y then that's a tick in our books'We went to an ODAC committee, appointed by the FDA in the event that their expertise is insufficient to make a decision by themselves.The ODAC, including a prof. of biostatistics, deemed that MSB had done enough to show both safety and efficacy in a vote of 9-1.The dissenter was quoted that his criticism was that a randomised controlled trial was required to adequately demonstrate efficacy.The trial design had previously been discussed with the FDA and the FDA agreed it was unethical to perform an RCT with such a high mortality rate.For the first time ever, the FDA went against a vote as strong as 9-1 and issued a CRL citing concerns over the single-arm design they previously agreed to (if we are to believe SI) and mechanism of action (MoA).This MoA has since been agreed on.MSB want to go ahead and run a pre-planned adult RCT that they would have run anyway to get a label extension into adults, as a condition to approval in paediatrics.They are doing this by progressing down the Dispute resolution pathway - when has a buttload of bureaucracy and time tied in.SI said he believed this would have delayed commercialisation by 6 months, which is over tomorrow/todayNow this is where no one can really know what is going on. All 'rules' have been broken, a trial (which design was agreed to by the FDA) met its primary endpoint, went to an ODAC review, passed with flying colours, and was rejected.When I spoke to a regulations expert, they said that only makes sense if the company had not discussed with the FDA, or had the FDA recommend against the trial design. SI has said that the FDA had previously agreed to the trial design - so I think everyone is just as confused as eachother.This one is pretty unpredictable. It obviously SHOULD be approved, as it has shown both efficacy and safety - which was agreed by a panel of experts, in a trial that's design was agreed to by the historic FDA.Will it get approved? That's a coin toss based on politics (which is more favourable now I'd hazard a guess), and whatever obligations the FDA have to follow through on previously agreed on pathways.Tune in this HY.Gang gang1CIBMTR, Decision resources GVHD Epi Nov 20122Number of hematopoietic stem cell transplants registered with the CIBMTR by US centers, 2008 ? 2012, by year of transplant3Decision resources Niche Markets and Rare diseases: GVHD Nov 20124Jacobsohn, David A and Vogelsang, Georgia B. Acute graft versus host disease. Orphanet J Rare Dis. 2007; 2: 35.5Westin, Jason R. et al. Steroid-Refractory Acute GVHD: Predictors and Outcomes. Advances in Hematology.6Jingbo Yu, Shree#$%$ Parasuraman, Anshul Shah & Daniel Weisdorf (2019) Mortality, length of stay and costs associated with acute graft-versus-host disease during hospitalization for allogeneic hematopoietic stem cell transplantation, Current Medical Research and Opinion, 35:6, 983-988, DOI: 10.1080/03007995.2018.1551193
MSB 2.32 = MESO 8.99
Talk about discounts. I'll let others speculate on whether the PPS may go up or down near term. Depending on news and other forces it could go either way, just as with any other stock. But one thing is certain. A deep-pocket investor just put in US $110 million, no exchange rate needed to determine the amount. And the deal has closed. For that they received 60 million MSB shares. That's the equivalent of 12 million MESO ADR's. Which means they paid $9.16666 per MESO share. That rounds to $9.17 per share for a stock currently trading at $8.26...ie someone buying today is getting a 10% per share discount to what the sophisticated SurgCenter investors paid. Looking at the deal globally SurgCenter may be obliged to buy an additonal 15 million MSB shares (equivalent to 3 million MESO ADRs) via the exercise of warrants the company has the right to call. That represents 20% of of the total shares they're obliged to purchase and it's based on “a 25% premium to the placement price”, which would be approximately $11.46 per MESO share, but of course only on condition the Australian stock price is sustained above Au$4.32/MSB share for 45 days (about US $16.42/MESO share). Bottom line, there's a 6.5% reduction on 80% of the shares, but SurgCenter will pay a 25% premium on 20% of the shares, which takes us close to 100% of full Feb 25 price for all shares involved in the deal. Upon full exercise of warrants SurgCenter would end up with the equivalent of 15 million ADRs for which they will have paid an approximate total of US $144 million. That's the equivalent of $9.60 per MESO share. Judge today's price in that light.
Someone also talked about this being like a “loan”. A loan is something very different to my mind. Note that Mesoblast - assuming they found a willing lender - could have borrowed $144 million and used it to buy back 75 million MSB shares, thereby lowering the outstanding share count by 12% and perhaps driving up the PPS. I say perhaps because such leverage comes with significant additional risk compared to a stock sale, starting with sizable interest payments on the $144 million and the potential for the loan to be called and the company potentially put out of business in the event of default or failure to adhere to covenants. The equity raise by comparison de-risks investment in the Company, because the $144 million incurs no interest and never has to be re-paid. That puts the SurgCenter investors in the same risk pool as the rest of us - only they paid a premium to get there (if you bought in today). And 12% plus a board seat is far from having “bought” the company. If Mesoblast ever gets sold it's not going to be to SurgCenter, imo glta
Something is up. News is leaking. Volume up in addition to the price.
@Left-e - first of two posts from Pharmagang
I'm pretty triggered by anyone calling themselves a health professional in the other thread and saying that they haven't seen enough to say that the therapy works. They are either lying, misinformed, unqualified or all of the above.
As I have said before, I am a translational scientist/business analyst with a background as a physiologist.
The standard of care (SoC) for CHF is furosemide (or equivalent) or a heart transplant.
Furosemide is treating the symptoms of CHF by making a patient pee a lot to get rid of more fluid than they would normally to get rid of some of the load on the failing heart. This requires escalated dosing as the heart failure progresses/tolerance is built. This method has a significantly high associated morbidity and it does nothing for the breathlessness of the patient while they perform minimal exertion (like getting out of bed and walking a few metres) and they have to pee every half hour depending on the severity of their disease and the corresponding dosage. This presents its own problem as the patient losses a significant amount of salts that they need to stay on top of to prevent other significant issues. My own grandmother got to this stage and very seriously asked me to up her dosage of morphine to a stage where she would not wake up. I, of course, did not increase my grandmother's dosage - but the morbidity associated with this standard of care is crippling and a massive toll on the individual and their families.
A heart transplant has obvious shortcomings. You need a donor, you need to not reject the graft, and even then, a graft is usually only expected to last around 10 years. It also involves open-heart surgery with a significant theatre time (costs hospitals and surgeons money).
Facts About Heart Failure in the United States:
- About 6.2 million adults in the United States have heart failure.1
- In 2018, heart failure was mentioned on 379,800 death certificates (13.4%).1
- Heart failure costs the nation an estimated $30.7 billion in 2012.2 This total includes the cost of health care services, medicines to treat heart failure, and missed days of work.
Mesoblast is a minimum of 7 years ahead of all competitors for cellular medicines targeting heart failure.
Mesoblast has an extensive patent portfolio, that will require significant litigation even when someone catches up to them. The barrier for Mesoblast for MSB is not whether the product works or not. That is known as the results of a gold standard RCT in the US showed a statistically significant reduction in deaths by 60% in patients with class II heart failure. Estimations based on study recruitment rates is that Class II heart failure will be 30-60% of the total number of heart failure cases. Lets low ball this and say 30% (which is, as I say, low balling). 30% of 6.2 million is 1,860,000 people who could be benefiting and receiving Rexlemestrocel. This doesn't even take into consideration Class I patients who will also be inflammatory and class III patients who, while did not show a reduction in mortality, seemed to show an improvement in quality of life.
The barrier for Mesoblast is purely regulatory. And that is only a delay - will it be this year or 2 years time (reduced sample size requirements in a targeted study population).
If I go to Mr/Ms big pharma and say "Hey we got screwed by an unpredictable mechanism of the disease because we didn't show a reduction in 'decompensated non-fatal recurrent heart failure associated events' but we have a significant reduction in death in this population, a prevention of disease progression, and a reduction in heart attack, stroke, and death."
Do you REALLY THINK that big pharma - OR ANYONE ELSE!?!?! Is going to be like "Oh but that 'decompensated non-fatal recurrent heart failure associated events' p value tho"
Worst case scenario is that they pay for another Phase III, wait 2-5 (conservatively) years, and have a multi-billion dollar therapy.
And don't even get me started on CLBP I swear.
Maxim upgrades PT $18
$MESO: Maxim Group ups to Buy https://www.briefing.com/calendars/updown?Filter=Upgrades
$MESO: Maxim Group ups to Buy https://www.briefing.com/calendars/updown?Filter=Upgrades
Mesoblast (NASDAQ:MESO) was upgraded by investment analysts at Maxim Group from a "hold" rating to a "buy" rating in a report released on Wednesday, The Fly reports. The firm presently has a $18.00 target price on the stock. Maxim Group's target price points to a potential upside of 113.02% from the company's previous close.
A number of other brokerages also recently weighed in on MESO. HC Wainwright reaffirmed a "buy" rating and issued a $20.00 target price on shares of Mesoblast in a report on Tuesday, December 15th. Zacks Investment Research upgraded Mesoblast from a "sell" rating to a "hold" rating in a research note on Thursday, March 4th. Finally, Jefferies Financial Group downgraded Mesoblast from a "buy" rating to a "hold" rating in a research note on Tuesday, January 19th. One research analyst has rated the stock with a sell rating, three have issued a hold rating and three have issued a buy rating to the stock. Mesoblast presently has a consensus rating of "Hold" and a consensus price target of $15.79.
GroupInvestor has said that based on share price results, Mesoblast's CEO should suffer the same fate, ie “early retirement”, as $ATHX's. For each investor to decide. Meanwhile, here's Left-e's handy list of clinical trial and FDA announcements made by both companies over the past year. For your reading convenience, those announcements that allowed investors to make direct inferences as to patient outcomes (positive or negative) or progress towards FDA approval get a ** after the date. Those that deal only with an IND/ initiation of a trial or hitting enrollment percentages do not.
01 April 2020** FDA Accepts BLA for RYONCIL and Agrees to Priority Review
06 April 2020 FDA Clears IND for Remestemcel Use in COVID-19 ARDS Patients
09 April 2020 US NIH Trials Network to Conduct COVID-19 Phase 2/3 Trial
17 April 2020** Inflammatory Lung Disease Outcomes For Presentation at ISCT
24 April 2020** 83% Survival in COVID-19 ARDS Patients with Remestemcel-L
30 April 2020 Phase 2/3 Trial in COVID-19 ARDS Begins Enrollment
06 May 2020 First Patients Dosed in Phase 2/3 Trial for COVID-19 ARDS
25 May 2020** 3 Articles on RYONCIL GvHD Trial Results Published in BBMT
01 June 2020** Remestemcel-L Improves Outcomes in Inflammatory Lung Disease
06 July 2020 EAP for Remestemcel-L in Children with MIS-C due to COVID-19
21 July 2020** FDA Advisory Committee Sets Review Date for Remestemcel-L
30 July 2020** COVID-19/GVHD Update, Quarterly Report and Appendix 4C
14 August 2020** ODAC Votes in Favor of Remestemcel-L for GvHD
02 September 2020 Ethics Approval to Treat COVID-19 Patients in Australia
04 September 2020** DSMB Recommends Continuation of Phase 3 COVID-19 Trial
02 October 2020** Update on BLA for Graft Versus Host Disease
13 October 2020 Phase 3 Trial in COVID-19 ARDS Surpasses 50% Enrollment
22 October 2020 Remestemcel Controlled Study in Crohns & Ulcerative Colitis
11 November 2020** DSMB Analysis Recommends to Continue P3 COVID-19 ARDS Trial
02 December 2020** Remestemcel-L FDA Fast Track Designation for COVID-19 ARDS
07 December 2020** Remestemcel-L Reduces Biomarkers for Mortality in SR-aGVHD
15 December 2020** Mesoblast Phase 3 Chronic Heart Failure Results
18 December 2020** Mesoblast Update on COVID-19 ARDS Trial
11 January 2021** Rexlemestrocel Reduces Heart Attacks/Strokes/CV Death in CHF
11 February 2021** Mesoblast Phase 3 Chronic Low Back Pain Results
17 February 2021** Remestemcel-L for COVID-19 MIS-C published in Pediatrics
Here's the list for Athersys
13 April 2020 FDA Authorizes Athersys to Initiate a Pivotal Clinical Trial Evaluating MultiStem® Cell Therapy in Patients With COVID-19 Induced Acute Respiratory Distress Syndrome
15 April 2020 FDA Authorizes Initiation of a Phase 2 Trial Evaluating MultiStem® Cell Therapy in Trauma Patients
1 May 2020 Athersys and University Hospitals Cleveland Medical Center Announce Activation of the First Clinical Site for the MACOVIA Study, a Pivotal Phase 2/3 Study Evaluating MultiStem® Cell Therapy for COVID-19 Induced ARDS
5 May 2020 Athersys Announces Commencement of Patient Enrollment in the MACOVIA Study, a Pivotal Phase 2/3 Trial Evaluating MultiStem® Cell Therapy for COVID-19 Induced ARDS
18 May 2020** Athersys Announces Upcoming Presentations at the International Society of Cell and Gene Therapy Virtual Conference
23 September 2020** FDA Grants RMAT Designation to MultiStem Cell Therapy for the Treatment of Acute Respiratory Distress Syndrome
21 December 2020 UTHealth in Houston and Athersys Announce Commencement of Patient Enrollment in a Phase 2 Trial Evaluating MultiStem® Cell Therapy in Trauma
31 March 2021 Athersys Reports That Healios Has Completed Enrollment in the ONE-BRIDGE Study of MultiStem® for Acute Respiratory Distress Syndrome in Japan
Totals: Mesoblast 26 Announcements with 18 getting a **
Athersys 8 Announcment with 2 getting a **
It would appear we are at the pointy end of town where data is being pushed to the next person to analyse and take note.
Those that currently sit at the table would not be shy in asking we are also interested in other trails Mesoblast have completed. (at this point).
As we can see there has been some great progress made.
(Left-e 7 days ago)
Yes, that’s right 7 days ago, so time is moving on and soon we will see what all the hard work has come to.
Stay focused on the good references and remember to put the trash out Monday night.
My two cents.... Nothing really new said in the corporate update. Unless anything knew comes out and we all know things can change on a dime, short term sentiment is not all positive.
Let's face it and I have been in the OSIR/MESO game forever and still holding, but the news starting in 4q20 which was supposed to be positive, only added more time to our timeline. I was expecting approvals from the FDA and we only got politics. The FDA is still waiting for a new chief and still lagging, so I am not surprised MESO does not have any updates or see anything happening soon.
In regards to SCD, I was hoping for Big Pharma, not quick buck artists. They have a not so stellar history and being in healthcare, I have some familiarity with some of how they operate. The money MESO received was great, but I do not have a warm fuzzy with SCD involvement. They are more into flipping, then into getting the true value, which is far more greater.
Time will tell and I am a FIRM believer in the science and nobody is closer than MESO. But, until knew news comes out, which can happen at any time (please no more trading halts, these have not been kind to us), sentiment right now and the foreseeable future is not that rosy.
Here is hoping that I am wrong and here is hoping that some unexpected positive news comes out SOON. GLTA
Up over $9.00, MAYBE this is the start of something. Volume still low, but 32,000 shs trades traded at 12:57 ET. Keeping finger crossed.
MSB 2.30 = MESO 8.908. Slight boost from xchg rate.
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