From Coppo report yesterday . Mesoblast {1.58 0.03 1.94%} re-iterating it's a BUY - maybe now is finally time to Buy this !! Trump wants to cut the deaths of Americans taking legal opiods for “back pain” – MSB stem cells could be the answer…
This is an interesting stock – has been around a long time but looks like they may FINALLY be getting very close to a number of big company changing milestones.
If you buy now it could do nothing for a while–but 1 day we’ll come in & some deal or approval I think will see a substantial re-rate.
BUT I fear that a takeover by a US firm is also possible is a chance – anytime – in the next year or 2..
.. if they bid they wouldn’t get it for less than $3.00 minimum – most shareholders know its “true value”
Aussie instos have overlooked this & just 2 Aussie instos on the register – but the US (and UK) instos – who have a longer time frame are all over this. Big names like Capital Inc (8.5%), M&G (13%), Teva Pharmaceuticals (5%), Prudential plc (13%) Vanguard (2%) & here Thorney (owns 5.2%)
Buyer in mkt right now
The stock in the last few days has been on the move, it was sold off from $1.64 a month ago & has been around $1.40 / $1.50 overt the last month..
BUT in the last few days stock has popped to over $1.60 ...
On Monday & Tuesday we saw 2.3m shares trade each day vs 650,000 on a normal day- so a large insto buyer is sucking up as many as they quietly can down here...
Even though volume on high for last few days, already on 5 day volume - its running +60% above at 1.2m shares vs 787,000 - but that will rise in the next few days..
They were back again buying today..
Maybe this snippet that came out late last week has got them excited ??
Manufacturers of pain medications and treatments for opioid addiction are closely watching Congress and the Trump administration as they seek to enact significant measures aimed at combating opioid addiction.
Key congressional committees are considering comprehensive legislation, and the FDA is seeking to expand medication-assisted treatment options.
They have a number of products that are all coming closer to fruition.
But there is one that is really going to get a lot of attention & could well be accelerated through the FDA after Trump has pretty much declared they need a new product that can save lives..
In August, President Trump said he intends to declare the US opioid crisis a national emergency. Trump has made clear that his Administration will fight back against the opioid crisis & directed actions across the entire executive branch designed to target drug addiction and opioid abuse.
But the opioid problem is not restricted to the US, and there are fears that a similar painkiller addiction epidemic is under way in the UK. Codeine-related deaths have more than doubled in Australia since 2000, prompting the Austrlai (just recently) to ban over-the-counter sales of the painkiller from February 2018.
Now this is where Mesoblast may be the saviour…
New treatments for back pain will be important for fighting this, but Caleb Alexander of the Johns Hopkins Center for Drugs Safety and Effectiveness in Maryland says existing alternatives to opioids – such as non-steroidal anti-inflammatory drugs and physical therapy – have more immediate potential for alleviating the epidemic.
“Any practical application of these types of treatments is a long way off, and there are countless reasons why thesepromising early results may not translate into tomorrow’s cures,” warns Alexander.
But Thomas says existingtreatments for back pain often fail or are only minimally effective. “We really do need better treatments for lower back pain, so this is encouraging,” he says. “But we need to see how it works out.”
But Mesoblast’s stem cell treatment could finally bring relief to millions of people with chronic lower back pain.
If it works, the injection could become a crucial tool for curbing the opioid epidemic currently killing thousands in the US.
Overdoses from prescription opioids have quadrupled since 1999, and
opioids accounted for 33,000 deaths in 2015 alone.
Many of those deaths occur as a result of people becoming addicted to opioids after being prescribed drugs such as oxycodone, hydrocodone or methadone to relieve lower back pain.
It is a common health issue that affectsaround 28 million people in the US and accounts for around half of all opioid painkiller prescriptions there.
Stem cells might change that
Injected into damaged discs between the vertebrae of the spine, each dose containsaround 6 million cells.
Called mesenchymal precursor cells, they dampen down inflammation and secrete factors that help rebuild damaged tissue.In experiments in sheep, these cells completely rebuilt damaged vertebral discs, prompting Silviu Itescu of the firm Mesoblast in Melbourne, Australia, and his team to try the technique in people.
“In 100 patients, we’ve shown substantial improvements in function and pain relief that last two years or more,”says Itescu.
MRI scans found that the cells seemed to rebuild damaged discs in people too.
“If we’re successful in [our] larger trial currently under way, we can hopefully keep people away from opioids,” says Itescu.
“In 100 patients, we’ve shown substantial improvements in function and pain relief that last two years or more,” says Itescu. MRI scans found that the cells seemed to rebuild damaged discs in people too. “If we’re successful in [our] larger trial currently under way, we can hopefully keep people away from opioids,” says Itescu.
Just recently
A 2 mths back ago MSB announced they completed enrolment in back pain trial with greater number of patients than originally planned
Mesoblast has announced the completion of enrollment in its Phase 3 chronic low back pain trial with MPC-06-ID.
The trial has enrolled 404 patients suffering from chronic low back pain due to degenerative disc disease, a higher number than the original target of 360 patients, across 48 sites in the US and Australia.
The company allowed the additional patients still in screening at the point when 360 patients were enrolled into the trial to complete enrollment. Tanushree Jain says that the completion of enrollment in this trial as an important milestone for the company.
Although Top-line results from this trial (24 months follow up) are not expected till early CY20, we believe the completion of enrollment will now assist MSB in its discussions with the US FDA for a potential accelerated pathway for this product via a potential RMAT designation under the 21st century Cures Act and also assist the company in its ongoing partneringnegotiations for the product. We believe that the product could be eligible for an RMAT designation due to being a non-opioid alternative forback pain and having also shown a reduction in opioid use in treated patients in its previousPhase 2 trial. With the opioid epidemic front and centre in US, both with president Trump declaring it as a public health emergency and FDA Commissioner’s statement implying more efforts will be made to prevent new addictions which would include promoting development of non-opioid pain treatments and the fact that ~50% of opioid prescriptions in the US are for chronic low back pain, we believe MPC-06-ID has a strong case for being considered for the RMAT designation by the FDA.
Stock rallied post result
When they reported they came out with a “beat” stock was rallying before result after MSB has reported impressive Top-line data from its Phase 3 trial with MSC-100-IV in 55 children with steroid refractory aGvHD. …
But after hitting a high of $2.05 (Capital Inc looks to be quietly building a position) the stock has dropped back to $1.60– which looks like a good level to get in..
Strong outlook for 2018
We believe MSB is on track to deliver on its announced clinical and commercial milestones.
Tanushree Jain’s view the recent Phase 3 GvHD results as an important de-risking milestone for the company which not only validates its technology platform and clinical design strategy, but also takes it closer to having its first product approved in the US market. MSB remain in active discussions with potential partners for their Tier 1 assets.
We continue to believe that positive data read outs are likely to lead to partnering deals which would not only serve to ameliorate MSB’s cash burn but also provide external validation from a commercial partner.
Valuation lifted recently to $3.87, Retain Buy (speculative)
At >16x Cy18, some will think stock still way too expensive, still way too much priced in for a volume & marginrecovery.
Cash postion is fine for 2018
Tanu Jain notes that MSB recently securing of US$75m debt funding from Hercules Capital. 4 yr term at 9.45%.
They have drawn US$35m already, can draw another $15m before end of Cy18, & $25m before 3Q19 subject to milestones.
Will give them some negotiating wiggle room on potential partnership deals following positive recent Phase 3 GvHD results.
Key milestones coming up
include 100 day survival data on Phase 3 GvHD in 2Q18,
180 day survival in 3Q18,
& top line results from Phase 2B CHF trial in 3Q18.
(20min delay)