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TOPIC: MESO trading halt extended

MESO trading halt extended 03 Jun 2016 10:48 #7146

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As per Seeking Alpha today---

Mesoblast trading halt to stay in place until June 10, bad news expected
Jun 3 2016, 11:00 ET | About: Mesoblast (MESO) | By: Douglas W. House, SA News Editor Contact this editor with comments or a news tip

.The trading halt in Mesoblast (NASDAQ:MESO) ADSs, instituted June 1, will remain in effect until June 10, at the company's request. Based on experience, this type of scenario almost always portends negative news.
.Analysts speculate that Teva Pharmaceutical Industries (TEVA -2.3%) could pull out of its collaboration with the company since it lies outside of its core business or the news could relate to an accounting issue, FDA warning or safety matter. In a tweet, TheStreet's Adam Feuerstein speculated that the news could be related to a criminal probe of Osiris Therapeutics (OSIR -1.9%), whose culture-expanded mesenchymal stem cell business Mesoblast acquired in 2013

Personally I tip option 2- the fact that Emerson Perin as Principal Investigator of the TEVA/MESO CHF clinic looks at other opportunities is rather indicative. Allogeneic over-cultured cells simply are not very potent- holistic own cells are the future- with or without BIG PHARMA involvement. :grin:

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Board moderator and Site-owner. I still regret the day I started analysing the prospects of MacroPore (now Cytori) back in 2004- a left-over from the tech-bubble at that time from the century change in my portfolio- and became addicted to Cytori´s fat cell technology. :cry:

MESO trading halt extended 03 Jun 2016 12:50 #7147

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I personally believe it is very positive news. I bought some ATHX yesterday as an add on trade. Silvu has been stating for a long time that they are in end stage negotiations for a partnership.
I do not trust SEEKING ALPO at all

From the company website
(a) the voluntary suspension is requested pending an announcement by the Company
regarding material corporate developments with respect to certain assets of the
Company;
(b) the Company expects the voluntary suspension to remain in place until the earlier of
the commencement of trading on 10 June 2016 and the Company making an
announcement with respect to the corporate developments; and
(c) the Company is not aware of any reason why the securities should not be suspended.

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MESO trading halt extended 03 Jun 2016 13:47 #7148

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I do hope for the industry space, that you are right and I am wrong, Joey.

Time will tell rather soon.

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Board moderator and Site-owner. I still regret the day I started analysing the prospects of MacroPore (now Cytori) back in 2004- a left-over from the tech-bubble at that time from the century change in my portfolio- and became addicted to Cytori´s fat cell technology. :cry:

MESO trading halt extended 06 Jun 2016 12:38 #7163

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Could cytori be somehow involved with Meso in kind of partnership?

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MESO trading halt extended 06 Jun 2016 12:53 #7164

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Not a chance.
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MESO trading halt extended 06 Jun 2016 15:57 #7174

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Which companies would be potentially interested in cytori? I already acquired some knowledge about the Stem cell sector, but not as good to connect the dots..so, holding bag until they give us a wildcard or getting profitable.

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MESO trading halt extended 06 Jun 2016 17:24 #7175

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CYTX has one of the better pipelines, unfortunately management and BOD are not commensurate with
the products.
Have sold most of original position, (2006 and 2007 buys).

Former CEO CC and Hendrick have no idea how to put together a deal. Not even minimum wage qualifiers.

JMO

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MESO trading halt extended 10 Jun 2016 06:41 #7205

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I just checked the ASX..

MSB voluntary trading halt - again- extended until June 14th.

The MSB page itself is down for maintenance... :whistle:

This smells...heavily.

File Attachment:

File Name: meso-asx.pdf
File Size: 62 KB
Attachments:

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Board moderator and Site-owner. I still regret the day I started analysing the prospects of MacroPore (now Cytori) back in 2004- a left-over from the tech-bubble at that time from the century change in my portfolio- and became addicted to Cytori´s fat cell technology. :cry:

MESO trading halt extended 10 Jun 2016 08:31 #7207

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I agree....good news likely not coming for MSB holders.

Question is, is there something with their data, something with their books or something else.
That is Speculation of course, but I cant believe something hasn't leaked after all this time.

Hoping the best for MSB holders.

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MESO trading halt extended 13 Jun 2016 21:03 #7230

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Took another hit in the cells market. Where is Big pharma and what are they waiting for? Maybe we need a technology company to become invested

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MESO trading halt extended 14 Jun 2016 01:37 #7231

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So- it ws TEVA giving up at this stage...

MESOBLAST PROVIDES UPDATE ON GLOBAL HEART FAILURE PROGRAM
Key points:
• Mesoblast regains worldwide rights to cardiovascular field for its cell therapy platform
• Lead product candidate in cardiovascular portfolio is MPC-150-IM for heart failure, with
multibillion dollar blockbuster potential and no financial consideration to Teva Pharmaceutical
Industries Ltd
• Independent Data Monitoring Committee recommended continuation of the 600-patient heart
failure trial without modification after clinical data review of first 175 patients
• Mesoblast aims to complete the Phase 3 heart failure trial, almost 40% recruited, within
eighteen months
• To meet the program’s remaining funding requirements, Mesoblast has been offered an equity
finance facility
• FDA approval has been obtained to incorporate into the heart failure program a widely-used
second catheter delivery system which is likely to result in accelerated recruitment and provide
a commercial distribution channel
• Japan conditional approval pathway provides potential early revenue opportunity
• Mesoblast now has unencumbered rights to partner with a leading cardiovascular company
with a commitment to heart failure product commercialization
New York, USA; and Melbourne, Australia; 14 June 2016: Mesoblast Limited (ASX:MSB;
Nasdaq:MESO) today announced that it has regained full worldwide rights and full strategic
flexibility to exploit its mesenchymal precursor cell (MPC) technology platform for the
cardiovascular field. The lead asset in this cardiovascular portfolio is Mesoblast’s Phase 3 product
candidate MPC-150-IM for advanced chronic heart failure, which has the potential to be a
multibillion dollar blockbuster for Mesoblast, with no financial consideration to Teva.
In April the Data Monitoring Committee of the 600-patient Phase 3 trial for this product candidate
recommended that the trial continue without any modification after having reviewed efficacy and
safety data for the first 175 patients. The trial is now close to 40% recruited, and is scheduled for
completion within eighteen months. Mesoblast has been offered an equity finance facility which
can be used by the company to meet the program’s funding requirements.
Mesoblast Chief Executive Dr Silviu Itescu said, “We are delighted to regain full control of this very
valuable asset in our portfolio, and to have been offered a finance facility we can draw on to meet
the funding requirements for the program. The growing body of clinical evidence validates our
strong conviction in the potential of our product candidate MPC-150-IM to change the way that
advanced heart failure is treated. We thank our partner Teva for having brought our Phase 3 heart
failure program to this advanced stage of development, and acknowledge their decision is based
on strategic reasons aligned to their core therapeutic areas of focus. Mesoblast now has
unencumbered rights to partner with a leading cardiovascular company with a commitment to
heart failure product commercialization.“
In addition, Mesoblast announced that the United States Food and Drug Administration (FDA) has
approved the use of a second navigational catheter system in Mesoblast’s Phase 3 program for
advanced heart failure. Over 2,000 of these FDA-approved systems are currently in use across the
United States for the treatment of atrial fibrillation, and their use in Mesoblast’s program is likely
to result in accelerated Phase 3 trial recruitment and potentially a simplified distribution process
through existing commercial channels once the product is approved.
The Phase 3 trial has enrolled over 230 patients out of a total of 600 patients with advanced heart
failure, with the primary endpoint agreed to with the FDA for product registration being recurrent
heart failure-related hospitalizations or deaths (Heart Failure-Related Major Adverse
Cardiovascular Events, HF-MACE). In the completed Phase 2 trial, patients treated with MPC-150-
IM had no HF-MACE over 36 months of follow-up, compared with 11 recurrent HF-MACE events in
the control group (p<0.001, log rank test). In patients with advanced heart failure as defined by
baseline Left Ventricular Systolic Volume >100ml, who closely resemble the patients being
recruited in the Phase 3 trial, 71% of controls had at least one HF-MACE event vs 0 of those who
received a single injection of MPC-150-IM (p<0.001).
Mesoblast’s heart failure Phase 3 asset represents a prime partnering opportunity with leading
cardiovascular companies committed to commercializing heart failure products globally. While the
United States and Europe are leading markets for our product candidate, Japan presents a nearerterm
commercial opportunity in light of the Pharmaceuticals and Medical Devices Agency’s (PMDA)
new regulatory framework for cell therapy that enables early conditional approval and
reimbursement of cell therapy products based on Phase 2 trial results.
In addition to the ongoing Phase 3 trial in patients with advanced heart failure, a second trial of
MPC-150-IM in 120 patients with end-stage heart failure and an implantable left ventricular assist
device is almost 60% recruited, and is being fully funded by the National Institutes of Health. The
trial’s results are expected in the second half of 2017 and will be used to support the marketing
approval application for the product candidate.
Dr. Emerson Perin, Director of Clinical Research for Cardiovascular Medicine and Medical Director
Stem Cell Center, Texas Heart Institute, and a co-Principal Investigator on the Phase 3 heart
failure trial, said “The trial has progressed extremely well and has been given a green light for
continued enrolment by the Data Monitoring Committee. I have a deep sense that this is
extremely important and meaningful work and have dedicated my career towards it.”


There was a CC early this morning...visit the Mesoblast site for that (31 Minutes)

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Board moderator and Site-owner. I still regret the day I started analysing the prospects of MacroPore (now Cytori) back in 2004- a left-over from the tech-bubble at that time from the century change in my portfolio- and became addicted to Cytori´s fat cell technology. :cry:

MESO trading halt extended 14 Jun 2016 06:59 #7232

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Kind of a yawner other than dilution.
Now a major partner deal would be interesting for them.

***FDA approval has been obtained to incorporate into the heart failure program a widely-used
second catheter delivery system which is likely to result in accelerated recruitment and provide
a commercial distribution channel***

Seems delivery challenge not Cytori specific.

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MESO trading halt extended 14 Jun 2016 07:51 #7233

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myownhedgefund wrote: Kind of a yawner other than dilution.
Now a major partner deal would be interesting for them.

***FDA approval has been obtained to incorporate into the heart failure program a widely-used
second catheter delivery system which is likely to result in accelerated recruitment and provide
a commercial distribution channel***

Seems delivery challenge not Cytori specific.


Curious that Teva took over 2 years to find out, that cardiac is non-strategic.. :whistle: They do hold the shares that Cephalon acquired from MSB, so I presume they will also be non-strategic.
Anyway- the equity funding is very interesting- Aussie government maybe? And yes- if I would be Medtronic or Boston Scientific, Baxter, Daiichi Sankyo or Tekada I would be very interested to talk to Sylvio. :grin:

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Board moderator and Site-owner. I still regret the day I started analysing the prospects of MacroPore (now Cytori) back in 2004- a left-over from the tech-bubble at that time from the century change in my portfolio- and became addicted to Cytori´s fat cell technology. :cry:

MESO trading halt extended 14 Jun 2016 07:56 #7234

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Funny that all these allo Companies have no issue getting partners Genzyme- Osiris, Pfizer, Chagui Athersys and Cephalon/Teva MesoBlast, but that they do not last and give up somewhere half way. :whistle:

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Board moderator and Site-owner. I still regret the day I started analysing the prospects of MacroPore (now Cytori) back in 2004- a left-over from the tech-bubble at that time from the century change in my portfolio- and became addicted to Cytori´s fat cell technology. :cry:

MESO trading halt extended 14 Jun 2016 09:06 #7235

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FAS, Though many of us have been unhappy with the CYTX pps over the past 2 plus years, I think CYTX departure from the cardio indication and focusing in various niche clinical program is smart.

I think the current Meso's potential financial situation may suggest their cardio phase 3 will end prematurely.

CYTX will do well with the current clinical and marketing strategy. The company can raise more cash with less shares (if there is need) when we are more good news re scleroderma (particularly when FDA filing is near).

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MESO trading halt extended 14 Jun 2016 10:12 #7236

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franshei wrote: FAS, Though many of us have been happy with the CYTX pps over the past 2 plus years, I think CYTX departure from the cardio indication and focusing in various niche clinical program is smart.

Franshei- surely all longs have been very unhappy, the past 2 years, but nobody is challenging the corporate strategy- the progress is undeniable and the goal-line in sight.

I think Emerson's departure from the Meso's cardio trials and the current Meso's potential financial situation may suggest their cardio phase 3 will end premature.

I didnt pick up anywhere that Perin is leaving the study. Apparently MSB has the remainder (60%) already funded and Emerson was also on to days´ conference call (which I only listened for about 10 Minutes)

CYTX will do well with the current clinical and marketing strategy. The company can raise more cash with less shares (if there is need) when we are more good news re scleroderma (particularly when FDA filing is near).

Hopefully they achieve what they said- no more dilution. As we all know that is very much dependent on the IDIS program. I still see a US partner for OA coming too.

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Board moderator and Site-owner. I still regret the day I started analysing the prospects of MacroPore (now Cytori) back in 2004- a left-over from the tech-bubble at that time from the century change in my portfolio- and became addicted to Cytori´s fat cell technology. :cry:

MESO trading halt extended 14 Jun 2016 10:23 #7237

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Funny that all these allo Companies have no issue getting partners Genzyme- Osiris, Pfizer, Chagui Athersys and Cephalon/Teva MesoBlast, but that they do not last and give up somewhere half way.


One could say the same about Astellas (Liver) and Lorem on the autologous side.

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MESO trading halt extended 14 Jun 2016 10:57 #7238

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FAS, I always type HAPPY, instead of UNHAPPY - my error. I misunderstand that Emerson has left MESO, after I read Celactive's web pages (it is a conflict of interest for him?).

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MESO trading halt extended 14 Jun 2016 12:04 #7241

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franshei wrote: FAS, I always type HAPPY, instead of UNHAPPY - my error. I misunderstand that Emerson has left MESO, after I read Celactive's web pages (it is a conflict of interest for him?).


The wording of my comments were very poor at the time and apparently subject to misunderstanding, which even Jacky (Emerson´s wife) pointed out to me. But we all know that Investigators regardless whether they are Principal or not, are normal INDEPENDENT doctors mainly working for scientific institutions and University Clinics and are paid by their clinic employers. These doctors never are on the payroll of Corporations ordering and paying for the clinical trials, so Emerson is surely still paid by Texas Heart/St. Lukes and continues the work he did for MESO like he did for Cytori. But I guess also- Co-Pi´s are always replaceable- like anybody is.

WST- To me Astellas and Lorem were catastrophes- not partner deals- since both did not come off the ground even. Anyway- in my book only one deal have been made sofar- the MSB one with > 100 Mio upfront. Compared to that the rest was all peanuts...(in my book)
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Board moderator and Site-owner. I still regret the day I started analysing the prospects of MacroPore (now Cytori) back in 2004- a left-over from the tech-bubble at that time from the century change in my portfolio- and became addicted to Cytori´s fat cell technology. :cry:

MESO trading halt extended 14 Jun 2016 13:34 #7242

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FAS, re Astellas

As first Clinical R/D director and first Planning director of Fujisawa USA (before it became Astellas, here in Deerfield), I understand Astellas well.

Astellas is sometimes run by sales/marketing people, but mostly run by basic r/d scientists, with no interest in commercialization of drug products. The company throw away a lot of money away in small ventures (such as a small fermentation plant here in Chicago) to test certain concepts outside their core business.

The company would often walk away from many of these ventures, even if there is no real outcomes. CYTX would not fit into Astellas' overall business concepts. The company will not get approval from the Planning Department to proceed into a medical device venture, unless it will develop into a separate division as Abbott would do. I think CYTX has been barking the wrong tree here and with K T Lim.

K T Lim has no background in life sciences and his pocket is not deep enough to develop the celution system in China. If K T Lim has the real money (his money is all highly leveraged) and put it into CYTX/China, things would be different.

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