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Subject: Intellicell in The Life Sciences Repon...at the end
Date: Thu, 14 Mar 2013 21:07:09 40000
Streetwise Reports The Life Scie9HESPr
Home Sheehy -se Interviews Recomniendatons Compa me
MM.
The Stem Cell Revolution Can Jump-Start
'ATM has one of the Your Portfolio: Jason Kolbert COMMENT
on this article
best manufacturing
ro
processes in
allogeneic cell therapy No single solution will emerge from the grovnng realm of stem cell technology and
I've ever seen? ThJason
regenerative methane. Instead. multiple innovations will succeed in a field that
(3/14413)Athessys Inc.- Holbert
promises to forever change the practice of medicine—innovations generated by the
The Life Sciences
Report Interview with recognition that hying cells are capable of perfonning a platform of functions that
Jason 'Colbert 7.10,e a present-day drugs simply cannot In this Life Sciences Report interview. Jason
Kolbert senior vice president and biotechnology analyst with Maxim Group. provides a
detailed analysts of the industry and names companies that investors should be aware
"II phase 2b ASSURE of now, while valuations are remarkably low.
trial results show a
significant decrease in
atherosclerotic plaque The Life Sciences Report: It was curious and COMPANIES MENTIONED AASTROM BIOSCIENCES
INC. : ATNERSYS INC.: BAVARIAN NORDIC : BIOTIME
volume, it will be a interesting to find out that you speak Japanese. INC CYTORI THERAPEUTICS INC. DEICREON
huge win for RVX." CORP. : GEFtON CORP. : IMMUNOCELLULAR
(3/7/13iResverlogix Jason Holbert: Hat so desu (Yes. that's so). Japan is a THERAPEUTICS LTD. INTELLICELL BIOSCIENCES
INC. : MEDIVAMON INC. : MERCK & CO. INC. :
Corp. - The Life big part of my life. I think ifs a fascinating country. MESCRLAST LTD. : NEOSTEIA INC. : ORRIS
Sciences THERAPEUTICS INC. : PFIZER INC. PLURISTEIA
ReputMerViewwith THERAPEUTICS INC.: PRIMA BIOMED LTD.
I was in Japan in the early 1990s. working for Schering-
George Ztwoce More >
Plough Corp. (acquired by Merck & Co. Inc.
(MRK:NYSE) in November 2009) and latrichkog Intron A (interferon aria-2b) for hepatitis C (HCV). What I
It is very rare to see a discovered during my time in the country was that the Japanese have the highest incidence and
ShOM market cap prevalence ki the world of hepatitis C. My experiences in Japan showed me what an nsidious disease
company with all the
HCV is. because it's asymptomabc. You don't know you have it. but later in He-10.20. 30 years later—it
positive attributes
kits you by causing liver failure and liver cancer. We saw interferon sales go from nominally tens of millions
LPTN
has." (2/14/13)Lpath fa' hairy cell leukemia to well north of S1 billion (SIB) once Intrce A was approved for HCV treatment.
Inc. - The Ufa Sciences
Raportiolerview with When I returned to the States many years later. I became acutely aware of the opportunity in HCV.
Ram Setvara)u More > Companies like Vertex Pharmaceuticals Inc. (VRTX:NASDA0). Pharmasset (acquired by Gilead
Sciences Inc. (GILD:NASDAO) in January 2012). Achillion Pharmaceuticals Inc.
(ACHN:NASDAO)and Idenix Pharmaceuticals Inc. (IDIX:NASDAO) were all emerging as leaders in
'GALE is a promising
stay: K is attacking direct antiviral therapies, and driving a paradigm shift
breast cancer with a
vaccine? (2114113)Gale
EFTA00956529
na Eftephanna Inc.. The I don't follow the Japanese stock market. nor do I follow Japanese companies. The nuances of following a
bre Sciences company. especially in Japan. require an analyst to be. essentially. in county and exclusively focused. On
Report ineenifew waft the other hand, when a company I do follow. Ike Gilead Sciences. announces its intention to buad Gilead
Ram Setvaraju More a Japan aid not go through a Japanese marketing partner, that tells me Gilead is very senous about
penetrating the HCV market—and that the company is intent on realaing and enhancing a return on its
"CUR had a S11B acquisition of Pharmasset. It will do this is by making sure its oral. pan-genotypic nucleoside
01011011101tai year In sofosbuvir (formerly GS-7977), which it got in the Pharmasset deal. not only does well in Japan but also
2012.- (2/1O13)Neurals that it doesn't spit the profits with a Japanese national.
tem Inc. - 7he LiTe
Sciences TLSR: I know you follow Melbourne. Australia-based Mesoblast Ltd. (MSB:ASE: MBLTY:OTCPK). a
Reportnierview with Pacific Rim company. Tell me about it.
Ram Setvaraju More a
JK: Australia is definitely emerging as a biotechnology powerhouse. I am interested in covering Australian
companies. but I am very aware of the differences between Australia and the U.S in terms of biotech and
stem cell business development It was no accident that Dr. Silviu Itescu founded Mesoblast in Austraka. It
was Dr. Itesais goal to avoid some of the problems that micro-cap biotechnology stocks have seen in the
U.S.. where if companies go public early. and are initially plagued with failures. it hurts valuations. Geron
Corp.'s (GERN:NASDAO) departure from the stem cell space is a great example: it made 10 years of
investments only to see its programs fail. It is interesbng that Geron's programs have been acquired by
BiciTme Acquisition Corp.. a subsidiary of BloTime Inc. (BTX:NYSE). and Dr. Tom Oluarma, the former
Caron CEO. Is now at BiciTme.
On the other hand, in the world of pharmaceuticals and
"Australia is definitely emerging biotechnology. it's almost a misnomer to think of a
company as Australian. Japanese or Amencan.
as a biotechnology
Investors have to think of companies as global. That's
powerhouse."
very much in evidence with Mesoblast. in that it's
moving forward with a global. 1.700-patient congestive
heart failure (CHF) trial that wa be paid for and run by Teva Pharmaceutical Industries Ltd.
(TEVA:NASDAO). When you think about the irnpacations of running that kind of trial. you can understand
how Mesoblast is not merely an Australian company. It's a global company.
TLSR: What were some of the issues that Or. Itescu wanted to avoid by founding the company in
Australia?
JK: Or. Itescu looked at the market capitalizatom of the U.S. cell therapy companies. He was very keenly
aware of what his benchmarks wadd be if he founded Mesoblast in the States.
For example. how do you differentiate what Mesoblast is doing versus what Athersys Inc.
(ATHX:NASDAO) is doing?As someone who has studied those two companies in great doted. I could walk
you through that differentiation process. but the reality is that both programs are Sogeneic. meaning they
use other people's cells. and they both represent the pills-in-a-bottle or cells-in-a-bodle pharma model.
They both have the potential to treat local disease. like heart disease or bone defects. as well as systemic
disease. In addition to heart disease. Mesoblast is pursuing degenerative disc disease (DOD) and spinal
fusion. both local indications. and systemically. type 2 diabetes and rheumatoid anhntis. all with its
mesenchymal precursor cells (MPCs). Athersys is pursuing ischemic stroke in the framework of a systemic
disease. graft versus host disease. which is systemic. and acute heal disease. Athersys is partnered
with Pfizer Inc. (PFE:NYSE) in an ulcerative colitis program. and Mesoblast is partnered with Teva. In
many ways. Athersys and Mesoblast look similar.
What's different is that Mesoblast was incorporated in Australia. and the kitial finds were raised there.
What drove the valuation in Mesoblast was the partnership it was abre to make with Cephaion Inc. (which
was acquired by Teva in October 2011). Being an Australian company made the capital-raising process
easier because a dynamic exists in Australia that does not exist in the U.S.: Retail shareholders are able to
invest directly in the company. They can literally mail checks to the company. Ma seen other Australian
companies do this as well. Prima BloMed Ltd. (PRR:ASX) has successfuly raised capital n the home
market in Australia.
Why do companies then leave Australia? Ultimately. I think they outgrow the country, and must look for the
larger acquisition of capital that exists in the U.S. marketplace—although Mesoblast recently raised $175
melon ($175M) overseas. which seems to contradict this logic.
TLSR: You have Mesobtast rated Buy, and your target price is $11. The company is currently trading at
$6.50. What is your investment thesis here?
JK: I am often asked the question: If Mesoblast is currently trading at a S2Et market cap with S178M in
cash, or an enterprise value (EV) of about S1.88. versus Athersys. which is trading at a market cap doser
to 588M. or an EV closer to SSOM. how can you have a Buy relax) on Mesoblast?
The answer is that I don't look at Athersys to make a valuation decision about Mesoblast, This a a very
important point. While Athersys may trade at S50M EV. I would argue that Athersys is too low. rather than
Mesoblast being too high. As an analyst I've been trained to determine whether there's enough on the
balance sheet to get to the next inflection point. I have concluded that yes. $178M at the current burn rate
wa allow Mesoblast to operate for at least three years.
Ttwee years from now the company is gong to have a dramatically different outlook in terms of its data
sets. In January, the company announced data around its spinal fusion program. It ran two phase 2 clinical
tnals. and looked at low-dose and high-dose applications of its MPCs versus autologous bone graft.
Investigators were able to show the rate of fusion success was equivalent—not better and not worse—to
the autograft. where bone is harvested from the patients hip.
EFTA00956530
If surgeons can avoid harvesting bone from a patients
hip. that's significant because the process can leave a "in the world ofpharmaceuticals
patent with lagging pain. his also an opportunity for
and biotechnology investors
infection at the donor site. Many side effects in autograft
have to think of companies as
procedures occur as a result of the bone harvest rtseff.
global."
Every orthopedic surgeon we've spoken with has said
that if bone harvest can be avoided, fusion becomes a
home-run product We are waiting for one more trial to report—the third that which evaluates DOD. We
should see the phase 2 results by April. That trial hopes to restart vertebral height in patients and. in doing
so. help patients avoid becoming spinal fusion candidates. We believe the animal (ovine) models that
Mesoblast based this trial on are predictive n humans. In fact, this is one of the company's we strengths
—its ability to create preclinical data sets that derisk the clinical programs in humans.
About 30M people in the U.S. who suffer from back pain seek medical help—usually in the form of steroid
injections—before they Deccan candidates fa a fusion. What we're talking about is a therapy using cells
rather than the temporary aid of steroid injections. The neurologist, instead of steroids, would inject cells in
much the same process.
To get back to your question: How do you value something like that? The treatment has huge potential.
The phase 2 fusion data look good. and I believe Mesoblast wdl repkate those results in a larger nat.
When I add it all up. I see the potential of Mesoblast's technology to change the paradigm of how we treat
failing hearts, as well as its potential in orthopedics and the fact that Mesoblast doesn't have to repeal
phase 1 trials because it has already proven its cells are safe. Multiple indications exist for these cells, and
what's unique about cell therapy is that once the phase 1 work is complete, it doesn't need to be repeated.
All the company needs do is demonstrate safety and efficacy in an animal model that is predictive In
humans, and then try the therapy in a phase 2 clinical trial in humans.
Maybe the most exciting indication is one that no one is talking about at Mesoblast—the ability for these
cells to be a multrfactceial solution to a multifactorial problem—rheumatoid arthritis (RA). That market is
worth between S10-258 globally. The potential for Mesoblast to become a significant player in RA is very
great.
What else differentiates Mesoblast from Athersys. Pluristem Therapeutics Inc. (PSTI:NASDAO) orCylorl
Therapeutics Inc. (CYTX:NASDACI)? Maybe the single largest differenbator is the amount of money
Mesoblast has—S178M on its balance sheet as of Dec. 31, while Teva is paying for its global CHF trial.
Mesoblast is in a position to run well-designed clinical teals and not be held back by a lack of capital.
Those factors combine to make me very bullish on the potential of this company. It has so many irons in
the fee. Its wed financed and es clearly in a strong position to change the paradigm.
TLSR: You can't patent cels. which are products of nature. The cells possess the physiological
mechanisms within them, and their paracrine effects are natural. trtl wondering why Athersys. Plunstem or
anyone else can't come along and use Mesoblast's technology. How does a company protect its
develcpment?
JK: I want to correct you. You can patent these cells. Companies cannot patent part of the human body,
but they can patent other specifics of the cells. Mesoblast has multiple patents. from composition of matter
to methods of manufacturing and methods of use. The investigators have picked a target cell. a
mesenchymal precursor cell. Its unique. A monoclonal antibody es used to pick out the specific cell type.
which originates In the bone marrow as an early precursor to a mesenchymal cell. Mesoblast uses a highly
proprietary manufacturing process and tightly controls the expansion of the cells into what ultimately
becomes the final product. These steps are patentable and. in fact. we have seen multiple patents issued
to companies with existing commercial stem cell products. such as Osiris Therapeutics Inc.'s
(OSIR:NASDAO) Prochymal (remestemcel-L). The reality is that the Athersys cell. the Pluristem cell and
the Mesoblast cell are all different
TLSR: So patent protection begins with the selection of the cell. the separation of cells using the antibody
and the expansion and manufacturing process. There are multiple factors that can be protected as
intellectual property (lP). correct?
JK: I would call them hurdles. Competitive hurdles. as well as IP hurdles. prevent competitors from coming
ei. Each company has IP around its cell types. cell characteristics. methods of use and manufacturing
processes—so much so that. in fact I don't think the concern is that someone MI knock off anyone's
product.
TLSR: You've mentioned Athersys several times in the context of Mesoblast. I get the Impression that you
Ike the company. Your thoughts?
JK: I Ike Athersys. I see it as a mini-Mesoblast—in many ways equivalent to Mesoblast—but it doesn't
have the market cap. Athersys. with its MultiStem (multipotent adult progenitor cell) product. has one of the
best manufacturing processes in allogeneic cell therapy that I've ever seen. If the results from its phase 2
ulcerative colitis/Crohn's disease trial. which is being run by Pfizer. are good, this stock could take off. If the
results from its European phase 2 stroke trial are good. again. this stock could take off.
I also respect the management team. the fundamental science and quality of science that is practiced at
Athersys. Gil Van &Woolen was previously the head of the Alliance for Regenerative Medicine. He is a
very down-to-earth. practical CEO. with high ethics and standards. Not every CEO n this space meets this
standard.
TLSR: Would you mention another company?
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JK: I also cover Dendreon Corp. (0NDN:NASDAO) and ImmunoCellular Therapeutics Ltd.
(IMUC:OTCBB). therapeutic vaccine companies.
I view Dendreon's Provenge (sipuleucel-T) as a breakthrough cell therapy for the treatment of prostate
cancer, but it's a first-generation product. meaning ifs not perfect. Another company I follow. Medivatlon
Inc. (MDVN:NASDAO). has an oral small molecule. chemotherapy agent. Xtandi (enzalutamide). which is
close to Provenge in terms of efficacy. In fact. Xtandi may turn out to be more efficacious. cheaper. easier
to manufacture and more convenient for the patient Provenge is very inconvenient for the patient, because
each time a "batch' is made, the patient must go through a cumbersome apheresis process. Provenge is
very expensive to manufactse and the margin are low by comparison to traditional biotechnology drugs.
ImmunoCeaular Therapeutics was founded by Cr. John
Yu. a practicing neurologist at the department of
"A dynamic exists in Australia
neurosurgery at Cedars-Sinai Medical Center. Dr. Yu
that does not exist in the U.S.:
had a visionthat dendmic cells (antigen-presenting cells
Retail shareholders are able t0
that make up part of the immune system) could offer
invest directly in the company.'
hope for patients with gboblastoma multiform (GSM).
an aggressive brain tumor that is essentially a death
sentence. One of the differences between the approaches that ImmunoCellular and Dendreon have taken
is that Provenge targets one antigen expressed in prostate cancer, the prostate-speak antigen (PSA).
Cancer cets are smart. If you are killing a cancer based on one antigen. the cancer will often down-
regulate the expression of that antigen as a survival mechanism.
But it's less likely that cancer cells can simultaneously down-regulate the expression of six antigens.
ImmunoCelular's cancer vaccine. ICT-107. targets six. The probability that the cancer cell can down-
regulate two or even three antigens is lower than for one. It makes scientific and pragmatic sense.
TLSR: Jason. you commented that Dendreon's margins were very low with Provenge. and that investors
are now concerned about margins associated with autologous cell therapies. What about the cost of
manufacturing the cats used in ICT-107?
JK: Remember that Dendreon's Provenge was a first-generation cell therapy. ImmunoCellular's ICT-107 is
a second-generation dendrilic cell. Actually. I consider it a third-generation cell because it's so innovative. It
is more robust and, in fact. can be cryopreserved (frozen). Prostate cancer patients receiving Provenge
must have each dose made fresh. Patients treated with ICT-107 would sit down once for the apheresis
procedure. and from that multiple doses—as many as 30. let's say—could be made. cryopreserved and
used to treat the patent. The cost of goods sold (COGS) of ICT-107 is in Isle with more biotechlike
products. and the vaccine becomes a Ngh-margin product.
TLSR: You've made the case for ImmunoCellular targeting multiple antigens and the potential for
significantly improved efficacy with its platform. as well as for much improved margins. But what are the
data saying? Please speak to the valuation as well.
JK: I'm very hopeful that we are going to see not just good efficacy. but dramatic efficacy A phase 2 clinical
trial has been completed. It is event-driven with a mortality endpoint We will see how many patients who
got the vaccine are still alive versus patients who got the control. If there is a dramatic difference, as was
seen in the open-Label phase 1 clinical trial, then this drug would be rapidly adopted in the orphan
population of GBM. Beyond that. It suggests the ImmunoCellular platform is very viable.
It's very rare for me to take what is essentially a $2.50 stock and put an $18 target on it. But even rf the
vaccine doesn't work. ImmunoCellulars stock does not go to zero. because the vaccine is a second-
generation product If ICT-107 does work. the reward is dramatic.
ImmunoCelular has a second vaccine. ICT-121. targeting recurrent GBM. which is resistant to most types
of therapies and for which no standard treatment is available. This dendritic cell-based vaccine stimulates
all immune response to CD-133. a novel cell membrane protein that has been identified as a marker of a
subset of neural stem cells and gliciblastoma stemlike cells. The company has begun a physician-
sponsored. FDA-approved, phase I trial at Cedars-Sinai. enrols-lc 12-15 patents.
Beyond these two vaccines is another. ICT-140. a
multivalent. dendritic cell-based vaccine for the
"High reward and managing risk
treatment of ovarian cancer. Ovarian cancer is the fifth
—looking to manage risk with
most common cancer among American women and
multiples of upside-is what
usualy has a poor prognosis. The five-year survival rate
biotech investing is all about."
is approximately 47%. ICT-140 is designed to target
multiple antigens. including EphA2 and mesothelin. The
company licensed the IP surrounding EphA2 (a tyrosine kinase receptor highly expressed in ovarian
cancer and other advanced metastatic cancers) from the University of Pittsburgh. Additionally.
ImmunoCelular has licensed the IP surrounding mesothelin (an antigen highly expressed in pancreatic
cancer. ovarian cancer and mesothelioma) from Johns Hopkins University
High reward and managing risk—looking to manage risk with multiples of upside—is what biotech investing
is all about.
TLSR: Just for ctresity. Is anyone working on an off-the-shelf therapeutic vaccine. an allogeneic model?
JK: The dendrite cells in the ImmunoCellular paradigm always come from the patient. But Bavarian
Nordic (BAVA:OMX) is working on a new and novel alogeneic vaccine. Prosivac. It is the subject of
several ongoing clinical trials in men with metastatic castrate-resistant prostate cancer and is intended for
use in patients whose disease has recurred after surgery or radiotherapy, an unmet medical need.
Prostvac and its related PSA-containing poxwal vaccines have been investigated in more than 500
patients already. According to the company. Prostvac significantly improved overall survival (OS) to 8.5
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months on average. It is currently being evaluated in a large phase 3 study: data is not expected until
2O15.
One key opinion leader we spoke with said: 'If Prostvac demonstrates an OS benefit equal to or superior to
Provenge. oornbined with its ease of manufacturing and distribution. and substantially lower COGS. it
could become a category killer.'
In the out-years. there will likely be multiple new cancer vaccines. While none are a threat to Provenge
today, the development of these new products bears watching.
TLSR: Can you give me another name?
JK: Let's talk about Cytori Therapeutics. Most people don't understand fat—adipose tissue. In and around
fat cells is what's allied a stromal vascular hectic.% and in this cell bed are stem cells. In fact. it turns out
that adipose tissue is about 10.003 times mote plentiful a source of stem cells than bone marrow. Cytori
has a machine, called the Celution system. for which it is pursing an Investigational Device
Exemptionipremarket approval (PMA) around the indication of chronic myocardial 'schema (CMI). It is in
a phase 2 plot study. The only reason I add the word plot is because I want to highlight the device
pathway for approval. When you go down the device pathway. safety is generaly not an issue. Companies
just have to show efficacy. This triaLATHENA. is enrolling very rapidly.
The Celubon device is a highly engineered smart centrifuge. The patients own adipose tissue—about the
volume of a full soda can—es taken. typically from the abdomen using liposuction. The tissue is loaded into
the machine. where a oollagenase digests the fat. An hour later the machine generates a dose of stem
cells—what the company calls its adipose-derived stem and regenerative cells (ADRCs). It is important to
note that this is a point-of-care. very inexpensive way to do cellular processing. It has the potential to
change the balance for CMI. a chronic indication.
Let me differentiate the indications. If you have an acute myocardial infarction—a heart attack—you don't
want to have liposuction and wait an hour before your treatment can begin. In fact. you don't want to wait a
minute. You want to be rushed into the oath lab. and as the interventional cardiologist is placing the stent to
unblock the coronary occlusion. you'd like him or hOf to have the stem cells to inject. Though rt seems
unbelievable. many head attack patients won't retum to the hospital once rearmed. so a cardiologist's best
chance to treat the head is right there. in the cath lab. during the crisis. I worry when companies claim it is
best to wart until the head becomes hypoxic. and then deliver cells. I believe. for acute injury. you want
allogeneic models like those being developed by Mesoblast. Pluristem and Athersys.
On the other hand. the autologous model. like Cytori's
or IntelliCellElioSciences Inc.'s
The goodnews Is That cell
(SVFC:OTCPK)adipose sonifcation process (cells are
therapy has virtually arrived. It's
separated using sonic energy). could be very attractive
no longer a question ofit but
for cardiac patients with CMI. If we think of the lowest of
when."
the low-hanging fruit. we think of anybody undergoing a
tummy tuck. What is happering to that fat now? It's
being thrown away. Imagine if that was reintroduced into your body Ice rejuvenation. Now the person
getting liposuction is a candidate for stem cal therapy. Many physicians are actually doing this today under
minimally manipulated and homologous guidelines. The area is in dispute and represents a gray area in
terms of FDA regulations.
I can see a day when stem cells from these procedures are cryopresened. Down the road. should you
break your arm or your ankle. those cells could be used to help you heal rapidly. I think Cyton's device has
enormous potential. I respect the fact that it is targeting CMI with a peak oxygen consumption endpoint
along a PMA (device) pathway.
Once the company completes the current phase 2 study successfully. all it will need to do is one modestly
sized phase 3 trial. Proving safely is less of an issue with the device pathway. so the pivotal trial's focus is
a p-value (statistically valid result) on a relevant endpoint.
TLSR: Do you have one or two ideas to close with?
JK: I'd like to talk about IntelliCell BioSciences—and I know this will be controversial. only because its
CEO. Dr. Steven Victor. is also the founder of ReGen Medical. ReGen Medical is a state-of-the-art hospital
in midtown Manhattan that provides stromal vascular fraction cellular therapy, which contains stem cells. to
patients today. The hospital is a beautiful. brand-new facility that treats high-end patients.
The therapy is provided to patients through physicians (orthopedists. urologists, plastic surgeons, etc.) that
have practicing rights at ReGen Medical. The clinicians are allowed to put a patients own cells back into
his or her own body. provided the cells are not manipulated, processed or expanded. The is in accordance
with the FDA's 'minimal manipulake and homologous use' rule.
The IntelliCell process. branded IntelliSonics. is similar to the Cytori process in that they both use
lipoaspirate. But the IntelliCel process produces a different cellular population because, with its
sonification (ultrasound) process. the blood components are not washed out. The stromal vascular fraction
of IntelliCell contains the hematopoiebc cells. The final product is quaMy-ccelroled. checked for any
contamination and cell viabdrty is measured.
IntelliCell BioSciences has completed the preclinical protocols in anticipation of beginning a clinical trial for
osteoanhritrs of the knee under an FDA investigational new drug application in mid-2O13. The company
provides product today to ReGen Medical. and in doing so is building fantastic database of patient
experience that wit be used to focus on clinical applications.
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I'd also like to mention Aastrom Bios<lances Inc. (ASTM:NASDAO). This company is working to
complete a phase 3 pivotal Vial of its stem cell therapy in critical limb ischemia (CLI). Based on the phase 2
data set and the size and powering of the pivotal trial, we believe Aastrom has a good probabibly of
success.
The friars goal is to demonstrate an improvement in the amputation-free survival rate of the treated
patients. Aastrom uses a bone marrow aspirate and expands the cells, optimizing the heterogeneous
population mix. Key to Aastrcm's success will be validating the thesis that the cell product has been
optimized and therefore is advantageous.
Aastrom is positioned to have the first approved therapy for CLI in the marketplace. We believe *first mover
advantage is vitally important for the company, as it is likely to face future competition from others. such
as Pluristem. in CLI. Investors should appreciate that Asstrorn's core expertise is n cell manufacturing. As
such. the company's COGS are low for an autologous-processed product. By comparison, the processing
COGS associated with the Baxter International Inc. (BAX:NYSE). NeoStem Inc.
(NBS:NYSA.A) and Cytomedix Inc. (CMXI:OTCBB) approaches are very high. The fact that the NeoStem
product requires more than 20 bone marrow needle punctures and multiple pulls on each needle concerns
us. as does the Baxter approach of administering granulocyte colony-stimulating factor (GcSF) to CMI
patients and then subjecting them to apheresis. Investors today are fearful of all the autologous models. as
the Dendreon experience is still fresh in their minds.
We believe that companies like ImmuneCellular. Cytcri. IntelliCell and Aastrom represent new paradigms in
autologous therapy. whereas other approaches are closer to the labor-intensive and less-patient-fnencly
Dendreon model. We believe low COGS, availability and on-site processing may be critical success
factors, dependent on the indication (acute or ductile). whether the therapy meets an unmet medical need
and whether there is intense competition in the space.
The good news is that cell therapy has virtualy arrived. It's no longer a question of if. but when. There are
multiple late stage trials onocing now. Strengths, weakness. opportunities and threats. also known as
SWOTs. w be deciding factors in the future.
VVill a product be first in the marketplace in a selected indicaben? Is the product virtually off the shelf? Is
the ccet of goods high or low? Investors need to ask these questions as companies position themselves for
the market-share battles of the future.
TLSR. Its been a pleasure speaking with you. Best wishes.
JK: My pleasure. Thank you.
Jason Kolbert has worked extensWely in the healthcare sector as product manager for a leading
pharmaceutical company. as a fundmanager end as an equity analyst. Pifer rejoining Maxim Gnxip, he
spent seven yen at Susquehanna International Group LLP. where he managed a healthcare fund and
later founded SIG's seaside biotechnology team. Previously. Kota? served as the healthcare strategist for
Salomon Smith Barney. He is frequently quoted in Barron's end is regulady featured on CNBC. Phone
beginning his Wall Street career. KOZOli sewed as a product manager for Schering-Plough in Osaka.
Japan. He received a bachelor's degree in chemistry 119i77 State University of New York at New Patti and
master's degree in business administration from the University of New Haven.
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DISCLOSURE:
1) George S. Mack conducted this interview for The Life Sciences Report and provides services to The Life
Sciences Report as an employee or as an independent contractor. He or his family own shares of the
following companies mentioned in this interview. None.
2) The following companies mentioned in the interview are sponsors of The Life Sciences ReportAthersys
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TICKERS ASTIA. MW. SAVA. SIX. CM. 0N0N. GERN. 51WC. SVFC. LIMN. IARK.1.455. PARTY. NSS. OSIR. PFE. PSII.
PRR
Steven Victor MD
IntelliCell BioSciences
Chairman/CEO
460 Park Avenue 17th Floor
EFTA00956534
New Yak New York 10022
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CeIIIIIIII
www.IntelliCeeBioSciences.com
EFTA00956535
ℹ️ Document Details
SHA-256
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7
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