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Crimson Publishers-The Risk Level of Viet Nam Listed Medical and Human Resou...CrimsonPublishers-SBB
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GDG Cloud Southlake #33: Boule & Rebala: Effective AppSec in SDLC using Deplo...
Neostem Research Report by JMP Securites
1. FOR DISCLOSURE AND FOOTNOTE INFORMATION, REFER
TO THE JMP FACTS AND DISCLOSURES SECTION
INVESTMENT HIGHLIGHTS
• We are initiating coverage of NeoStem with a Market Outperform rating and $3 price
target. NeoStem is a company with core expertise in the field of stem cells and cellular therapies
that has recently undergone a transition to a focused therapeutic development company.
Through the acquisitions of Progenitor Cell Therapies (PCT) and Amorcyte, NeoStem has
strengthened its core expertise in the stem cell arena and added industry-leading manufacturing
expertise as well as a Phase II-ready development candidate. We anticipate that, over the
coming 12-18 months, we will gain increased clarity on value-driving clinical catalysts for AMR-
001 in addition to the potential for further product candidate acquisitions. That said, we believe
that investors are currently getting a "free call" on the potential for AMR-001 as a result of our
view that the present value for the company's leading immunotherapy manufacturing business
(~$50MM) and its China pharma subsidiary (~$35MM) provide downside valuation protection.
Therefore, we are establishing a place-marker price target of $3.00 based on a sum-of-the-parts
analysis including AMR-001 (5x revenue of $730MM in 2019, discounted by 40% per year),
manufacturing service revenue from PCT (3x revenue of $25MM in 2012, discounted at 15%),
and sales from the company's Chinese pharmaceutical division Suzhou Erye (50% ownership of
1x revenue of $70MM in 2011).
• AMR-001 emphasizes transition to a therapeutics-focused company. NeoStem is driving the
transformation to a high-value therapeutics company through the development of AMR-001. This is
an autologous cellular therapy poised to enter Phase II development to prevent progressive cardiac
tissue damage in patients following acute myocardial infarction (heart attack). This 150-patient trial
is on track to begin enrollment in 1Q12 with results expected in 2H13.
• PCT provides core expertise in cellular therapies that can be leveraged both to grow current
manufacturing revenues but also to advance NeoStem's pipeline candidates. NeoStem's
January 2011 acquisition of Progenitor Cell Therapies (PCT) expanded the company's expertise in
stem cell technologies and provided a service business nearing breakeven. PCT has played a key
role in the advancement of emerging development-stage cellular therapy candidates (notably
leading the manufacturing development of Dendreon's Provenge), and we believe that this industry-
leading experience can be leveraged both to offset cash burn and, more importantly, to advance
the development of NeoStem's own proprietary development programs.
Biotechnology - Initiation of Coverage September 16, 2011
NeoStem, Inc. (1,3)
Initiation - Transformative Acquisitions Position Emerging Cell Therapy Player
MARKET OUTPERFORM NBS $0.65
Price $0.65 FY Dec 2010A 2011E 2012E
Target Price $3.00 Revenue (M) 1Q $15.8 $19.6A --
52-Wk Range $0.60 - $2.15 2Q $19.4 $18.5A --
Shares Out. (M) 97 3Q $16.5 $20.6 --
Market Cap. (M) $63 4Q $18.1 $21.6 --
Average Daily Vol. (000) 200 FY $69.8 $80.3 $12.0
Float (M) 62
2010A 2011E 2012E
LT Debt (M) $7 EPS 1Q ($0.12) ($0.14)A --
Cash (M) $20 2Q ($0.11) ($0.13)A --
Enterprise Value (M) $114 3Q ($0.13) ($0.12) --
Cash/Share $0.21 4Q ($0.10) ($0.12) --
FY ($0.46) ($0.50) ($0.18)
P/E NM NM NM
Previous FY -- NE NE
CY ($0.46) ($0.50) ($0.18)
PE NA NA NA
NC indicates no change to previous estimate. NE indicates no previous estimate.
Source: Company reports and JMP Securities
Jason N. Butler, PhD
jbutler@jmpsecurities.com
(212) 906-3505
2. 2
COMPANY DESCRIPTION
NeoStem is a diversified stem cell technology company that is focusing its broad expertise and
resources on the development of high-value cellular therapies aimed at impacting outcomes of serious
diseases with an unmet medical need. The company expanded its core expertise in stem cell
technologies into manufacturing and therapeutics through acquisitions over the past 12 months. Its lead
therapeutic candidate is AMR-001, an autologous cell therapy being developed for the treatment of
patients following acute myocardial infarction to prevent progressive cardiac tissue damage. Results
from a 31-patient Phase I trial established preliminary evidence of safety and efficacy, and NeoStem is
preparing to initiate a Phase II trial in 1Q12, intended to inform the design of a Phase III registration
program. NeoStem has two further therapeutic platform technologies from which we expect to see
candidates emerge into clinical development over the next 12-24 months. The company also has a
profitable pharmaceutical subsidiary in China, of which it holds 51% ownership, the divestiture of which
is currently being explored.
FIGURE 1: NeoStem Historical Price Chart
0.6
0.8
1
1.2
1.4
1.6
1.8
2
2.2
Sep Oct Nov Dec Jan Feb Mar Apr May Jun Jul Aug
0
4
Source: FactSet
VALUATION
We value NeoStem based on a sum-of-the-parts analysis including AMR-001, manufacturing service
revenue from the Progenitor Cell Therapy (PCT) subsidiary, and sales from the company's Chinese
pharmaceutical division, Suzhou Erye.
FIGURE 2: Absolute Valuation
Sales Revenue year Profit share Multiple
Discount
rate
Current value
Current value
per share
AMR-001 730 2019 90% 5 40% 312 $2.10
PCT CM revenue 25 2015 100% 3 15% 49 $0.33
Suzhou Erye 70 2011 51% 1 36 $0.24
Total 397 $2.67
Source: JMP Securities, LLC
3. 3
Our price target assumes an estimate for fully diluted shares outstanding of approximately 148 million
shares. This estimate is based on approximately 96 million shares outstanding following the July equity
offering, approximately 33 million warrants with an exercise price below our objective, and 19 million
stock options with an average exercise price of $1.79.
AMR-001
We value AMR-001 based our projections for sales in acute myocardial infarction patients at high risk of
experiencing further major adverse cardiac events (MACE). We conservatively only include sales
projections in the U.S. Our model assumes that AMR-001 will be approved in 2016 and will be launched
by a specialized sales force assembled by NeoStem. We project peak sales in the U.S. of
approximately $715MM in 2019, the third full year of commercialization, of which the company owes a
10% royalty to Amorcyte shareholders. We then derive our valuation by applying a 5x multiple to our
2019 sales projection, discounted by 40% per year to the end of 2012. In our view, this discount rate
reflects higher than average clinical and regulatory risk despite the positive Phase I results and clear
scientific rationale, which takes into consideration uncertainties in cellular therapies arena.
There are approximately 1.25 million people who suffer from an acute myocardial infarction in the U.S.
each year. Of these, approximately 40% are ST-segment elevated myocardial infarctions (STEMI), as
characterized by electrocardiogram. Patients with ST elevation are experiencing ongoing cardiac tissue
injury and require immediate treatment to remove any blockage and restore blood flow. It is estimated
that half of STEMI patients will have a low ejection fraction (< 50%) and 60% of these patients are at
high risk for adverse cardiac remodeling, which involved changes in size, shape, and function of the
heart after injury that results in increased stress to the organ and a high risk for further MACE. Based on
these assumptions, we view the target population for AMR-001 is at least 150,000 patients per year in
the U.S.
We model AMR-001 penetration into this patient population projecting that peak penetration of 9.5% will
be achieved in 2019. We assume a cost of therapy of $50,000, conservatively with no annual price
increases, and therefore derive a peak sales estimate of $730MM. We believe that at peak sales,
NeoStem can achieve gross margins of 80%. We note that NeoStem has issued patents covering AMR-
001's composition of matter that extend through 2028. In addition, given the manufacturing and
regulatory complexities in the cellular therapeutics field, we do not view generic competition as a
meaningful risk at this time.
FIGURE 3: AMR-001 Revenue Model
US AMR-001 market 2015 2016 2017 2018 2019 2020
Acute myocardial infarction (MI) incidence 1,255,000 1,261,275 1,267,581 1,273,919 1,280,289 1,286,690
ST-elevated MI incidence 502,000 504,510 507,033 509,568 512,116 514,676
STEM with low ejection fraction 251,000 252,255 253,516 254,784 256,058 257,338
Patients at increased risk of MACE 150,600 151,353 152,110 152,870 153,635 154,403
AMR-001 penetration 0.0% 0.5% 1.5% 5.0% 9.5% 9.5%
Treated patients 757 2,282 7,644 14,595 14,668
Cost of therapy ($, annual) 50,000 50,000 50,000 50,000 50,000
Sales ($MM) 38 114 382 730 733
Source: Company reports and JMP Securities, LLC
4. 4
PCT
In 2010, PCT generated services revenue of approximately $10MM, which is approaching breakeven
for this business. We project that sales can grow to $25MM in 2015 based on 1) an increasing number
of clients and 2) clients progressing product candidates through to later stages of development and
ultimately commercialization. We value revenue generated by PCT by applying a 3x multiple to our
2015 revenue estimate of $25MM, discounted by 15% per year to the end of 2012. We estimate that
$25MM would reflect manufacturing service for clinical product to treat between 1,000 and 1,500
patients.
Suzhou Erye
In 2010, NeoStem reported sales of approximately $70MM from Suzhou Erye and in 1H11 sales were
$34MM. We project sales for FY11 of $71MM, to which we apply a 1x multiple and attribute 51% to
NeoStem based on its ownership stake.
Relative Valuation
We corroborate our absolute valuation methodology with a relative, comparable company analysis for
which we evaluated other companies with core platform technologies that can be leveraged to develop
high value therapeutic candidates. We focused also on companies with hybrid business models that
generate cash flow or value appreciation through existing non-core partnerships. Companies in our
comparable universe have a median enterprise value of $231 million (range of $76-447MM). This
compares favorably to the current enterprise value of NeoStem of $64MM. Using this median value, we
derive a 12-month price target of approximately $3 per share.
FIGURE 4: Relative Valuation
Company Name Ticker Price Shares Market Cap Cash Debt Enterprise Value
Aastrom Biosciences Inc. ASTM $2.62 38.6 101 19 0 83
Isis Pharmaceuticals Inc. ISIS $7.17 99.7 715 395 143 462
Lexicon Pharmaceuticals Inc. LXRX $1.28 337.7 432 164 24 292
Rockwell Medical Technologies Inc. RMTI $8.73 18.1 158 21 0 137
Sangamo BioSciences Inc. SGMO $5.93 52.5 311 91 0 220
Median 311 239
Neostem NBS $2.61 96.6 252 13.4 0 239
Source: JMP Securities, LLC and FactSet
KEY UPCOMING CATALYSTS
1Q12 Initiate Phase II trial for AMR-001 in AMI patients
2012 Initiate Phase I trial(s) for Athelos T reg therapeutic candidate(s)
2012 Monetize 51% ownership in Suzhou Erye
KEY INVESTMENT POINTS
NeoStem is positioning to become a leading player in cellular medicine. NeoStem is a
biopharmaceutical company with a focus in the field of stem cell technologies, with core expertise in
collection, storage, and manufacturing of stem cells globally. The company's Progenitor Cell Therapy
(PCT) unit is a key player providing contract manufacture and development/regulatory consultancy to
stem cell therapeutics companies. NeoStem is now leveraging their core expertise to advance emerging
therapeutic programs. Through the recent acquisition of Amorcyte, NeoStem has gained rights to AMR-
001, a well characterized autologous cell therapy product candidate with an established mechanism of
action and defined threshold dose. The company completed an equity financing over the summer,
raising gross proceeds of $16.5MM, which we believe can further enable the transformation into a
focused therapeutics development company and progress AMR-001 into Phase II development. In our
view, execution on the AMR-001 development program and continued commitment to high-value
therapeutic assets will further establish NeoStem as a focused development-stage biotechnology
company and can provide multiple value-inflecting milestones over the next 12-18 months. In turn, we
5. 5
believe, investors will begin to more appropriately value the potential of the company's assets and
capabilities.
Cellular therapies - emerging investable opportunities. The therapeutic potential of stem cells has
long been recognized as a powerful approach to treating diseases, especially in the field of regenerative
medicine but beyond this in a wide array of diseases ranging from autoimmune to neurodegenerative
and cardiovascular. However, there have been multiple challenges faced and, in many examples not
overcome, including ethical, technical, regulatory, and commercial considerations. Just as biologic
therapies (e.g., monoclonal antibodies) are considerably more complex than small molecule
pharmaceuticals, cellular therapies are even more complex. However, just as the therapeutic potential
of biologics was realized, we believe cellular therapies are now entering a period of development when
successes can become more frequent.
PCT unit provides core, industry leading expertise as well as growing contract manufacturing
revenue. NeoStem acquired Progenitor Cell Therapies (PCT) in January 2011. Since its inception in
1997, PCT has become an industry-leading resource in the cellular therapy space, specifically for
clinical trial products. The company has established cGMP manufacturing capabilities on the East and
West coasts of the U.S. and participated in the advancement of a growing list of clinical candidates, in
terms of product and process development, regulatory advice, manufacturing, and logistics. Its most
notable client has been Dendreon, and PCT's expertise and experience was influential in the
development of its now-approved cellular therapy product Provenge. The company intends to continue
growing its CMO offerings as cellular therapies emerge as a key focus for biopharmaceutical
development in coming years. In our view, the PCT business unit provides NeoStem with a high-
visibility, low-risk revenue stream; as the products of PCT’s clients advance through clinical
development and commercialization, and the number of clients grows (currently ~25), revenues can
also grow. In 2010, PCT's revenue was approximately $10MM, and we project that revenue can grow to
$25MM by 2015. Moreover, we believe this expertise can be leveraged to advance the development of
NeoStem's own proprietary therapeutic programs, including AMR-001, as well as provide unique
diligence insights on potential product acquisition candidates.
Amorcyte acquisition brings on board Phase II-ready asset. In July, NeoStem announced the
acquisition of Amorcyte for up to $18MM in NBS stock ($10MM up front, $2MM warrants, $6MM vesting
upon achievement of certain clinical milestones). Amorcyte's lead development candidate is AMR-001,
an autologous bone marrow-derived cellular therapeutic. This cellular product contains an enriched
population of CD34+CXCR4+ cells, which are believed to better satisfy energy requirements of heart
muscle following acute myocardial infarction, limiting apoptosis, promoting neoangiogenesis, and
reducing post-AMI tissue damage. AMR-001 is protected by a patent including composition of matter
claims through 2028. A completed Phase I trial (31 patients, 4 U.S. sites, 6 month duration) has
established a threshold dose for efficacy in acute myocardial infarction patients, and a Phase II trial is
expected to begin in 1Q12. The Phase I trial demonstrated positive signals of efficacy in terms in key
measures of cardiac function (hypoperfusion, ejection fraction, and end systolic volume) as well as a
favorable safety profile. The planned Phase II trial is expected to enroll approximately 150 patients at 30
sites in the U.S. for a treatment follow-up period of six months. The aim of this trial is to inform the
design of a Phase III program that best enables regulatory success. We look to gain further clarity on
enrollment timelines, but we currently believe results could be available in 2H13.
Proprietary technologies provide additional clinical candidates. In addition to Amorcyte, NeoStem
has two proprietary therapeutic platforms from which clinical candidates may emerge over the coming
12-24 months. The first is the company’s Athelos unit, a joint venture with Beckton Dickinson, of which
Neostem owns 80%. The Athelos technology is based on T cells that are harvested from peripheral
and/or cord blood and then activated and expanded. These cells are believed to have applications in
therapeutics for a range of auto-immune diseases. NeoStem is on track to begin Phase I trials for
therapeutic candidates from the Athelos platform in 2012 with possible indications including GvHD, solid
organ transplant rejection, and other in autoimmune diseases including asthma and diabetes.
NeoStem's second proprietary platform is VSEL (Very Small Embryonic Like) stem cells. VSELs have
the attractive attributes of embryonic stem cells (i.e., pluripotent) but without the ethical considerations.
In our view, this technology can be applicable to multiple regenerative medicine opportunities, and we
look to gain increased visibility in emerging clinical candidates.
6. 6
Intended divesture of profitable Chinese pharmaceuticals business can further strengthen
balance sheet. NeoStem is the majority (51%) stakeholder of Suzhou Erye, a Chinese pharmaceuticals
business focused primarily on generic antibiotics. Since NeoStem acquired its share in Suzhou Erye,
sales have more than doubled from $32MM in 2007 to $69MM in 2010. Growth in this business has
been driven both by strong growth in the Chinese healthcare sector as well as by development of a new
manufacturing facility built and validated with NeoStem's investment, doubling capacity. In 1H11,
NeoStem reported sales from Suzhou Erye of $35MM, and we project full year sales exceeding $70MM.
In line with its focus on high-value cellular therapeutic programs, NeoStem intends to divest this asset to
generate further cash to fund clinical development programs and/or further potential therapeutic asset
acquisitions. The company is progressing negotiations to sell Suzhou Erye, and we believe that it could
generate upwards of $35MM from this transaction (51% of 1x sales).
INVESTMENT RISKS
Clinical risk. NeoStem's development candidates could fail to generate expected results in current or
future clinical trials.
Regulatory risk. The FDA, and/or other ex-U.S. regulatory agencies, could reject any of the firm's, or its
partners', future regulatory filings or require additional studies prior to granting approval.
Commercial risk. If successfully developed, NeoStem's products may face competition both from
approved products and also potentially from new product candidates in development by biotechnology
and pharmaceutical companies.
Balance sheet risk. The expenses associated with drug development are high. It is possible that the
company will return to the capital markets to secure additional financing to fund current or future
development programs. As of June 30th, 2011, NeoStem had approximately $5MM in cash and
equivalents and subsequently raised net proceeds of $15MM from an equity financing. We do not
believe current funds will be sufficient to support operations through profitability.
AMORCYTE
NeoStem announced the acquisition of Amorcyte in July 2011 in an all-stock transaction valued at up to
$18MM. The transaction included an upfront payment of $10MM in NBS stock as well as warrants for
$2MM in NBS stock and up to a further $6MM in NBS vesting on the achievement of certain clinical
milestones. The primary reason for the acquisition was Amorcyte's lead product candidate AMR-001, a
cellular therapy being developed to reduce heart muscle damage following a heart attack. Amorcyte has
completed a 31-patient, randomized, controlled Phase I trial for AMR-001 that established preliminary
evidence of safety and efficacy as well as a threshold dose for progression in to Phase II development.
Through this transaction, NeoStem acquired a Phase II-ready asset that we believe demonstrates solid
execution on its transition to a development-stage therapeutics company.
Scientific rationale and clear mechanism of action provide basis for clinical utility. AMR-001 is
comprised of an enriched population of autologous bone marrow-derived stem cells, co-expressing
CD34 and CXCR4 (CD34+CXCR4+). The cells are harvested from a patient following an acute
myocardial infarction (AMI), are enriched, and are then infused into the infarct-related artery six to ten
days post-AMI, within the timeframe required for clinical benefit. The cells do not undergo expansion
during this procedure. Preclinical studies have provided insight into the mechanism of action, which, in
our view, informs the potential for clinical success. Following an AMI, the body acts to rescue damaged
tissue, and preclinical data have demonstrated that CD34+CXCR4+ cells play a role in this process. A
distress signal, hypoxia induced factor (HIF), is released by the damaged heart muscle, which, in turn,
induces synthesis of stromal cell-derived factor (SDF) and vascular endothelial growth factor (VEGF).
This process mobilizes CD34+CXCR4+ cells, which travel along the SDF gradient to the area of
damage, the peri-infarct zone. The cells are then involved in preventing apoptosis and effecting
neoangiogenesis. Further tissue damage results from a limited natural availability of regenerative
CD34+CXCR4+ cells, and AMR-001 serves to reduce this burden, reducing or preventing progressive
tissue damage.
7. 7
AMR-001 Phase I results provide sufficient evidence of efficacy to progress development.
Amorcyte completed a 31 patient Phase I trial for AMR-001, providing what we view to be encouraging
preliminary evidence of safety and efficacy. The results demonstrated that patients treated in the two
higher dose cohorts (10 to 15 million cells) achieved improved cardiac perfusion. In our view, results
from the Phase I trial established the feasibility and reproducibility of AMR-001 treatment, including cell
harvest, enrichment, and infusion, and provided a sufficient basis to progress development into a Phase
II trial. Furthermore, we believe the data establish a threshold dose for AMR-001, an important concept
in the development of cellular therapies. The trial demonstrated that while improved cardiac perfusion
was observed in the higher dose cohorts, no therapeutic benefit was seen with the low dose cohort or
the control group.
Phase II well designed and powered to build on Phase I experience. NeoStem is preparing to
initiate a 150-patient Phase II trial assessing AMR-001 in patients following acute myocardial infarction.
The design of this trial is based on the Phase I trial while providing substantially greater statistical
power. The aim of this trial is to inform the design of a Phase III program that best enables clinical and
regulatory success. As with the Phase I trial, the primary efficacy measure will be preservation of
cardiac function. We expect the trial to begin enrolling patients in 1Q12, based on which we believe
results could be available in 2H13.
Baxter experience establishes clinical evidence of effect, but candidate therapy leaves room for
improvement. Baxter previously completed a randomized, placebo controlled Phase II trial using
autologous CD34+ stem cells in patients with chronic myocardial ischemia. The aim of this 150 patient
trial was to assess the potential for this cellular product to reduce the frequency of angina episodes. The
results demonstrated that, at six months after treatment, patients treated with the cellular therapy had
significantly fewer episodes of angina per week than patients treated with placebo (6.8 vs. 10.9), a
difference that was maintained at one year (6.3 vs. 11.0). In addition, patients in the treatment arm of
the trial were able to exercise significantly longer at six months (139 seconds vs. 69 seconds). These
results were published in August in the journal Circulation Research (Circulation Research
2011;109:428-436). In contrast to AMR-001, Baxter's product is derived from G-CSF mobilized CD34+
cells. G-CSF has been demonstrated to neutralize CXCR4+ cells, therefore implying that Baxter's
product would not be able to home to the peri-infarct zone, a key differentiating attribute of AMR-001.
Given that Baxter's product cannot rely on a targeting mechanism, the company is pursuing a Phase III
program in cardiac ischemia that employs local delivery of the therapeutic candidate using a NOGA
"mapping" catheter.
AMR-001 Clinical Development
NeoStem is preparing to initiate a 150 patient, placebo-controlled trial to assess the safety and efficacy
of AMR-001 in the preservation of cardiac function in patients following acute myocardial infarction.
Enrollment is expected to begin in 1Q12, and patients will be recruited at 30 clinical sites in the U.S.
The design of the trial is based on the Phase I trial but will provide greater statistical power. Patients will
be randomized to receive a single administration of AMR-001 or placebo and assessed following a six
month treatment period. The dose of AMR-001 is release of at least ten million cells. The primary
endpoint is increased cardiac perfusion (RTSS) measured by SPECT at six months post infusion.
Secondary endpoints include a composite of measures of cardiac function (preservation of LVEV,
LVEF, prevention of adverse remodeling) and quality of life measures (KCQQ and SAQ).
Phase I Results
Amorcyte completed a 31-patient, randomized Phase I trial with AMR-001, demonstrating meaningful
biological activity of the product candidate in patients following myocardial infarction as well as
establishing a threshold dose. The trial was completed at four clinical sites in the U.S., and results were
published earlier this year in the American Heart Journal (Quyyumi et al., Am Heart J 2011; 161: 98-
105). The aim of this study was to establish preliminary evidence of the therapy's safety; however, a
composite of measures of cardiac function including perfusion (RTSS) was included.
Patients were randomized into one of four treatment groups (escalating doses of AMR-001 or placebo)
following an ST elevation myocardial infarction (STEMI). Eligible patients had received an intracoronary
stent, implanted within three days of a myocardial infarction, and had an LVEF of less than 50%. A total
of 15 patients were enrolled in the control group and 16 were enrolled to receive one of three escalating
8. 8
doses (5, 10, or 15 million cells) of AMR-001. Between five and eight days after stent implantation,
patients in the AMR-001 group underwent bone marrow harvest following which, harvested cells were
selected for CD34 and enriched to 5, 10, and 15 million cell doses. The cells were infused via the
infarct-related artery 7-11 days following the STEMI.
The primary efficacy measure in the trial was hypoperfusion, measured as the resting total severity
score (RTSS) by single-photon emission computed tomography (SPECT). RTSS was measured at
baseline and three and six months after treatment. The study results demonstrated that, in patients
receiving 10 to 15 million cells, there was a significant improvement (reduction) in RTSS at six months
as compared to patients receiving 5 million cells and control (p=0.11). In addition, there was a trend
towards improvement in ejection fraction and infarct size with increasing cell doses.
FIGURE 5: Phase I Results - Hypoperfusion
Control
5mil 10mil 15mil
Patient numbers 15 5 5 5
RTSS
Baseline 259 714 999 584
6 mos 273 722 636 462
Change 14 8 -363 -122
% change 5.4% 1.1% -36.3% -20.9%
AMR-001
Source: Company reports
It is important to note that patients in the control group had a smaller baseline RTSS than patients in the
treatment groups (p=0.04), implying that these patients were less sick. However, the five million cell
dose cohort, which did not demonstrate an improvement in RTSS, had a more similar baseline score to
the 10 and 15 million cell dose cohorts, providing a more robust comparison, in our view. We believe
these data demonstrate an encouraging signal of efficacy.
FIGURE 6: Phase I Results - Subgroup Analyses
Below Threshold Above Threshold
% change
RTSS 3.3% -31.4%
Ejection fraction 1.3% 9.4%
End systolic volume 4.6% -6.1%
Source: Company reports
As shown in Figure 6, subgroup analyses, combining data for groups below the threshold dose (control
group and 5 million cell dose cohort) and above threshold dose (5 and 10 million cell dose cohorts)
further supports the treatment effect above this threshold, demonstrating improvements in additional
measures of cardiac function.
9. 9
PROGENITOR CELL THERAPIES
Progenitor Cell Therapies (PCT) is a cell therapy services business that provides development,
manufacturing, and regulatory expertise participating in the advancement of candidate cellular
therapeutics. PCT was acquired by NeoStem in January 2011 in an all-stock transaction valued at
approximately $20MM. The business unit has core expertise in manufacturing cell-based products,
through which it has demonstrated success facilitating the progression of product candidates through
preclinical and clinical development, most notably with Dendreon's Provenge. Contract manufacturing
services are provided through state of the art, cGMP-compliant facilities in Allendale, NJ, and Mountain
View, CA. In 2010, PCT generated revenues of approximately $10MM, which we believe can grow
substantially through further recognition of its industry-leading capabilities as well as more broadly
through increased investment in the development of cellular therapies.
Established expertise and execution in cellular therapies. PCT was founded in 1997 by Drs.
Andrew Pecora, MD, and Robert Preti, PhD, who remain active members of NeoStem's leadership. Dr.
Pecora currently serves as NeoStem's Chief Medical Officer and Dr. Preti as PCT's President and Chief
Scientific Officer. In our view, the continued contribution of PCT's management team can drive further
success both in the growth of the contract manufacturing business and in the progressing development
of NeoStem's therapeutic candidates. To date, PCT has provided contract manufacturing services for
upwards of 100 clients, assisting in more than 15,000 cell therapy procedures in over 5,000 patients.
PCT has participated in more than 50 regulatory filings in the U.S. and EU PCT participates in all
aspects of a candidate stem cell product's advancement from bench to patient including establishing
product characterization and comparability, cell processing, manufacturing scale up, storage, and
distribution and delivery logistics.
Proven record of success with pivotal role in the pioneering of Provenge manufacturing.
Dendreon's Provenge is an autologous stem cell therapy approved by the FDA in April 2010 for the
treatment of advanced prostate cancer. PCT played a key role in the development of the Provenge,
manufacturing more than 60% of clinical trial product, supporting all stages of clinical development as
well as BLA submission and approval. In our view, this experience demonstrates PCT's execution and
success in the development and manufacture of a commercially viable asset. Furthermore, we believe
that PCT has gained valuable expertise with regulatory authorities that could be leveraged as cellular
therapies emerge as investable development options. Beyond Dendreon, PCT currently has more than
25 clients with product candidates in or near clinical stage development.
CM growth potential from multiple sources. We believe that revenue growth for PCT's contract
manufacturing business can be driven both by advancement of product candidates into later stages of
development, where larger trials require greater amounts of product, as well as increasing the number
of clients, including the potential for a broadened client pool as development of cellular therapies
becomes an increasingly attractive strategic investment. Approximately 50% of PCT’s current clients
are conducting, or preparing to initiate, Phase I trials; another ~25% are in or preparing to commence
Phase II or Phase III trials; and ~5% are preparing for commercial production. As products progress
through clinical development, the size of trials increases as does the requirement for drug, which in the
case of cellular therapies has a limited shelf life (vs., e.g., a small molecule). Importantly, PCT's revenue
potential can continue to grow independent of the success of an individual development program.
Additionally, in our view, cellular-based therapies can become a key focus for biopharmaceutical
development in coming years. We draw a parallel to the emergence of monoclonal antibodies in the
early 2000s that were at first viewed with investor skepticism due to manufacturing and development
challenges but now represent a $20+ billion global market.
Opportunity to leverage PCT expertise for proprietary programs and conduct due diligence on
new opportunities. In addition to providing potential for near-term revenue growth, NeoStem is able to
leverage PCT's expertise as a cellular therapy service provider to advance the development of the
company's proprietary therapeutic programs, including AMR-001. Prior to being acquired by NeoStem,
Amorcyte was a PCT client, and AMR-001 development to date has been facilitated by PCT's
contributions. PCT's experience has the potential to maximize the cost and time efficiency of product
development decisions. In addition to providing NeoStem with expertise and infrastructure to progress
current development programs, we believe PCT provides the company with a unique insight into the
10. 10
development landscape of emerging cellular therapeutics. PCT's technical, scientific, clinical, and
business capabilities can, we believe, enable NeoStem to more optimally evaluate opportunities for
further strategic collaborations of asset acquisitions.
PIPELINE DEVELOPMENT OPPORTUNITIES
In addition to the recent Amorcyte acquisition, NeoStem is pursuing development of proprietary
therapeutic candidates through two stem cell platforms, the Athelos joint venture and VSEL technology.
While these programs are still early in development, we believe that they further demonstrate
NeoStem's renewed focus on high-value therapeutic candidates. We expect increasing visibility from
both of these platforms over the next 12-18 months but currently view these assets as upside to our
valuation.
Athelos
Athelos is a joint venture between NeoStem and Beckton Dickinson, of which NeoStem holds 80%
ownership. The joint venture was established to focus on development of cellular therapeutics for a
range of autoimmune diseases. These therapeutics are based on restoring the balance between T
effector cells and T regulatory (T reg) cells, an imbalance of which is thought to result in, or at least
contribute to, immune-mediated and autoimmune diseases. While there is recognition that T reg cells
can suppress immune responses, clinical application of this effect has been challenged by cell scarcity,
activity, and lack of specificity. Athelos is pursuing an approach that is intended to enhance both T reg
cell numbers and function. In this approach, T reg cells are harvested from peripheral and/or cord blood
by apheresis and isolated using surface markers including CD4+, CD25+, and FoxP3+. The cells are
then activated and expanded before being re-administered to the patient.
There are currently several investigator-led INDs exploring T reg cells and Athelos is planning to begin
Phase I trials in 2012 for the most promising candidates as determined by these ongoing studies.
Target indications currently being considered include graft-vs.-host disease (GvHD), solid organ
transplant rejection, and autoimmune diseases including asthma and diabetes. The intellectual property
covering the Athelos product candidates was in-licensed from the University of Pennsylvania and
University of Southern California, providing worldwide rights to approximately 30 issued patents and 50
pending patent applications. This broad intellectual property estate includes composition of matter and
method patents.
VSEL Technology
VSEL (Very Small Embryonic Like) stem cell technology is NeoStem's novel, proprietary approach to
cellular therapeutics. This cell population has many of the properties of embryonic stem cells
(pluripotent) but can be harvested from a patient's bone marrow or peripheral or cord blood. Importantly,
these cells do not undergo inducted pluripotency. Preliminary data support that significant quantities of
VSEL stem cells can be harvested from peripheral blood utilizing granulocyte-colony stimulating factor
(GCSF), and storage is straightforward through cryopreservation. In addition, data have been generated
providing evidence that VSEL stem cells are mobilized by the body in response to injury or stress
including acute myocardial infarction and stroke. The cells have also been shown to migrate to sites of
injury and, importantly, then differentiate into target cell types.
NeoStem licensed the VSEL technology from the University of Louisville, gaining worldwide rights to a
patent estate covering cell isolation, purification, and therapeutic use. We believe this technology may
have application in multiple regenerative medicine opportunities and look to gain further visibility on
clinical development plans.
11. 11
CHINA OPERATIONS
NeoStem's activities in China are focused in two areas: 1) expansion of its stem cell technologies into
this geography and 2) Suzhou Erye, a pharmaceuticals division 51% owned by the company. We view
the company's China operations as non-core assets and do not expect it to commit substantial capital to
these efforts going forward. Furthermore, we believe that the intended divesture of Suzhou Erye will be
a source of cash, strengthening NeoStem's balance sheet to fund further clinical advancement of its
high-value therapeutic programs.
Suzhou Erye
NeoStem acquired a 51% controlling interest in Suzhou Erye in 2009, since which time it has grown
revenues at a CAGR of approximately 30%. Suzhou Erye was established in the 1960s and has more
than 160 approved products that it sells in China. Most products in Suzhou Erye's portfolio are
antibiotics, with more than 90% of revenues being derived from products containing penicillin or
cephalosporin as the key active ingredient. The Chinese pharmaceutical industry has been growing
rapidly at an annual rate of over 20% for the past 10 years, reaching $184 billion in 2010, according to
the Chinese State Department. Infectious diseases are an important therapeutic area in the country,
and drug sales from this category contribute 24% of total hospital drug sales. Within this, antibiotics are
a major drug category representing an estimated market size of $12 billion in 2009, according to the
Chinese State Food and Drug Administration (SFDA).
Regenerative Medicine
NeoStem has expanded its stem cell technology applications to China, where the company has ongoing
initiatives to advance cellular therapies in regenerative medicine. Since 2009, the company has initiated
and completed construction of a stem cell research and development laboratory and processing and
manufacturing facility in Beijing. In addition, it has in-licensed several cellular therapeutic development
candidates and has begun to establish relationships with hospitals in China to advance these therapies,
specifically, the company’s proprietary autologous mesenchymal stem cells extracted from bone
marrow for use in orthopedic indications. In 2010, NeoStem formed a collaboration with Shandong
Wendeng Orthopaedic Hospital to offer cellular-based orthopaedic treatments. Following this, additional
collaborations were formed with Shijiazhuang Third Hospital, in the provincial capital of Hebei Province,
and Tianjin Nankai Hospital, located approximately 80 miles from Beijing.
MANAGEMENT
Robin L. Smith, M.D., MBA
Chairman & Chief Executive Officer
Dr. Smith joined NeoStem in September 2005 as Chairman of its Advisory Board and in June 2006 was
appointed CEO and Chairman of the Board. Prior to joining the company, from 2000 to 2003, Dr. Smith
served as President and CEO of IP2M, a multi-platform media company specializing in healthcare sold
to a publicly-traded company in 2003. Previously, from 1998 to 2000, she was Executive Vice President
and CMO of HealthHelp, Inc., a National Radiology Management company that managed 14% of the
healthcare dollars spent by large insurance companies. In addition, Dr. Smith currently serves on the
Board of Trustees of the NYU Medical Center Board and is past Chairman of the Board of Directors for
the New York University Hospital for Joint Diseases. She is also the President and serves on the Board
of Directors of The Stem for Life Foundation. Dr. Smith received a medical degree from Yale University
in 1992 and a master's degree in business administration from the Wharton School in 1997.
Andrew L. Pecora, M.D., F.A.C.P.
Chief Medical Officer
Dr. Pecora joined NeoStem following the company's acquisition of Progenitor Cell Therapies, where he
was Chairman and Chief Executive Officer. In addition, Dr. Pecora currently serves as Vice President of
Cancer Services and Chief Innovations Officer of the John Theurer Cancer Center at Hackensack
University Medical Center (HUMC) and Co-Managing Partner of the Northern New Jersey Cancer
Center, a private physicians practice group affiliated with HUMC. He is a Professor of Medicine at the
University of Medicine and Dentistry of New Jersey. He also serves as Chairman of the Board of
12. 12
Directors of Tetralogics, a private venture-funded biotechnology company developing small molecules
for cancer therapy, and of Cancer Genetics, a private venture-funded cancer diagnostics company. Dr.
Pecora received his medical degree from the University of Medicine and Dentistry of New Jersey and
completed his medical education in internal medicine at New York Hospital and in hematology and
oncology at Memorial Sloan-Kettering Cancer Center. He is board certified in internal medicine,
hematology, and oncology.
Robert A. Preti, Ph.D.
President and Chief Scientific Officer, Progenitor Cell Therapy
Dr. Preti joined NeoStem following the company's acquisition of Progenitor Cell Therapies where he
was co-founder, President, and Chief Scientific Officer. Previously, Dr. Preti served as Scientific and
Laboratory Director of Hackensack University Medical Center's stem cell processing and research
laboratory and Scientific Director of the Clinical Services Division at the New York Blood Center. Dr.
Preti is a founding member of the International Society for Cellular Therapies (ISCT, formerly the
International Society for Hematotherapy and Graft Engineering) and also serves on professional, state,
and federal regulatory committees charged with the development and refinement of regulations for the
developing field of cellular therapy. Dr. Preti received his Doctor of Philosophy degree from New York
University.
Jason Kolbert, MBA
Vice President of Strategic Business Development
Jason Kolbert joined NeoStem in March 2011 as Vice President of Strategic Business Development.
Prior to joining NeoStem, Mr. Kolbert spent 16 years on Wall Street as a sell side and buy side analyst
focused on biotechnology companies. Most recently, he was a managing director of National Securities
where he founded the firm's research effort in emerging biotechnology companies. Before his career on
Wall Street, Mr. Kolbert spent several years in the pharmaceutical industry with Schering-Plough in
Japan. Mr. Kolbert has an undergraduate degree in Chemistry (New Paltz) and an MBA in Finance
(University of New Haven).
Larry A. May
Chief Financial Officer
Mr. May joined NeoStem in 2003 and was appointed CFO in 2006 following the company's acquisition
of NS California where he had served as CFO and then CEO. Previously, from 2000 to 2003, Mr. May
served as the CFO of Saronyx, Inc., a company focused on developing productivity tools and secure
communication systems for research scientists. From 1998 to 2000, Mr. May served as the Senior Vice
President, Finance and Chief Financial Officer of Biosource International, Inc., a provider of biologic
research reagents and assays. He is the former Treasurer of Amgen where he served in roles of
increasing responsibility from 1983 to 1998, including as Corporate Controller (1983 to 1988), Vice
President/Corporate Controller/Chief Accounting Officer (1988 to 1997), and Vice President/Treasurer
(1997 to 1998). Mr. May received a Bachelor of Science degree in Business Administration &
Accounting from the University of Missouri.
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