1) NeoStem will begin a Phase II clinical trial of its product AMR-001 for the treatment of Acute Myocardial Infarction by the fourth quarter of 2011. AMR-001 uses enriched bone marrow derived stem cells to increase blood flow in heart muscle and limit damage after a heart attack.
2) China pharmaceutical sales for NeoStem were down in the second quarter due to a strategic decision to discontinue certain low margin products, but are expected to rebound.
3) NeoStem is transitioning to focus on cellular therapeutics and stem cell services through acquisitions like Progenitor Cell Therapy, while exploring options for non-core assets such as its Chinese
BioNeutral Group (OTCBB: BONU) is a specialty technology-based life science company which has developed a technology platform that neutralizes harmful environmental contaminants, toxins and dangerous micro-organisms including bacteria, viruses, mold, fungi and spores. BioNeutral's products, Ygiene™ and Ogiene™, kill germs and clean surfaces with a dramatic increase in speed and power over their rivals in the marketplace.
BioNeutral Group (OTCBB: BONU) is a specialty technology-based life science company which has developed a technology platform that neutralizes harmful environmental contaminants, toxins and dangerous micro-organisms including bacteria, viruses, mold, fungi and spores. BioNeutral's products, Ygiene™ and Ogiene™, kill germs and clean surfaces with a dramatic increase in speed and power over their rivals in the marketplace.
El siguiente trabajo muestra el contenido sobre el tema: "LAS APPS". Elaborado como uno de los puntos importantes de un trabajo final. Esperando sirva de apoyo academico.
Caprock: "We are initiating coverage on Pegasi Energy Resources Corporation with a
STRONG BUY rating and with a 12-month price target of $1.50. We believe PGSI’s shares offer investors a unique and favorable risk/reward profile."
Në barrën e keqkuptimeve që, me kalimin e shekujve, vijnë duke u shtuar mbi marrëdhëniet e
Perëndimit me vendet ballkanike, bën pjesë edhe përçmimi për thuajse gjithë sa është
ballkanike, duke e përfillur këtë rajon si vis pa qytetërim "oksidental". Duke i veshur
Ballkanit prirjen për të përmbysur situatat gjeopolitike të Europës, intelektualë mediokër të
Perëndimit europian i fajësojnë popujt ballkanikë për mynxyra deri nga ato që s'i nxë mendja.
Analistët madje flasin rëndom për "bal kanizim", në një kuptim fortësisht pejorativ, për të
dëftuar gjithë sa, në doke, në kulturë dhe në nivelin e jetesës, i kundërvihet Perëndimit "të
tyre". Kështu Ballkani, më shumë se një rajon, është bërë një problem, duke qenë fjala për një
"Ballkan" që ekziston më së shumti në mendje, se në terren.
Në një situatë të tillë është bërë tanimë detyrë të thyerit e mjaft prej modeleve me të cilat janë
modeluar faktet e historisë botërore përkundrejt historisë së rajonit tonë, posaçërisht të atyre
modeleve që përftojnë një shembëlltyrë të shformuar mbi zhvillimin e historisë europiane në
të cilën Lindja shfaqet si një periferi e Perëndimit. Sidomos "ne ballkanikët" s'kemi më se
përse të vijojmë duke pranuar një histori të njerëzimit siç është shkruar në mënyrë diverguese
vetëm prej "popujve të mëdhenj", një histori që e vështron rajonin tonë si një "botë shtojcë", e
cila gjallin jashtë qendrës së historisë botërore të identifikuar me një traditë vetëm e vetëm
"oksidentale".
NeoStem, Inc. (AMEX: NBS; Stock Twits: $NBS) is engaged in the development and manufacturing of cell-based therapies in the U.S. Its January 2011 acquisition of Progenitor Cell Therapy, LLC ("PCT") is central to the Company's strategic mission of capturing the paradigm shift to cell therapy. The acquisition of PCT gives NeoStem not only access to a world class contract manufacturing cell therapy company but provides a platform and expertise around the evaluation, development and regulatory requirements to develop autologous, allogeneic, immunomodulatory and vaccine-based therapeutics. NeoStem also holds the worldwide exclusive license to VSEL(TM) Technology, which uses very small embryonic-like stem cells, shown to have several physical characteristics that are generally found in embryonic stem cells, and is pursuing the licensing of other technologies for therapeutic use.
Headquartered in San Francisco, JMP Securities was founded in January 2000 in response to the consolidation of established independent research boutiques by large commercial banks. Since the mid-1990s nearly 50 regional investment banks—including San Francisco’s Montgomery Securities, Hambrecht & Quist and Robertson Stephens—have been acquired by major financial institutions. Such industry consolidation has pressured a new breed of bulge-bracket investment banks to compete for large market-capitalization clients and has greatly reduced Wall Street’s focus on the middle market. JMP Securities was formed in the mold of its independent, research-driven predecessors as a growth-oriented, entrepreneurial firm dedicated to serving the needs of small and midsized companies and the institutions that invest in them.
The report contains the following four chapters:
Chapter 1: Global Pharmaceutical Market
Chapter 2: Solutions to Challenges
Chapter 3: Global Players
Chapter 4: Overview of Industry Trends
You may follow my blog: biostrategyanalytics.wordpress.com for further posts related to financial and strategic issues in the Pharmaceutical / Biotechnology sector.
For any questions or recommendations do not hesitate to contact me.
Despite facing stringent regulatory limitations and ethical concerns, the stem cell regeneration is witnessing a welcoming change in terms of increased awareness, formulation of regulations and regulatory acceptance. According to the latest research conducted by Infinity Research Limited, the global stem cell industry is poised to grow at a CAGR of whooping 36.52% by 2021, attracting a lot of interest.
Here is a look at the top 5 promising U.S listed stem cell stocks .
El siguiente trabajo muestra el contenido sobre el tema: "LAS APPS". Elaborado como uno de los puntos importantes de un trabajo final. Esperando sirva de apoyo academico.
Caprock: "We are initiating coverage on Pegasi Energy Resources Corporation with a
STRONG BUY rating and with a 12-month price target of $1.50. We believe PGSI’s shares offer investors a unique and favorable risk/reward profile."
Në barrën e keqkuptimeve që, me kalimin e shekujve, vijnë duke u shtuar mbi marrëdhëniet e
Perëndimit me vendet ballkanike, bën pjesë edhe përçmimi për thuajse gjithë sa është
ballkanike, duke e përfillur këtë rajon si vis pa qytetërim "oksidental". Duke i veshur
Ballkanit prirjen për të përmbysur situatat gjeopolitike të Europës, intelektualë mediokër të
Perëndimit europian i fajësojnë popujt ballkanikë për mynxyra deri nga ato që s'i nxë mendja.
Analistët madje flasin rëndom për "bal kanizim", në një kuptim fortësisht pejorativ, për të
dëftuar gjithë sa, në doke, në kulturë dhe në nivelin e jetesës, i kundërvihet Perëndimit "të
tyre". Kështu Ballkani, më shumë se një rajon, është bërë një problem, duke qenë fjala për një
"Ballkan" që ekziston më së shumti në mendje, se në terren.
Në një situatë të tillë është bërë tanimë detyrë të thyerit e mjaft prej modeleve me të cilat janë
modeluar faktet e historisë botërore përkundrejt historisë së rajonit tonë, posaçërisht të atyre
modeleve që përftojnë një shembëlltyrë të shformuar mbi zhvillimin e historisë europiane në
të cilën Lindja shfaqet si një periferi e Perëndimit. Sidomos "ne ballkanikët" s'kemi më se
përse të vijojmë duke pranuar një histori të njerëzimit siç është shkruar në mënyrë diverguese
vetëm prej "popujve të mëdhenj", një histori që e vështron rajonin tonë si një "botë shtojcë", e
cila gjallin jashtë qendrës së historisë botërore të identifikuar me një traditë vetëm e vetëm
"oksidentale".
NeoStem, Inc. (AMEX: NBS; Stock Twits: $NBS) is engaged in the development and manufacturing of cell-based therapies in the U.S. Its January 2011 acquisition of Progenitor Cell Therapy, LLC ("PCT") is central to the Company's strategic mission of capturing the paradigm shift to cell therapy. The acquisition of PCT gives NeoStem not only access to a world class contract manufacturing cell therapy company but provides a platform and expertise around the evaluation, development and regulatory requirements to develop autologous, allogeneic, immunomodulatory and vaccine-based therapeutics. NeoStem also holds the worldwide exclusive license to VSEL(TM) Technology, which uses very small embryonic-like stem cells, shown to have several physical characteristics that are generally found in embryonic stem cells, and is pursuing the licensing of other technologies for therapeutic use.
Headquartered in San Francisco, JMP Securities was founded in January 2000 in response to the consolidation of established independent research boutiques by large commercial banks. Since the mid-1990s nearly 50 regional investment banks—including San Francisco’s Montgomery Securities, Hambrecht & Quist and Robertson Stephens—have been acquired by major financial institutions. Such industry consolidation has pressured a new breed of bulge-bracket investment banks to compete for large market-capitalization clients and has greatly reduced Wall Street’s focus on the middle market. JMP Securities was formed in the mold of its independent, research-driven predecessors as a growth-oriented, entrepreneurial firm dedicated to serving the needs of small and midsized companies and the institutions that invest in them.
The report contains the following four chapters:
Chapter 1: Global Pharmaceutical Market
Chapter 2: Solutions to Challenges
Chapter 3: Global Players
Chapter 4: Overview of Industry Trends
You may follow my blog: biostrategyanalytics.wordpress.com for further posts related to financial and strategic issues in the Pharmaceutical / Biotechnology sector.
For any questions or recommendations do not hesitate to contact me.
Despite facing stringent regulatory limitations and ethical concerns, the stem cell regeneration is witnessing a welcoming change in terms of increased awareness, formulation of regulations and regulatory acceptance. According to the latest research conducted by Infinity Research Limited, the global stem cell industry is poised to grow at a CAGR of whooping 36.52% by 2021, attracting a lot of interest.
Here is a look at the top 5 promising U.S listed stem cell stocks .
NeoStem, Inc. (AMEX: NBS; Stock Twits: $NBS) is engaged in the development and manufacturing of cell-based therapies in the U.S. Its January 2011 acquisition of Progenitor Cell Therapy, LLC ("PCT") is central to the Company's strategic mission of capturing the paradigm shift to cell therapy.
Suresh Gopalan - AstraZeneca Business Strategy Evaluation/Recommendations (Ap...Suresh Gopalan
This is an evaluation/recommendations on the business strategy of AstraZeneca (in April 2013) that I prepared for Foundations of Business Strategy course @Coursera. The report was highly appreciated by an executive in AstraZeneca for insightful content and accuracy. Did not have time for finishing touches - misunderstanding of timezone deadline. I would like to draw your attention especially to Exhibit 5.
Maxim Group research coverage on Medgenics (NYSE AMEX: MDGN), which is developing and commercializing Biopump, a proprietary tissue-based platform technology for the sustained production and delivery of therapeutic proteins using the patient's own skin biopsy for the treatment of a range of chronic diseases including anemia, hepatitis C and hemophilia. Medgenics believes this approach has multiple benefits compared with current treatments, which include regular and costly injections of therapeutic proteins.
FORM 8-K. Filed 05/07/12 for the Period Ending 05/07/12. A PowerPoint presentation that Ventrus Biosciences, Inc. will present at the 37th Annual Deutsche Bank Health Care Conference in Boston, MA on Monday, May 7, 2012.
Sections include: Company Overview --- Focus on Fibromyalgia and Post-Traumatic Stress Disorder. Large Markets with Unmet Need --- Novel Formulation Technology Applied to Known Ingredients = Better Drugs --- Robust Product Pipeline with Nearterm Milestones, and more.
Early this morning, SunSi announced it is acquiring 51% of
TransPacific Energy, Inc., a U.S.-based company that
designs and sells energy systems which maximize heat
recovery and convert waste heat into electrical energy.
APDN sells patented DNA security solutions to protect products, brands and intellectual property from counterfeiting and diversion. SigNature DNA is a botanical mark used to authenticate products in a unique manner that essentially cannot be copied. Our mark provides a forensic chain of evidence that can be used to prosecute perpetrators. To learn more, go to www.adnas.com where APDN routinely posts all press releases.
VAT Registration Outlined In UAE: Benefits and Requirementsuae taxgpt
Vat Registration is a legal obligation for businesses meeting the threshold requirement, helping companies avoid fines and ramifications. Contact now!
https://viralsocialtrends.com/vat-registration-outlined-in-uae/
Implicitly or explicitly all competing businesses employ a strategy to select a mix
of marketing resources. Formulating such competitive strategies fundamentally
involves recognizing relationships between elements of the marketing mix (e.g.,
price and product quality), as well as assessing competitive and market conditions
(i.e., industry structure in the language of economics).
The world of search engine optimization (SEO) is buzzing with discussions after Google confirmed that around 2,500 leaked internal documents related to its Search feature are indeed authentic. The revelation has sparked significant concerns within the SEO community. The leaked documents were initially reported by SEO experts Rand Fishkin and Mike King, igniting widespread analysis and discourse. For More Info:- https://news.arihantwebtech.com/search-disrupted-googles-leaked-documents-rock-the-seo-world/
Building Your Employer Brand with Social MediaLuanWise
Presented at The Global HR Summit, 6th June 2024
In this keynote, Luan Wise will provide invaluable insights to elevate your employer brand on social media platforms including LinkedIn, Facebook, Instagram, X (formerly Twitter) and TikTok. You'll learn how compelling content can authentically showcase your company culture, values, and employee experiences to support your talent acquisition and retention objectives. Additionally, you'll understand the power of employee advocacy to amplify reach and engagement – helping to position your organization as an employer of choice in today's competitive talent landscape.
In the Adani-Hindenburg case, what is SEBI investigating.pptxAdani case
Adani SEBI investigation revealed that the latter had sought information from five foreign jurisdictions concerning the holdings of the firm’s foreign portfolio investors (FPIs) in relation to the alleged violations of the MPS Regulations. Nevertheless, the economic interest of the twelve FPIs based in tax haven jurisdictions still needs to be determined. The Adani Group firms classed these FPIs as public shareholders. According to Hindenburg, FPIs were used to get around regulatory standards.
Top mailing list providers in the USA.pptxJeremyPeirce1
Discover the top mailing list providers in the USA, offering targeted lists, segmentation, and analytics to optimize your marketing campaigns and drive engagement.
Recruiting in the Digital Age: A Social Media MasterclassLuanWise
In this masterclass, presented at the Global HR Summit on 5th June 2024, Luan Wise explored the essential features of social media platforms that support talent acquisition, including LinkedIn, Facebook, Instagram, X (formerly Twitter) and TikTok.
Event Report - SAP Sapphire 2024 Orlando - lots of innovation and old challengesHolger Mueller
Holger Mueller of Constellation Research shares his key takeaways from SAP's Sapphire confernece, held in Orlando, June 3rd till 5th 2024, in the Orange Convention Center.
Personal Brand Statement:
As an Army veteran dedicated to lifelong learning, I bring a disciplined, strategic mindset to my pursuits. I am constantly expanding my knowledge to innovate and lead effectively. My journey is driven by a commitment to excellence, and to make a meaningful impact in the world.
LA HUG - Video Testimonials with Chynna Morgan - June 2024Lital Barkan
Have you ever heard that user-generated content or video testimonials can take your brand to the next level? We will explore how you can effectively use video testimonials to leverage and boost your sales, content strategy, and increase your CRM data.🤯
We will dig deeper into:
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An introduction to the cryptocurrency investment platform Binance Savings.Any kyc Account
Learn how to use Binance Savings to expand your bitcoin holdings. Discover how to maximize your earnings on one of the most reliable cryptocurrency exchange platforms, as well as how to earn interest on your cryptocurrency holdings and the various savings choices available.
[Note: This is a partial preview. To download this presentation, visit:
https://www.oeconsulting.com.sg/training-presentations]
Sustainability has become an increasingly critical topic as the world recognizes the need to protect our planet and its resources for future generations. Sustainability means meeting our current needs without compromising the ability of future generations to meet theirs. It involves long-term planning and consideration of the consequences of our actions. The goal is to create strategies that ensure the long-term viability of People, Planet, and Profit.
Leading companies such as Nike, Toyota, and Siemens are prioritizing sustainable innovation in their business models, setting an example for others to follow. In this Sustainability training presentation, you will learn key concepts, principles, and practices of sustainability applicable across industries. This training aims to create awareness and educate employees, senior executives, consultants, and other key stakeholders, including investors, policymakers, and supply chain partners, on the importance and implementation of sustainability.
LEARNING OBJECTIVES
1. Develop a comprehensive understanding of the fundamental principles and concepts that form the foundation of sustainability within corporate environments.
2. Explore the sustainability implementation model, focusing on effective measures and reporting strategies to track and communicate sustainability efforts.
3. Identify and define best practices and critical success factors essential for achieving sustainability goals within organizations.
CONTENTS
1. Introduction and Key Concepts of Sustainability
2. Principles and Practices of Sustainability
3. Measures and Reporting in Sustainability
4. Sustainability Implementation & Best Practices
To download the complete presentation, visit: https://www.oeconsulting.com.sg/training-presentations
Kseniya Leshchenko: Shared development support service model as the way to ma...Lviv Startup Club
Kseniya Leshchenko: Shared development support service model as the way to make small projects with small budgets profitable for the company (UA)
Kyiv PMDay 2024 Summer
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Understanding User Needs and Satisfying ThemAggregage
https://www.productmanagementtoday.com/frs/26903918/understanding-user-needs-and-satisfying-them
We know we want to create products which our customers find to be valuable. Whether we label it as customer-centric or product-led depends on how long we've been doing product management. There are three challenges we face when doing this. The obvious challenge is figuring out what our users need; the non-obvious challenges are in creating a shared understanding of those needs and in sensing if what we're doing is meeting those needs.
In this webinar, we won't focus on the research methods for discovering user-needs. We will focus on synthesis of the needs we discover, communication and alignment tools, and how we operationalize addressing those needs.
Industry expert Scott Sehlhorst will:
• Introduce a taxonomy for user goals with real world examples
• Present the Onion Diagram, a tool for contextualizing task-level goals
• Illustrate how customer journey maps capture activity-level and task-level goals
• Demonstrate the best approach to selection and prioritization of user-goals to address
• Highlight the crucial benchmarks, observable changes, in ensuring fulfillment of customer needs
Premium MEAN Stack Development Solutions for Modern BusinessesSynapseIndia
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LifeTech Capital Updates NeoStem (NBS) Strong Buy $4.00 Target
1. Unlocking the Value of Science ™ Boca Raton San Francisco New York
NeoStem, Inc. (NBS)
UPDATE REPORT
August 24, 2011 AMR-001 Phase II Trial in AMI (Heart Attack) to Begin Q4
Rating Target China Pharma Sales Down on Strategic Mix Adjustment
Strong Buy $4.00 Continuing Transition to a Therapeutics-Focused Company
Analyst
Stephen M. Dunn 1.) AMR-001 to Begin Phase II Trial: Through the recent acquisition of
Sr. Managing Director Research Amorcyte (private), NeoStem gained all rights to the company’s lead
sdunn@LifeTechCapital.com development candidate AMR-001, an autologous, bone marrow derived,
(954) 240-9968 pharmaceutical grade cell-based product. AMR-001, is expected to initiate a
William D. Dawson Phase II trial in Acute Myocardial Infarction (AMI) by Q4’11 and initiate a
Senior VP Research Phase I trial in congestive heart failure during 2012. The AMI Phase II trial is
wdawson@LifeTechCapital.com expected to complete enrollment within 12 months with top-line data 6
(561) 504-5818 months after the last patient is treated or mid-2013.
2.) Suzhou Erye Revenues Down for Q2 2011: China pharmaceutical
revenues for Q2 2011 were $16.2M as compared to $18.1M Q1 2011 and
$19.4M in prior year Q2. The lower sales are reflective of a strategic decision
by management to discontinue selling certain pharmaceutical intermediates, in
order to create capacity within the existing production lines for higher margin
products in the future. Management expects these decreases in sales to be
temporary. It is important for investors to note that management is presently
Symbol: NBS considering multiple strategies in respect to its majority interest in Suzhou
Market: NYSE Amex Equities Erye Pharmaceutical Co. including its possible divestiture (see Possible Sale
420 Lexington Avenue, of Eyre Pharmaceuticals)
Suite 450
New York, NY 10170 3.) Transition to Cellular Therapeutics Company: While R&D efforts are
(212) 584-4180 ongoing in the U.S., including VSEL™ technology (Very Small Embryonic
www.neostem.com Like), AMR-001 therapy for AMI and Athelos T-cell therapy, NeoStem
CEO – Dr. Robin L. Smith already has commercialized adult stem cell therapies in China with
CFO – Larry A. May indications such as orthopedics, wellness, cosmetic & anti-aging. The
acquisition activity during the past year has highlighted managements desire
to transform NeoStem into a leading international provider (cont. next page)
Market Data Share Data Most Recent Quarter
Price $0.65 Outstanding 98.0M* Revenue $18.5M
52-Week $0.60-$2.15 Cash/Share $0.21* Net Income ($10.8M)
Market Cap $63.7M* Book/Share $0.44* EPS ($0.13)
Avg. Daily Vol. 615,500 Price/Book 1.5x* Cash $20.4M*
% Short 3.0%* Debt/Share $0.40* Debt $38.8M
Financial Results and Projections
FYE Dec. 31 2009 2010 2011E 2012E 2013E
Revenue $11.5M $69.8M $82.9M $96.5M $112.4M
Net Income ($30.9M) ($23.5M) ($41.6M) ($38.8M) ($37.9M)
EPS ($2.38) ($0.46) ($0.52) ($0.38) ($0.31)
* Includes 13.8M shares for $15.5M net cash proceeds from 7/22/11 financing
Please see last two pages for important disclosures and analyst certification
NeoStem, Inc (NBS) Page 1
2. www.LifeTechCapital.com August 24, 2011
3.) Transition to Cellular Therapeutics Company (continued): …of cell based therapies and a premier stem cell
service provider through the Progenitor Cell Therapy division. The company is exploring different ways to achieve this
transition including the possible sale of non-core assets such as their majority interest in Suzhou Erye Pharmaceutical Co.
4.) We are maintaining our Strong Buy rating and 12-18 month Price Target of $4.00 based on a 35x multiple on
projected 2017 earnings and discounted 30% to adjust for risk: We have made changes to our financial model
reflecting management’s new business development goals moving forward. We are now including AMR-001 for Acute
Myocardial Infarction (AMI) in our model and accordingly we have raised our discount rate from 20% to 30% to account
for the clinical development risk. We have extended stem cell-based revenues into 2017 where we expect to see growth
driven by both Progenitor Cell Therapy services and approved stem cell therapies in China. Suzhou Erye Pharmaceutical
Co. continues to be a significant revenue generator for NeoStem while management is currently exploring the
monetization of the asset.
Company Description
New York, NY-based NeoStem is a multi-faceted, multinational medical company.
Among their business are adult stem cell collection, processing and storage in the
U.S., research and development for diagnostic and therapeutic applications using
autologous adult stem cells, including their VSEL™ technology (very small
embryonic-like stem cells) and several China-based, adult stem cell therapeutics
operational and R&D activities for adult stem cell therapeutics focused on regenerative medicine. In addition, NeoStem
and the Vatican's Pontifical Council for Culture announced a joint initiative with their charitable foundations to expand
research and raise awareness of adult stem cell therapies. A 3-day international conference at the Vatican on adult stem
cell research, including VSEL™ technology, is planned for 2011 and will focus on medical research presentations and
theological and philosophical considerations and implications of scientific achievements.
In addition to NeoStem’s adult stem cell business in the U.S. and China, NeoStem acquired 51% of Chinese
pharmaceutical company Suzhou Erye Pharmaceuticals in October 2009. Erye is over 50 years old and manufactures and
distributes generic antibiotic products with sales of $70 million during 2010. They have 160+ production certificates from
the Chinese State Food and Drug Administration (SFDA) for both antibiotic prescription drugs and active pharmaceutical
intermediates (APIs).
In January 2011, NeoStem completed their acquisition of Progenitor Cell Therapy (PCT), an internationally recognized
cell therapy services and development company that, through its cell therapy manufacturing facilities and team of
professionals, facilitates the preclinical and clinical development and eventual commercialization of cellular therapies for
clients in the United States and internationally. PCT offers cGMP-compliant cell transportation, manufacturing, storage
and distribution services and supporting clinical trial design, process development, logistics, and regulatory and quality
systems development services.
Finally, on July 14, 2011 NeoStem announced a definitive merger agreement to acquire Amorcyte (private). Amorcyte’s
lead development candidate, AMR-001 is an autologous, bone marrow derived, pharmaceutical grade cell-based product
that uses a CD34+CXCR4+ enriched cell population and is thought to limit the damage of heart muscle that develops
following Acute Myocardial Infarction (AMI). AMR-001 has completed Phase I safety studies and is currently scheduled
to start enrolling for a Phase II study in AMI in Q4, 2011.
AMR-001 (Amorcyte Acquisition)
On July 14, 2011, NeoStem announced a definitive merger agreement to acquire Amorcyte (private) whose lead
candidate, AMR-001, is expected to initiate a Phase II trial in Acute Myocardial Infarction (AMI) by Q4’11 and
initiate a Phase I trial in congestive heart failure during 2012. The AMI Phase II trial is expected to complete
enrollment within 12 months with top-line data 6 months after the last patient is treated or mid-2013.
NeoStem, Inc. (NBS) Page 2
3. www.LifeTechCapital.com August 24, 2011
About AMR-001
AMR-001 is an autologous, bone marrow derived, pharmaceutical grade cell-based product that uses a CD34+CXCR4+
enriched cell population and is thought to limit the damage of heart muscle that develops following AMI.
Mechanism of Action
AMR-001 works by increasing microvascular blood flow in the myocardium via neoangiogenesis, thereby reversing post-
infarct ischemia and rescuing tissue from hibernation and preventing eventual death (apoptosis):
CD34+CXCR4+ cells are harvested from the patient’s own bone marrow and isolated to increase potency
The selected cells are infused via the infarct-related artery 6-10 days following the ST-Elevation MI (STEMI) –the
optimal time frame for cellular intervention, after the pro-inflammatory “hot phase” and prior to permanent scar
formation
The infused CD34+CXCR4+ cells home to the at-risk tissue via the SDF-1 (Stromal Cell-Derived Factor-1)
gradient, inducing neoangiogenesis and a resultant functional benefit
CD34+CXCR4+ Cells are a Natural Repair Mechanism
1.) A distress signal (hypoxia-inducible
factors or HIF) is induced by hypoxia in the
peri-infarct zone
2.) HIF induces synthesis of SDF and
VEGF, which mobilize CD34+CXCR4+
cells
3.) The mobilized cells are trophic to the
peri-infarct zone, preventing apoptosis and
effecting neoangiogenesis
Source: NeoStem Inc.
Phase I Clinical Trial Results
The Phase I clinical trial results of AMR-001 for Acute Myocardial Infarction (AMI) were published in the January 2011
issue of the American Heart Journal in a paper titled “CD34+ cell infusion after ST elevation myocardial infarction is
associated with improved perfusion and is dose dependent” which is summarized below:
Background: The objective of the study was to determine whether the effects of infarct-related artery (IRA) infusion of
autologous bone marrow–derived CD34+ cells after ST elevation myocardial infarction (STEMI) are dependent on the
dose (quantity and mobility) of the cells infused. Beneficial effects of IRA infusion of mononuclear cells after STEMI
have been inconsistent, possibly because of differences in timing, cell type, quantity, and mobility of infused cells.
Methods: Patients were randomized to bone marrow harvest (n = 16) or control (n = 15). At a median of 8.3 days after
coronary stenting for STEMI, CD34+ cells were infused via the IRA at 3 dose levels (5, 10, and 15 × 106) in cohorts of 5
patients each. Baseline and follow-up imaging and ex vivo CD34+ cell mobility were performed.
Results: Cell harvest and infusion were safe. Quantitative rest hypoperfusion score measured by single-photon emission
computed tomography improved at 6 months in the ≥10 million cohorts compared with controls (−256 vs +14, P = .02).
There was a trend toward improved ejection fraction at 6 months (+4.5%) in the ≥10 million cohorts compared with no
change in the controls and 5 million cohort (+0.7%). Improved perfusion and infarct size reduction correlated with the
quantity and mobility of the infused CD34+ cells.
NeoStem, Inc. (NBS) Page 3
4. www.LifeTechCapital.com August 24, 2011
Conclusions: The effects of CD34+ cell IRA infusion during the repair phase after STEMI are dose dependent and,
at a threshold dose of 10 million CD34+ cells, associated with a significant improvement in perfusion that may limit
deterioration in cardiac function.
Note: for the complete clinical trial design see http://clinicaltrials.gov/ct2/show/NCT00313339
Positive Dose Response Demonstrated
Increasing Doses of AMR-001 Reduced the Size of the Infarct Region
Increasing Doses of AMR-001 Reduced RTSS (hypoperfusion)
Source: Quyyumi AA et al “CD34+ cell infusion after ST elevation myocardial infarction is associated with improved perfusion and is dose
dependent” 2011, American Heart Journal; 161(1) 98-105 http://www.ahjonline.com/article/S0002-8703(10)00894-X/abstract
Threshold Dose of 10 Million Cells Shows Significant Improvement in Perfusion
RTSS Cohort Baseline 6 Months Change % Change
Control 259.0 273.5 +14.5 +5.6%
5M Cells 714.2 722.0 +7.8 +1.1%
10M Cells 998.6 635.8 -362.8 -36.4%
15M Cells 584.0 462.0 -122.0 -20.9%
Source: Quyyumi AA et al “CD34+ cell infusion after ST elevation myocardial infarction is associated with
improved perfusion and is dose dependent” 2011, American Heart Journal; 161(1) 98-105
http://www.ahjonline.com/article/S0002-8703(10)00894-X/abstract
Subgroup Analysis of ≥10 Million Cell Threshold on Additional Cardiac Functions
RTSS Ejection Fraction End Systolic Volume Drop in Ejection Fraction
% Change % Change % Change % Change
Control & 5M Cells +3.3% +1.3% +4.6% 30%-40%
10M & 15M Cells -31.4%* +9.4 -6.1% 0%
* Statistically Significant p=0.01
Source: Quyyumi AA et al “CD34+ cell infusion after ST elevation myocardial infarction is associated with improved perfusion and is dose dependent” 2011,
American Heart Journal; 161(1) 98-105 http://www.ahjonline.com/article/S0002-8703(10)00894-X/abstract
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Proposed Phase II Trial Design (subject to change)
The new clinical trial is to investigate the potential of AMR-001 to preserve heart muscle function post-AMI and
consequently improve both quality-of-life and longevity by reducing the incidence and severity of Major Adverse Cardiac
Events (MACE). The Phase II trial is expected to be a 150-patient U.S. multicenter, blinded, prospective, randomized,
controlled clinical trial to evaluate evaluate the efficacy and safety of a single intra-coronary infusion of ≥10 million cells
of AMR-001 after STEMI in subjects with ejection fraction of <48%, as determined by screening CMR 96 hours post
stenting.
PROPOSED PHASE II HUMAN CLINICAL TRIAL PROTOCOL
Intra-coronary Infusion of Bone Marrow Derived Autologous CD34+ Selected Cells in Patients With Acute
Title
Myocardial Infarction
Trial Design Randomized 1:1, Double-Blind, Placebo-Controlled Phase II Trial
# of Patients 150 (male and female)
Ages 18 to 75 Years
Arm 1: Placebo
Arm 2: Intra-coronary infusion of an autologous bone marrow derived CD34+ stem cell product ≥10 million cells
Primary
Increased Cardiac Perfusion (RTSS) measured by SPECT and preservation of LVEF by CMR
Endpoints
Secondary
Reduction in cumulative MACE at 12 months and 18 months, KCCQ & SAQ improvement
Endpoints
Centers 25 Centers in United States
Primary Data 18 Months (RTSS 12 months enrollment plus 6 month post-treatment)
Secondary Data 24 through 48 Months (MACE 12 months enrollment plus 12, 18, 24 and 36 months post-treatment)
Source: NeoStem Inc.
Progenitor Cell Therapy (PCT)
On January 20, 2011, NeoStem announced they had closed their acquisition
of Progenitor Cell Therapy (PCT) which will continue as a wholly-owned
subsidiary of NeoStem. PCT has served over 100 clients worldwide and has
experience with over 20 different cell based therapeutics. PCT has
performed over 30,000 cell therapy procedures in its cell therapy
manufacturing facilities and processed and stored over 18,000 cell therapy
products (including approximately 7,000 umbilical cord blood units, 10,000
blood and marrow derived stem cells and 1,000 dendritic cells) and arranged the logistics and transportation for over
14,000 cell therapy products for clinical use by over 5,000 patients. PCT Revenues for 2009 were $8.2M and $6.8M
($5.8M excluding NeoStem) YTD Q3 2010. (Investors should note that LifeTech Capital, a division of Aurora Capital
LLC, acted as financial advisor to NeoStem.)
PCT CELL THERAPY SERVICES We believe a merger with NeoStem could
provide the critical mass needed by PCT
to increase their clinical service revenues
in the future while reducing costs through
synergies with NeoStem. We also note
that NeoStem and Progenitor Cell
Therapy were already strategic partners
for autologous adult stem cell processing
and storage services under current Good
Manufacturing Practices (cGMP) standards
and the construction of a Beijing Facility,
consisting of a clean room for adult stem
Source: Progenitor Cell Therapy cell clinical trial processing, research and
development laboratory space, collection and stem cell storage area and offices, together with the furnishings and
equipment as well as quality control systems consisting of materials management, equipment maintenance and calibration,
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environmental monitoring and compliance and adult stem cell processing and preservation which comply with cGMP
standards.
Stem Cell Banking Synergies
Investors should that NeoStem and PCT were already partners for stem cell processing and long-term storage. The
acquisition allows NeoStem to now have
these capabilities as cost. In addition, PCT FACILITES (in Square Feet)
NeoStem and PCT were already partners Manufacturing Facilities Developed Undeveloped Total
in building a “Turn-Key” facility in Mountain View, California 17,425 7,599 25,024
Beijing China which can also be done at Allendale, New Jersey 22,000 8,067 30,067
cost. But perhaps even more importantly,
Total 39,425 15,666 55,091
NeoStem now has the expertise in-house Source: Progenitor Cell Therapy
to leverage for increased scalability for
their projects.
Consulting Synergies
We believe the merger with NeoStem brings PCT CELL PRODUCT EXPERIENCE
credibility and financial stability to PCT.
With the backing of a sizable, publicly-
traded company with significant revenues
(generated by China pharmaceuticals), PCT
can now bid for contract work with new and
larger clients, which in turn provides more
long-term, complex projects with higher
gross margins. Of note is that PCT played
an instrumental role in manufacturing
Dendreon’s (Nasdaq:DNDN) Provenge®
autologous cellular immunotherapy
through their clinical trials to FDA Source: Progenitor Cell Therapy
approval on April 29, 2010.
Stem Cell R&D Synergies
We believe PCT has the expertise to provide faster and cheaper development timelines for NeoStem’s stem cell therapies
including their VSEL™ development program. PCT brings considerable experience with the FDA and the regulatory
framework that will be needed to progress development.
PCT New Product & Process Development Services
Process development, optimization and scale-up Batch production record development
Cost of goods reduction Product shipping validation
Process validation Analytical test method development
Product comparability studies Product characterization
Stability studies Potency assays & Analytical test methods validation
Source: Progenitor Cell Therapy
Details can be found at: http://www.sec.gov/Archives/edgar/data/320017/000114420410066939/v205571_424b3.htm
For a limited time:
Background information can be found at: http://www.progenitorcelltherapy.com
Corporate Presentation: http://www.progenitorcelltherapy.com/~DOCUMENTS/PCT_Corporate_Presentation_11-07.pdf
Transaction Summary
On January 19, 2011 NeoStem completed its acquisition of Progenitor Cell Therapy, LLC. NeoStem acquired all of the
membership interests of PCT, and PCT is now a wholly-owned subsidiary of NeoStem. NeoStem issued 10.6M shares of
common stock for the acquisition. In addition, there are warrants to purchase between 1M and 3M shares of NeoStem
Common Stock, based on the following:
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(i) common stock purchase warrants to purchase 1,000,000 shares of NeoStem Common Stock exercisable over a
seven year period at an exercise price of $7.00 per share (the “$7.00 Warrants”), and which will vest only if a
specified business milestone is accomplished within three (3) years of the closing date and
(ii) if the volume weighted average of the closing prices of sales of NeoStem Common Stock on the NYSE-Amex
for the three (3) trading days ending on the trading day that is two (2) days prior to the Closing Date is less than
$2.50, common stock purchase warrants to purchase 1,000,000 shares of NeoStem Common Stock exercisable
over a seven year term at an exercise price of $3.00 per share (the “$3.00 Warrants”); and
(iii) if the Parent Per Share Value is less than $1.70, common stock purchase warrants to purchase 1,000,000
shares of NeoStem Common Stock exercisable over a seven year period at an exercise price of $5.00 per share
(the “$5.00 Warrants” and, collectively with the $7.00 Warrants and the $3.00 Warrants, the “Warrants”).
Background: Prior Partnership Agreements with Progenitor Cell Therapy
In January 2009, NeoStem and Progenitor Cell Therapy (PCT) entered into a Cell Processing and Storage Customer
Agreement. Under the Agreement, PCT provides NeoStem autologous adult stem cell processing and storage services
under current Good Manufacturing Practices (cGMP) standards. Under the Terms of the agreement, NeoStem agreed to
use PCT for processing and storage services for commercial purposes on an exclusive basis after PCT completed certain
preliminary services, consisting of technology transfer, protocol review, revision to ensure that the processing and storage
services are cGMP compliant, and confirmation that PCT ready and able to start the processing and storage services. The
terms were met and NeoStem announced on April 15th, 2009 that they will be utilizing Progenitor Cell Therapy, LLC
exclusively for commercial adult stem cells processing and storage operations. PCT agreed to provide to NeoStem, stem
cell processing and long term storage services for NeoStem’s business on an exclusive basis. The services are provided at
both PCT’s California and New Jersey facilities. The agreement is for four years, and is subject to early termination given
a 1 year notice.
Another agreement between the companies was constructed to include NeoStem’s business operations in China. On
December 31, 2009 NeoStem, NeoStem (China), and PCT entered into an agreement where NeoStem and NeoStem
(China) engaged PCT to:
Construct a Beijing Facility, consisting of a clean room for adult stem cell clinical trial processing and other stem
cell collections, which will have the processing capacity on an annual basis sufficient for at least 10,000 samples,
research and development laboratory space, collection and stem cell storage area and offices, together with the
furnishings and equipment.
Effect the installation of quality control systems consisting of materials management, equipment maintenance and
calibration, environmental monitoring and compliance and adult stem cell processing and preservation which
comply with cGMP standards and regulatory standards that would be applicable in the United States under Good
Tissue Practices (GTP) standards, as well as all regulatory requirements applicable to the program under the laws
of the People’s Republic of China (PRC).
The aggregate cost of the program, including the phase 1 equipment purchases, is expected to be approximately $3
million. The project commenced on April 1, 2010, and is anticipated to take until the end of 2010 to complete. NeoStem
has the option to terminate the agreement without cause with 60 days written notice to PCT. Under these circumstances
NeoStem would be required to pay for any services performed up to the date of termination and certain costs and expenses
incurred by PCT. PCT has agreed to provide at least 90 days of support services to NeoStem for an additional fee after
completion of the project, which is renewable at NeoStem's request for an additional 90 days.
Athelos (Progenitor Cell Therapy)
Through it’s acquisition of Progenitor Cell Therapy, LLC, NeoStem gained 80% ownership in Athelos, a private company
developing regulatory T cells (T-reg) as a therapeutic to treat disorders of the immune system. Imbalance of the immune
system is attributed to multiple different diseases and disorders. T-reg therapy represents a new approach to treating these
diseases by restoring balance to the immune system by enhancing T-reg cell number and function. Athelos has a strong IP
position in the T-reg field and has established a consulting relationship with David Horowitz, MD, Chief of the Division
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of Rheumatology and Immunology at the University of Southern California Keck School of Medicine. Pre-clinical and
phase I studies are underway in multiple different indications including T-reg-based therapeutics to prevent and treat Graft
vs. Host Disease, solid organ rejection as well as a broad class of other autoimmune diseases, such as asthma. There are 2
different development initiatives:
Athelos 001- a cord blood or peripheral blood derived T-reg therapy to prevent and treat GvHD and solid organ
rejection
Athelos 002- a peripheral blood derived T-reg therapy for all autoimmune disease
Results from on going trials will determine the next steps in the development of these drug candidates. Though not
included in our model or projections, investors should note that future success in these initiatives could represent potential
upside for NeoStem.
What are Stem Cells?
Stem cells have the ability to grow into different cell types in the body and when a stem cell divides, each new cell can
either remain a stem cell or become another type of cell with a more specialized function, such as a muscle cell, a red
blood cell, or a brain cell.
The two types of stem cells are embryonic and non-embryonic (also called adult stem cells) differ from their origins.
Embryonic stem cells are derived from in vitro fertilized eggs. Because of their early-stage, they are theoretically more
capable of differentiating into any required cell type. The drawbacks to embryonic stem cells are potential for tumors or
teratomas (tumorigenicity) as well as the moral and ethical issues surrounding the source.
In contrast, NeoStem utilizes non-embryonic stem cells (adult stem cells), which are undifferentiated cells within
tissue or organs that can renew and differentiate into some, or all, of the major specialized cell types of the tissue or organ.
The primary roles of adult stem cells are to maintain and repair the tissue in which they are found.
In addition, adult stem cells can be either the patients own (autologous) or donated from someone else (allogeneic).
NeoStem utilizes autologous adult stem cells which eliminates the risk of immune system attack or Graft vs. Host
Disease (GvHD).
Non-Embryonic (Adult Stem Cell) Types and Indications
Stem Cell Type Indication
These stem cells give rise to all the types of blood cells: red blood cells, B lymphocytes, T lymphocytes, natural
Hematopoietic
killer cells, neutrophils, basophils, eosinophils, monocytes, and macrophages.
These stem cells give rise to a variety of cell types: bone cells (osteocytes), cartilage cells (chondrocytes), fat
Mesenchymal
cells (adipocytes), and other kinds of connective tissue cells such as those in tendons.
These stem cells give rise to its three major cell types: nerve cells (neurons) and two categories of non-neuronal
Neural
cells—astrocytes and oligodendrocytes.
These stem cells are in the lining of the digestive tract and occur in deep crypts and give rise to several cell
Epithelial
types: absorptive cells, goblet cells, paneth cells, and enteroendocrine cells.
These stem cells occur in the basal layer of the epidermis and at the base of hair follicles. The epidermal stem
Skin cells give rise to keratinocytes, which migrate to the surface of the skin and form a protective layer. The
follicular stem cells can give rise to both the hair follicle and to the epidermis.
Source: U.S. National Institutes of Health (NIH) Resource for Stem Cell Research
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Non-Embryonic (Adult) Stem Cell Differentiation
Source: U.S. National Institutes of Health (NIH) Resource for Stem Cell Research
NeoStem VSEL™ Technology
In the US, in addition to the company’s stem cell banking VSEL™ (Very Small Embryonic Like Stem Cell)
business, NeoStem is engaged in research and development of
new therapies based on a specific type of bone marrow derived
adult stem cell called VSEL™ (Very Small Embryonic Like).
The research and development is being conducted in collaboration
with the Stem Cell Biology Program at the James Graham Brown
Cancer Center at the University of Louisville. The head of the
Stem Cell Biology Program, Dr. Mariusz Ratajczak, has shown
that bone marrow contains a natural population of stem cells that
have properties similar to those of embryonic stem cells, and that
these cells can be collected in the peripheral blood in substantial
quantity when a patient has been treated with granulocyte-colony
stimulating factor, also known as Neupogen®.
NeoStem’s VSEL technology identifies and collects circulating Source: James Graham Brown Cancer Center, University of Louisville
stem cells in the blood that have many physical characteristics typically found in embryonic stem cells using apheresis
flow cytometry. These VSELs are very small in size, around 3.6 μm across. The cells also exhibit specific cell surface
proteins (Oct-4+CXCR4+SSEA-1+Sca-1+CD45-lin-) and possess large nuclei containing unorganized chromatin
(euchromatin). When these cells are place in co-cultures with C2C12 cells, they form embryoid body-like spheres (VSEL-
DSs) that contain primitive stem cells that are capable of differentiating into cells from all three germ layers (e.g.,
myocardium, neural tissue, and pancreas).1 Data from a study by the Univeristy of Louisville and collaborators published
at the 50th annual ASH meeting in late 2008 concluded that VSELs show a similar methylation pattern to progenitor germ
cells (precursors to embryonic stem cells) in very specific regions. It is this similarity that supports their ability to
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differentiate in ways analogous to embryonic stem cell differentiation. The scientist went on to further surmise that the
developmental origin of VSEL’s is directly form the epiblast/germ line, stating that that they are deposited during
embryogenesis in the adult
VSEL Differentiation into all Three Germ Layers tissues as a backup for tissue
committed stem cells.1
Therefore, VSEL technology
seems to have the potential and
potency of embryonic stem cell
techniques without the moral
and regulatory hangs ups that
accompany the development of
them.
More published studies at the
University of Louisville have
shown that VSEL stem cells
have a role in cardiac
regeneration and may help
identify those at risk for
cardiovascular disease. Both
animal and human studies have
Source: The National Institutes of Health: Resource for Stem Cell Research shown that the level or amount
of VSELs in the circulating peripheral blood increases after acute myocardial infarction and other stress inducing events
such as stroke. This suggests that VSELs may be the body’s natural way of repairing damage to many different types of
tissue when called upon by certain stresses and mobilized to the circulating bloodstream. This discovery supports the use
of VSEL’s in therapy for MI and other cardiac indications.
Congruent with the research being preformed and the University of Louisville, NeoStem is performing research of its
own. The Company opened an 8,000 square foot, state-of-the-art facility at the Riverside Technology Center in
Cambridge, Massachusetts on April 27th 2010. This facility will Collection Room at Cambridge Facility
focus on expanding the current VSEL™ technology; performing
detailed characterization, purification and expansion of the stem
cells. There will also be collection rooms for the harvesting of
Autologous VSELs for storage and private use. Research into the
use of VSEL technology for both therapeutic as well as
diagnostic purposes will be preformed on premises. One specific
diagnostic potential currently under investigation is a stem cell
biomarker screening panel. Such a test would use anti bodies to
quantify levels of several stem cell populations that are known to
be found circulating in the bloodstream, including VSELs. These
levels could then be compared to an age adjusted reference level
of circulating stem cells to give researchers a better indication of
the overall wellness of an individual. Source: NeoStem, Inc
There has been supporting evidence of VSELs effectiveness in treating conditions other than in cardiac indications. A
study published in the Perspectives of Stem Cells found the same correlation of VSEL mobilization to the peripheral blood
in patients following a stroke as previously mentioned in patients experiencing myocardial infarction. What is more is that
there was a positive correlation between the amounts of circulating VSELs found in the patient and the extensiveness of
the stoke, suggesting the possible use of prognostic type of test and the possibility of these cells importance in neural
regeneration.2 On August 11th, 2010 NeoStem Announced a sponsored research agreement (SRA) with the Schepens Eye
Research Institute, a charitable corporation of Massachusetts and an affiliate of Harvard Medical School. Under the
agreement NeoStem will collaborate with Schepens in research focused on VSEL therapy for both age-related macular
degeneration (AMD) and Glaucoma. The principal investigators are Dr. Michael Young, Ph.D., Director of the Institute's
Minda de Gunzburg Center for Ocular Regeneration, and Dr. Kameran Lashkari, M.D. The research will examine the
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regenerative potential of VSEL™ Technology in the visual system through the engraftment of very small embryonic-like
stem cells in animal models.
Reference References
1
Shin, Ph.D., Dong-Myung, Mariusz Z. Ratajczak, M.D, Ewa K. Zuba-Surma, Ph.D, and Magdalena Kucia. "The Unique Pattern of
Somatic Imprint in Oct-4+ Very Small Embryonic Like (VSEL) Stem Cells Isolated from Adult Tissues Further Supports Both Their
Epiblast/Germ Line Origin and Explains Quiescent Status: Potential Modification of Somatic Imprint as a Key to Longevity?" Online
Programs and Abstracts. 50th ASH Annual Meeting and Exposition, 8 Dec. 2008. Web.
http://ash.confex.com/ash/2008/webprogram/Paper8719.html
2
Ratajczak, Mariusz Z., Ewa Zuba-Surma, Magda Kucia, Przemyslaw Nowacki, and Bogdan Machalinski. "Potential Application of
Very Small Embryonic Like (VSEL) Stem Cells in Neural Regeneration." Perspectives of Stem Cells (2010): 231-43. SpringerLink.
Web. 2 Sept. 2010. http://www.springerlink.com/content/h3nh4261663x1579/
Adult Stem Cell Business in the United States
NeoStem is a leading provider in the U.S. of adult stem cell collection, processing and storage services. The practice of
collecting and storing adult stem cells at a younger age for later autologous use should they be needed has been termed by
the company as a “Bio-Insurance” program. Autologous cells have many advantages to currently used allogenic
procedures most notably being that a patient would have a known quantity of cells that have no risk for rejection or Graft
versus Host Disease (GvHD). NeoStem has focused on a select group of customers initially, concentrating on people who
could potentially benefit from having a supply of their stem cells available for personal therapeutic use, including:
Individuals with a family history of serious diseases
Those at high risk for burns, wounds and other trauma, such as first responders and military personnel
Individuals at occupational risk from prolonged radiation or chemical exposure, such as healthcare
providers, laboratory personnel and nuclear power plant workers
Wellness, cosmetic and anti-aging focused individuals
Athletes and others who could benefit from regenerative therapies
NeoStem has collection center strategically positioned in Southern California and the Northeast, and plans to have 10
centers opened by the end of 2010. The procedure of stem cell collection and storage has both an upfront and a recurring
fee. They charge $7,500 dollars for the stem cell collection, which involves treating the patient with a low-dose, short-
course of mobilizing agent granulocyte-colony stimulating factor, also known as Neupogen™ (for an additional $1,000
fee). Neupogen™ stimulates the migration of the stem cells from the bone marrow into the peripheral blood stream where
they can be collected through a minimally invasive procedure called apheresis. The cells are then processed and sorted
using flow cytometry and stored in multiple vials containing different stem cell types. The process does not change or
alter the underlying cells and does not require expansion technology. There is a recurring fee of $750 per year (if paid
monthly or $699 if paid annually) for the storage of the stem cells. NeoStem uses Progenitor Cell Therapy (PCT) on an
exclusive basis for the storage of all stem cell samples. (see Partnerships)
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United States Department of Defense (DoD) Contracts
NeoStem continues to strengthen its ties to the Department of Defense (DoD) with another possible, and larger, grant for
using VSEL™ technology to treat osteoporosis. This follows their previous DoD contract for rapid wound healing.
Update:
On August 8, 2011 NeoStem announced that the Department of Defense, Peer Reviewed Medical Research Program of
the Office of the Congressionally Directed Medical Research Programs awarded NeoStem $1,780,049 to be applied
towards funding VSEL™ Technology. The award will support investigation of Very Small Embryonic-Like (VSEL) stem
cells, for its bone building and regenerative effects in the treatment of osteoporosis. The award is being made under the
NeoStem’s FY2010 Technology/Therapeutic Development Award application number PR101055.
On July 12th 2010, NeoStem announced it had been awarded a $700,000 contract from the U.S. Army Medical Research
and Materiel Command, Telemedicine and Advanced Technology Research Center (USAMRMC-TATRC). The U.S.
Army Medical Research Acquisition Activity contract number: (W81XWH-10-2-0039) is for the purpose of evaluating
the use of topically applied bone marrow-derived adult mesenchymal stem cells (MSCs) for rapid wound healing.
Development in this field could help save soldiers from amputations and immobilization due to injuries. This First step by
the Department of Defense could represent the beginning of more collaborative projects in regenerative therapy for
combat soldiers including spinal cord injury and retinal damage.
Adult Stem Cell Business in China
NeoStem has made significant progress in commercializing their approved stem cell therapies in China, including
additional sites, pricing and reimbursement allowances.
On December 9, 2010, NeoStem announced that an affiliated entity had entered into an agreement with Shijiazhuang
Third Hospital in the People's Republic of China (PRC) to offer NeoStem's licensed treatments for orthopedic
applications. Shijiazhuang Third Hospital is located in Shijiazhuang, Hebei Province, approximately 170 miles south of
Beijing. Shijiazhuang Third Hospital has 800 beds, 350 of which are dedicated to orthopedics. Shijiazhuang Third
Hospital specializes in orthopedics with extensive experience in spinal, joint, and hand and foot surgeries. It also boasts a
highly regarded orthopedic trauma emergency room.
This follows the November 2, 2010 announcement that Weihai Municipal Price Bureau, the local authority in charge of
pricing for public medical services in China, approved the pricing for single side and bilateral arthroscopic orthopedic
autologous adult stem cell based treatment being administered at Wendeng Orthopedic Hospital ("Wendeng Hospital"),
one of the leading specialist orthopedic hospitals in China based in Wendeng, Shandong Province, China. Additionally,
Weihai Municipal Labor Bureau Medical Insurance Office approved Wendeng Hospital's application for reimbursement
effective November 1, 2010, whereby patients are eligible to receive reimbursement for up to 80% of the cost of the
orthopedic procedure under the new technology category.
Update:
On May 17, 2011 Neostem announced that an affiliated entity has entered into an agreement with Tianjin Nankai Hospital
in the People's Republic of China (PRC) to offer NeoStem's licensed treatments for orthopedic applications. This new
agreement with Tianjin Nankai Hospital is now the third location where Chinese citizens can receive adult stem cell
treatments for arthritis and orthopedic conditions based on technology exclusively licensed by NeoStem for Asia. Nankai
Hospital is located in Tianjin, approximately 80 miles from Beijing, less than a 30 minute ride on the new high-speed
train. Tianjin is a city with a population of over 14 million and has over 400 hospitals. Tianjin Nankai Hospital has
approximately 1,100 patient beds, of which approximately 88 are dedicated to orthopedics. Following the completion of
its planned new hospital building, orthopedic beds are expected to be expanded to approximately 1,000 beds.
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China’s regulatory and scientific environment is more accepting of cellular based therapies. In addition to the more
relaxed regulatory framework, China also has a rapidly expanding upper and middle class that are interested in
regenerative medicine and have the means to pay for such therapies. In 2009, NeoStem began to address this potential
market by creating a separate stem cell business unit. Regulations in the Peoples Republic of China are restrictive to
foreign business. NeoStem created a wholly foreign-owned entity (WFOE), by the name NeoStem (China) Inc. to
alleviate some of these potential restrictions to their business. In addition to the creation of the WFOE the stem cell
business initiates are being conducted via two Chinese domestic entities to further comply with PRC law. Qingdao Niao
Bio-Technology Ltd. and Beijing Ruijieao Bio-Technology Ltd are the domestic entities and are controlled by the WFOE
through various contractual arrangements. All of the stem cell based initiatives in China are being led by US employees
who are utilizing Chinese experts in the respective applications and markets being pursued. The current focuses of the
company include the following initiatives in China:
Developing a pipeline of regenerative medicine therapies initially focused on orthopedic conditions utilizing
licensed procedure, Regenexx™.
Developing wellness, cosmetic and anti-aging applications through in-licensed technology from Vincent
Giampapa, M.D.
Participating in the medical tourism market for regenerative medical treatments.
Establishing a network of collection, processing and storage facilities through a partnership with Enhance
BioMedical Holdings Limited.
Engaging in research and development designed to improve and expand our service and product offerings
Regenexx™ Therapy and the Orthopedic Market
In March 2009, NeoStem acquired an exclusive license for Asia to use the Regenexx™ stem cell procedure, developed by
Colorado-based Regenerative Sciences, Inc. (see Partnerships). The patented procedure uses autologous mesenchymal
stem cell isolated from bone marrow for the treatment of a host of different orthopedic conditions including osteoarthritis,
meniscus tears of the knee, avascular necrosis and bulging lumbar discs. NeoStem plans to utilize there already proven
peripheral blood stem cell collection technique with the Regenexx™, which they feel will only increase the procedures
marketability in the Asian market due to the non-invasive nature of the collection. NeoStem is creating a network of
hospitals in China to provide the Regenexx™ procedure through Qingdao Niao Bio-Technology Ltd, the domestic entity
controlled by the WFOE (see China Corporate Structure). In June 2009, Wendeng Hospital and Qingdao Niao entered
into a five-year agreement to treat patients and conduct clinical research regarding the application of autologous stem cells
for the treatment of a variety of orthopedic conditions. Close to 90% of patients at Wendeng Hospital are seeking medical
attention in the orthopedic field and the hospital is considered to be one of the leading specialty orthopedic hospitals in
China. Personnel at the Wendeng have completed training by Regenerative Sciences, Inc. and operations began in the first
quarter of 2010.
Wellness, Cosmetic & Anti-Aging Applications
In February 2009, NeoStem entered into a world wide exclusive in-licensing agreement from Dr. Vincent Giampapa,
M.D. for autologous adult stem cell based skin rejuvenation therapies. The company plans to advance this regenerative
medicine business in both the United States and China. In the three year agreement, Dr. Giampapa agreed to provide
consulting services in the anti-aging giving guidance on a range of different cosmetic procedures. The procedures were to
be provided at Qingdao Second Sanatorium of Jinan Military Command through Qingdao Niao Bio-Technology Ltd.
Construction related delays at the hospital have prompted NeoStem to explore other options for the initial launch of these
therapies.
Medical Tourism
Medical tourism represents a significant potential source of revenue for NeoStem, as the trend of people traveling outside
of their country for access to medical therapies not currently available or affordable at home is projected to continue to
rise. In 2007, 750,000 Americans traveled outside of the US in order to undergo medical procedures. The World Bank
estimates that number could increase to 6 million by 2010 and the market world wide to be as large as 10 billion by 2011.
China has become and is continuing to become a desirable destination for patients seeking procedures in a diverse range
NeoStem, Inc. (NBS) Page 13
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of medical specialties. Both private and government hospitals in major Chinese cities have begun to capitalize on this
trend by establishing medical tourism departments to provide treatment to international patients using advanced Western
medical technology and techniques, including stem cell-based therapies. NeoStem plans to use this Chinese development
as both a driver for their stem cell collection business as well as their stem cell therapy businesses.
Stem Cell Collection and Storage Business
In June 2009, NeoStem entered into a ten-year, exclusive, royalty bearing agreement with Enhance BioMedical Holdings
Limited to develop an adult stem cell collection and treatment network of doctors and hospitals in Shanghai, Taiwan, and
the Chinese provinces of Jiangsu, Zhejiang, Fujian, Anhui and Jiangxi (Network Territory). Enhance BioMedical
Holdings Limited is a Shanghai corporation and a subsidiary of Enhance Holding Corporation, a multinational
conglomerate. Under the terms of the Agreement, NeoStem will provide Enhance BioMedical with the training, technical,
and other assistance required for it to offer stem cell-based therapies, for which the company will receive a six figure
technical assistance fee. After training is completed, the agreement gives Enhance BioMedical the exclusive right to
utilize NeoStem’s proprietary adult stem cell technologies to provide adult stem cell services and therapies in the
territories aforementioned. NeoStem will receive milestone payments and royalties on gross revenues derived from stem
cell based therapies from Enhance BioMedical. Subject to certain conditions, the agreement is renewable at the option of
Enhance BioMedical for an additional 10 years. The agreement also gives NeoStem the option to acquire up to a 20%
fully diluted equity interest in Enhance BioMedical until June 2014.
Enhance BioMedical already has relationships with doctors and hospitals in the territories covered in the agreement, and
also the Anti-Aging and Prevention Medical Center in Taipei, Taiwan. The Anti-Aging and Prevention Medical Center
focuses on the development of stem cell bases anti aging therapies and could principally benefit from the technology in-
licensed from Dr. Giampapa (See Wellness, Cosmetic & Anti-Aging Applications).
Research and Development
In May 2009, NeoStem through Qingdao Niao Bio-Technology Ltd., leased space from Beijing Zhongguancum Life
Science Park Development Corp., Ltd at the Life Science Innovation Center, Life Science Park, in Zhongguancum,
Beijing. The Facility is to be used for collection, processing and storage of adult stem cells as well as research and
development of cellular based therapies in China. The facility will support the development of the Regenexx™ procedure
at Wendeng Hospital. In addition to the therapies currently being pursued commercially in China, NeoStem will also be
conducting research on their VSEL technology at the Beijing Facility that could include their therapeutic use in neural,
cardiac and ophthalmic disease. In order to conduct cell-based clinical trials in collaboration with specialty hospitals,
NeoStem was required under PRC law to form a not-for-profit organization. In July 2009, NeoStem entered into a
cooperation agreement with their Chinese consultant, Shandong Life Science and Technology Research Institute (SLSI)
for assistance in the formation of the NPO. The organization was funded by NeoStem in the amount of 730,000 dollars
and another 500,000 dollars of funding is expected in the near future. NeoStem entered into an agreement Progenitor Cell
Therapy, LLC for the construction of the Beijing Facility on December 31, 2009 (see Partnerships)
China Corporate Structure & Suzhou Erye Pharmaceuticals Businesses
NeoStem China Corporate Structure
NeoStem has 2 business units in China, their China pharmaceutical business unit which owns 51% in Suzhou Erye
Pharmaceuticals Company and their China adult stem cell business unit conducted their wholly foreign-owned entity
(WFOE) NeoStem (China) with two Variable Interest Entities (VIE) Qingdao Niao Bio-Technology Ltd. and Beijing
Ruijieao Biotechnology Ltd.
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NeoStem China Corporate Structure & Ownership
VIE = Variable Interest Entities Source: NeoStem Inc. & LifeTech Capital
China Adult Stem Cell Business
Due to PRC restrictions on foreign entities from conducting certain activities, NeoStem operates the stem cell business
through NeoStem (China), a wholly foreign-owned entity (WFOE). To comply with China’s foreign investment
prohibition on stem cell research and development, this business is conducted via two Variable Interest Entities (VIEs)
Qingdao and Beijing Ruijieao under which NeoStem (China) is providing technical and management services to the VIEs
in exchange for substantially all net income of the VIEs. One VIE will be devoted to adult stem cell related research and
development activities and the other will be devoted to the commercialization of stem cell-based therapies in collaboration
with hospitals.
Also due to PRC restrictions, NeoStem (China) with their China consultant, SLSI, is forming a not-for-profit organization
to conduct various clinical trials in China. SLSI has taken responsibility for establishing and structuring clinical trials with
third parties, other research institutes and a number of partner hospitals.
China Pharmaceutical Business
On October 30, 2009, NeoStem completed a merger with China Biopharmaceuticals Holdings (CBH) resulting in a 51%
controlling interest in Suzhou Erye Pharmaceuticals Company (Erye). The remaining 49% ownership is represented by
Suzhou Erye Economy and Trading Co. (EET) through a joint venture agreement.
Suzhou Erye Pharmaceuticals Business
Suzhou Erye Pharmaceuticals (Erye) was founded over 50 years ago and is a vertically-integrated pharmaceutical
business, focused primarily on the manufacturing and sale of antibiotics. Specifically, Erye focuses on manufacturing and
distribution of generic antibiotic products and has received more than 160 production certificates from China’s State Food
& Drug Agency (SFDA) covering both antibiotic prescription drugs and active pharmaceutical ingredients (APIs). 2009
revenue was over $60 million (unaudited) with approximately 536 full-time and 209 part-time employees of December
31, 2009.
Update - Possible Sale of Eyre Pharmaceuticals
Following their January 2011 acquisition of PCT, NeoStem is pursuing strategic alternatives with respect to its 51%
interest in Erye. NeoStem is planning to devote its resources and management efforts to cell therapy manufacturing and
development, and other related activities, including adult stem cell collection and storage, and in further developing their
regenerative medicine business in China. NeoStem believes that the proposed acquisition of Amorcyte is in keeping with
NeoStem’s strategic mission. NeoStem also believes that if they could monetize Erye, NeoStem would have additional
capital needed to pursue the development of multiple cell therapies. As such, in June 2011, NeoStem engaged a financial
advisor to lead the effort to pursue the possible divesture of its 51% interest in Erye. Marketing efforts have commenced
however it is too early to determine whether such efforts will lead to a proposal to purchase at a price and on terms that
NeoStem would consider acceptable or whether, in the event a proposal or proposals on prices and terms acceptable to
NeoStem are received, whether a transaction would be completed. More information can be found in their 8-K (page 42)
at: http://www.sec.gov/Archives/edgar/data/320017/000114420411040514/v228561_8k.htm
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Pharmaceutical Products
Erye offers a highly diversified portfolio of pharmaceuticals with no single drug accounting for more than 10% of sales.
Erye’s top 10 products in sales for 2010 are shown below:
Erye Top Ten Drugs in 2010 (37% of Total Sales) % of Sales
Acetylspiramycin 5%
Cefamandole Natate for injection (0.5g) 4%
Oxacillin Sodium 4%
Amoxicillin/Sulbactum Sodium for injection 4%
Cefamandole Natate for injection (1.0g) 4%
Mezlocillin sodium for injection 4%
Amoxicillin & Clavulanate Potassium sodium 3%
Azlocillin sodium 3%
Ceftizoxime sodium for injection (0.5g) 3%
Ceftizoxime sodium for injection (1.0g) 3%
Source: NeoStem Inc.
It should be noted that currently, approximately 70% of their drug products are covered by insurance, and which is
expected to grow in the future.
New Pharmaceutical Pipeline
Erye also has a pipeline of recently approved pharmaceuticals, submitted pharmaceuticals and candidates currently in
clinical trials as show:
ERYE PHARMACEUTICAL PIPELINE
Status Indication Drug
Approved – Launch Pending GERD Omeprazol Capsules
Approved – Launch Pending Anti-Infective Cloxacillin Sodium
Awaiting Approval Antibiotic Clindamycin Phosphate Injection
Awaiting Approval HBV/HIV Adefovi Capsules & API
Clinical Trials Anti-Infective Faropenem sodium API
Clinical Trials Anti-Infective Faropenem Sodium Tablets
Clinical Trials HBV Tiopronin Enteric-Coated Capsules
Source: NeoStem Inc.
Distribution Channels
In China, pharmaceutical manufacturers are prohibited from selling directly to hospitals where the majority of
prescriptions are written. Erye has a distributor network that that covers all of mainland China’s provinces and
municipalities. Erye has over 40 internal sales and marketing personnel to supervise the distributor network through three
channels: exclusive distributors for newer higher-margin prescription drugs, non-exclusive distributors for mature, lower-
margin prescription drugs and exclusive distributors for active pharmaceutical ingredient sales to large pharmaceutical
manufacturers.
Manufacturing
Erye currently operates a production facility in the City of Suzhou, containing approximately 33,490 square meters of
offices, dormitories, a food court, warehouse and production facilities, including 8 cGMP production lines certified by the
SFDA, workshops and laboratory areas. Erye is currently transitioning to a new, state-of-the-art production facility in the
Xiangcheng District of Suzhou. The new facility includes 12 buildings containing a total of approximately 53,000 square
meters of space, for which the external building construction has been completed and manufacturing equipment is being
assembled and tested. Erye began transferring its operations in January 2010 and received notification that the SFDA has
approved the cGMP certification to manufacture solvent crystallization sterile penicillin and freeze dried raw sterile
penicillin at the new facility. Erye’s goal is to become one of the largest antibiotics producers in Eastern China.
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Update:
On April 26, 2011 NeoStem announced their majority-owned Suzhou Erye Pharmaceutical Company received 2 awards at
the 4th annual Chempharm Brand Summit 2011 in China where companies in the pharmaceutical industry are recognized
for outstanding achievement in specific categories. Specifically, Erye Pharmaceutical was awarded "Top 10 Anti-Infection
Drug Award" and "Top 100 Brand Names Award".
On June 13, 2011 Neostem announced that Erye Pharmaceutical had received approval from the State Food and Drug
Administration (SFDA) in China for its lyophilized (freeze dried) powder for injection production line which is
responsible for the production of over 20 finished pharmaceutical products, 80% of which are on the National Insurance
Drug List. The combined production lines now certified by the SFDA are six of eight planned and were responsible for
approximately 99% of Erye’s 2010 revenues. Approvals for the 2 remaining product lines (the oral active pharmaceutical
ingredient (API) line and the capsule line) are expected by year end. The approval of this cGMP product line importantly
removes the capacity constraints associated with old Erye manufacturing facility.
Erye Pharmaceuticals Facilities and Planned Campus
Source: NeoStem Inc.
NeoStem and Vatican Pontifical Council Initiative on Adult Stem Cells
On May 19, 2010 NeoStem and the Vatican's Pontifical Council for Culture announced a joint initiative with their
charitable foundations to expand research and raise awareness of adult stem cell therapies. NeoStem's Stem for Life
Foundation and the Pontifical Council's STOQ (Science Theology and the Ontological Quest) International foundation,
will work on collaborative activities advancing scientific research on adult stem cells, exploring clinical applications in
regenerative medicine and the cultural relevance on theological and ethical issues. Reverend Tomasz Trafny, of the
Pontifical Council for Culture stated “We are particularly excited about NeoStem's VSEL™ technology and believe that
mutual collaboration between NeoStem and the Pontifical Council for Culture could lead to significant financial
commitment to support VSEL™ technology research."
A 3-day international conference at the Vatican on adult stem cell research, including VSEL™ technology, is planned for
2011 and will focus on medical research presentations and theological and philosophical considerations and implications
of scientific achievements.
Update:
NeoStem and the Vatican's Pontifical Council for Culture announced more details regarding their partnership designed to
advance adult stem cell research and their upcoming signature event, the international Vatican conference on adult
stem cells which will be held November 9th – 11th at the Vatican.
The conference will include the foremost experts in adult stem cell research and recognized leaders in medicine as well as
Church and scientific leaders, policymakers, ethicists, educators, Ministers of Health from around the world, ambassadors
to the Holy See, and representatives of the stem cell therapeutic business community. The conference goal is to create a
greater awareness of adult stem cells and their promise and discuss the latest research and developments along with the
implications for the future of culture, medicine, religion, and public policy. The event will also be broadcast via radio and
television. The conference website can be accessed at www.adultstemcellconference.org
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NeoStem's charitable organization, “Stem for Life Foundation” and the Pontifical Council's Foundation, STOQ
International (Science Theology and the Ontological Quest) are also sponsors of the efforts. More information on these
can be found at www.stemforlifefoundation.com and www.stoqinternational.org
The joint mission of the partnership, with the complete support of the Pontifical Council for Health Care Workers and the
Pontifical Academy for Life, will be to:
1) Foster the highest levels of scientific research on adult stem cells and to explore the cultural, ethical and human
implications of their use.
2) Seek to create awareness about the promise of scientific research in concordance with ethical values through the further
development of adult stem cell technology.
3) Determine short-term and long-term actions which political, scientific, educational, and religious leaders can take to be
part of the cultural paradigm shift arising from the next wave - regenerative medicine.
4) Lay the groundwork for a collaborative network of scientists and patrons who embrace the promise of adult stem cells
to reduce human suffering, advance scientific research on adult stem cells and explore their clinical application in the field
of regenerative medicine, as well as the cultural impact of such research.
5) Advance adult stem cell research and facilitate its safe transformation from the lab to the clinic.
Partnerships
University of Louisville
NeoStem is engaged in research and development of new therapies based on VSEL technology with the University of
Louisville Research Foundation, or ULRF, and has a worldwide exclusive license rights. The agreement was previously
made with Stem Cell Technologies, Inc. (SCTI). SCTI was acquired by NeoStem in November of 2007. Under the
License Agreement, The Company agreed to engage in a diligent program to develop the VSEL technology. Certain
license fees and royalties are to be paid to University of Louisville Research Foundation (“ULRF”) by NeoStem, and the
Company is responsible for all payments for patent filings and related applications. The Agreement has an initial term of
20 years and portions of the license may become non-exclusive if NeoStem does not diligently develop the VSEL™
technology. The Agreement can be terminated entirely if NeoStem chooses to not pay for the filing and maintenance of
any patents. The License Agreement calls for the following specific payments:
Reimbursement of $29,000 for all expenses related to patent filing and prosecution incurred before the effective
date (“Effective Date”) of the license agreement
Non-refundable prepayment of $20,000 creditable against the first $20,000 of patent expenses incurred after the
Effective Date
Non-refundable license issue fee of $46,000
Non-refundable annual license maintenance fee of $10,000 upon issuance of the licensed patent in the United
States
Royalty of 4% on net sales
Specified milestone payments
Specified payments in the event of sublicensing.
The agreement was amended February 2009 and items 2 and 3 were paid in March 2009. The License Agreement contains
certain provisions relating to "stacking," permitting NeoStem to pay royalties to ULRF at a reduced rate in the event it
is required to also pay royalties to third parties exceeding a specified threshold for other technology in furtherance of
the exercise of its patent rights or the manufacture of products using the VSEL technology.
Regenerative Sciences, Inc.
In March 2009, NeoStem acquired an exclusive license for Asia to use the RegenexxTM stem cell procedure.
RegenexxTM was developed by Colorado-based Regenerative Sciences, Inc. and is an innovative process that expands a
NeoStem, Inc. (NBS) Page 18
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patient’s own adult stem cells to treat a variety of musculoskeletal diseases. The licensed procedure uses autologous
mesenchymal stem cells extracted from bone marrow for the treatment of various orthopedic conditions, including
osteoarthritis, meniscus tears of the knee, avascular necrosis and bulging lumbar discs. Under the Terms of the
agreement, RSI must provide consulting services to NeoStem in the area of stem cell-based orthopedic therapies for the
Asia market. The company feels that the integration of peripheral blood collection processes (instead of invasive bone
marrow collection) into the RegenexxTM procedure will enhance its marketability in the Asian market.
Immuneregen Biosciences
On April 22, 2010 NeoStem entered into a Collaborative Research Agreement with ImmuneRegen BioSciences, Inc., a
wholly owned subsidiary of IR BioSciences Holdings, Inc. (IRBS.OB). The Agreement is focused on the development of
ImmuneRegen’s advanced, adult human stem cell product called Homspera®. Under the agreement, NeoStem will
investigate the effects of Homspera®, which has been shown to enhance stem cell activity, in combination with
NeoStem's VSEL technology. Under the collaboration, NeoStem has the right to execute an option agreement to negotiate
an exclusive license to resulting technology.
Enhance BioMedical Holdings Limited
In June 2009, NeoStem entered into a ten-year, exclusive, royalty bearing agreement with Enhance BioMedical Holdings
Limited, a Shanghai corporation and a subsidiary of Enhance Holding Corporation, a multinational conglomerate. The
Agreement is to develop an adult stem cell collection and treatment network of doctors and hospitals in Shanghai, Taiwan,
and the Chinese provinces of Jiangsu, Zhejiang, Fujian, Anhui and Jiangxi (Network Territory). Under the terms of the
Agreement, NeoStem will provide Enhance BioMedical with the training, technical, and other assistance required for it to
offer stem cell-based therapies, for which the company will receive a six figure technical assistance fee. After training is
completed, the agreement gives Enhance BioMedical the exclusive right to utilize NeoStem’s proprietary adult stem cell
technologies to provide adult stem cell services and therapies in the territories aforementioned. NeoStem will receive
milestone payments and royalties on gross revenues derived from stem cell based therapies from Enhance BioMedical.
Subject to certain conditions, the agreement is renewable at the option of Enhance BioMedical for an additional 10 years.
The agreement also gives NeoStem the option to acquire up to a 20% fully diluted equity interest in Enhance BioMedical
until June 2014.
Enhance BioMedical already has relationships with doctors and hospitals in the territories covered in the agreement, and
also the Anti-Aging and Prevention Medical Center in Taipei, Taiwan. The Anti-Aging and Prevention Medical Center
focuses on the development of stem cell bases anti aging therapies and could principally benefit from the technology in-
licensed from Dr. Giampapa (See Wellness, Cosmetic & Anti-Aging Applications).
In addition to being a partner with NeoStem, Enhance BioMedical is also a large share holder in the company as well. The
companies CEO, Jack Ling, invested $5M in an $11M April 13th, 2009 private placement financing. As of March 15,
2010, Enhance BioMedical owned approximately 16.7% of NBS common stock
Intellectual Property
NeoStem has a number of patents and patent applications as shown below. We expect additional patent applications will
be filed in the future as development progresses.
NUMBER DESCRIPTION FILED
Selected NeoStem UNITED STATES Intellectual Property Filings
Method and Compositions for Restoration of Age Related Tissue Loss Granted
7414021
in the Face or Selected Areas of the Body 8/19/08
Elective Collection and Banking of Autologous Peripheral Blood Stem
11/396,238 3/30/06
Cells
11/763,655 Processing Procedure for Peripheral Blood Stem Cells 6/15/07
61/266,825 Mesenchymal Stem Cells Isolated from Mobilized Peripheral Blood 12/04/09
Method of Isolation of Stem Cell Populations from Peripheral Blood
61/266,860 12/4/09
Using Size-Based Separation
12/096,754 Very Small Embryonic-Like Stem Cells and Methods of Isolating and 11/02/06
NeoStem, Inc. (NBS) Page 19
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Using the Same
Very Small Embryonic-Like Stem Cells and Methods of Isolating and
12/261,958 10/30/08
Using the Same
Transplantation of Very Small Embryonic-Like Stem Cells for Cardiac
PCT/US2008/081832 10/30/08
Repair Following Myocardial Infarction
Methods for Isolating Very Small Embryonic-Like Stem Cells from
PCT/US2009/005414 9/30/09
Cord Blood
Autologous Bone Marrow-Derived Cultured Mesenchymal Stem Cells
61/039,941 Delivered in a Fibrin Spray Accelerate Healing in Murine and Human 3/27/07
Cutaneous Wounds
Autologous Bone Marrow-Derived Cultured Mesenchymal Stem Cells
12/413,250 Delivered in a Fibrin Spray Accelerate Healing in Murine and Human 3/27/09
Cutaneous Wounds
Autologous Bone Marrow-Derived Cultured Mesenchymal Stem Cells
PCT/US2009/038666 Delivered in a Fibrin Spray Accelerate Healing in Murine and Human 3/27/09
Cutaneous Wounds
Method and Compositions for Restoration of Age Related Tissue Loss
12/218,334 7/14/08
in the Face or Selected Areas of the Body
Method and Composition for Restoration of Age Related Tissue Loss
61/175,275 5/04/09
in the Face or Selected Areas of the Body
Mesenchymal Stem Cell Isolation and Transplantation Method and
60/761,441 1/24/06
System to be Used In a Clinical Setting
Mesenchymal Stem Cell Isolation and Transplantation Method and
PCT/US2007/60889 1/23/07
System to be Used In a Clinical Setting
Mesenchymal Stem Cell Isolation and Transplantation Method and
12/161,911 11/07/08
System to be Used In a Clinical Setting
Methods and Compositions for Optimized Expansion and Implantation
11/773,774 7/05/07
of Menechymal Stem Cells
Methods and Compositions for Optimized Expansion and Implantation
PCT/US2008/68202 6/25/08
of Menechymal Stem Cells
61/014,987 Compositions to Promote Implantation and Engraftment of Stem Cells 12/19/07
PCT/US2008/87452 Compositions to Promote Implantation and Engraftment of Stem Cells 12/18/08
61/036,551 Compositions and Method for Cartilage Repair 3/14/08
PCT/US2009/037126 Compositions and Method for Cartilage Repair 3/13/09
61/120,098 Methods and Compositions for Intervertabral Disc Repair 12/05/08
61/154,874 Methods and Compositions for Intervertabral Disc Repair 2/24/09
Selected NeoStem EUROPE Intellectual Property Filings
07809600.95 Processing Procedure for Peripheral Blood Stem Cells 6/15/07
Very Small Embryonic-Like Stem Cells and Methods of Isolating and
06827358.0 11/02/06
Using the Same
Mesenchymal Stem Cell Isolation and Transplantation Method and
07762515.0 1/23/07
System to be Used In a Clinical Setting
Selected NeoStem CHINA Intellectual Property Filings
200780030328.6 Processing Procedure for Peripheral Blood Stem Cells 6/15/07
Very Small Embryonic-Like Stem Cells and Methods of Isolating and
200680052508.X 11/02/06
Using the Same
Selected NeoStem CANADA Intellectual Property Filings
Elective Collection and Banking of Autologous Peripheral Blood Stem
2548580 4/05/04
Cells
Mesenchymal Stem Cell Isolation and Transplantation Method and
2640185 1/23/07
System to be Used In a Clinical Setting
Selected NeoStem HONG KONG Intellectual Property Filings
Mesenchymal Stem Cell Isolation and Transplantation Method and
09103392.9 1/23/07
System to be Used In a Clinical Setting
Source: NeoStem, Inc
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Recent Financing Activity
On July 22, 2011, NeoStem completed an underwritten offering of 13,750,000 units at a purchase price of $1.20 per unit
yielding gross proceeds of $16.5M with each unit consisting of one share of Common Stock and a five year warrant to
purchase 0.75 of a share of Common Stock (10,312,500 shares) at an exercise price of $1.45 per share.
On July 14, 2011, the NeoStem announced their intention to acquire Amorcyte, Inc. and will issue 6,821,283 shares of
common stock plus warrants to purchase 1,881,008 shares of NeoStem common stock. In addition, 4,092,768 shares of
NeoStem stock will vest upon achievement of AMR-001 milestones. Amorcyte shareholders will receive additional
consideration in the form of an earn-out upon commercialization. The closing of the merger is subject to approval by
NeoStem and Amorcyte stockholders.
On April 5, 2011, NeoStem completed a private placement with nine persons and entities of 1,244,375 shares of Common
Stock at a purchase price of $1.28 for gross proceeds of $1.6M.
On March 3, 2011, NeoStem completed a private placement of 2,343,750 shares of Common Stock at a purchase price of
$1.28 a share for gross proceeds of $3M. Five persons and entities were involved in the private placement including
Steven S. Myers, a NeoStem director who purchased 390,625 shares, and Dr. Andrew L. Pecora, Chief Medical Officer of
NeoStem’s subsidiary PCT who purchased 78,125 shares
PCT Acquisition Transaction Summary
On January 19, 2011 NeoStem completed its acquisition of Progenitor Cell Therapy, LLC. NeoStem acquired all of the
membership interests of PCT, and PCT is now a wholly-owned subsidiary of NeoStem. NeoStem issued 10.6M shares of
common stock for the acquisition. In addition, there are warrants to purchase between 1M and 3M shares of NeoStem
Common Stock, based on the following:
(i) common stock purchase warrants to purchase 1,000,000 shares of NeoStem Common Stock exercisable over a
seven year period at an exercise price of $7.00 per share (the “$7.00 Warrants”), and which will vest only if a
specified business milestone is accomplished within three (3) years of the closing date and
(ii) if the volume weighted average of the closing prices of sales of NeoStem Common Stock on the NYSE-Amex
for the three (3) trading days ending on the trading day that is two (2) days prior to the Closing Date is less than
$2.50, common stock purchase warrants to purchase 1,000,000 shares of NeoStem Common Stock exercisable
over a seven year term at an exercise price of $3.00 per share (the “$3.00 Warrants”); and
(iii) if the Parent Per Share Value is less than $1.70, common stock purchase warrants to purchase 1,000,000
shares of NeoStem Common Stock exercisable over a seven year period at an exercise price of $5.00 per share
(the “$5.00 Warrants” and, collectively with the $7.00 Warrants and the $3.00 Warrants, the “Warrants”).
On November 19, 2010, NeoStem, completed concurrent offerings of (i) an underwritten offering of 6,337,980 common
stock units at a purchase price of $1.45 per unit, with each unit consisting of one share of common stock par value $0.001
and a warrant to purchase 0.5 of a share of common stock with an exercise price of $1.85 per share, and (ii) a registered
direct offering of 10,582,011 preferred stock units at a purchase price of $0.945 per unit, with each unit consisting of one
share of Series E 7% Senior Convertible Preferred Stock, par value $0.01 per share, convertible at $2.0004, maturing May
20, 2013; a warrant to purchase 0.25 of a share of common stock with an exercise price of $2.0874 per share; and 0.0155
of a share of common stock.
As of June 30, 2011, there were 23.6 million warrants to purchase shares outstanding with a weighted average price of
$2.70, a weighted average remaining life of 3.7 years as shown in the table. Also as of June 30, 2011, there were 16
million stock options issued with a weighted average price of $1.76 and a weighted average remaining life of 7.7 years
under the U.S. Equity Plan. Of these, 8.1 million stock options were vested and exercisable as of June 30, 2011.
Additionally, as of June 30, 2011, there were 3.1 million stock options issued with a weighted average price of $1.95 and
a weighted average remaining life of 8.8 years under the Non-U.S. Equity Plan. Of these, 817K stock options were vested
and exercisable as of June 30, 2011. Finally, as of August 10, 2011, there were 98,048,447 shares common stock
outstanding.
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Management
Dr. Robin L. Smith, Chairman and CEO: Dr. Smith joined the Company as Chairman of its Advisory Board in
September 2005 and, effective June 2, 2006, became the Chief Executive Officer and Chairman of the Board. Dr. Smith,
who received a medical degree from Yale University in 1992 and a master's degree in business administration from the
Wharton School in 1997, brings to the Company extensive experience in medical enterprises and business development.
From 2000 to 2003, Dr. Smith served as President & Chief Executive Officer of IP2M, a multi-platform media company
specializing in healthcare. During her term, the company was selected as being one of the 10 fastest growing technology
companies in Houston. IP2M was sold to a publicly-traded company in February 2003. Previously, from 1998 to 2000,
she was Executive Vice President and Chief Medical Officer for HealthHelp, Inc., a National Radiology Management
company that managed 14 percent of the healthcare dollars spent by large insurance companies.
Dr. Smith has acted as a senior advisor and investor to both publicly traded and privately held companies where she has
played a significant role in restructuring and or growing the companies. Dr. Smith served on the Board of Directors of two
privately held companies, Talon Air and Biomega, and also served on the Chemotherapy Foundation Board of Trustees
and The New York Theatre Ballet. She currently serves on the Board of Trustees of the NYU Medical Center Board, is
past Chairman of the Board of Directors for the New York University Hospital for Joint Diseases where she headed up
new development efforts and board member recruitment, and served on the Board of Choose Living. Dr. Smith is the
President and serves on the Board of Directors of The Stem for Life Foundation.
Larry A. May, CFO: Mr. May, the former Treasurer of Amgen (NasdaqGS: AMGN), one of the world’s largest
biotechnology companies, initially joined NeoStem to assist with licensing activities in September 2003. He became an
officer upon our acquisition of the business of NS California in January 2006. For the last 25 years, Mr. May has worked
in the areas of life sciences and biotechnology. From 1983 to 1998, Mr. May worked for Amgen as Corporate Controller
(1983 to 1988), Vice President/Corporate Controller/Chief Accounting Officer (1988 to 1997), and Vice
President/Treasurer (1997 to 1998). At Amgen, Mr. May helped build Amgen’s accounting, finance and IT organizations.
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. From 2000 to May 2003, Mr. May served as the
Chief Financial Officer of Saronyx, Inc., a company focused on developing productivity tools and secure communication
systems for research scientists. From August 2003 to January 2005, Mr. May served as the Chief Financial Officer of NS
California. In March 2005, Mr. May was appointed CEO of NS California and in May 2005 he was elected to the Board
of Directors of NS California. He received a Bachelor of Science degree in Business Administration & Accounting in
1971 from the University of Missouri.
Joseph Talamo, VP Corporate Controller and Chief Accounting Officer: Mr. Talamo formerly held various senior
positions at OSI Pharmaceuticals, Inc., a publicly-traded biopharmaceutical company focused on discovering, developing
and commercializing products for the treatment of cancer, diabetes and obesity, and most recently served as its Vice
President and Corporate Controller. While at OSI from 1996 to 2010, Joe helped build the accounting and finance
infrastructure to support the clinical development and commercial launch of Tarceva®, OSI's targeted therapy approved
for the treatment of patients with non-small cell lung cancer and pancreatic cancer. Prior to OSI, Joe worked at Bristol-
Myers Squibb from 1995 to 1996 in the Financial Reporting and Consolidations Group, and at KPMG from 1993 to 1995
in the Health Care and Life Sciences Audit Group. Joe also served as Treasurer of OSI Pharmaceuticals Foundation from
2008 to 2010.
Catherine M Vaczy, VP and General Counsel: Ms. Vaczy joined NeoStem in April 2005 as Vice President and General
Counsel and is responsible for overseeing our legal affairs. From 1997 through 2003, Ms. Vaczy held various senior
positions at ImClone Systems Incorporated, a then publicly-traded company developing a portfolio of targeted biologic
treatments to address the medical needs of patients with a variety of cancers, most recently as its Vice President, Legal
and Associate General Counsel. While at ImClone (NasdaqGS: IMCL), Ms. Vaczy served as a key advisor in the day-to-
day operation of the company and helped forge a number of important strategic alliances, including a $1 billion co-
development agreement with Bristol Myers Squibb (NYSE: BMY) for Erbitux® and ImClone’s targeted therapy approved
for the treatment of metastatic colorectal and head and neck cancers. From 1988 through 1996, Ms. Vaczy served as a
corporate attorney advising clients in the life science industry at the New York City law firm of Ross & Hardies. Ms.
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