GroundFloor

August 2012
Inside This Issue
The Claros Evolution
The Microfluidics
Breakthrough
Vol. 6 Issue 10
Ground-Floor Opportunity:
A New Biological Oracle That
Will Disrupt and Transform the
Medical Diagnostics Industry
By Patrick Cox
Huge Market Opportunities
This month, I’d like to tell you about a company on the front lines of a revolution in
medical diagnostics and personalized medicine. The innovators behind this company’s
platform are transforming the current inefficient, expensive molecular diagnostics paradigm.
Their technology takes the most-advanced medical tests on the market and moves them
from the laboratory to the physician’s office.
Portfolio Positions
The company I am talking about is called Opko Health (NYSE:OPK) and its recently
acquired subsidiary, Claros Diagnostics.
A New Gold Standard in
Point-of-Care Diagnostics
In preparing this issue, I had the pleasure of interviewing with Dr. Phillip Frost, CEO and
chairman of Opko Health’s board; Michael J. Magliochetti, Ph.D., president and CEO of
Claros Diagnostics; and David Steinmiller, Claros Diagnostics co-founder and COO.
The Claros Evolution
First, I’d like to tell you about this company’s history. I’ll start by saying that the Claros
technology enjoys the highest scientific and medical pedigrees imaginable. Claros’ original
technology was born at the George Whitesides Research Group in the department of
chemistry and chemical biology at Harvard University. George Whitesides, a winner of the
National Medal of Science and a founder of Genzyme, was the principal investigator for
the research that led to the Claros diagnostic platform. Today, he sits on the company’s
advisory board.
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Whitesides’ discovery research team included Sam Sia, Ph.D., a Claros founder and
co-inventor of the diagnostic platform, who is also an associate professor of biomedical
engineering at Columbia University. Today, he is part of the company’s scientific advisory
board. Claros’ CTO, Vincent Linder, Ph.D., is also a founding member of the company
that co-invented the technology while a postdoctoral fellow at the Whitesides laboratory.
Dr. Magliochetti first discovered Claros while working as entrepreneur-in-residence at Oxford
Bioscience Partners, an early-stage venture capital firm specializing in the life sciences and
health care sectors. Magliochetti had previously served as CEO of urology and orthopedics
product companies, both of which have been acquired. A chemical engineer by training
and a serial entrepreneur with extensive experience operating life sciences companies, he
was hired by the firm to focus on finding emerging technologies in the field of urology.
While at Oxford Bioscience, Magliochetti’s task of evaluating new opportunities included
Continued on Next Page…
the option of becoming a part of the management of any subsequent investment.
While at Oxford Bioscience, Magliochetti assembled a group of the world’s top urologists. The group included:
• Dr. Peter Scardino, chairman of the department of urology at Memorial Sloan-Kettering Cancer Center
• Dr. Alan Wein, chairman and professor of surgery at the department of urology of the University of
Pennsylvania Medical Center
• Dr. E. Darracott Vaughan, chairman emeritus of the department of urology at Cornell University and former president of the American Urological Association
• Dr. Georg Bartsch, chairman of the department of urology at Innsbruck Medical University, Austria
• Dr. Stephen P. Dretler, director of the Kidney Stone Center at Massachusetts General Hospital
• Dr. Stephen Zappala, department of urology, Lahey Clinic.
Today, this urological who’s who list forms part of Claros’ advisory board.
Once a month, Magliochetti would fly in this group of eminent urologists to review new investment opportunities in the
field. At other times, the group would meet with innovators working on the latest technologies to assess whether this
could form the basis for launching a new company. It was during this time that Magliochetti decided to investigate what
was going on at Harvard’s Whitesides laboratory. What he saw there was impressive, although it wasn’t specific to urology.
However, he decided to at least meet with several of the founders of Claros, who included David Steinmiller, Sam Sia and
Vincent Linder.
Steinmiller, a graduate of MIT’s Sloan School of Management and Stanford’s mechanical engineering program, had
already done a great deal of work on breakthrough diagnostic technology. The Whitesides team had been working on
developing a diagnostic platform for infectious diseases in places like Africa.
When Magliochetti reviewed the technology, however, he did so through the prism of a urologist. As an engineer, he
saw that the basic diagnostic platform was not only applicable to infectious disease diagnosis, but also to urology —
and far more. The next step was to have the Whitesides team present their technology to the battery of experts he had
assembled at Oxford.
Magliochetti’s team was a tough crowd. Other aspiring startups had pitched their wares to it before, only to be dismissed
after only a few minutes. This time, however, things proceeded differently.
While meeting with the inventors, the panel quickly understood the potential of the technology. Not only did the
platform make sense for urology, but its applicability outside urology — such as in cardiology, women’s health and
infectious disease — was vast. What the Whitesides researchers had invented was a textbook platform technology.
Magliochetti dropped everything to work on funding Claros. Oxford Bioscience led the initial venture investment in the
startup, and Magliochetti became CEO. With exception of Sam Sia, who took an academic position to research the
platform’s applicability in infectious disease diagnostics at Columbia, all the original inventors became part of Claros’
management team.
So what makes the Claros’ diagnostic platform so special?
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2
The Microfluidics Breakthrough
Claros’ technology builds on microfluidics, a branch of science dealing with the behavior of tiny volumes of fluid only
millionths of a liter in size. By the 1990s, enabled by an ability to build structures at tiny scales originally developed by
the semiconductor industry, researchers began to investigate the use of microfluidic devices for the biomedical field.
Researchers believed that if they could miniaturize liquid-handling steps, they could effectively replace a laboratory with
a microfluidic device.
Microfluidics has been adopted in biomedical research, permitting the creation of “labs on chips” used for everything from
enzyme assays to DNA sequencing. However, despite all the fanfare that accompanied earlier microfluidic breakthroughs,
the basic technology hasn’t yet fully lived up to its promise. In biomedical applications, microfluidic technology has been
largely confined to academia and large labs.
One reason microfluidics hasn’t been to date successful in breaking out of the lab is the expense of making microfluidic
devices, as well as complex equipment required to reduce it to practice.
Furthermore, the technology has not been robust or simple to use. Successfully controlling tiny amounts of liquid is difficult,
and a careless operator can accidentally introduce air bubbles into the miniscule tubing that captures and transports analytes
and reagents. Microfluidic devices, therefore, still need the expert laboratory technicians that previous generations of
technology required.
However, from the start, the developers of Claros’ technology were focused on overcoming the drawbacks of existing
technology. They wanted to make the technology inexpensive — including the disposable “lab on a chip,” or cassette, as
well as the device interfacing with it. They also wanted to make the system robust and simple so that an operator didn’t
need a degree in chemistry or physics to use it.
A Bubbly Conundrum
One of the first microfluidic challenges attacked by the Claros diagnostic platform is bubbles. Bubbles are a big problem
in microfluidic devices, because an air bubble will tend to stick to the wall of a fluid channel and redirect liquid flow. Lab
scientists have to be careful in preventing air bubbles, because if they get
into a system, it will stop working correctly.
However, the Claros diagnostic system is designed in such a way that if a
bubble gets in, if flows right through. Claros has also found uses for air
bubbles in a microfluidic system that no one has thought of before.
The Claros cartridge, roughly the size of a credit card, stores all the chemical
reagents needed for a diagnostic assay — and keeps them separated with
bubbles of air. Since the channels in the plastic card are miniscule, the
surface tension is correspondingly high. This keeps the various reagents
separated, even if the cartridge is dropped or handled roughly.
The air bubbles move only when the cartridge is inserted into the analyzer
unit. The analyzer then creates a slight vacuum, which pulls the analyte
and reagents through the cartridge’s plumbing.
Essentially, Claros has taken an issue that has been a problem in microfluidics
and made it a part of its design. The major bug of microfluidic devices has
become a feature.
Source: Claros Diagnostics.
A New Gold Standard in Point-of-Care Diagnostics
This isn’t the only challenge solved by the innovators at Claros, however. The founding team also adapted a nonstandard
chemical process for use in protein detection and signal amplification in microfluidic assays.
3
The current standard technology, used in labs throughout the world, is called ELISA (enzyme-linked immunosorbent assay).
Basically, in an ELISA assay, the analyte (in many cases, contained in plasma or serum derived from blood) is added to a
container (such as a tube or a microwell in a plate) with a surface studded with antibodies designed to bind to a desired
protein. Once the protein is captured by this target antibody, the sample fluid is removed. Additional fluids can be added
and removed as well to wash the container and attach an additional enzyme-linked antibody to the protein, which can
produce an optical signal (such as fluorescence) in the solution.
The degree of fluorescence in
this molecular “sandwich” is
then analyzed by a piece of
lab equipment. The degree
of fluorescence in the sample
correlates to the amount of
the target protein captured
in the sample. The result is a
diagnostic measurement.
This standard chemistry for
large pieces of equipment is
not well suited for use outside
of a lab. While ideal for a
batch system employing tubes
Source: Claros Diagnostics.
and microwells, it may not
perform adequately in a microfluidic environment in which flow of fluids will wash away the optical signal. In addition, the
optical instrumentation required is not available outside a lab setting, such as a physician’s office. To solve these problems,
the Claros founders have borrowed a form of chemistry that has long been used in the photography industry. Instead of
using a signal antibody with a fluorescing molecule for the test, Claros uses an antibody with an attached gold (“Au” in
the graphic below) molecule instead.
After the molecular sandwich is created, the sample
is washed in a silver (“Ag” in
the graphic above) solution,
which layers onto the gold
molecules. As the silver builds
up — a process taking only a
few minutes — the color of
the sample changes to silver.
The analyzer component of
the diagnostic system then
measures the amount of
target protein present using light.
Source: Claros Diagnostics.
The end result of applying this technology is that — unlike bulky laboratory
systems — the entire Claros diagnostic platform can be miniaturized to fit
in the palm of your hand. It doesn’t require complex optics to measure the
amount of a protein present in blood, so it is inexpensive. Moreover, the
system is incredibly sensitive.
Using a relatively simple chemistry to yield a robust reaction in small channels
the width of a human hair is a real breakthrough. With Claros’ innovative
microfluidics and chemistry technology, any imaginable centralized laboratory
protein test performed by a large piece of equipment can now be brought to
the physician’s office, the bedside or the emergency room. All the complex
laboratory liquid-handling steps — including blood, amplification reagents and
wash solutions — are integrated into the card, invisible to the user.
4
Source: Claros Diagnostics.
Quite simply, a physician can obtain a quantitative, laboratory-quality result by simply pricking a finger to obtain a drop of
blood, much as diabetics do for glucose monitoring.
Furthermore, instead of waiting hours or days, results are available in only 10 minutes. Lastly, the disposable cartridges are
designed so that several different tests can be loaded onto a single credit-card-sized piece of plastic at the same time. All
the end-user needs to do is add a small drop of blood obtained from a finger stick, and the stored chemicals in the system
take care of the rest.
Claros holds exclusive rights to the three patents originally filed at Harvard. The company has also filed an additional 10
patents protecting its technology (three of which have been granted to date).
Huge Market Opportunities
Opko Health is working with its new Claros acquisition on several fronts
to advance commercialization of the diagnostic platform. For example,
Opko is preparing for a European launch. Although the analyzer can be
made small enough to be hand-held, Opko’s marketing research has
revealed that physicians prefer a small desktop unit (about the size of a
toaster) that can fit in an examining room, yet won’t be easily dropped
or misplaced.
Opko/Claros’ plan is to partner with other firms to launch the platform
outside the U.S. In the U.S., the company is currently in strategic discussions over whether to build its own sales force, partner or create
a hybrid arrangement. It is also working to build out a menu of tests
in urology and infectious disease. In infectious disease, for example, a
triplex test for HIV, hepatitis C and syphilis on the Claros platform has
been field-tested in Rwanda by professor Sia at Columbia University.
Opko/Claros is also developing a Vitamin D test. Here, the revenue
opportunity is vast. Experts have described Vitamin D deficiency as an
epidemic in the U.S. Some 60 million tests are ordered yearly, and the
number is increasing rapidly as Vitamin D deficiency awareness grows.
Globally, the number of tests swells to 100 million. With an average
price of approximately $50 per test, Opko has billions of dollars of
potential revenue that can be generated from the Vitamin D tests alone.
Source: Claros Diagnostics.
Presently, Vitamin D tests are performed in a laboratory. Typically, a patient is sent by his or her physician to a local lab,
and a result becomes available a few days or weeks later. Since the cost of the test is eaten up by the laboratory, it
doesn’t represent much of a profit center for the physician.
The Claros platform, however, can radically change the economics of these kinds of tests from a physician’s perspective.
The disposable diagnostic cartridges, despite the fact that they incorporate gold and silver reagents, are actually very
inexpensive to manufacture, since the amount of these metals required is miniscule. In fact, Claros’ manufacturing facility
for the reagents is actually quite small, and requires only a beaker full of silver or gold reagents to produce hundreds of
thousands of disposable cartridges.
This means that Opko can offer the test to physicians at a steep discount and still enjoy an impressive profit margin. The
physician can bill insurance at the standard reimbursement rates, and still pocket a significant percentage of the difference.
And let’s not forget, results are ready in minutes, rather than days.
This will change the way medicine is practiced in many areas. Physicians are under tremendous time and financial pressure.
Quick, inexpensive tests will dramatically increase efficiency of medical practice, and inexpensive tests will provide a financial
incentive for physicians to bill and collect for diagnostic tests in the office, instead of having to send them to the lab.
In addition to standard tests like Vitamin D, Claros is also developing tests for folic acid and Vitamin B. These tests can
5
either be offered singly or combined on a single card. Diagnostic assays for use in women’s health and cardiology are also
in development.
Imagine a patient suspected of having a heart attack. Today, blood tests for the relevant biomarkers are usually administered
at hospital labs, and it can take hours for a result to become available. With Claros technology, the test could be administered
in the ambulance, with caregivers knowing the result before arriving at the hospital. This means patients can be treated
faster, and lives will be saved.
Furthermore, Opko is developing all-new diagnostic tests that aren’t currently available.
There is an incredible amount of synergy created by Opko and Claros’ joining of forces. Opko has a diagnostic marker
discovery engine identifying novel biomarkers for Alzheimer’s disease, Parkinson’s disease, pancreatic cancer, lung cancer
and others. Developed at the University of Texas, the technology uses peptoid chemistry to detect disease-specific antibodies. Peptoids, which mimic small proteins known as peptides, can be used to discover and study novel biomarkers
that have not yet been previously identified.
Tests based on these markers are not yet considered standard of care, but there is an opportunity for Opko to gain
approval for them in the future, and also to make them available at the point of care using the Claros platform.
One of these opportunities is in prostate cancer screening. It is estimated that over 20 million PSA (prostate-specific antigen)
tests are performed per year in the U.S., with economics similar to Vitamin D tests. Here, Opko and Claros have an opportunity to replace the standard, laboratory-based test with one a physician can run in the office. The opportunity for Opko,
however, extends far beyond simply bringing the current PSA test to the point of care.
A great deal of controversy swirls around the effectiveness of the current PSA assay. The standard procedure today is to
repeat a PSA test for patients showing an abnormal reading. If the second reading is also abnormal, patients typically undergo an ultrasound-guided transrectal prostate biopsy, usually consisting of some dozen needle punches. This is not, to put it
mildly, a pleasant event, and the procedure can be accompanied by serious side effects, such as bleeding and infection.
In addition, biopsies are often unnecessary. Studies have shown that 60% of the 1.2 million biopsies performed each year
are medically unnecessary. This accounts for billions of dollars of waste, not to mention the additional cost of complications
stemming from the procedure.
Opko, however, has purchased rights to a new test based on research performed at Memorial Sloan-Kettering Cancer
Center and Finland’s University of Turku. The test, called 4KScore, is a battery of four blood-based markers, instead of
one. It includes the original PSA test, as well as three other biomarker proteins. Ten years of exhaustive published research
in over 10,000 patients have shown that the test reduces the amount of unnecessary biopsies by over 50%, with a bias
toward catching more-aggressive cancers.
Opko is in the process of building the test on its Claros platform, which will, of course, require navigation through
the regulatory process. Opko, however, has an avenue for early commercialization of 4KScore by offering the test as a
laboratory-development test (LDT) in an accredited laboratory. By working with a lab and developing the test in a strict
quality-controlled environment, Opko can provide the medical community access to this important test panel, while it is
also being adapted and validated on the Claros point-of-care platform.
Since Opko owns the exclusive rights to the biomarkers, it can derive revenue through a sharing program with laboratories.
Opko has already signed an agreement in the U.K. for the prostate cancer battery, and hopes to have a U.S. partner by
the end of the year. In Alzheimer’s, a deal has already been signed in the U.S. with LabCorp.
While deriving revenues from the laboratory version of its new tests, the company can work on achieving future regulatory
clearance on the Claros platform.
Claros Is Just One Piece of the Opko Puzzle
As exciting as the Claros technology is, Opko has far more going for it. Opko specializes in “search and development” —
6
in other words, acquiring promising early-stage biotechnologies like Claros.
In addition to diagnostics, Opko is developing numerous therapeutics. An important Opko therapeutic compound is
licensed to Tesaro Inc., a clinical-stage oncology company. The licensed compound, called rolapitant, began Phase 3 trials
for the prevention of chemotherapy-induced nausea and vomiting (CINV) last year. Up to 90% of chemotherapy patients
suffer from nausea and vomiting, and severe episodes can lead to hospitalization, as well as discontinuation of lifesaving
therapies. In the U.S., 6.6 million patients receive CINV treatments per year, and rolapitant has the potential to achieve
over $1 billion in annual sales.
Under the terms of the licensing agreement with Tesaro, Opko is eligible for $121 million in upfront and milestone
payments, as well as a double-digit royalty from future sales. In addition, Opko received 1.5 million shares of Tesaro
stock, which currently trades at $13.80 per share.
And then there is Opko’s development of therapies for neurodegenerative disease. In March of this year, Opko
announced a global license agreement with Florida’s Scripps Research Institute for the development and commercialization
of a new compound that blocks the destruction of brain cells in animal models.
Called SR-3306, it targets c-Jun N-terminal kinases (JNKs), enzymes that play a role in protecting neural cells. If successful,
SR-3306 might become the first-ever drug to protect the brain from Parkinson’s disease progression, rather than simply
treating the symptoms. It could also potentially see service in defending against other conditions affecting the brain and
nervous system, such as Lou Gehrig’s disease, multiple sclerosis, Alzheimer’s disease and stroke.
Lucrative Emerging Opportunities on Multiple Fronts, With a World-Class CEO
at the Helm
With an IPO in January 2011, Opko Health is a relatively new public company. It specializes in identifying and acquiring
valuable early-stage therapeutic platforms. With the right decision makers, this is a formula in biotechnology that has been
proven time and again to grow revenues in a relatively short amount of time.
Where management is concerned, Opko enjoys the leadership of a world-class pharmaceutical executive and investor: Dr.
Phillip Frost. With a long string of successes under his belt, including Key Pharmaceuticals and Ivax Pharmaceuticals — sold
to Teva Pharmaceuticals in 2007 for over $7 billion — Frost’s track record in generating shareholder value is legendary.
Furthermore, Dr. Frost has “skin in the game.” He is Opko’s largest shareholder and has continually purchased large
blocks of shares in the open market. Other members of Opko’s management have done the same.
Opko currently sports a market cap of only $1.4 billion. The Claros platform alone has the potential to generate many
billions of yearly revenues. Based on the potential of the Claros platform alone, Opko Health is undervalued. And then,
of course, there is the added value of the rest of the company’s clinical programs. Opko Health has the potential to
return thousands of percent to early investors.
Recommendation: Buy Opko Health (NYSE:OPK) up to $5.05 using a strict limit order.
Yours for transformational profits,
Patrick Cox and Ray Blanco
7
Breakthrough Technology Alert
Portfolio Positions
as of 7/18/2012
Company
Symbol
Buy Date
Buy Price
Current Price
Claim%
Alnylam Pharmaceuticals, Inc.
ALNY
1/22/08
$30.50
$18.76 -59.67%
Altair Nanotechnologies Inc.1
ALTI
2/19/08
$3.69
$0.35 -86.99%
China Direct2
CDII
3/7/08
$6.00
$0.24 -95.50%
Arrowhead Research3
ARWR
4/7/08
$29.50
$3.70 -87.59%
Immersion
IMMR
6/4/08
$8.76
$5.84 -36.53%
Anavex Life Sciences
AVXL.OB
6/30/08
$4.85
$1.39 -75.05%
BioTime Inc
BTIM.OB
8/4/08
$0.75
$4.50 512.00%
iRobot Corp
IRBT
9/4/08
$14.18
$20.79 47.32%
Galena Biopharma Inc
GALE
9/30/08
$8.37 $2.12 -80.53%
Stereotaxis
STXS
11/4/08
$4.43
$1.68 -55.08%
Lightbridge Corp.4
LTBR
2/2/09
$6.90
$2.59 -65.36%
Marina Biotech Inc5
MRNA
3/26/09
$18.00
$0.26 -98.17%
Harris and Harris Group Inc.
TINY
6/26/09
$5.55
$4.18 -28.29%
Nanosphere
NSPH
7/29/09
$5.30
$2.72 -43.40%
Compugen Ltd.
CGEN
8/27/09
$2.90
$3.55 55.86%
Starpharma6
SPL.AX
9/25/09
$0.55
$1.46 161.82%
NanoViricides Inc
NNVC
10/28/09
$0.88
$0.56 -37.50%
Applied Materials Inc.
AMAT
12/31/09
$13.94
$10.60 -24.18%
mPhase Technologies
XDSL
1/27/10
$0.024
$0.000 -95.00%
Arena Pharmaceuticals
ARNA
3/2/10
$3.13
$10.24
255.59%
Galectin Therapeutics7
GALT 5/10/10$3.60 $1.69
-48.89%
EchoMetrix
TXTM
5/27/10$0.195 $0.010
-93.85%
Neuralstem
CUR 7/15/10$2.35 $0.950
-59.15%
BioMimetic
BMTI 7/27/10$8.78 $3.560
-61.62%
Inovio Pharmaceuticals INO
9/1/10
$0.96
$0.510
-53.13%
Rosetta Genomics8
ROSG 10/12/10$75.00 $9.83
-86.91%
Echo Therapeutics, Inc.
ECTE
12/21/10
$1.50
$1.71
6.67%
Sangamo Biosciences, Inc.
SGMO
1/14/11
$7.98
$5.24
-33.83%
Provectus Pharmaceuticals, Inc.
PVCT
2/11/11
$0.98
$0.73
-15.71%
Star Scientific, Inc.
CIGX
3/18/11
$3.46
$4.29
32.37%
PolyMedix, Inc. PYMX
6/16/11
$0.69
$0.29
-57.97%
MIPS Technologies, Inc. MIPS
7/18/11
$6.42
$6.35
-1.71%
International Stem Cell Corp. ISCO
8/19/11
$0.73
$0.32
-61.64%
Aura Systems Inc. AUSI
9/15/11
$0.80
$0.42
-48.50%
Echelon Corporation
ELON
11/15/11
$5.59
$3.65
-38.46%
Hadasit Bio-Holdings Ltd.
HDST.TA
12/19/11
$12.12
$0.00
-15.80%
ChromaDex Corp CDXC
1/18/12
$0.96
$0.80
-29.90%
Acorn Energy, Inc. ACFN
2/13/12
$8.24
0.8.4
3.28%
ADVENTRX Pharmaceuticals
ANX
3/16/12
$0.61
$0.77
-6.56%
OncoSec Medical Inc
ONCS
4/20/12
$0.17
$0.24
57.65%
RXi Pharmaceuticals Corporation9 RXII 4/27/12$0.13 $0.15
15.38%
Protalix BioTherapeutics Inc.
PLX
6/20/12
$6.50
$5.68
-12.62%
Opko Health, Inc.
OPK
7/18/2012
NEW
$4.59
Buy Up To $5.05
Watchlist
Novint Technologies Inc.
NVNT
CellceutixCTIX
Pediatrx, Inc. PEDX
1Price reflects 4:1 reverse stock split
2Ticker changed from CDS to CDII
3Price reflecs 1:10 reverse split
4Ticker change from THPW to LTBR, price reflects a 30-1 reverse split
5Price reflects 10-1 reverse stock split
6Trades on the Australian Securities Exchange (ASX)
8
7Price reflects 1:6 reverse split
8Price reflects 1:15 reverse stock split
9Spin-off from Galena Biopharma on 4/27/2012
Note: Returns are based on recommended entry and exit prices as mentioned in the BTA
e-mail alerts. Brokers’ fees are not taken into consideration when calculating returns. If
you are not receiving the BTA e-mail alerts, please send us an e-mail to customerservice@
agorafinancial.com. All numbers are believed to be correct. Prices as of 7/18/12.

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