United
States Securities And Exchange Commission
Washington,
DC 20549
FORM
8-K
CURRENT
REPORT
Pursuant
to Section 13 or 15(d) of the Securities Exchange Act of
1934
Date
of
Report: August 3, 2005
(Date
of
earliest event reported: July 28, 2005)
ISORAY,
INC.
(Exact
name of registrant as specified in its charter)
Minnesota
(State
or other jurisdiction
of
incorporation)
|
000-14247
(Commission
File
Number)
|
41-1458152
(IRS
Employer
Identification
No.)
|
350
Hills Street, Suite 106, Richland, Washington 99354
(Address
of principal executive offices) (Zip Code)
(509)
375-1202
(Registrant's
telephone number)
ITEM
2.01 Completion of Acquisition or Disposition of Assets
On
July
28, 2005, the merger (the "Merger") contemplated by the Merger Agreement
dated
as of May 27, 2005 by and among Century Park Pictures Corporation, Century
Park
Transitory Subsidiary, Inc., IsoRay Medical, Inc. and certain shareholders
(the
"Merger Agreement"), was completed as of the filing of a Certificate of Merger
with the Secretary of State of Delaware, merging Century Park Transitory
Subsidiary, Inc. into IsoRay Medical, Inc.
As
a
result of the Merger and pursuant to the Merger Agreement, IsoRay Medical,
Inc.
has become a wholly-owned subsidiary of Century Park Pictures Corporation,
Century Park Pictures Corporation has changed its name to "IsoRay, Inc."
(hereinafter referred to as the "Registrant"), and the Registrant is issuing
shares of its common stock and shares of its preferred stock to holders of
common and preferred stock of IsoRay Medical, Inc. at a rate of 0.842362
share
of the Registrant's stock for each share of IsoRay Medical, Inc. stock. Options
and warrants to purchase common and preferred stock of IsoRay Medical, Inc.
will
also be converted at the same rate into options and warrants to purchase
common
and preferred stock of the Registrant. At the time of the Merger and following
its recent 30:1 reverse stock split, the Registrant had approximately 2,498,000
shares of common stock outstanding.
Following
the Merger, the Registrant will have 10,237,797 shares of common and preferred
stock outstanding. The total amount of shares outstanding, on a fully-diluted
basis, post merger will be 13,880,822, which includes not only shares of
common
stock, but also shares of preferred stock, warrants, options and convertible
debentures that could be exercised or converted into shares of common stock.
Following the Merger, on a fully diluted basis, the shareholders of IsoRay
Medical, Inc. own 82% of the Registrant's outstanding securities, and the
Registrant's shareholders own 18% of the Registrant's outstanding securities.
Among
the
conditions to the closing of the Merger, (i) all officers and directors of
IsoRay Medical, Inc. have agreed to lock-up the shares of the Registrant
they
have received as part of the Merger for a period of one year from the closing;
(ii) a major shareholder of the Registrant has agreed to lock-up 233,333
shares
of the Registrant's common stock for a period of one year from the closing;
(iii) IsoRay Medical, Inc. and the Registrant granted certain piggyback and
demand registration rights to certain shareholders of the Registrant and
holders
of convertible debentures issued by IsoRay Medical, Inc. (for the shares
of
common stock into which the debentures are convertible); and (iv) Thomas
Scallen, the Registrant's former Chief Executive Officer, and a major
shareholder of the Registrant have each agreed to escrow 50,000 shares of
the
Registrant's common stock for a period of three years from the closing as
collateral for these individuals' possible indemnification obligations pursuant
to the Merger Agreement.
Business
of the Registrant and Its Subsidiary
Cautionary
Note Regarding Forward-looking Statements and Risk
Factors
The
Company's Form 10-KSB, any Form 10-QSB or any Form 8-K of the Company or
any
other written or oral statements made by or on behalf of the Company may
contain
forward-looking statements which reflect the Company's current views with
respect to future events and financial performance. The words "believe,"
"expect," "anticipate," "intends," "estimate," "forecast," "project," and
similar expressions identify forward-looking statements. All statements other
than statements of historical fact are statements that could be deemed
forward-looking statements, including any statements of the plans, strategies
and objectives of management for future operations; any statements concerning
proposed new products, services, developments or industry rankings; any
statements regarding future economic conditions or performance; any statements
of belief; any statements regarding the validity of our intellectual property
and patent protection; and any statements of assumptions underlying any of
the
foregoing. Such "forward-looking statements" are subject to risks and
uncertainties set forth from time to time in the Company's SEC reports and
include, among others, the Risk Factors beginning on page 20
below.
Readers
are cautioned not to place undue reliance on such forward-looking statements
as
they speak only of the Company's views as of the date the statement was made.
The Company undertakes no obligation to publicly update or revise any
forward-looking statements, whether as a result of new information, future
events or otherwise.
Explanatory
Note
Unless
otherwise indicated or the context otherwise requires, all references below
in
this report on Form 8-K to "we," "us" and the "Company" are to IsoRay, Inc.,
a
Minnesota corporation and its subsidiary, IsoRay Medical, Inc., a Delaware
corporation. References to "IsoRay Medical" are to IsoRay Medical, Inc.,
a
Delaware corporation.
Business
of IsoRay, Inc.
Immediately
prior to the completion of the Merger, the Registrant did not conduct any
business operations and had minimal assets and liabilities.
Business
of IsoRay Medical, Inc.
IsoRay
Medical, Inc. was formed on June 15, 2004 as a corporation in the State of
Delaware, and in October 2004 it merged with two predecessor companies to
combine all of the IsoRay operations into one company.
IsoRay
Medical intends to utilize its patented radioisotope technology, chemists
and
engineers, and management team to create a major therapeutic medical device
company with a goal of providing improved patient outcomes in the treatment
of
prostate cancer and other solid cancer tumors. IsoRay Medical began production
and sales of its initial Food and Drug Administration ("FDA") approved product,
the IsoRay Cs131
brachytherapy seed, in October 2004 for the treatment of prostate cancer.
Management believes its technology will allow it to capture a leadership
position in an expanded brachytherapy market. The more clinically beneficial
characteristics of the Cesium-131 (Cs-131 or Cs131)
isotope
are expected to decrease radiation exposure to the patient and reduce the
severity and duration of side effects, while treating cancer cells as
effectively, if not more so than I-125 and Pd-103. Cs-131 offers a combination
of patient benefits management believes are superior to currently available
brachytherapy isotopes. Cs-131 could also enable meaningful penetration in
other
solid tumor applications such as breast cancer, expanding the total available
market opportunity. The second radioisotope, Yttrium-90 (Y-90 or Y90),
is
currently being used in the treatment of non-Hodgkin's lymphoma and is in
clinical trials for other applications. Other manufacturers have received
FDA
approval for Y90
and
IsoRay Medical believes production will not require clinical trials or an
extensive FDA application process. Production is expected to begin in late
2005.
Management
believes that the IsoRay Cs131seed
represents the
first
major advancement in brachytherapy technology in over 17 years with attributes
that management believes could make it the long term "seed of choice" for
internal radiation procedures. The Cs131seed
has
FDA approval for treatment of malignant disease (e.g. cancers of the head
and
neck, brain, breast, prostate, etc.) and may be used in surface, interstitial,
and intracavity applications for tumors with known
radiosensitivity.
The
Cs131
isotope
has specific clinical advantages for treating cancer over Iodine (I-125 or
I125)
and
Palladium (Pd-103 or Pd103),
the
other isotopes commonly used in brachytherapy procedures. IsoRay Medical
believes that the short half life and high-energy characteristics of
Cs131
will
expand industry applications and facilitate meaningful penetration into the
treatment of other forms of cancer tumors such as breast cancer. The shorter
half life of 9.7 days (versus 17.5 days for Pd103
and 60
days for I125)
mitigates negative affects of long radiation periods on healthy tissue and
is
believed to reduce the duration of certain side effects. The high energy
is
believed to prove more effective on fast growing cancers by aggressively
attacking cancer cells and disrupting cancer cell re-population cycles. The
characteristics of Cs131
may
result in the use of 10-30% less seeds per procedure thereby reducing the
total
physical radiation dose to the patient and reducing the costs of the procedure
for both third party payers and the patient.
Brachytherapy
seeds are small devices used in an internal radiation procedure. In recent
years
the procedure has become one of the primary treatments for prostate cancer
and
is now used more often than surgical removal of the prostate. The brachytherapy
procedure places radioactive seeds as close as possible to the cancer tumor
(the
word "brachytherapy" means close therapy). The seeds deliver therapeutic
radiation by
killing
the immediate tumor cells and cells located in the vicinity of the tumor
while
minimizing exposure to adjacent healthy cells.
This
allows doctors to administer a higher dose of radiation at one time than
is
possible with external beam radiation. Each seed contains a radioisotope
sealed
within a welded titanium capsule. Approximately 85 to 135 seeds are permanently
implanted in the prostate in a 45-minute outpatient procedure. The isotope
decays over time and the seeds become inert. The seeds may be used as a primary
treatment or in conjunction with other treatment modalities such as external
beam radiation therapy, chemotherapy, or as treatment for residual disease
after
excision of primary tumors.
IsoRay
Medical's second product, Yttrium-90, is also a short-lived (half life of
64
hrs) radioisotope that is already used in the treatment of non-Hodgkin's
lymphoma, leukemia, ovarian cancer, prostate cancer, osteosarcomas, and tumors
of the breast, lung, kidney, colon and brain. These applications apply primarily
to metastasized, or spread through the body, cancers. Currently more than
20
clinical trials using Y90
are
underway in the U.S. Also, Y90
is
used
extensively at multiple treatment centers in Europe. Several members of the
current IsoRay Medical team developed a process to produce high-purity
Y90
for
medical applications during the mid-1990s. Currently over 90 percent of the
Y90
used
in
the U.S. is imported. IsoRay Medical's management believes there is an immediate
market opportunity for a highly purified Y90.
IsoRay
Medical and its predecessor companies have accomplished the following key
milestones:
¨ |
Development
of treatment protocol by leading oncologist (January
2005);
|
¨ |
Treated
the first patient (October 2004);
|
¨ |
Production
of the Cs131seed
commenced (August 2004);
|
¨ |
Five
additional patent applications filed for Cs-131 and Y-90 processes
(November 2003 - August 2004);
|
¨ |
Radioactive
Materials License received from Washington State Department of
Health
(July 2004);
|
¨ |
Hired
first two sales and marketing executives (July 2004);
|
¨ |
ISO-9000
Quality Management System and production operating procedures (under
continuing development);
|
¨ |
Completed
the Seed Integration Test object required by the Washington State
Department of Health and the FDA (October 2004);
|
¨ |
Signed
the Commercial Work for Others Agreement between Battelle (manager
of the
Pacific Northwest National Laboratory or PNNL) and IsoRay Medical,
allowing initial production of seeds, through 2006, at PNNL (April
2004);
|
¨ |
Raised
over $10.3 M in debt and equity funding (September 2003 - July
2005);
|
¨ |
Obtained
favorable Medicare reimbursement codes for the Cs-131 brachytherapy
seed
(November 2003);
|
¨ |
FDA
approval to market the first product: the Cs-131 brachytherapy
seed (March
2003);
|
¨ |
Initial
seed production and design verification, computer modeling of the
radiation profile, and actual dosimetric data compiled by the National
Institute of Standards and Technology and PNNL (October 2002);
and
|
¨ |
Patent
obtained for Cs-131 isotope separation and purification (May 2000).
|
Certain
Defined Terms
The
technical terms defined below are important to understand as they are used
throughout this discussion of the business of IsoRay Medical. When used in
this
report, unless the context requires otherwise:
"Brachytherapy"
refers
to the process of placing therapeutic radiation sources in, or near, diseased
tissue. Brachytherapy is derived from a Greek term meaning "short distance"
therapy.
"Cesium-131"
or
"Cs-131"
is an
isotope of the element Cesium that gives off low energy, "soft" x-rays as
it
decays. Cs-131 decays to 50% of its original activity every 9.7 days, becoming
essentially inert after 100 days.
"Chelate"
and
"bifunctional
chelate"
are
molecules to which an element or radioisotope is chemically bound, typically
having a biologically active portion that selectively binds to cancerous
or
diseased cells. Chelate also refers to the process of attaching an element
or
radioisotope to a molecule. A bifunctional chelate is a chelate with two
functional groups able to form two chemical bonds per molecule.
"EBRT"
(external beam radiation therapy) is the external treatment of prostate cancer
using an x-ray-like machine that targets a beam of radiation at the cancer
site.
The treatment damages genetic material within the cancer cells, which prevents
the cells from growing and the affected cells eventually die. Treatments
are
generally performed at an outpatient center five days a week for seven or
eight
weeks.
"Half
life"
means
the time required for a radioisotope to decay to one-half of its previous
activity. The amount of radiation emitted thus decreases to 25% of original
activity in two half-lives, 12.5% in three half-lives, and so on.
"Isotope"
refers
to atoms of the same element that have different atomic masses. The word
"isotope" means "same place," referring to the fact that isotopes of a given
element have the same atomic number and hence occupy the same place in the
Periodic Table. Thus, they are very similar in their chemical behavior.
"Cs131seed"
is the
name by which IsoRay Medical's first product, the Cesium-131-based brachytherapy
seed, is currently known.
"Pure-beta
particle emitter"
is a
radioisotope whose only emissions during radioactive decay are electrons.
Beta
particles can travel several millimeters in tissue.
"RP"
(radical
prostatectomy or prostatectomy) is the complete surgical removal of the
prostate, under significant anesthesia. Two main types of surgery have evolved:
nerve-sparing and non nerve-sparing. The nerve-sparing surgery is designed
to
minimize damage to the nerve that controls penile erection.
"Radiobiologic"
is
characteristic of the effects of radiation on organisms or tissues, most
commonly the effectiveness of therapeutic radiation in interrupting cell
growth
and replication.
"Radioisotope"
is a
natural or man-made isotope of an element that spontaneously decays while
emitting ionizing radiation.
"Seed"
is a
common term for small radiation sources having a radioisotope sealed within
a
biocompatible capsule such as gold or titanium, suitable for temporary or
permanent brachytherapy implantation.
"Therapeutic
radiation" refers
to
ionizing radiation with sufficient energy to disrupt basic biological processes
of cells.
"Yttrium-90"
(Y-90)
is a radioisotope that emits high energy beta particles with a half life
of 2.67
days.
"Zirconium-90"
is a
stable (non-radioactive) decay product of Yttrium-90.
Industry
Information
Incidence
of Prostate Cancer
Excluding
skin cancer, prostate cancer is the most common form of cancer, and the second
leading cause of cancer deaths, in men. The American Cancer Society estimated
there would be about 230,900 new cases of prostate cancer diagnosed and an
estimated 29,900 deaths associated with the disease in the United States
during
2004. Because of early detection techniques (e.g. PSA) approximately 70%
(154,700) of these cases are potentially treatable with seed brachytherapy,
when
the cancers are still locally confined within the prostate.
The
expanding population of men over age 55 and increased PSA screening leading
to
earlier diagnosis of prostate cancer in the U.S. may lead to growth in the
number of prostate cancer cases treatable with brachytherapy. Also, positive
changes in Medicare reimbursement for brachytherapy seeds together with a
decrease in reimbursement rates for competing technologies have created a
more
favorable financial environment and stimulated market expansion.
Treatment
Options and Protocol
In
addition to brachytherapy, localized prostate cancer is most commonly treated
with radical prostatectomy (RP) and external beam radiation therapy (EBRT).
Other treatments include cryosurgery, hormone therapy, watchful waiting,
and
finasteride, a drug commonly prescribed to treat benign enlargement of the
prostate and male baldness. Some of these therapies may be combined in special
cases to address a specific cancer stage or patient need. When the cancerous
tissue is not completely eliminated, the cancer typically returns to the
primary
site, often with metastases to other areas.
Prostate
cancer patients electing seed therapy first undergo an ultrasound test or
CT
scan, which generates a two-dimensional image of the prostate. With the
assistance of a computer program, a three-dimensional treatment plan is created
that calculates the number and placement of the seeds required for the best
possible distribution of radiation to the prostate. Once the implant model
has
been constructed, the procedure is scheduled and the seeds are ordered. The
number of seeds implanted normally ranges from 85 to 135, with the number
of
seeds varying with the size of the prostate. The procedure is usually performed
under local anesthesia in an outpatient setting. The seeds are implanted
using
needles inserted into the prostate. When all seeds have been inserted, seed
placement is verified through an ultrasound image, CT scan, fluoroscope or
MRI.
An experienced practitioner typically performs the procedure in approximately
45
minutes, with the patient normally returning home the same day.
Brachytherapy
seeds
One
of
the first reports in the medical literature regarding brachytherapy seeds
that
deliver "soft x-ray" radiation directly to tumors by permanent implantation
appeared in 1965, authored by Donald C. Lawrence and U.K. Henschke. Don Lawrence
later pioneered development of the titanium-encapsulated I-125 brachytherapy
seed. His company, Lawrence Soft Ray Inc., provided the world's supply of
seeds
from 1967 to 1978 until the 3M Corporation purchased the technology. Eventually
3M sold the business to Amersham, which spun off this business to ONCURA,
today
the market leader in Iodine-125 seeds. All commercially available seeds trace
their origin to Mr. Lawrence's invention. Don Lawrence was a founder of IsoRay,
LLC, a predecessor company to IsoRay Medical.
Brachytherapy
has been used as a treatment for prostate cancer for more than 30 years.
Formerly, seeds containing the radioactive isotope Iodine-125 or I-125 were
implanted in prostate tumors through open surgery. However, this technique
fell
into disfavor because the seeds were often haphazardly arranged resulting
in
radiation not reaching all of the targeted cancerous prostate tissue.
Compounding this was the fact that often an unintended radiation dose was
delivered to healthy surrounding tissues, particularly the urethra and rectum.
Clinical results indicate that the brachytherapy insertion procedure, computer
modeling, advanced imaging and other techniques used in brachytherapy today
have
significantly ameliorated these drawbacks.
The
introduction of Palladium-103 or Pd-103 in the mid-1980's represented a major
technology advance in brachytherapy and played a significant role in the
dramatic increase in the number of brachytherapy procedures performed. Within
a
relatively short time, Pd-103 captured 40% of the growing brachytherapy market.
Cs131
represents the
first
major advancement in brachytherapy technology in over 17 years with attributes
that management believes could make it the long term "seed of choice" for
internal radiation procedures. The Cs131seed
has
specific
clinical advantages for
treating cancer over
I-125 and Pd-103.
There
is
a large and growing potential market for the Company's products. Several
significant clinical and market factors are contributing to the increasing
popularity of the brachytherapy procedure. Brachytherapy has become the
treatment of choice for early-stage prostate cancer and is now more common
than
surgery. Brachytherapy has significant advantages over competing treatments
including lower cost, better survival data, fewer side effects, a faster
recovery time and the convenience of a single 30 to 45 minute outpatient
procedure.
Clinical
Results
Long
term
survival data is now available for brachytherapy with Pd-103 and I-125, which
support the efficacy of brachytherapy. Clinical data indicates that
brachytherapy offers success rates for early-stage prostate cancer treatment
that are comparable to or better than those of RP or EBRT. While clinical
studies of brachytherapy to date have focused on results from brachytherapy
with
Pd-103 and I-125, management believes that this data will be relevant for
brachytherapy with Cs-131, and Cs-131 may offer improved clinical outcomes
over
Pd-103 and I-125, given its shorter half life.
Improved
patient outcomes.
A number
of published studies on the use of brachytherapy in the treatment of early-stage
prostate cancer have been very positive.
· |
A
nine-year clinical study published in the March 2000 issue of International
Journal of Radiation Oncology, Biology and Physics,
reported that 83.5% of patients treated with the Pd-103 device
were
cancer-free at nine years. The study was conducted by Dr. John
Blasko of
the Seattle Prostate Institute and included 230 patients with clinical
stage T1 and T2 prostate cancer. Only 3% experienced cancer recurrence
in
the prostate.
|
· |
Results
from a 10-year study conducted by Dr. Datolli and Dr. Wallner published
in
the International
Journal of Radiation Oncology, Biology and Physics
in
September 2002, were presented at the October 2002 American Society
for
Therapeutic Radiology and Oncology conference confirming the effectiveness
of the Pd-103 seed in patients with aggressive cancer who previously
were
considered poor candidates for brachytherapy. The 10-year study
was
comprised of 175 patients with Stage T2-T3 prostate cancer treated
from
1991 through 1995. Of these patients, 79 percent remained completely
free
of cancer without the use of hormonal therapy or
chemotherapy.
|
· |
A
study by the Northwest Prostate Institute in Seattle, Washington
reported
79% disease-free survival at 12 years for brachytherapy in combination
with external beam radiation (Ragde, et
al.,
Cancer,
July 2000). The chance of cure from brachytherapy is nearly 50%
higher
than for other therapies for men with large cancers (PSA 10-20)
and over
twice as high as other therapies for men with the largest cancers
(PSA
20+) (K. Wallner, Prostate
Cancer: A Non-Surgical Perspective,
Smart Medicine Press, 2000).
|
The
table
below summarizes published results comparing survival rates 10 years after
treatment for patients undergoing different types of treatment. Biochemical
Disease-Free Survival is defined as the percentage of patients with normal
prostate specific antigen or PSA after treatment and is the most rigorous
definition of treatment success. Disease-Specific Survival is defined as
the
percentage of patients not dying from prostate cancer.
Comparative
Survival and Disease-Free States
Treatment
|
Seed
Implants
|
External
Radiation
|
Prostatectomy
|
Disease-Free
Survival
|
64%
- 85%
|
59%
- 78%
|
65%
|
Disease-Specific
Survival
|
98%
- 100%
|
75%
- 97%
|
84%
- 85%
|
Source:
Kaiser Brachytherapy Department, Roseville,
CA
|
Reduced
Incidence of Side Effects.
Because
the IsoRay Cs131
seed
delivers a highly concentrated and confined dose of radiation directly to
the
prostate, healthy surrounding tissues and organs typically experience less
radiation exposure. Management believes, and initial results appear to support,
that this should result in fewer incidents of side effects and complications
than may be incurred with other conventional therapies, and if side effects
do
occur, they should be lower in intensity and resolve more rapidly than those
experienced with competing I-125 and Pd-103 isotopes.
Sexual
potency and urinary incontinence are two major concerns men face when choosing
among various forms of treatment for prostate cancer. Kaiser patient education
information lists the following data from clinical studies that monitored
rates
of impotence and incontinence.
Comparative
Rates of Potency and Incontinence
Treatment
|
Seed
implants
|
External
Radiation
|
Prostatectomy
(nerve sparing)
|
Prostatectomy
(non nerve-sparing)
|
Rate
of Impotence
|
10%
- 50%
|
40%
- 60%
|
14%
- 56%
|
65%
- 90%
|
Urinary
Incontinence
|
1%
|
1%
|
NR
|
7%
- 8%
|
Source:
Kaiser Brachytherapy Department, Roseville,
CA
|
Favorable
Market Factors
Lower
Treatment Cost.
The
total one-time cost of brachytherapy ranges from $13,000 to $17,000 per
procedure. This is approximately two-thirds the cost of a radical prostatectomy
or RP, which ranges from $19,000 to $25,000, excluding treatment for side
effects and post-operative complications that can be quite costly. Brachytherapy
cost is comparable to the cost of EBRT (external beam radiation), which ranges
from $13,000 up to $40,000 for a seven to nine week course of treatment.
Favorable
Demographics.
Prostate cancer incidence and mortality increase with age. Prostate cancer
is
found most often in men who are over the age of 50. The National Cancer
Institute has reported that the incidence of prostate cancer increases
dramatically in men over the age of 55. Currently, one out of every six men
is
at lifetime risk of developing prostate cancer. More than seven out of ten
men
diagnosed with prostate cancer are over the age of 65. At the age of 70,
the
chance of having prostate cancer is 12 times greater than at age 50. According
to the American Cancer Society, prostate cancer incidence rates increased
between 1988 and 1992 due to earlier diagnosis in men who otherwise had no
sign
of symptoms. Early screening has fostered a decline in the prostate cancer
death
rate since 1990.
The
number of prostate cancer cases in the U.S. is expected to increase due to
the
expanding population of men over the age of 55. The U.S. Census Bureau estimates
this segment of the population will increase from 25.9 million men in 2000
to 32
million men by 2008 - a 24% increase. Extrapolating that data, management
believes that the U.S. will provide over 180,000 candidates annually for
prostate brachytherapy by 2008.
Increased
PSA Screening.
Early
PSA screening and testing leads to early diagnosis. The American Cancer Society
recommends that men without symptoms or risk factors and who have a life
expectancy of at least ten years, should begin regular annual medical exams
at
the age of 50, and believes that health care providers should offer as part
of
the exam the prostate-specific antigen blood test. The PSA blood test determines
the amount of prostate specific antigen present in the blood. PSA is found
in a
protein secreted by the prostate, and elevated levels of PSA can be associated
with either prostatitis (a noncancerous inflammatory condition) or a
proliferation of cancer cells in the prostate. Industry studies have shown
that
the PSA test can detect prostate cancer up to five years earlier than the
digital rectal exam. Ultrasound tests and biopsies are typically performed
on
patients with elevated PSA readings to confirm the existence of cancer.
Our
Strategy
The
key
elements of IsoRay Medical's strategy include:
· |
Introduce
the IsoRay Cs131seed
into the U.S. brachytherapy market.
Utilizing a direct sales organization and selected channel partners,
IsoRay Medical intends to capture a leadership position by expanding
overall use of the brachytherapy procedure for prostate cancer
capturing
much of the incremental market growth and taking market share from
existing competitors.
|
· |
Create
a state-of-the-art manufacturing process.
IsoRay Medical plans to construct a state-of- the-art manufacturing
facility in Richland, Washington, or if I-297 presents a strategic
roadblock to the Company, in another state, implementing our proprietary
manufacturing process designed to improve profit margins, provide
adequate
manufacturing capacity to support future growth and ensure quality
control. Working with leading scientists, IsoRay Medical is in
the process
of designing a proprietary separation process for the manufacturing
of
enriched barium, a key source material for Cs131,
to ensure adequate supply and greater manufacturing efficiencies.
Also
planned is a value-added repackaging service to supply pre-loaded
needles,
stranded seeds and pre-loaded cartridges used in the implant procedure.
IsoRay Medical plans to enter into a long-term program with a leading
brachytherapy seed automation design and engineering company to
design and
build a highly automated manufacturing process to help ensure constant
quality and improve profitability.
|
· |
Introduce
Cs131
therapies for other solid cancer tumors.
IsoRay Medical intends to partner with other companies to develop
the
appropriate delivery technology and therapeutic delivery systems
for
treatment of other solid cancer tumors such as breast, neck, and
brain
cancer. IsoRay Medical's management believes that the first major
opportunity may be for the use of Cesium 131 for adjunct therapy
for the
treatment of breast cancer.
|
· |
Introduce
other isotope products to the U.S. market.
IsoRay Medical plans to introduce its Yttrium-90 radioisotope in
late
2005. Currently, FDA approved Y90
manufactured by other suppliers is used in the treatment of non-Hodgkin's
lymphoma and is in clinical trials for other applications. Other
products
may be added in the future as they are developed. IsoRay Medical
has the
ability to make several different isotopes for multiple medical
and
industrial applications. During 2005 the Company plans to identify
and
prioritize additional market opportunities for these
isotopes.
|
· |
Support
clinical research and sustained product development.
The Company plans to structure and
support clinical studies on the therapeutic benefits of Cs-131
for the
treatment of solid tumors and other patient benefits. We will support
clinical studies with several leading radiation oncologists to
clinically
document patient outcomes, provide support for our product claims
and
compare the performance of our seeds to competing seeds. IsoRay
Medical
plans to sustain long-term growth by implementing research and
development
programs with leading medical institutions in the U.S. to identify
and
develop other applications for IsoRay Medical's core radioisotope
technology.
|
Management
believes there is a large and growing addressable market for IsoRay Medical's
products. Several factors appear to contribute to the increasing popularity
of
the brachytherapy procedure. Long-term survival data is now available for
brachytherapy. Brachytherapy has become the treatment of choice for early-stage
prostate cancer and is now more common than surgery. Brachytherapy has
significant advantages over competing treatments including lower cost, better
survival data, fewer side effects, a faster recovery time and the convenience
of
a 45 minute outpatient procedure. Over 50,000 procedures were forecasted
to
occur in the U.S. in 2004. This represents a $150 million seed market that
is
forecast to grow to $242 million by 2009 according to a recent market survey
performed by Frost & Sullivan, a nationally recognized market research firm.
IsoRay Medical's management believes that the Cs131seed
will
add incremental growth to the existing brachytherapy seed market as physicians
who are currently reluctant to recommend brachytherapy for their prostate
patients due, in part, to side effects caused by longer-lived isotopes, become
comfortable with the shorter half life of Cs-131, and the anticipated reduction
of side effects.
Products
IsoRay
Medical markets the Cs131seed
and
intends to market Yttrium-90 and other radioactive isotopes in the future.
Additionally, it will attempt to create a market, primarily in clinical trials,
for the liquid Cs-131 isotope, which is created in the production of IsoRay
Medical's Cs131seed.
Cs-131
Seed Product Description and Use in Cancer Treatment
Brachytherapy
seeds are small devices that deliver therapeutic radiation directly to tumors.
Each seed contains a radioisotope sealed within a welded titanium case. In
prostate cancer procedures, approximately 85 to 135 seeds are permanently
implanted in a 45 minute outpatient procedure. The isotope decays over time,
and
the seeds become inert. The seeds may be used as a primary treatment or in
conjunction with other treatment modalities such as external beam radiation
therapy, chemotherapy, or as treatment for residual disease after excision
of
primary tumors.
Significant
advantages of brachytherapy over competing treatments include: fewer side
effects (impotence and incontinence are reduced when seeds are used to treat
prostate cancer); short, convenient outpatient procedure (typically 30 -
45
minutes); faster recovery time (days vs. weeks); lower cost than other treatment
modalities; higher cure rates for solid tumors; and less pain.
A
diagram
of the IsoRay seed appears in Figure 1. The
seed
contains an x-ray opaque marker surrounded by a ceramic substrate to which
the
isotope is chemically attached. The seed core is placed in a titanium tube
and
precision laser welded to form a hermetically sealed source of therapeutic
radiation suitable for permanent implantation. The x-ray marker allows the
physician to accurately determine seed placement within the tumor.
Figure
1: Cross section of Cs131seed
Competitive
Advantages of Cs-131
Cs131
has
specific
clinical advantages for
treating cancer over
I-125 and Pd-103, the other isotopes currently used in brachytherapy seeds.
The
table below highlights the key differences of the three seeds. The Company
believes that the short half life, high-energy characteristics of Cs131
will
increase industry growth and facilitate meaningful penetration into the
treatment of other forms of cancer tumors such as breast cancer.
Brachytherapy
Isotope Comparison
|
Cesium-131
|
Palladium-103
|
Iodine-125
|
Half
Life
|
9.7
Days
|
17.5
days
|
60
days
|
Energy
|
29
KeV
|
22
KeV
|
28
KeV
|
Dose
Delivery
|
90%
in 33 days
|
90%
in 58 days
|
90%
in 204 days
|
Total
Dose
|
110
Gy
|
125
Gy
|
145
Gy
|
Anisothrophy
Factor*
|
.969
|
.877
(TheraSeed 2000)
|
.930
(Oncura 6711)
|
*degree
of symmetry of therapeutic dose, a factor of 1 indicates
symmetry.
|
Shorter
Half life. The
Company believes that Cesium-131's shorter half life of 9.7 days will prove
to
have greater biological effectiveness by mitigating the negative effects
of long
radiation periods on healthy tissue and reducing the duration of any side
effects. A shorter half life produces more intense therapeutic radiation
over a
shorter period of time and may reduce the potential for cancer cell survival
and
tumor recurrence. Radiobiological studies indicate that shorter-lived isotopes
are more effective against faster growing tumors (Dicker, et. al., Semin.
Urol. Onc.
18:2,
May 2000). Other researchers conclude that "half-lives in the approximate
range
4-17 days are likely to be significantly better for a wide range of tumor
types
for which the radiobiologic characteristics may not be precisely known in
advance." (Armpilia CI, et. al., Int.
J. Rad. Oncol. Biol. Phys. 55:2,
February 2003).
High
Energy.
The
Cs-131 isotope decay energy of 29 to 34 KeV (versus 22 KeV for P-103 and
28 KeV
for I-125) generates a therapeutic radiation field that extends beyond the
current dosimetry reference point of 1 cm. Pd-103 seeds emit radiation that
does
not penetrate as far in tissue (up to 40% lower than Cs-131) and therefore
more
Pd-103 seeds are required to attain the same therapeutic dose as if Cs-131
seeds
were used. This increase in the number of seeds implanted increases the time
and
cost required to perform Pd-103-based procedures. The
higher
energy from Cs131
seeds is
more effective on fast growing cancers than other isotopes by aggressively
attacking cancer cells and disrupting cancer cell re-population cycles,
resulting in reduced side effects.
Reduced
side effects. Because
the IsoRay Cs131seed
device delivers a highly concentrated and confined dose of radiation directly
to
the prostate, healthy surrounding tissues and organs are exposed to less
radiation than with other treatments. This should result in fewer and less
severe side effects and complications than may be incurred with other
conventional therapies.
Shape
of radiation field. The
shape
of the radiation field generated by a Cs131seed
is
uniform, and this uniformity may result in better radiation dose coverage
and
improved therapeutic effectiveness. The adjacent picture is an autoradiograph
(film exposed by radiation from the seed itself) of an IsoRay seed, which
shows
this uniformity of the radiation field that is expected to result in better
radiation dose coverage. IsoRay Medical has conducted extensive computer
modeling and testing of the seed design. The IsoRay seed has passed all Nuclear
Regulatory Commission ("NRC")
requirements for sealed radioactive sources. Dose uniformity was tested and
the
results compared well to those predicted by industry standard computer modeling
techniques. In the third quarter of 2002, seeds were sent to the National
Institute for Standards and Technology for calibration, and have undergone
dosimetry testing according to American Association of Physicists in Medicine
("AAPM") protocols. Data from these tests were compiled in IsoRay Medical's
510(k) submission to the FDA. The results of these tests showed superior
dose
characteristics relative to the leading I-125 and Pd-103 seeds.
Figure
2. Cs131 seed Autoradiograph
Reduced
Costs.
The
characteristics of Cs131
seeds
described above may result in the use of 10%-30% less seeds per procedure,
compared to other isotopes, thereby reducing the total physical radiation
dose
to the patient and reducing the costs of the procedure for the third party
payers and the patient.
Yttrium-90
Y-90
and
Cs-131 are short-lived isotopes that are well suited to treatment of tumors
by
cell-directed therapy. The Company plans to introduce its second product,
Yttrium-90, by the end of 2005. When used in combination with molecular targets,
Y-90 is proving to be an ideal isotope to provide localized radiation therapy
for various types of cancer, such as non-Hodgkin's lymphoma, leukemia, ovarian
and prostate cancers, osteosarcomas, and tumors of the breast, lung, kidney,
colon, and brain. Y-90's properties of short half life, high specific activity,
high energy and pure beta-emissions can be chemically attached to targeting
agents that are highly selective for specific tumors. These targeting agents
may
include monoclonal antibodies, molecules derived from antibodies, peptides,
or
other tumor-specific molecules. Most Y-90 currently used in the U.S. is imported
with varying degrees of quality. IsoRay Medical is currently developing a
proprietary separation process that will produce Y-90 that management believes
should meet or exceed the purity and quality required for clinical trials
and
medical applications.
Y-90
is a
significant component of several commercially available products. These products
use radiopharmaceutical grade Y-90 derived by using manufacturing methods
and
techniques that conform to current cGMP (current Good Manufacturing Practices),
allowing them to be used invasively in commercially available healthcare
products.
We
will
initially target the clinical trial market. Currently there are several clinical
trials and medical applications involving Y-90 underway around the world
that
represent a potential market for Y-90. These customers hold significant growth
potential, as products undergoing successful trials become approved for general
use. Our strategy will be to attempt to develop exclusive sales arrangements
with companies that are close to FDA approval or foreign companies authorized
to
commercially sell their products in various overseas markets.
Y-90
is a
pure-beta particle emitter with a physical half life of 64.1 hours (2.7 days)
that decays to stable Zirconium-90. The average energy of the beta emissions
from Y-90 is 2.37 MeV, with an effective path-length in tissue of 5.3 mm.
This
means that 90% of the energy is absorbed within a 5.3-mm radius.
Y-90
is
manufactured by chemical separation from a long-lived Strontium-90 (Sr-90)
generator stock. We intend to purchase or lease the Sr-90 feedstock from
U.S.
DOE and international suppliers. Due to the radiological characteristics
of
Sr-90, initial processing will occur under stringent radiological controls
in a
highly shielded isolator or "hot cell" using remote manipulators. Following
preliminary separation, the Y-90 is further purified and converted to
pharmaceutical grade material in a shielded environmentally-controlled glove
box. After completing the separation process every two weeks (e.g., collecting
or "milking" the therapeutic Y-90), the residual Sr-90 generator is recycled
for
subsequent separations. In theory, the Sr-90 generator can continue to generate
Y-90 for decades. However, the process periodically requires infusion of
new
Sr-90. In addition to acquiring Sr-90, we will need to acquire equipment
and
develop manufacturing policies and procedures for the Y-90 isotope that will
meet cGMP criteria. While we initially plan to produce solely radiochemical
purity Y-90, which does not need to meet the more stringent manufacturing
standards required for radiopharmaceutical purity Y-90, we intend to develop
our
manufacturing methods to this higher level and produce radiopharmaceutical
purity Y-90 in the future.
IsoRay
Medical has identified four principal suppliers of Y-90: MDS Nordion, Inc.,
Perkin-Elmer Life Sciences, Inc., Amersham PLC and Iso-Tex Diagnostics, Inc.
Cs-131
Manufacturing Process
Cs-131
is
a radioactive isotope that can be produced by the neutron bombardment of
Barium-130. When Ba-130 is put into a nuclear reactor it becomes Ba-131,
the
radioactive material that is the parent of Cs-131. The process includes the
following:
· |
Isotope
Generation. The
radioactive isotope Cs-131 is normally produced by placing a quantity
of
stable non-radioactive barium (ideally pure Ba-130) into the neutron
flux
of a nuclear reactor. The irradiation process converts a small
fraction of
this material into a radioactive form of barium (Ba-131). The Ba-131
decays by electron capture to the radioactive isotope of interest
(Cs-131). IsoRay Medical has evaluated several international nuclear
reactors and many potential facilities in the United States. Due
to the
short half life of both the Ba-131 and Cs-131 isotopes, the isotope
generation cycle must occur over several weeks as dictated by the
physics
of isotope formation and decay and the facilities must be capable
of
removing irradiated materials from the reactor core on a routine
(daily or
weekly) basis. Reactor personnel will ship the irradiated barium
on a
mutually agreed schedule to our facilities for subsequent separation,
purification and seed assembly. The Company has identified five
reactors
in the U.S. and Europe that are capable of meeting these requirements.
This routine isotope generation cycle at supplier reactors will
allow
significant quantities of Ba-131 to be on hand at our facilities
for the
completion of the rest of the manufacturing process, which can
be
accomplished in three to five days, following customer orders.
To ensure
Cesium supply reliability, we intend to seek agreements with multiple
facilities to produce Cs-131. As of the date of this report, IsoRay
Medical has an agreement in place with its supplier for irradiated
Ba-131.
The Company is engaged in the development of a barium enrichment
device
that, if successful, would reduce the cost of Cs-131 while maintaining
the
purity and consistency needed for expeditious manufacture of Cs-131
isotope products.
|
· |
Isotope
Separation and Purification. Following
the harvesting of Ba-131, the isotope decays, becomes Cs-131, and
is moved
through a number of proprietary processes until it reaches seed
form.
After receiving the irradiated barium feedstock from the nuclear
reactor
facility, the rest of the manufacturing process will occur at our
facilities. This includes the isotope purification required prior
to
insertion in the seed. Due to the high-energy decay of Ba-131,
initial
processing will occur under stringent radiological controls in
a highly
shielded isolator or "hot cell" using remote manipulators. After
removal
of the energetic Ba-131, subsequent seed processing will be completed
in
locally shielded fume hoods or glove boxes. Isotope purification
involves
chemically separating the Cs-131 isotope from the irradiated material.
Upon completion of the separation process (e.g., collecting or
"milking"
the therapeutic Cs-131), the residual enriched barium will be recycled
back to the reactor facility for subsequent irradiation. This material
will be recycled as many times as economically feasible, which
should make
the process more cost effective.
|
· |
Internal
Seed Core Technology. The
purified Cs-131 isotope will be incorporated into an internal assembly
that contains a binder, spacer and X-ray marker. This internal
core
assembly is subsequently inserted into a titanium case. The dimensional
tolerance for each material is extremely important. Several carrier
materials and placement methods have been evaluated, and through
a process
of elimination, we have developed favored materials and methods
during our
laboratory testing. The equipment necessary to produce the internal
core
will include accurate cutting and gauging devices, isotope incorporation
vessels, reaction condition stabilization and monitoring systems,
and
tools for placing the core into the titanium tubing prior to seed
welding.
|
· |
Seed
Welding. Following
production of the internal core and placement into the titanium
capsule, a
seed is hermetically sealed to produce a sealed radioactive source
and
biocompatible medical device. This manufacturing technology requires:
accurate placement of seed components with respect to the welding
head,
accurate control of welding parameters to ensure uniform temperature
and
depth control of the weld, quality control assessment of the weld
integrity, and removal of the finished product for downstream processing
or rejection of unacceptable materials to waste. Inspection systems
will
be capable of identifying and classifying these variations for
quality
control ensuring a minimal amount of material is wasted. Finally,
the
rapid placement and removal of components from the welding zone
will
affect overall product throughput.
|
· |
Quality
Control. We
expect to establish procedures and controls to meet all FDA and
ISO
9001;2000 Quality Standards. Product quality and reliability will
be
secured by utilizing multiple sources of irradiation services,
feedstock
material, and other seed manufacturing components. An intensive
production
line preventive maintenance and spare parts program will be implemented.
Also, an ongoing training program will be established for customer
service
to ensure that all regulatory requirements for the FDA, DOT and
applicable
nuclear radiation and health authorities are fulfilled.
|
The
Company intends to implement a just-in-time production capability that is
keenly
responsive to customer input and orders to ensure that individual customers
receive a higher level of customer service from us than from existing seed
suppliers who have the luxury of longer lead times due to longer half life
products. Time from order to completion of product manufacture can be reduced
to
three to five days, including receipt of irradiated barium (from a supplier's
reactor), separation of Cs-131 (at our facilities), isotope labeling of the
core, and loading of cores into pre-welded titanium "cans" for final welding,
testing, quality assurance and shipping.
Automated
Manufacturing Process
IsoRay
Medical has begun discussions with a leading designer and manufacturer of
automated seed manufacturing equipment that developed an automated line in
the
US for manufacturing Iodine-125 that was sold to a competitor in early 2003.
In
addition, IsoRay Medical is engaged in preliminary discussions with another
seed
manufacturer regarding obtaining an existing automated production line. An
automated production line would require less labor, reduce costs, and help
ensure consistent manufacturing quality.
Manufacturing
Facility
The
initial production of the IsoRay Cs-131 brachytherapy seed commenced at PNNL
in
2004. IsoRay Medical has signed a lease agreement for a new interim production
facility that management anticipates will be ready by September of 2005.
The
Company is also considering Idaho as a location for a future facility, either
as
the Company's sole manufacturing facility or as a secondary facility. No
agreements have been reached for any possible facilities in Idaho.
Repackaging
Services
Most
brachytherapy manufacturers offer their seed product to the end user packaged
in
four principal packing configurations provided in a sterile or non-sterile
package depending on the customer's preference. These include:
· |
Pre-loaded
needles
(loaded with 3 to 5 seeds and
spacers)
|
· |
Strands
of seeds
(consists of seeds and spacers in a biocompatible "shrink wrap")
|
· |
Pre-loaded
Mick cartridges
(fits the Mick applicator - seed manufacturers usually load and
sterilize
Mick cartridges in their own manufacturing
facilities)
|
No
single
package configuration dominates the market at this point. Market share estimates
for each of the four packaging types are: loose seeds (20% - 30%) Mick
cartridges (25% - 35%), pre-loaded needles (40% - 55%) and strands (10% -
20%).
Market trends indicate some movement to the recently introduced stranded
configuration, as there is some clinical data suggesting less post implant
seed
migration when a stranded configuration is used.
The
role
of the repackaging service is to package, assay and certify the contents
of the
final product configuration shipped to the customer. A commonly used method
of
providing this service to the customer is through independent radiopharmacies
such as Advanced Care Pharmacy and Custom Care Pharmacy. Manufacturers send
loose seeds along with the physician's prescription to the radiopharmacy
who, in
turn, loads needles and/or strands the seeds according to the doctor's
prescription. These pharmacies then assay and certify the final packaging
prior
to shipping the product directly to the end user.
IsoRay
Medical has held discussions with the major independent radiopharmacies and
determined the shortest achievable turnaround time from delivery of loose
seeds
to the radiopharmacy to delivery of the final assayed and packaged seeds
to the
end user is 3 - 4 days. Because of the short half life of Cs-131, management
believes adding 3 - 4 days to the product delivery schedule is prohibitive
on a
long-term basis although to boost immediate sales we intend to use these
services on an interim basis until our value-added repackaging service is
operational.
Because
the short half life of the Cs-131 isotope requires fast delivery to the end
user, the Company intends to establish its own value-added repackaging service
to provide these services. The Company intends to market its seeds to the
end
user in all four of the commonly used packaging configurations, and the Company
has retained an experienced consultant to assist in the development of the
value-added repacking service.
Prior
to
the establishment of a value-added repackaging service, IsoRay Medical is
offering loose seeds which will require the implant center to load the seeds
into their preferred implant configuration. Management has contacted the
maker
of Mick cartridges and believes it will be able to load Mick cartridges on
site
for those implant centers using the Mick applicator as their method of injecting
the seeds into the prostate. The Company currently offers non-sterile,
pre-loaded Mick cartridges. As soon as the Company acquires the proper
sterilization equipment, loose seeds and pre-loaded Mick cartridges will
be
offered in a sterile package. When the value-added repackaging service is
operational, the Company will add pre-loaded needles and strands in a sterile
and non-sterile package. Management believes the value-added repacking service
will be operational by the end of 2005.
Independent
radiopharmacies usually provide the final packaging of the product delivered
to
the end user. This negates an opportunity for reinforcing the "branding"
of the
seed product. By providing its own repackaging service, the Company preserves
the product branding opportunity and eliminates any concerns related to the
handling of its product by a third party prior to delivery to the end
user.
Providing
different packaging configurations adds significant value to the product
while
providing additional revenue stream and incremental margins to the Company
through the pricing premiums that can be charged. The end users of these
packaging options are willing to pay a premium because of the savings realized
by eliminating the need for loose seed handling and loading capabilities
on
site, eliminating the need for additional staffing to load and sterilize
seeds
and needles and eliminating the expense of additional assaying of the seeds.
Management
estimates the cost of establishing a value-added repackaging service in its
new,
leased facility to be $100,000 to $150,000 and adequate space has already
been
identified in that facility. One or more technicians will be added to the
staff
to handle the seed loading, stranding and assaying operations. Our customer
service staff will provide assistance with shipping, documentation and tracking
of all orders from the repackaging service to the end user.
Barium
Enrichment Device
Barium-130
is the original source material for Cs-131. When Ba-130 is put into a nuclear
reactor it becomes Ba-131, the radioactive material that is the parent of
Cs-131. Barium metal found in nature contains only 0.1% of Ba-130 with six
other
isotopes making up the other 99.9%. As part of its manufacturing process
the
Company intends to develop a barium enrichment device that should create
"enriched barium" with a higher concentration of the Ba-130 isotope than
is
found in naturally occurring barium. In addition to creating a higher purity
Ba-130, which translates into higher purity Cs-131, a barium enrichment device
will result in higher yields of Cs-131. The Company has found sources of
enriched barium that we believe we can use until the barium enrichment device
is
developed.
Marketing
And Sales
Marketing
Strategy
The
Company intends to position Cs-131 as the isotope of choice based on its
clinical advantages over Iodine and Palladium. Management believes there
is no
apparent clinical reason to use Palladium-103 or Iodine-125 when Cesium-131
is
available. The advantages associated with a high energy and short half life
isotope are generally accepted within the clinical community and the Company
intends to help educate potential patients about the clinical benefits a
patient
would experience from the use of Cs-131 for his brachytherapy seed treatment.
The potential negative effects of the prolonged radiation times associated
with
the long half life of Iodine-125 make this isotope less attractive than
Cesium-131.
We
intend
to target these competing isotopes as our principal competition rather than
the
various manufacturers and distributors of these products. In this way, the
choice of brachytherapy isotopes will be less dependent on the name and
distribution strengths of the various Iodine and Palladium manufacturers
and
distributors and more dependent on the therapeutic benefits of Cs-131. The
Company will focus the purchasing decision on the advantages and functionality
of the Cs-131 isotope while seeking to educate the prostate cancer patient
about
these clinical benefits.
The
professional and patient market segments each play a unique and important
role
in the ultimate choice of prostate cancer treatment and the specific isotope
chosen for seed brachytherapy treatment. The Company will tailor its marketing
message to each audience. IsoRay Medical has retained an advertising agency
in
the Seattle area to assist with its marketing communication program. The
agency
will coordinate the creation and distribution of all advertising material
and
work with the print and visual media.
The
clinical advantages of Cs-131's unique combination of high energy and short
half
life will be heavily promoted within the clinical market. Because there is
no
apparent clinical reason to choose Palladium over Cesium, we have and will
continue to target those high volume users of Palladium as our first implant
sites. We will also emphasize the prolonged radiation times and the high
doses
of radiation given to the patient by the Iodine isotope and the possible
negative effects of this prolonged radiation to the adjacent healthy tissues.
We
believe that this is an important marketing message because clinicians generally
agree the radiation given by Iodine has little or no clinical benefit after
120
to 150 days.
To
promote our products to the clinical and professional audience, we will use
a
combination of marketing messages to appear in print and visual media. Planned
marketing activities include: exhibiting at the major brachytherapy related
clinical conferences to exhibit our products and provide marketing information
for annual meetings, conferences and other forums of the various professional
societies; print advertising in brachytherapy clinical journals; and promoting
clinical presentations by experts in the field at major
conferences.
In
today's U.S. health care market patients are more informed and involved in
the
management of their health and any treatments required. Many physicians relate
incidents of their patients coming for consultations armed with articles
researched on the Internet and other sources describing new treatments and
medications. In many cases, these patients are demanding a certain therapy
or
drug and the physicians are complying when medically appropriate.
Because
of this market factor, we will also promote its products directly to the
general
population. The audience targeted will be the prostate cancer patient, his
spouse, family and care givers. The marketing message to this segment of
the
market will emphasize the specific advantages of Cs-131, including fewer
side
effects, less total radiation, and shorter period of radiation. The Company
plans to reach this market through its website, located at www.isoray.com,
advertising in magazines read by prostate cancer patients and their care
givers,
and through patient advocacy efforts.
Another
key element of our strategy will be to validate and support all product claims
with well designed and executed clinical studies that support the efficacy
and
positive patient outcomes of our Cs-131 seed. We intend to sponsor
physician-directed studies that will compare the performance of our seeds
to the
seeds of our competitors. During the remainder of 2005, IsoRay Medical plans
to
continue its collaboration with leading physicians to develop clinical data
on
the efficacy of Cs-131 seeds. Noted contributors from the medical physics
community will be consulted regarding the benefits of brachytherapy using
shorter half life, improved dosimetry, and higher decay energy seeds. Articles
will be submitted to professional journals such as Medical
Physics
and the
International
Journal of Radiation Oncology,
Biology, and Physics.
Sales
and Distribution
According
to a recent industry survey, approximately 2,000 hospitals and free standing
clinics are currently offering radiation oncology services in the United
States.
Not all of these facilities offer seed brachytherapy services. These
institutions are staffed with radiation oncologists and medical physicists
who
provide expertise in radiation therapy treatments and serve as consultants
for
urologists and prostate cancer patients. We will target the radiation
oncologists and the medical physicists as well as urologists as key clinical
decision makers in the type of radiation therapy offered to prostate cancer
patients.
IsoRay
Medical has already started to build a direct sales organization to introduce
Cs-131 to radiation oncologists and medical physicists. In August 2004 IsoRay
Medical hired two highly successful sales professionals from the brachytherapy
industry that bring well established relationships with key radiation
oncologists and medical physicists, and in 2005, IsoRay Medical expanded
its
sales force to four experienced individuals. By hiring experienced and
successful brachytherapy sales people, the Company reduces the risk of delay
in
penetrating the market due to a lack of knowledge of the industry or
unfamiliarity of the key members of the brachytherapy community.
The
initial response to our new isotope from prominent radiation oncologists,
medical physicists and urologists in the US has been very positive. The Company
has begun its implant program by supplying the Cs131seed
to 9
well-known implant centers strategically located throughout the U.S. Implant
centers are currently located in the states of Arizona, California, Illinois,
Pennsylvania, Tennessee, Texas and Washington, which have implanted our seed
into 49 patients as of July 28, 2005. As production increases, additional
centers will be added. Clinical results from the patients implanted through
July
28, 2005, while not a large enough group to draw any statistically significant
conclusions, have been consistent with the reduced side effects expected
from
the shorter half life of Cs-131.
The
Company will expand its U.S. sales force as it increases production capacity
and
expands the customer base. If the Company expands outside the U.S. market,
it
plans to use established distributors in the key markets in these other
countries. This strategy will eliminate the time and expense required to
identify, train and penetrate the key implant centers and establish
relationships with the key opinion leaders in these markets. Using established
distributors also significantly reduces the time spent acquiring the proper
radiation handling licenses and other regulatory requirements of these
markets.
Pricing
Payment
for IsoRay Medical products comes from third-party payers including
Medicare/Medicaid and private insurance groups. These payers reimburse the
hospitals and clinics via well-established payment procedures. On October
31,
2003, as a result of IsoRay Medical's predecessor's filing for an Additional
Device Category, CMS (Centers for Medicare and Medicaid Services) approved
a
HCPCS/CPT code for Cs-131 brachytherapy seeds of $44.67 per seed. This is
the
same price as awarded to Pd-103 seeds, and compares favorably to the $37.34
price granted to I-125 seeds. Medicare is the most significant U.S. payer
for
prostate brachytherapy services, and is the payer in close to 70% of all
U.S.
prostate brachytherapy cases.
Prostate
brachytherapy is typically performed in the outpatient setting, and as such,
is
covered by the CMS Outpatient Prospective Payment System. In January 2004,
brachytherapy procedure prices were unbundled by CMS, allowing itemized
invoicing for seeds with no limit on the number of seeds used per procedure,
and
CMS currently reimburses hospitals and clinics for their seed purchases on
a
cost basis. Other insurance companies have followed these CMS changes. With
the
new reimbursement structure and industry consolidation, prices of brachytherapy
seeds are expected to stabilize and increase marginally during the next few
years.
Management
believes the Cs131seed
will
command a premium because of its unique characteristics and its clinical
advantages over Palladium and Iodine. Pricing premiums for pre-loaded needles,
strands and pre-loaded Mick cartridges will be added as these packaging
alternatives are offered to our customers. When charges for the seeds are
correctly submitted in the appropriate format to CMS, 100% of the total cost
of
the seeds is reimbursed to the hospital or clinic by CMS.
Other
Information
Proprietary
Rights
The
Company relies on a combination of patent, copyright and trademark laws,
trade
secrets, software security measures, license agreements and nondisclosure
agreements to protect its proprietary rights. Some of the Company's proprietary
information may not be patentable.
The
Company intends to vigorously defend its proprietary technologies, trademarks,
and trade secrets. Members of management, employees, and certain equity holders
have previously signed non-disclosure, non-compete agreements, and future
employees, consultants, advisors, with whom the Company engages, and who
are
privy to this information, will be required to do the same. A patent for
the
Cesium separation and purification process has been granted by the U.S. Patent
and Trademark Office (USPTO) under Patent Number 6,660,302. The process was
developed by Lane Bray, a shareholder of the Company, and has been assigned
exclusively to IsoRay Medical. IsoRay's predecessor also filed for patent
protection in four European countries under the Patent Cooperation Treaty.
Those
patents have been assigned to IsoRay Medical.
Our
management believes that certain aspects of the IsoRay seed design and
construction techniques are patentable innovations. These innovations have
been
documented in IsoRay laboratory records, and patent applications were filed
with
the USPTO on November 12, 2003. Certain methodologies regarding isotope
production, separation, and seed manufacture are retained as trade secrets
and
are embodied in IsoRay Medical's procedures and documentation. In June and
July
of 2004, three patent applications were filed relating to methods of deriving
Cs-131 and Y-90 developed by IsoRay Medical employees. The Company is currently
working on developing and patenting additional methods of deriving Cs-131
and
Y-90, and other isotopes.
There
are
specific conditions attached to the assignment of the Cs-131 patent from
Lane
Bray. In particular, the associated Royalty Agreement provides for 1% of
gross
profit payment from seed sales (gross seed sales price minus direct production
cost) to Lane Bray and 1% of gross profit from any use of the Cs-131 process
patent for non-seed products. If IsoRay Medical reassigns the Royalty Agreement
to another company, these royalties increase to 2%. The Royalty Agreement
has an
anti-shelving clause which requires IsoRay Medical to return the patent if
IsoRay Medical permanently abandons sales of products using the invention.
Additionally, when IsoRay Medical attains a 15% domestic market share, it
will
pay to the Lawrence Family Trust, a major shareholder of the Company, 1%
of the
"Factory Price" with a minimum annual royalty of $4,000, pursuant to an
agreement with Don Lawrence.
Research
And Development
From
inception (December 17, 2001) through December 31, 2004, IsoRay Medical and
its
predecessor companies incurred more than $1.6 million in costs related to
research and development activities. The Company expects to continue to have
employees working on activities that will be classified as research or
development for the foreseeable future.
Government
Regulation
The
Company's present and future intended activities in the development, manufacture
and sale of cancer therapy products are subject to extensive laws, regulations,
regulatory approvals and guidelines. Within the United States, the Company's
therapeutic radiological devices must comply with the U.S. Federal Food,
Drug
and Cosmetic Act, which is enforced by the FDA. The Company is also required
to
adhere to applicable FDA regulations for Good Manufacturing Practices, including
extensive record keeping and periodic inspections of manufacturing facilities.
IsoRay
Medical's predecessor obtained FDA 510(k) clearance in March 2003 to market
the
IsoRay Cs131seed
for
the treatment of localized solid tumors. A new 510(k) clearance would be
required for any modifications in the device or its labeling that could
significantly affect the safety or effectiveness of the original
product.
Washington
voters approved Initiative 297 in late 2004, which may impose additional
restrictions on sites at which mixed radioactive and hazardous wastes are
generated and stored, including PNNL. The constitutionality of this initiative
has been challenged, but if it were enforced it could impact our ability
to
manufacture our seeds, whether at PNNL or elsewhere in the State of
Washington.
Seasonality
The
Company is aware of a decrease in orders for the Cs131seed
during the month of December. This decrease in orders is related to a decrease
in the number of brachytherapy procedures performed during the month of
December, as many physicians are on vacation. The Company is not aware of
any
other significant seasonal influences on its business. The composition of
certain products and services changes modestly with shifts in weather with
no
material impact on total revenues.
Employees
Currently
IsoRay, Inc. has no employees, but certain executives of IsoRay Medical will
likely be employed by IsoRay, Inc. prior to September 30, 2005. IsoRay Medical
employs twenty-one full-time individuals, two temporary individuals and three
part-time individuals. The Company's future success will depend, in part,
on its
ability to attract, retain, and motivate highly qualified technical and
management personnel. From time to time, the Company may employ independent
consultants or contractors to support its research and development, marketing,
sales and support and administrative organizations. Neither the Company's
nor
IsoRay Medical's employees are represented by any collective bargaining unit.
IsoRay Medical estimates that successful implementation of its growth plan
would
result in up to 15 additional employees by the end of 2005.
Plan
of Operations
The
Company has $1,191,545 cash on hand as of July 28, 2005. At the Company's
current operational burn rate of approximately $500,000 per month, cash on
hand
and additional financing currently available would fund the Company's operations
until November 2005, not including capital expenses. Management believes
that an
additional $9.4 million will need to be raised by the end of 2005 to fund
planned growth and operations through 2006.
IsoRay
Medical has four outstanding loans. The first, from TRIDEC, with a principal
amount of $40,000, was funded in 2001 and requires annual principal only
payments of $10,000. It is non-interest bearing and unsecured. The second
loan
is with the Benton-Franklin Economic Development District in the amount of
$230,000 and was funded in December 2004. It bears interest at eight percent
and
has a sixty month term with a final balloon payment. This loan is secured
by
certain equipment, materials and inventory of IsoRay Medical, and also required
personal guarantees, for which the guarantors were issued 83,640 shares of
common stock in IsoRay Medical. The third loan is a line of credit, from
Columbia River Bank in the amount of $395,000. It bears interest at a floating
prime plus two percent rate, and is secured by certain accounts receivable
and
inventory and personal guarantees, for which the guarantors were issued 127,500
shares of common stock of IsoRay Medical. The fourth loan is with Columbia
River
Bank in the amount of $150,000, of which $50,000 was funded as of July 28,
2005.
This loan is to be used for equipment purchases only and is secured by the
equipment purchased with the borrowed funds. It bears interest at seven percent
for thirty-six months. IsoRay Medical is in negotiations with the Hanford
Area
Economic Investment Fund Committee (HAEIFC) for a $1,400,000 loan. There
can be
no assurance that this loan will be funded.
On
April
4, 2005 a capital lease agreement was executed by IsoRay Medical with Nationwide
Funding LLC, whereby the lessor will fund the $75,000 acquisition of a glove
box
being built to the Company's specifications by Premier Technology, Inc. of
Pocatello, ID. This is a 48 month agreement with a minimum monthly lease
payment
of $2,475.38.
On
May
16, 2005 a capital lease agreement was executed by IsoRay Medical with Vencore
Solutions LLC. This is a capital lease for a hot cell with a lease line in
the
amount of $430,000. This is a 36 month lease, a provision of which is that
IsoRay Medical can purchase the hot cell for fair market price, defined in
the
lease agreement as not more than 15% of the initial fair value purchase price.
Based on this amount, for the first five months, the minimum monthly lease
payment will be $7,589.50. The minimum monthly lease payment increases to
$15,910 for the remaining 31 months, based on the entire value of the $430,000
lease line. In connection with the lease agreement, IsoRay Medical granted
warrants to purchase 6,757 shares of its common stock at $3.50/share. These
warrants expire after four years from the date of issuance, and were converted
at the ratio listed above as part of the merger.
Property
The
Company's executive offices are located at 350 Hills Street, Suite 106,
Richland, WA 99354, (509) 375-1202, where it currently leases approximately
3,100 square feet of office and laboratory space for $4,196 per month. The
lease
expires December 31, 2005. Additional office space will be needed as employees
are hired, and is currently available at this location. The Company believes
that the current administrative facilities will be adequate until the end
of
2005, but it will need additional facilities at that time. In the future,
due to
business growth, the Company may elect to combine administrative services
and
production in one building which the Company may lease or build depending
on
market conditions.
In
April
2004, IsoRay Medical's predecessor signed a contract with PNNL, permitting
IsoRay Medical to subcontract certain of its manufacturing needs to PNNL,
use
PNNL facilities to produce the Cs-131 brachytherapy seeds, and ship them
to
customers from the PNNL facilities. Using PNNL's facilities has reduced the
immediate need for IsoRay Medical to purchase specialized capital-intensive
equipment. The contract allows it to manufacture Cs131
seeds in
PNNL for up to 18 months subsequent to commencement of production in PNNL.
The
PNNL facility has limited capacity and if demand for Cs131
seeds
exceeds this capacity the Company may need to shift production to its new
leased
facility before the end of the 18 month period. We have entered into a lease,
to
commence as of regulatory licensing approval, for an approximately 4300 square
foot facility located in Richland, Washington that our management believes
will
provide adequate space to manufacture the Cs-131 product for the prostate
cancer
markets until late 2007. The lease is for a term of twelve months following
regulatory licensing approval, which management believes will be obtained
during
the third quarter of 2005, and payment for the lease term is the issuance
of
25,800 shares of IsoRay Medical (pre-merger) common stock. The lease may
be
extended on a month-to-month basis by mutual agreement of the parties.
Legal
Proceedings
There
are
no legal actions pending against the Company.
Competition
The
Company competes in a market characterized by technological innovation,
extensive research efforts and significant competition. In general, the IsoRay
seed competes with conventional methods of treating localized cancer, including,
but not limited to, radical prostatectomy and external beam radiation therapy
which includes intensity modulated radiation therapy, as well as competing
permanent devices. RP currently represents the most common medical treatment
for
early-stage, localized prostate cancer. EBRT is also a well-established method
of treatment and is widely accepted for patients who represent a poor surgical
risk or whose prostate cancer has advanced beyond the stage for which surgical
treatment is indicated. Management believes that if general conversion from
these treatment options (or other established or conventional procedures)
to the
IsoRay seed does occur, such conversion will likely be the result of a
combination of equivalent or better efficacy, reduced incidence of side effects
and complications, lower cost, quality of life issues and pressure by health
care providers and patients.
History
has shown the advantage of being the first to market a new brachytherapy
product. For example, ONCURA currently claims nearly 50% of the market with
the
original I-125 seed. Theragenics, which introduced the original Pd-103 seed,
is
second with a nearly 30% market share. The Company believes it will obtain
a
similar and significant advantage by being the first to introduce a Cs-131
seed.
The
Company's patented Cs-131 separation process is likely to provide us a
sustainable competitive advantage in this area. Production of Cs-131 also
requires specialized facilities (hot cells) that represent high cost and
long
lead time if not readily available. In addition, a competitor would need
to
develop a method for isotope attachment and seed assembly, would need to
conduct
testing to meet NRC and FDA requirements, and would need to obtain regulatory
approvals before marketing a competing device.
Because
the exterior seed dimensions of all seeds are substantially the same, the
threshold to physician acceptance of the IsoRay seed is not significant.
Treatment planning systems and seed implantation equipment used worldwide
all
rely on seeds of the same length and diameter. Technical costs for users
to
switch from I-125 and Pd-103 to the IsoRay Cs-131 seed should be minimal.
Several
companies have obtained regulatory approval to produce and distribute
Palladium-103 and Iodine-125 seeds, which compete directly with our seed.
Ten of
those companies represent nearly 100% of annual brachytherapy seed sales
worldwide: ONCURA,
Theragenics Corp., North American Scientific, Inc., Mentor Corp., Implant
Sciences Corp., International Brachytherapy S.A., Cardinal Health, Inc.,
SourceTech Medical LLC, DRAXIMAGE
(a
division of DRAXIS
Health,
Inc.) and Best Medical International, Inc. The top three - ONCURA, Theragenics,
and North American Scientific - currently garner nearly 90% of annual sales.
It
is
possible that three or four of the current I-125 or Pd-103 seed manufacturers
(i.e., Oncura, Theragenics, North American Scientific, etc.) are capable
of
producing and marketing a Cs-131 seed, but none have reported efforts to
do so.
Best Medical obtained a seed core patent in 1992 that named 10 different
isotopes, including Cs-131, for use in their seeds. Best Medical received
FDA
510(k) approval to market a Cs-131 seed on June 6, 1993 but has failed to
produce any products for sale.
Additional
Growth Opportunities
The
Cs-131 isotope has the performance characteristics to be a technological
platform for sustained long-term growth. The most immediate opportunities
are
introducing Cs-131 to Europe and other international markets, introducing
Cs-131-based therapies for other forms of solid tumors focusing first on
breast
tumors, and through the marketing other radioactive isotopes. These growth
initiatives are in the early stages of planning and appear to be significant
incremental opportunities.
The
Company plans to introduce Cs131
initially
into Europe and later into other international markets through partnerships
and
strategic alliances with channel partners for manufacturing and distribution.
Another advantage of the Cs-131 isotope is its potential applicability to
other
cancers and other diseases. Cs-131 has FDA approval to be used for treatments
for a broad spectrum of cancers including breast, brain, and liver cancer,
and
the Company believes that a major opportunity exists as an adjunct therapy
for
the treatment of breast cancer. In addition to Y-90, there is the opportunity
to
develop and market other radioactive isotopes to the US market, and to market
the Cs-131 isotope itself, separate from its use in our seeds.
Risk
Factors
IsoRay
Medical Has Begun Generating Revenue But Is Not Yet Profitable.
IsoRay
Medical began generating revenue in October 2004, generated revenue of
approximately $262,836 through July 28, 2005, and is in the early stages
of
marketing its IsoRay Cs131seed.
IsoRay Medical and the Company have minimal historical, operating or financial
information upon which to evaluate its performance. There can be no assurance
that the Company will obtain profitability.
Our
Revenues Depend Primarily Upon One Product.
Our
revenues depend upon the successful production, marketing, and sales of the
IsoRay Cs131
seed.
A
number of factors may affect the rate and level of market acceptance of this
product including:
¨ |
the
perception by physicians and other members of the healthcare community
of
its safety and efficacy as compared to that of competing products,
if
any;
|
¨ |
the
clinical outcomes of the patients
treated;
|
¨ |
the
effectiveness of our sales and marketing efforts in the United
States;
|
¨ |
any
unfavorable publicity concerning our product or similar
products;
|
¨ |
its
price relative to other products or competing
treatments;
|
¨ |
any
decrease in current reimbursement rates from Medicare and/or third
party
payers;
|
¨ |
regulatory
developments related to the manufacture or continued use of the
product;
|
¨ |
ability
to produce sufficient quantities of this product;
and
|
¨ |
the
ability of physicians to properly utilize the device and avoid
excessive
levels of radiation to patients.
|
Because
of our reliance on this product as the sole source of our revenue, any material
adverse developments with respect to the commercialization of this product
may
cause us to incur losses rather than profits in the future.
We
Have Limited Data On The Clinical Performance Of Cs-131.
As of
July 28, 2005, the IsoRay Medical Cs131
seed has
been implanted in forty-nine patients.
While this limited number of patients prevents us from drawing statistically
significant conclusions, we can report that the side effects experienced
by
these patients were consistent with the types of side effects seen in seed
brachytherapy with Iodine and Palladium. These early results indicate that
the
onset of side effects generally occurs between one and three weeks post-implant,
and the side effects are resolved between weeks six and eight post-implant,
indicating that, at least for these initial patients, side effects resolved
more
quickly than the side effects that occur with competing seeds. These limited
findings support management's belief that the Cs131
seed
will result in less severe side effects than competing treatments, but we
will
have to wait for outcomes from additional patients before we can definitively
establish the incidence of side effects from our seeds.
Our
Subsidiary's Independent Accountants Have Expressed Doubt About Its Ability
To
Continue As A Going Concern.
IsoRay
Medical's ability to continue as a going concern is an issue raised as a
result
of the material operating losses incurred since inception, and its stockholders’
deficit. We expect to continue to experience net operating losses. Our ability
to continue as a going concern is subject to our ability to obtain necessary
funding from outside sources, including obtaining additional funding from
the
sale of our securities or obtaining loans and grants from various financial
institutions where possible. The going concern increases the difficulty in
meeting such goals.
We
Will Need To Raise Additional Capital.
The
hiring of upper level sales executives, entry into capital lease agreements
for
a glove box and a hot cell, and entry into executive contracts requiring
payments upon reaching certain milestones significantly increased IsoRay
Medical's monthly cash "burn rate" since August 2004. Ongoing obligations
to
meet greater payroll obligations coupled with legal and accounting fees related
to completing the recent merger with Century Park Pictures Corp. have resulted
in greater amounts of short term cash demands than ever before in the history
of
IsoRay Medical. We have been actively raising capital and will need to continue
to do so in greater amounts than we have raised in the past.
We
will
also need substantial funds to complete the development, manufacturing, and
marketing of our potential future products. Consequently, we will seek to
raise
further capital through not only public and private offerings of equity and
debt
securities, but also collaborative arrangements, strategic alliances, and
equity
and debt financings or from other sources. We will need to raise at least
$9.4
million of additional funding by the end of 2005 to fund working capital
through
2006 and to acquire additional equipment for the interim production facility
currently under construction. IsoRay Medical has entered into a lease, to
commence as of regulatory licensing approval, for an approximately 4300 square
foot facility located in Richland, Washington that its management believes
will
provide adequate space to manufacture the Cs-131 product for the prostate
cancer
markets until late 2007.
We
may be
unable to raise additional capital on commercially acceptable terms, if at
all,
and if we raise capital through additional equity financing, existing
shareholders may have their ownership interests diluted. Our failure to be
able
to generate adequate funds from operations or from additional sources would
harm
our business.
In
the
event of our insolvency, bankruptcy, liquidation, reorganization, or dissolution
or upon our default in payment with respect to any indebtedness or an event
of
default with respect to such indebtedness resulting in the acceleration thereof,
our assets are not expected to be sufficient to result in any payment to
holders
of the Company's preferred or common stock.
The
Recent Passage Of Initiative 297 In Washington May Result In The Relocation
To
Idaho Of Our Manufacturing Operations.
Washington
voters approved Initiative 297 in late 2004, which may impose additional
restrictions on sites at which mixed radioactive and hazardous wastes are
generated and stored, including PNNL. The U.S. Secretary of Energy is a party
to
litigation challenging the constitutionality of this initiative in U.S. District
Court. Due to this litigation, the State of Washington and the U.S. Justice
Department have agreed to delay any implementation of Initiative 297 for
an
indefinite period of time. Thus, we have the ability to manufacture seeds
at
PNNL for some period of time. If the State of Washington begins enforcement
of
the initiative and the protective legislation described above has not been
enacted, we may be unable to continue to produce seeds at PNNL under our
Commercial Work For Others contract with the Department of Energy, and if
we
cannot continue to produce seeds at PNNL, we would have to move our
manufacturing operations to an alternate facility that may be outside the
State
of Washington.
Management
believes that we will be able to continue our manufacturing operations in
the
State of Washington for the foreseeable future, whether at PNNL or at our
leased
interim facility in the State of Washington. In the event Initiative 297
is
enforced against us, management has been engaged in discussions with officials
in Idaho regarding an alternate manufacturing facility in Idaho. Because
Idaho
has a business friendly environment and the state has offered an attractive
incentive package, we would expect to be able to build our own manufacturing
facility at a cost below that anticipated for a similar facility in the State
of
Washington. We may consider moving all or part of our operations to Idaho
even
if Initiative 297 is not enforced against us.
We
Have Limited Manufacturing Experience And May Not Be Able To Meet
Demand.
Our
manufacturing experience is limited and existing management team and staff
of
IsoRay Medical and the Company have experience primarily in research and
development of products and not in manufacturing products. IsoRay Medical
began
commercial production of the Cs131
seed
in
the fourth quarter of 2004. IsoRay Medical has not tested commercial production
of Yttrium-90, although certain members of its management team previously
produced weekly batches of Y-90 for the research market when they were
affiliated with another company. Although IsoRay Medical's management team
has
significant radiochemistry experience, there is a possibility that
commercial-scale production may result in challenges that may be too expensive
or difficult to overcome. IsoRay Medical has procured equipment for a
semi-automated process of laser welding, but its ability to produce the
Cs131
seed
in
very large quantities may be limited by the current lack of a completely
automated process for welding. IsoRay Medical believes it will find a more
efficient means of welding the titanium seeds, however, there can be no
assurance that seeds will not be welded individually by the semi-automated
process for the foreseeable future. Consequently, we cannot ensure that either
IsoRay Medical's manufacturing process or its ability to sustain ongoing
production of its products will be able to meet demand.
We
Have Limited Sales And Marketing Experience.
Some
members of IsoRay Medical's team have extensive experience in successfully
establishing and training domestic and international sales forces as well
as
successfully introducing new medical devices to the market, but we have limited
specific experience with the commercial sales and marketing of the Cesium-131
radioisotope. IsoRay Medical has marketing professionals with extensive
experience selling medical devices, including radioisotopes for large,
international companies. Its initial marketing activities have begun, and
we
will need to recruit additional employees to assist with these functions.
We
cannot be certain that our products will be marketed and distributed in
accordance with our expectations or that our market research will be accurate.
We also cannot be certain that we will ever be able to develop our own sales
and
marketing capabilities to the extent anticipated by management. We may need
to
rely on third-party efforts and distribution channels and may not be able
to
maintain satisfactory arrangements with the third parties on whom we rely.
We
are currently developing in-house customer service, order entry, shipping,
billing, customer reimbursement assistance and sales support. We cannot be
certain that we will successfully develop and coordinate these departments
and
may need to find outside contractors to carry out part or all of these
functions. Even if needed, we cannot be certain that we can successfully
contract with outside contractors or that they will be available at projected
prices.
Our
Operating Results Will Be Subject To Significant Fluctuations.
Our
quarterly revenues, expenses, and operating results are likely to fluctuate
significantly in the future. Fluctuation may result from a variety of factors,
including:
¨ |
our
achievement of product development objectives and
milestones;
|
¨ |
demand
and pricing for the Company's
products;
|
¨ |
effects
of aggressive competitors;
|
¨ |
hospital
and clinic buying decisions;
|
¨ |
research
and development and manufacturing
expenses;
|
¨ |
patient
outcomes from our therapy;
|
¨ |
physician
acceptance of our products;
|
¨ |
government
or private healthcare reimbursement
policies;
|
¨ |
our
manufacturing performance and
capacity;
|
¨ |
incidents,
if any, that could cause temporary
shutdown;
|
¨ |
the
amount and timing of sales orders;
|
¨ |
rate
and success of product approvals;
|
¨ |
timing
of FDA approval, if any, of competitive products and the rate of
market
penetration of competing products;
|
¨ |
foreign
currency exchange rates;
|
¨ |
seasonality
of purchasing behavior in our
market;
|
¨ |
overall
economic conditions; and
|
¨ |
the
successful introduction or market penetration of alternative
therapies.
|
We
Rely Heavily On A Limited Number Of Suppliers.
Some
materials used in our products are currently available only from a limited
number of suppliers. Any interruption or delay in the supply of materials
required to produce our products could harm our business if we were unable
to
obtain an alternative supplier for these materials in a cost-effective and
timely manner. Additional factors that could cause interruptions or delays
in
our source of materials include limitations on the availability of raw materials
or manufacturing performance experienced by our suppliers and a breakdown
in our
commercial relations with one or more suppliers. Some of these factors may
be
completely out of our control.
We
Are Subject To Uncertainties Regarding Healthcare Reimbursement And
Reform.
In
2003,
IsoRay Medical's predecessor applied for, and CMS (Centers for Medicare and
Medicaid Services) created a classification for reimbursement for our
Cs131seed
(HCPCS code C2633 and APC code 2633) The initial reimbursement under these
codes
was $44.67 per seed. However, since January 1, 2004 hospitals and clinics
ordering our seeds are to be paid on a cost basis instead. On an ongoing
basis,
our ability to commercialize products depends in part on the extent to which
healthcare services and products are paid by governmental agencies, private
health insurers and other organizations, such as health maintenance
organizations, for the cost of such products and related treatments. Our
business could be harmed if healthcare payers and providers implement
cost-containment measures and governmental agencies implement healthcare
reform
measures that reduce payment to our customers for their use of our products.
Our
Industry Is Intensely Competitive.
The
medical device industry is intensely competitive. We compete with both public
and private medical device, biotechnology and pharmaceutical companies that
have
been established longer than we have, have a greater number of products on
the
market, have greater financial and other resources and have other technological
or competitive advantages. We also compete in the development of technologies
and processes and in acquiring personnel and technology from academic
institutions, government agencies, and other private and public research
organizations. We cannot be certain that one or more of our competitors will
not
receive patent protection that dominates, blocks or adversely affects our
product development or business; will benefit from significantly greater
sales
and marketing capabilities or will not develop products that are accepted
more
widely than ours.
We
May Be Unable To Adequately Protect Or Enforce Our Intellectual Property
Rights
Or Secure Rights To Third-Party Patents.
Our
ability and the abilities of our partners to obtain and maintain patent and
other protection for our products will affect our success. We are assigned,
have
rights to, or have exclusive licenses to patents in the U.S. and four foreign
countries. The patent positions of medical device companies can be highly
uncertain and involve complex legal and factual questions. Our patent rights
may
not be upheld in a court of law if challenged. Our patent rights may not
provide
competitive advantages for our products and may be challenged, infringed
upon or
circumvented by our competitors. We cannot patent our products in all countries
or afford to litigate every potential violation worldwide.
Because
of the large number of patent filings in the medical device and biotechnology
field, our competitors may have filed applications or been issued patents
and
may obtain additional patents and proprietary rights relating to products
or
processes competitive with or similar to ours. We cannot be certain that
U.S. or
foreign patents do not exist or will not issue that would harm our ability
to
commercialize our products and product candidates.
Our
Cs-131 separation patent is essential for production of Cesium-131. The owner
of
the patent, Lane Bray, a shareholder of the Company and Chief Chemist of
IsoRay
Medical, has the right to terminate the license agreement that allows the
Company to use this patent if we discontinue production for any consecutive
18
month period. The Company has no plans to discontinue production, and management
considers it highly unlikely that production will be discontinued at any
significant period at any time in the future.
Failure
To Comply With Government Regulations Could Harm Our Business.
As a
medical device and medical isotope manufacturer, we, as well as our contract
manufacturers and suppliers are subject to extensive, complex, costly, and
evolving governmental rules, regulations and restrictions administered by
the
FDA, by other federal and state agencies, and by governmental authorities
in
other countries. In the United States, our products cannot be marketed until
they are approved for market by the FDA. IsoRay Medical has received FDA
approval for the marketing of the Cs131seed
and
our competitors have received FDA approval for marketing Yttrium-90.
Accordingly, we believe our application for FDA approval of our Y-90 will
be
limited, and require no patient trials.
Obtaining
FDA market approval involves the submission, among other information, of
the
results of preclinical and clinical studies on the product, and requires
substantial time, effort and financial resources. The FDA, Washington State
Department of Health, and other federal and state agencies, as well as
equivalent agencies of other countries with whom we will export our products,
will also perform pre-licensing inspections of our facility and our contract
manufacturers' and suppliers' facilities. Our failure or the failure of our
partners, contract manufacturers, or suppliers to meet FDA or other agencies'
requirements would delay or preclude our ability to sell our products
potentially having an adverse material effect on our business.
Even
with
FDA market approval, we, as well as our partners, contract manufacturers
and
suppliers, are subject to numerous FDA requirements covering, among other
things, testing, manufacturing, quality control, labeling and continuing
review
of medical products, and to permit government inspection at all times. Failure
to meet or comply with any rules, regulations, or restrictions of the FDA
or
other agencies could result in fines, unanticipated expenditures, product
delays, non-approval or recall, interruption of production, and criminal
prosecution.
Although
we have implemented internal compliance programs and will continue to address
any compliance issues raised from time to time by the FDA and the other
agencies, we may not be able to meet regulatory agency standards, and any
lack
of compliance may harm our business.
Our
Business Exposes Us To Product Liability Claims.
Our
design, testing, development, manufacture, and marketing of products involve
an
inherent risk of exposure to product liability claims and related adverse
publicity. Insurance coverage is expensive and difficult to obtain, and,
although we currently have a five million dollar policy, in the future we
may be
unable to obtain coverage on acceptable terms, if at all. If we are unable
to
obtain sufficient insurance at an acceptable cost or if a successful product
liability claim is made against us, whether fully covered by insurance or
not,
our business could be harmed.
Our
Business Involves Environmental Risks.
Our
business involves the controlled use of hazardous materials, chemicals,
biologics, and radioactive compounds. Manufacturing is extremely susceptible
to
product loss due to radioactive, microbial, or viral contamination; material
equipment failure; or vendor or operator error; or due to the very nature
of the
product's short half life. Although we believe that our safety procedures
for
handling and disposing of such materials comply with state and federal standards
there will always be the risk of accidental contamination or injury. In
addition, radioactive, microbial, or viral contamination may cause the closure
of the respective manufacturing facility for an extended period of time.
By law,
radioactive materials may only be disposed of at state-approved facilities.
We
currently dispose of our radioactive waste through the Battelle managed PNNL
site under a one year renewable agreement. We intend to open our own facility
and intend to use commercial disposal contractors. We may incur substantial
costs related to the disposal of these materials. If we were to become liable
for an accident, or if we were to suffer an extended facility shutdown, we
could
incur significant costs, damages, and penalties that could harm our
business.
We
Rely Upon Key Personnel.
Our
success will depend, to a great extent, upon the experience, abilities and
continued services of our executive officers and key scientific personnel.
If we
lose the services of any of these officers or key scientific personnel, our
business could be harmed. Our success also will depend upon our ability to
attract and retain other highly qualified scientific, managerial, sales,
and
manufacturing personnel and our ability to develop and maintain relationships
with key individuals in the industry. Competition for these personnel and
relationships is intense and we compete with numerous pharmaceutical and
biotechnology companies as well as with universities and non-profit research
organizations. We may not be able to continue to attract and retain qualified
personnel.
The
Value Of Our Granted Patent, and Our Patents Pending, Is
Uncertain.
Although
our management strongly believes that our patent on the process for producing
Cesium-131, our patent pending on the manufacture of the brachytherapy seed,
our
patent applications on additional methods for producing Cesium-131 and
Yttrium-90 which have been filed, and anticipated future patent applications,
which have not yet been filed, have significant value, we cannot be confident
that other like-kind processes may not exist or be discovered, or that any
of
these patents is enforceable.
Our
Ability To Initiate Operations And Manage Growth Is Uncertain.
Our
efforts to commercialize our medical products will result in new and increased
responsibilities for management personnel and will place a strain upon our
management, operating software, financial systems, and resources. To compete
effectively and to accommodate growth, if any, we may be required to continue
to
implement and to improve our management, operating and financial systems,
procedures and controls on a timely basis and to expand, train, motivate
and
manage our employees. There can be no assurance that our personnel, systems,
procedures, and controls will be adequate to support our future operations.
If
Cesium-131 were to become the "seed of choice," explosive sales growth could
occur, making it unlikely that we could meet demand. This would cause customer
discontent and invite competition.
Our
Reporting Obligations As A Public Company Will Be Costly. Operating
a public company involves substantial costs to comply with reporting obligations
under federal securities laws that are continuing to increase as provisions
of
the Sarbanes Oxley Act of 2002 are implemented. These reporting obligations
will
increase our operating costs. We may not reach sufficient size to justify
our
public reporting status.
There
Is A Limited Market For Our Common Stock. Currently
only a limited trading market exists for our common stock. Our common stock
trades solely on the Pink Sheets, a market with very limited liquidity and
minimal listing standards under the symbol "CPPC.PK." This symbol will change
as
a result of the Merger. Any broker/dealer that makes a market in our stock
or
other person that buys or sells our stock could have a significant influence
over its price at any given time. We intend to seek a listing on the Over-the
Counter Bulletin Board, but there can be no assurance that such a listing
will
be obtained. We cannot assure our shareholders that a market for our stock
will
be sustained. There is no assurance that our shares will have any greater
liquidity than shares that do not trade on a public market.
Our
Common Stock Is Subject To Penny Stock Regulation. Our
shares are subject to the provisions of Section 15(g) and Rule 15g-9 of the
Securities Exchange Act of 1934, as amended (the "Exchange Act"), commonly
referred to as the "penny stock" rule. Section 15(g) sets forth certain
requirements for transactions in penny stocks and Rule 15g-9(d)(1) incorporates
the definition of penny stock as that used in Rule 3a51-1 of the Exchange
Act.
The SEC generally defines penny stock to be any equity security that has
a
market price less than $5.00 per share, subject to certain exceptions. Rule
3a51-1 provides that any equity security is considered to be penny stock
unless
that security is: registered and traded on a national securities exchange
meeting specified criteria set by the SEC; authorized for quotation on The
NASDAQ Stock Market; issued by a registered investment company; excluded
from
the definition on the basis of price (at least $5.00 per share) or the
registrant's net tangible assets; or exempted from the definition by the
SEC.
Since our shares are deemed to be "penny stocks", trading in the shares will
be
subject to additional sales practice requirements on broker-dealers who sell
penny stocks to persons other than established customers and accredited
investors.
ITEM
3.02 Unregistered Sales of Equity Securities
Pursuant
to the Merger, the Registrant will issue 6,401,081 shares of its common stock,
1,338,167 shares of its Series B preferred stock, options to purchase 2,069,337
shares of its common stock, warrants to purchase 344,792 shares of its common
stock, and warrants to purchase 233,014 shares of its preferred stock. These
securities will be issued by the Registrant in reliance upon an exemption
from
registration under Section 4(2) and Regulation D of the Securities Act of
1933,
as amended.
Market
for Common Equity and Related Stockholder Matters; Description Of
Securities
Overview
The
Company's Articles of Incorporation provide that the Company has the authority
to issue 200 million shares of capital stock, which are currently divided
into
two classes as follows: 194 million shares of common stock, par value of
$0.001
per share; and 6 million shares of preferred stock, also with a par value
of
$0.001 per share. Immediately prior to the Merger, and following its recent
30:1
reverse stock split, the Company had approximately 2,498,000 shares of common
stock outstanding, and no shares of preferred stock outstanding. As of July
28,
2005, the Company had 8,899,630 shares of common stock and 1,338,137 shares
of
Series B preferred stock outstanding.
Since
October 1, 2002 and until their delisting earlier this year, the Company's
common shares have traded on the Pink Sheets under the symbol "CPPC.PK."
There
have been only very limited or sporadic quotations, none exceeded $0.10 per
share, and there has been no trading activity in our stock since February
17,
2005. As of July 28, 2005, there were approximately 676 beneficial holders
of
record of the Company's common stock, exclusive of shares held in street
name.
The
Common Stock
Voting.
Holders
of the common stock are entitled to one vote per share on all matters to
be
voted on by the Company's shareholders. The Company's bylaws provide that
a
majority of the outstanding shares of the corporation entitled to vote
constitute a quorum at a meeting of the shareholders.
Dividends.
The
Company's Board of Directors, in its sole discretion, may declare and pay
dividends on the common stock, payable in cash or other consideration, out
of
funds legally available, if all dividends due on the preferred stock have
been
declared and paid. The Company has not paid any cash dividends on its common
stock and does not plan to pay any cash dividends on its common stock for
the
foreseeable future.
Liquidation,
Subdivision, or Combination.
In the
event of any liquidation, dissolution or winding up of the Company or upon
the
distribution of its assets, all assets and funds remaining after payment
in full
of the Company's debts and liabilities, and after the payment to holders
of any
then outstanding preferred stock of the full preferential amounts to which
they
were entitled, would be divided and distributed among holders of the common
stock.
The
Preferred Stock
The
Company's preferred stock is divided into two series - Series A and Series
B -
designated as follows:
· |
1,000,000
shares of Series A are authorized and 5,000,000 shares of Series
B are
authorized. There are no shares of Series A issued and outstanding;
there
are 1,338,167 Series B preferred shares issued and outstanding.
The
Company has no plans to issue any Series A shares for the foreseeable
future.
|
· |
The
Series A shares are entitled to a 10% dividend annually on the
stated
value per share ($1.20) of the Series A, while the Series B shares
are
entitled to a cumulative 15% dividend annually on the stated value
per
share ($1.20) of the Series B. Such dividends will be declared
and paid at
the discretion of the Board to the extent funds are legally available
for
the payment of dividends.
|
· |
Both
series of preferred shares vote equally with the common stock,
with each
share of preferred having the number of votes equal to the voting
power of
one share of common stock, except that the vote or written consent
of a
majority of the outstanding preferred shares is required for any
changes
to the Company's Articles of Incorporation, Bylaws or Certificate
of
Designation or for any bankruptcy, insolvency, dissolution or liquidation
of the company.
|
· |
Upon
the liquidation of the company, the company's assets would be distributed
ratably to the holders of Series A preferred stock first, then
to the
holders of Series B preferred stock and then to the holders of
common
stock.
|
· |
Shares
of either series of preferred stock may be converted at the option
of the
holder into shares of common stock at a rate of one share of common
stock
for each share of preferred stock being converted, subject to adjustment
for certain corporate events.
|
· |
Both
series of preferred stock are subject to automatic conversion into
common
stock upon the closing of a firmly underwritten public offering
pursuant
to an effective registration statement under the Act, covering
the offer
and sale of common stock in which the gross proceeds to the Company
are at
least $4 million.
|
Equity
Compensation Plans
On
May
27, 2005, the Company adopted the 2005 Stock Option Plan (the "Option Plan")
and
the 2005 Employee Stock Option Plan (the "Employee Plan"), pursuant to which
it
may grant equity awards to eligible persons. The Option Plan allows the Board
of
Directors to grant options to purchase up to 1,500,000 shares of common stock
to
directors, officers, key employees and service providers of the Company,
and the
Employee Plan allows the Board of Directors to grant options to purchase
up to
1,500,000 shares of common stock to officers and key employees of the Company.
As of July 28, 2005, options to purchase 1,180,472 shares had been granted
under
the Option Plan and options to purchase 888,865 shares had been granted under
the Employee Plan as part of the Merger.
Plan
Category
|
|
Number
of securities to be issued upon exercise of outstanding options,
warrants
and rights (#)
|
|
Weighted-average
exercise price of outstanding options, warrants and rights
($)
|
|
Number
of securities remaining available for future issuance under equity
compensation plans
|
Equity
compensation plans approved by shareholders
|
|
N/A
|
|
N/A
|
|
N/A
|
Equity
compensation plans not approved by shareholders
|
|
2,069,337
|
|
$1.33
|
|
930,663
|
Total
|
|
2,069,337
|
|
$1.33
|
|
930,663
|
Recent
Sales of Unregistered Securities
In
addition to the securities issued pursuant to the Merger, the Company issued
an
aggregate of 2,500,000 shares of common stock in April 2005 (prior to the
30:1
reverse stock split) for cash proceeds of $85,000. These securities were
sold to
Andrew Eccelstone (1,470,000 shares), Gary Boster (882,000 shares) and Philip
and Stephanie Rogers (148,000 shares). Mr. Rogers served as the Company's
President prior to the Merger. The Company relied upon § 4(2) of the Securities
Act of 1933, as amended, as the exemption from registration for this
transaction. No underwriters were used in connection with this
transaction.
ITEM
5.01 Changes in Control of Registrant
Following
the Merger, the holders of all of the common stock of IsoRay before the Merger
only own 28.07% of the common stock, and 24.41% of the combined voting stock
of
the Company. The former holders of voting stock in IsoRay Medical now own
71.93%
of the common stock, and 75.59% of the combined voting stock of the Company.
ITEM
5.02 Departure of Directors or Principal Officers; Election of Directors;
Appointment of Principal Officers
In
conjunction with the Merger, and effective as of July 28, 2005 (the closing
date
of the Merger), Thomas Scallen resigned from his positions as Chief Executive
Officer and Chairman of the Board, Philip Rogers resigned from his position
as
President and a director, and Wally Bietak resigned from his position as
a
director of the Registrant.
Effective
as of July 28, 2005, Roger Girard and David Swanberg were appointed as directors
by the resigning Board, and, also effective as of July 28, 2005, they appointed
Robert Kauffman, Thomas LaVoy and Stephen Boatwright to fill the remaining
three
vacant Board positions. The Board has not yet determined on which Board
committees these five directors will serve, although it expects to do so
at its
next scheduled meeting after the Board establishes which committees the Company
will form. Further information about the new Board members may be found below.
Effective
as of July 28, 2005, Roger Girard was appointed as Chief Executive Officer
and
President of the Registrant and Michael Dunlop was appointed as Chief Financial
Officer and Treasurer of the Company. Also effective July 28, 2005, John
Hrobsky
was appointed Vice President, Sales and Marketing and David Swanberg was
appointed Secretary and Vice President, Operations. The Registrant has not
entered into employment agreements with any of these officers as of the date
of
this filing. Further information about these officers may be found
below.
Management
IsoRay's
management and directors and their respective ages as of the date of this
report
are set forth in the table below. Also provided is a brief description of
the
experience of each director and officer during the past five years and
directorships (if any) held by each director in other companies.
Name
|
Age
|
Position
|
|
|
|
Roger
Girard
|
61
|
CEO,
President, Chairman
|
John
Hrobsky
|
55
|
VP
- Sales and Marketing
|
Michael
Dunlop
|
53
|
CFO,
Treasurer
|
David
J. Swanberg
|
48
|
VP-Operations,
Secretary, Director
|
Robert
Kauffman
|
64
|
Director
|
Thomas
LaVoy
|
45
|
Director
|
Stephen
Boatwright
|
41
|
Director
|
Roger
Girard:
In
addition to serving as President, Chairman and CEO for the Registrant, Mr.
Girard is currently the CEO, President and Chairman of the Board of IsoRay
Medical, Inc., and has served in these positions since the formation of IsoRay
Medical, Inc. Mr. Girard was CEO and Chairman of IsoRay Medical's
predecessor company from August of 2003 until October 1, 2004.
Mr.
Girard has been actively involved in the management and the development of
the
management team at IsoRay Medical, and his experienced leadership has helped
drive IsoRay's development to date. From June 1998
until
August of 2003, Mr. Girard served as President of Strategic Financial Services,
a company designed to help wealthy individuals and companies with strategic
planning and financial strategy. Mr. Girard also
served as the
managing partner for the Northwest office of Capital Consortium during this
time. Mr. Girard has knowledge, experience and connections
to private, institutional and public sources of capital
and is
experienced in managing and designing capital structures for business
organizations as well as organizing and managing the manufacturing
process,
distribution, sales, and marketing, based on his 35 years of
experience.
John
Hrobsky:
Prior
to joining IsoRay's predecessor company as Executive Vice President of Sales
and
Marketing in 2004, Mr. Hrobsky was President, CEO and a director of Advanced
Cochlear Systems, positions he held beginning in 2001. From 1999 to 2001,
Mr.
Hrobsky served as President, CEO and a director of Zaxis International, Inc.,
a
biotechnology company. Prior to 1999, Mr. Hrobsky served as a senior executive
or CEO of a number of biotech and medical device companies. IsoRay Medical
products with which Mr. Hrobsky has experience include a medical device for
restoring neuro-control after spinal cord injury, the leading cochlear implant
worldwide, and radiology and imaging equipment. Notably, Mr. Hrobsky served
as
Vice President of Sales for Cochlear Corporation, the U.S. subsidiary of
Cochlear Ltd., an Australian based manufacturer of cochlear implants. Cochlear
Ltd. is the world's leading provider of cochlear implants commanding
approximately 60% of the market. Mr. Hrobsky earned a B.S. IsoRay Medical
Technology in 1971 from the University of Wisconsin - Eau Claire, and has
earned
credits toward an MBA from Regis University, Denver, CO.
Michael
Dunlop: Mr.
Dunlop has been responsible for IsoRay Medical and its predecessor companies'
financial and accounting operations and administrative services in his position
as CFO since April 2001. Mr. Dunlop has over 16 years of administrative
experience in the healthcare industry. As Director of Contracting and Marketing
for Community Choice, PHCO, an organized healthcare delivery system, from
October 1997 to December 2003, he assisted in developing the strategic direction
and business plan of the PHCO, negotiated and maintained contractual relations
with state-wide major health insurance plans, increased compensation for
80+
independent providers and 6 area hospitals, and enhanced PHCO provider
membership through development of programs that lowered clinic and hospital
operating costs. He was granted the Pentad Industry Council, Chelan-Douglas
Counties' 'Employer of the Year' award in 1996, while administrator of Lake
Chelan Clinic. Mr. Dunlop holds an M.B.A. from California State University
and
B.M. Education from Walla Walla College.
David
J. Swanberg: Mr.
Swanberg has more than 20 years experience in engineering and materials science,
nuclear waste and chemical processing, aerospace materials and processes,
and
environmental technology development and environmental compliance. During
the
past five years, until January 2004, Mr. Swanberg was employed full time
as Sr.
Chemical/Environmental Engineer for Science Applications International
Corporation working on a variety of projects including nuclear waste research
and development. Mr. Swanberg joined IsoRay Medical's predecessor company
in
March of 1999 and has held management positions in the IsoRay companies since
2000. He has been instrumental in development of IsoRay Medical's initial
product, the Cs-131 brachytherapy seed, including interfaces with technical,
regulatory, and quality assurance requirements. With IsoRay Medical and its
predecessor companies, he has managed the development and production of
radioactive seeds to support testing to meet NRC and FDA requirements, provided
technical guidance for characterization of the IsoRay seed to meet AAPM Task
Group 43 protocols, and coordinated production and testing of non-radioactive
seeds to conform to ISO standards for brachytherapy devices. He is President
of
the Nuclear Medicine Research Council. He holds an MS in Chemical Engineering,
is a licensed Chemical Engineer, and a certified Level II Radiation Worker.
Robert
Kauffman:
Mr.
Kauffman has served as Chief Executive Officer and Chairman of the Board
of
Alanco Technologies, Inc. (NASDAQ: ALAN), an Arizona-based information
technology company, since July 1, 1998. Mr. Kauffman was formerly President
and
Chief Executive Officer of NASDAQ-listed Photocomm, Inc., from 1988 until
1997
(since renamed Kyocera Solar, Inc.). Photocomm was the nation's largest publicly
owned manufacturer and marketer of wireless solar electric power systems
with
annual revenues in excess of $35 million. Prior to Photocomm, Mr. Kauffman
was a
senior executive of the Atlantic Richfield Company (ARCO) whose varied
responsibilities included Senior Vice President of ARCO Solar, Inc., President
of ARCO Plastics Company and Vice President of ARCO Chemical Company. Mr.
Kauffman earned an M.B.A. in Finance at the Wharton School of the University
of
Pennsylvania, and holds a B.S. in Chemical Engineering from Lafayette College,
Easton, Pennsylvania.
Thomas
LaVoy:
Mr.
LaVoy has served as Chief Financial Officer of SuperShuttle International,
Inc.,
since July 1997 and as Secretary since March 1998. He has also served as
a
director of Alanco Technologies, Inc. (NASDAQ: ALAN) since 1998. From September
1987 to February 1997, Mr. LaVoy served as Chief Financial Officer of
NASDAQ-listed Photocomm, Inc. Mr. LaVoy was a Certified Public Accountant
with
the firm of KPMG Peat Marwick from 1980 to 1983. Mr. LaVoy has a Bachelor
of
Science degree in Accounting from St. Cloud University, Minnesota, and is
a
Certified Public Accountant.
Stephen
Boatwright:
Mr.
Boatwright has been a member of Keller Rohrback, PLC in Phoenix, Arizona
since
January 2005. From 1997 through January 2005 Mr. Boatwright was a partner
at
Gammage & Burnham, PLC, also in Phoenix, Arizona. Throughout his career, he
has provided legal counsel to both private and public companies in many diverse
industries. In recent years, Mr. Boatwright's legal practice has focused
on
representing technology, biotechnology, life science and medical device
companies for their securities, corporate and intellectual property licensing
needs. Mr. Boatwright earned both a J.D. and an M.B.A. from the University
of
Texas at Austin, and holds a B.A. in Philosophy from Wheaton College.
Significant
Employees
Certain
significant employees of our subsidiary, IsoRay Medical, Inc., and their
respective ages as of the date of this report are set forth in the table
below.
Also provided is a brief description of the experience of each significant
employee during the past five years.
Name
|
Age
|
Position
with IsoRay Medical, Inc.
|
|
|
|
Lane
Bray
|
77
|
Chief
Chemist
|
Garrett
Brown
|
42
|
Chief
Technology Officer
|
Keith
Welsch
|
58
|
Chief
Quality Officer
|
Lane
Bray:
Mr.
Bray is known nationally and internationally as a technical expert in
separations, recovery, and purification of isotopes and is a noted authority
in
the use of Cesium and Strontium ion exchange for Department of Energy's West
Valley and Hanford nuclear waste cleanup efforts. In 2000, Mr. Bray received
the
'Radiation Science and Technology' award from the American Nuclear Society.
Mr.
Bray has authored or co-authored over 110 research publications, 12 articles
for
9 technical books, and holds 24 U.S. and foreign patents. Mr. Bray patented
the
USDOE/PNNL process for purifying medical grade Yttrium-90 that was successfully
commercialized in 1999. Mr. Bray also recently invented and patented the
proprietary isotope separation and purification process that is assigned
to
IsoRay. Mr. Bray was elected 'Tri-Citian of the Year' in 1988, nominated
for
'Engineer of the Year' by the American Nuclear Society in 1995, and was elected
'Chemist of the Year for 1997' by the American Chemical Society, Eastern
Washington Section. Mr. Bray is retired from the Pacific Northwest National
Laboratory and currently serves as a part time consultant for medical isotope
development. Mr. Bray has been a Washington State Legislator, a Richland
City
Councilman, and a Mayor of Richland. Mr. Bray has a B.A. in Chemistry from
Lake
Forest College.
Garrett
Brown:
Dr.
Brown was Manager of Radiochemistry - Hot Cell Operations for International
Isotopes, Inc., a major radiopharmaceutical and medical device startup company,
from January 1998 until May 1999 and was instrumental in bringing a new
brachytherapy seed implant device to commercialization. Dr. Brown’s
responsibilities included hands-on radiological work in fume hoods, glove
boxes
and remote manipulator hot cells, process definition, research, development,
installation, optimization, waste minimization, procedure documentation,
facility design and training. Dr. Brown also served as the technical interface
to executive management for business development, shipping/receiving, QA/QC,
facilities and marketing/sales. Dr. Brown, as a Senior Research Scientist
at the
Pacific Northwest National Laboratory, was responsible for the weekly production
of multi-Curie quantities of medical grade Y-90, and research programs to
develop high tech sorbents for separation of Cs-137, Sr-90 and Tc-99 from
high-level radioactive wastes stored at the Hanford Nuclear Reservation.
From
May 1999 to the present, Dr. Brown has been a technical consultant with GNB
Technical Consultants. Dr. Brown has co-authored numerous technical publications
in the field. Dr. Brown has a Ph.D. in Analytical Chemistry and BS in Chemistry,
cum laude. He has served as IsoRay Medical's Chief Technical Officer since
May
of 2000. In March 2004, Dr. Brown was certified as a Radiological Safety
Officer.
Keith
Welsch:
Mr.
Welsch is a quality control professional with experience in a wide range
of
organizations and disciplines including the nuclear, aerospace, environmental
restoration, construction, tubing, steel and aluminum industries. Mr. Welsch
managed the registration of a plant to ISO 9002:1994 and subsequently
transitioned the facility to ISO 9001:2000 and conducted continuous improvement
actions. These included statistical process control, six sigma, lean
manufacturing, and total preventive maintenance programs. Mr. Welsch's other
significant achievements include facilitation of quality improvement and
stand
down teams, innovative education training manager, management of records
review
for two nuclear sites, management of audit programs and corrective-action
systems, and teaching safety, technical, and quality courses. He has earned
the
Certified Quality Auditor, Certified Quality Technician and Certified Quality
Improvement Associate certifications from the American Society for Quality.
Mr.
Welsch received a BA in Business Administration from Washington State
University.
Executive
Compensation
The
following table provides certain summary information concerning the compensation
earned by IsoRay Medical's Chief Executive Officer or comparable officer
for
services rendered in all capacities to IsoRay Medical or its predecessor
companies for the calendar years ended December 31, 2002, 2003 and 2004.
No
other executive officer of IsoRay Medical or its predecessor companies received
compensation in excess of $100,000 during calendar years 2002, 2003 or 2004.
The
following information includes the dollar value of base salaries, bonus awards,
the number of stock options granted and certain other compensation, if any,
whether paid or deferred.
Summary
Compensation Table
|
Annual
Compensation
|
Long
Term Compensation
|
All
Other Compensation
($)
|
Awards
|
Payouts
|
Name
and Principal Position
|
Year
|
Salary
($)
|
Bonus
($)
|
Restricted
Stock Awards
($)
|
Securities
Underlying Options/ SARs
(#)
|
LTIP
Payouts
($)
|
Donald
Segna, President, IsoRay Products LLC
|
2002
|
0
|
0
|
0
|
0
|
0
|
0
|
2003
|
0
|
0
|
0
|
41,580
|
0
|
0
|
2004
|
24,000
|
0
|
0
|
0
|
0
|
0
|
Roger
Girard, CEO, IsoRay, Inc. and IsoRay Medical, Inc.
|
2003
|
12,000
|
0
|
49,900
|
0
|
0
|
0
|
2004
|
97,258
|
0
|
9,900
|
610,000
|
0
|
0
|
Securities
Ownership of Certain
Beneficial Owners and Management
The
following tables set forth certain information regarding the beneficial
ownership of the Company's common stock and preferred stock as of July 28,
2005
for (a) each person known by the Company to be a beneficial owner of five
percent or more of the outstanding common or preferred stock of the Company,
(b)
each executive officer, director and nominee for director of the Company,
and
(c) all directors and executive officers of the Company as a group. As of
July
28, 2005, the Company had 8,899,629.76 shares of common stock and 1,338,167.05
shares of preferred stock outstanding.
COMMON
STOCK SHARE OWNERSHIP AS OF JULY 28, 2005
|
|
Name
and Address of
Beneficial
Owner(1)
|
Amount
of
Common
Shares Owned
|
Options
or Warrants Exercisable Within 60 Days of July 28, 2005
|
Total
Shares Beneficially Owned
|
Percent
of
Common
Shares Owned(2)
|
|
|
|
|
|
Roger
Girard, Chief Executive Officer, President and Chairman
|
338,492.75
|
219,014.12
|
0
|
6.11%
|
|
|
|
|
|
Michael
Dunlop, Chief Financial Officer
|
136,619.33
|
0
|
0
|
1.54%
|
|
|
|
|
|
John
Hrobsky, Vice President
|
0
|
234,176.64
|
0
|
2.56%
|
|
|
|
|
|
David
Swanberg, Vice President
|
284,609.70
|
0
|
0
|
3.20%
|
|
|
|
|
|
Robert
Kauffman, Director
|
43,802.83
|
0
|
0
|
.49%
|
|
|
|
|
|
Thomas
LaVoy, Director
|
0
|
0
|
0
|
0%
|
|
|
|
|
|
Stephen
Boatwright, Director
|
0
|
84,236.20
|
0
|
.94%
|
|
|
|
|
|
Lawrence
Family Trust(3)
|
888,530.20
|
0
|
0
|
9.98%
|
|
|
|
|
|
Donald
Segna
|
511,214.35
|
0
|
0
|
5.74%
|
|
|
|
|
|
Anthony
Silverman(4)
|
777,020.84
|
296,431.89
|
27,376.77
|
11.67%
|
|
|
|
|
|
All
Officers and Directors
|
|
|
|
|
as
a group (7 persons)
|
803,494.61
|
537,426.96
|
0
|
14.21%
|
(1) Except
as
otherwise noted, the address for each of these individuals is c/o IsoRay,
Inc.,
350 Hills St., Suite 106, Richland, Washington 99354.
(2) Percentage
ownership is based on 8,899,629.76 shares of Common Stock outstanding on
July
28, 2005. Shares of Common Stock subject to stock options or warrants which
are
currently exercisable or will become exercisable within 60 days after July
28,
2005 are deemed outstanding for computing the percentage ownership of the
person
or group holding such options, but are not deemed outstanding for computing
the
percentage ownership of any other person or group.
(3) The
address of the Lawrence
Family Trust is 285 Dondero Way, San Jose, California 95119.
(4) The
address of Mr. Silverman
is 2747 Paradise Road #903, Las Vegas, Nevada 98109.
PREFERRED
STOCK SHARE OWNERSHIP AS OF JULY 28, 2005
Name
and Address of
Beneficial
Owner(1)
|
Amount
of
Preferred
Shares Owned
|
Options
or Warrants Exercisable Within 60 Days of July 28, 2005
|
Total
Shares Beneficially Owned
|
Percent
of
Preferred
Shares Owned(2)
|
|
|
|
|
|
Lebowitz
Living Trust(3)
|
142,189.03
|
0
|
0
|
10.63%
|
David
Swanberg, Vice President
|
14,218.23
|
0
|
0
|
1.06%
|
|
|
|
|
|
All
Officers and Directors
|
|
|
|
|
as
a group (7 persons)
(4)
|
14,218.23
|
0
|
0
|
1.06%
|
(1) Except
as
otherwise noted, the address for each of these individuals is c/o IsoRay,
Inc.,
350 Hills St., Suite 106, Richland, Washington 99354.
(2) Percentage
ownership is based on 1,338,167.05 shares
of
Preferred Stock outstanding on July 28, 2005. Shares of Preferred Stock subject
to stock options or warrants which are currently exercisable or will become
exercisable within 60 days after July 28, 2005 are deemed outstanding for
computing the percentage ownership of the person or group holding such options,
but are not deemed outstanding for computing the percentage ownership of
any
other person or group.
(3) The
address of the Lebowitz
Living Trust is 16123 Greenwood Road, Monte Sereno, California
95030.
(4) No
officers or directors other than Mr. Swanberg beneficially own shares of
Preferred Stock.
Certain
Relationships and Related Transactions
IsoRay
Medical's patent rights to its Cesium-131 process were acquired from Lane
Bray,
a shareholder of the Company, and are subject to a 1% royalty on gross profits
and certain contractual restrictions. Additionally, when IsoRay Medical attains
a 15% domestic market share, it will pay to the Lawrence Family Trust, a
major
shareholder of the Company, 1% of the "Factory Price" with a minimum annual
royalty of $4,000, pursuant to an agreement with Don Lawrence. In exchange
for
consulting services, Quatsch Ventures, LLC, an entity controlled by Stephen
Boatwright, one of the Company's directors, received options to purchase
84,236 shares
of
our common stock in 2004. Mr. Boatwright is a member of Keller Rohrback,
PLC,
which provides legal services to the Company and IsoRay Medical.
Indemnification
of Directors and Officers
The
Company's Articles of Incorporation provides to directors and officers
indemnification to the full extent provided by law, and provide that, to
the
extent permitted by Minnesota law, a director will not be personally liable
for
monetary damages to the Company or its shareholders for breach of his or
her
fiduciary duty as a director, except for liability for certain actions that
may
not be limited under Minnesota law.
Insofar
as indemnification for liabilities arising under the Securities Act of 1933
may
be permitted to directors, officers and controlling persons pursuant to the
foregoing provisions, or otherwise, in the opinion of the Securities and
Exchange Commission such indemnification is against public policy as expressed
in the Act and is, therefore, unenforceable.
ITEM
5.03 Amendments to Articles of Incorporation or Bylaws; Change in Fiscal
Year
On
June
28, 2005, the Registrant filed a Certificate of Designation with the Minnesota
Secretary of State to designate the rights, preferences and privileges of
Series
A and B Convertible Preferred Stock, as required by the Merger Agreement.
The
Registrant is now authorized to issue up to 1 million shares of Series A
Convertible Preferred Stock and up to 5 million shares of Series B Convertible
Preferred Stock. The Series A Preferred carries a dividend of ten percent
per
year on the stated value per share of $1.20 through March 31, 2007. The Series
B
Preferred carries a dividend of fifteen percent per year on the stated value
per
shares of $1.20, and accrued but unpaid dividends cumulate. Both series of
preferred stock vote equally with the common stock, and may be converted
into
common stock at a rate of one share of common stock for each one share of
preferred stock converted.
On
July
29, 2005, the Registrant filed a Certificate of Amendment to its Articles
of
Incorporation, changing the name of the Registrant from "Century Park Pictures
Corporation" to "IsoRay, Inc."
On
August
1, 2005, the Registrant determined that it would change its fiscal year end
from
September 30 to June 30, and by August 15, 2005 the Registrant will file
Form
1128 with the Internal Revenue Service (IRS) to effectuate this change. Pending
approval from the IRS, the Registrant will file its transition report on
Form
10-KSB.
ITEM 8.01
Other Events
As
a
result of the Merger, IsoRay has moved its principal executive offices to
350
Hills Street, Suite 106, Richland, Washington 99354.
ITEM
9.01 Exhibits
(a) Financial
Statements of Business Acquired
To
be
filed by amendment.
(b) Pro
Forma Financial Information
To
be filed by amendment.
(c) Exhibits
2.1 Merger
Agreement dated as of May 27, 2005, by and among Century Park Pictures
Corporation, Century Park Transitory Subsidiary, Inc., certain shareholders
and
IsoRay Medical, Inc.
2.2 Certificate
of Merger, filed with the Delaware Secretary of State on July 28,
2005
3.1 Certificate
of Designation of Rights, Preferences and Privileges of Series A and B
Convertible Preferred Stock, filed with the Minnesota Secretary of State
on June
29, 2005
3.2 Amendment
to Articles of Incorporation, filed with the Minnesota Secretary of State
on
July 29, 2005
4.1 Form
of
Lock-Up Agreement for Certain IsoRay Medical, Inc. Shareholders
4.2 Form
of
Lock-Up Agreement for Anthony Silverman
4.3 Form
of
Registration Rights Agreement among IsoRay Medical, Inc., Century Park Pictures
Corporation and the other signatories thereto
4.4 Form
of
Escrow Agreement among Century Park Pictures Corporation, IsoRay Medical,
Inc.
and Anthony Silverman
4.5 Form
of
Escrow Agreement among Century Park Pictures Corporation, IsoRay Medical,
Inc.
and Thomas Scallen
SIGNATURES
In
accordance with the requirements of the Exchange Act, the Registrant caused
this
report to be signed on its behalf by the undersigned, thereunto duly
authorized.
|
|
|
|
IsoRay,
Inc., a Minnesota corporation |
|
|
|
Dated: August
3, 2005 |
By: |
/s/ Roger
Girard |
|
|
|
Roger
Girard, CEO |