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MANHATTAN SCIENTIFICS INC - 10-Q - MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS.
(Edgar Glimpses Via Acquire Media NewsEdge) Forward Looking Statements
This Form 10-Q contains "forward-looking" statements including statements
regarding our expectations of our future operations. For this purpose, any
statements contained in this Form 10-Q that are not statements of historical
fact may be deemed to be forward-looking statements. Without limiting the
foregoing, words such as "may," "will," "expect," "believe," "anticipate,"
"estimate," or "continue" or comparable terminology are intended to identify
forward-looking statements. These statements by their nature involve substantial
risks and uncertainties, and actual results may differ materially depending on a
variety of factors, many of which are not within our control. These factors
include, but are not limited to, economic conditions generally and in the
industries in which we may participate. In addition, these forward-looking
statements are subject, among other things, to our successful completion of the
research and development of our technologies; successful commercialization of
our technologies; successful protection of our patents; and effective
significant industry competition from various entities whose research and
development, financial, sales and marketing and other capabilities far exceeds
ours. In light of these risks and uncertainties, you are cautioned not to place
undue reliance on these forward-looking statements. Except as required by law,
we undertake no obligation to announce publicly revisions we make to these
forward-looking statements to reflect the effect of events or circumstances that
may arise after the date of this report.
OVERVIEW
COMPANY HISTORY
Manhattan Scientifics, Inc., a Delaware corporation, was established on July 31,
1992 and has three operating wholly-owned subsidiaries: Metallicum, Inc.,
("Metallicum"), Senior Scientific LLC ("Senior Scientific"), and Scientific
Nanomedicine, Inc. ("Scientific Nanomedicine" or "SNMI"). The Company's goal is
to nurture visionary technologies into life changing success stories and
Metallicum, Senior Scientific and Scientific Nanomedicine are pursuing that
goal.
Manhattan Scientifics, Inc., operates as a technology incubator that seeks to
acquire, develop and commercialize life-enhancing technologies in various
fields, with emphasis in the areas of nanotechnology. Nanotechnology is the use
and manipulation of matter on an atomic and molecular scale. To achieve this
goal, the Company continues to identify emerging technologies through strategic
alliances with scientific laboratories, educational institutions, scientists and
leaders in industry and government. The Company and its executives have a long
standing relationship with Los Alamos Laboratories in New Mexico.
ACQUISITIONS
In June 2008, we acquired Metallicum, Inc. ("Metallicum") and its licensed
patented technology. We entered into a stock purchase agreement with Metallicum,
Inc. to acquire all of the outstanding capital in exchange for 15,000,000
restricted shares of our common stock. An additional 15,000,000 shares of our
common stock will be payable to Metallicum in the event of meeting certain
milestones. At December 31, 2011, one milestone was met. Metallicum was granted
an exclusive license by The Los Alamos National Laboratory on patents related to
nanostructured metals. In September 2009, we entered into a technology transfer
agreement and sale with Carpenter Technology Corporation, ("Carpenter") wherein
Carpenter will fully develop, manufacture and market a new class of high
strength metals. We earn annual revenues from these agreements and we expect to
earn licensing royalties when Carpenter begins selling our licensed technology.
On May 31, 2011, we entered into an Agreement and Plan of Reorganization to
acquire Senior Scientific and Scientific Nanomedicine. The total purchase price
was 21,668,000 restricted shares of our common stock (less 7,667,000 shares
previously issued pursuant to an option agreement). As a result of this
acquisition, we own patented technologies that can use biosafe nanoparticles and
sensitive magnetic sensors to detect and measure cancer cells in biopsies or in
the human body with the potential to transform how cancer is detected and
treated.
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ADVANCED METALS
Our licensed proprietary process will enable our commercial partners the ability
to build super-strength metals and alloys to make products that weigh far less
than in the past and without significant cost premiums. In September 2009, the
Company entered into a technology transfer agreement and sale with Carpenter.
Pursuant to these revenue generating agreements, Carpenter will fully develop,
manufacture and market a new class of high strength metals. We intend to
establish other manufacturing partner relationships with significant customers
in the medical device and prosthetics industries.
NANOMEDICINE
Our acquisition of Senior Scientific and Scientific Nanomedicine gives us the
commercial rights to technology and intellectual property with respect to the
detection and monitoring of diseases using nanotechnologies. The technology is
intended for the early detection of cancers, quantitative in vivo assessments of
tumors, and similar applications with other diseases identifiable by cell
surface markers. The technology does not require surgery, biopsy, radioactivity,
or exotically expensive instruments. Nanoparticles are introduced to the body,
for example, by intravenous injection. A sensitive magnetic instrument is used
to magnetize and measure the nanoparticles that have bound to the specific
targets (e.g., cells of a specific type of cancer). Other tissues, bone, scars,
etc. are all transparent to the magnetic fields used, so the technology can be
used to image and measure tumors in places inaccessible to other tests, and
tumors while they are still small enough to be treatable. The nanoparticles are
nontoxic, and the magnetic instrument is not harmful or expensive, so the tests
can be repeated as needed. The following bullet points summarize management's
current beliefs with respect to the benefits and commercialization of our
nanomedicine technology:
• Our technology can detect cancer at a mass of 100,000 cells, and is
currently being programmed to detect down to 12,000 cells;
• After development for commercial use - our technology may detect
cancer before stage one -- down to "a few thousand cells";
• Our technology uses a patented device now known as SQUID
(superconducting quantum interference device) which we hope to
develop for commercialization along with the nanoparticles that will
be used to detect cancer;
• MD Anderson Cancer Center signed on for a preclinical trial of our
magnetic nanoparticle technology in August 2011;
• There is revenue potential from lab/animal research and from human
medical applications;
• FDA approval may not be needed for lab/animal uses; and
• Since biosafe nanoparticles are already in use-there may be a
shortened FDA approval process for human medical applications.
Similar to our agreement with Carpenter, we plan to license our technology to a
pharmaceutical or medical device company who will use the technology for
non-invasive cancer biopsies and screenings.
OTHER TECHNOLOGIES
In the recent past, we have worked to develop and commercialize three
technologies:
· Haptics "Touch and Feel" computer applications, which is a
technology that allows computer users to be able to touch and feel
any objects they see on their computer screen with the aid of
special "mouse." Detailed texture, object-weight, stickiness,
viscosity and object density can be "felt" or sensed. Management
believes this haptics technology may positively impact the way
computers are used everywhere by introducing the ability to "touch."
(Please see Haptics "Touch and Feel" Internet Applications and
Investment in Novint Technologies, Inc." · Fuel Cell Technology - Micro fuel cell technology, which is designed
to become an ultra efficient miniature electricity generator that
converts hydrogen into electricity by chemical means, for portable
electronic devices, including cellular telephones, as a substitute
for lithium ion and other batteries in common use today. Mid-range
fuel cell technology, which is an ultra efficient medium-size
electricity generating device that converts hydrogen into
electricity, with potential applications including personal
transportation, cordless appliances, power tools, wheelchairs,
bicycles, boats, emergency home generators, military field
communications and laptop computers.
We are not presently using our resources to develop these technologies but will
take advantage of opportunities to commercialize and monetize these
technologies. We are also seeking to develop corporate opportunities to benefit
our shareholders.
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OUR DEVELOPMENT MODEL
Our goal has been to influence the future through the development of potentially
life changing technologies. Our business model is to: (i) identify significant
technologies, (ii) acquire them or the rights to them, (iii) secure the services
of inventors, engineers or other staff who were instrumental in their creation,
(iv) provide or contract for suitable work facilities, laboratories, and other
aids where appropriate, (v) prototype the technologies to demonstrate "proof of
principle" feasibility, (vi) secure patent and or other intellectual property
protection, (vii) secure early customers for product trials where feasible and
appropriate, and (viii) commercialize through licenses, sales or cooperative
efforts with other manufacturing and distribution firms.
Since our technologies are still in their development phase, the need for
operating and acquisition capital is a continuous concern requiring the ongoing
efforts of our management. The Company's success will depend in part on its
ability to obtain patents and product license rights, maintain trade secrets,
and operate without infringing on the proprietary rights of others, both in the
United States and other countries. There can be no assurance that patents issued
to or licensed by the Company will not be challenged, invalidated, or
circumvented, or that the rights granted thereunder will provide proprietary
protection or competitive advantages to the Company.
We utilize the intellectual property sale/licensing model, and not a production
model, though management is opportunistic and is open to explore all methods
leading to commercializing our technologies. We intend to consider all
appropriate avenues for the commercialization of our technologies.
DESCRIPTION OF TECHNOLOGIES
ADVANCED MATERIALS
Our business model is based on licensing metals technology to metals
manufacturers. Although competing commercial products are provided by existing
specialty metals companies, the only competing processes for creating
nanostructured metals are either limited or cannot be economically scaled.
Metallicum does not yet face direct competition, but expects competition will
emerge as the metal is commercialized.
In January 2009, we entered into a patent license agreement with Los Alamos
National Security, LLC for the exclusive licensing use of certain technology
relating to the manufacture and application of nanostructuring metals and
alloys. Pursuant to such agreement we provided a non-refundable fee and
2,000,000 shares of our common stock with a fair market value of $33,000.
Additionally, we are required to pay an annual license fee of $10,000 starting
in February 2010 and royalties on future net sales.
The technology is expected to trim thousands of pounds from airplanes and
hundreds of pounds from cars without sacrificing structural strength or adding
significant cost. The nanostructured metals also have wide implications for use
in the medical device and prosthetics industries including dental implants,
replacements for hips, shoulders, knees and cardio vascular
stents. Nanostructured metals is stronger than conventional metal alloys,
integrates more quickly with human bone,is expected to be more reliable, longer
lasting, and provide faster post-surgery healing. In December 2008, a
manufacturing joint venture partner in Albuquerque, N.M. received U.S. Food and
Drug Administration 510(k) clearance to market nanostructued titanium metal
dental implants using our technology. This clearance positions us closer to our
goal of commercializing our technology for nanostructured metals. We are in
talks with many of the key manufacturers of dental implants and have signed
material testing agreements with several manufacturers.
In September 2009, the Company entered into a contract with Carpenter to sell
certain nanostructured metal technologies acquired from Metallicum, Inc., its
wholly owned subsidiary, to Carpenter and to provide sub-license rights to
Carpenter covering license agreements that the Company has from Los Alamos
Laboratories. The agreement has two distinct elements: a sale and services
agreement and a sub-license agreement. The first element irrevocably transfers
the field technology to Carpenter and Carpenter may develop or use the
technology for its own benefit. Carpenter agreed to pay a sales price of
$600,000 and pay royalties for products developed using this technology. In
addition, the Company will receive additional service income for assisting
Carpenter in the production process. These additional services were elective and
do not affect the sale of the technology. The second element of the agreement is
a sub-license to Carpenter for patents (the LANS patents) that are licensed by
the Company from Los Alamos National Laboratories. The sub-license agreement
obligates Carpenter to pay MSI a running royalty on the sales of products that
require license to the LANS patents.
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For the nine months ended September 30, 2012 and 2011 recorded $171,000 and
$514,000, respectively, as revenue. The Company has received the following
amounts from Carpenter:
During the year ended December 31, 2009, the Company received $0.6
million for the sale of certain technology;
During the years ended December 31, 2009, 2010 and 2011, the Company
received from Carpenter $0.6 million of income for assisting with
development of the technology and is recognizing the income over the
term of the Agreement.
During the year ended December 31, 2009, the Company, received a
$1,000,000 one-time payment for satisfying a performance obligation
under the Technology Transfer Agreement
The Company recognized the sales revenue upon transfer of the technology and
satisfying the performance obligation by Manhattan to facilitate the purchase of
a current generation ECAP-C production machine by Carpenter and will recognize
the service income over the term of the agreement. The royalty income will be
recognized as products are developed using the field technology or sub-license.
The fees earned pursuant to the agreement with Carpenter are being
proportionately recognized as revenue based upon the total fees to be collected
over a 42 month period. The 42 month period is based on the time periods
described in the Agreement: 6 months after March 12, 2011 (the "Effective
Date"), 12 months after the Effective Date, and each of the first 3
anniversaries of Annuity date where the "Annuity date" is March 12, 2011.
In the near future, the Company believes that Carpenter will commercialize our
metals technology which will provide a steady revenue stream. Carpenter has
expressed optimism about the future and importance of the technology licensed
from us. They recently disclosed that they believe the technology is going to
change the future of metals over the next few decades. At a September investors
meeting for Carpenter's analysts, portfolio managers and shareholders, Carpenter
discussed the interest in the medical community about the advanced metal, which
Carpenter has trademarked under the name MithralMax. Carpenter reported that it
has sub-licensed the technology to a yet to be named, premium dental implant
manufacturer.. Carpenter now says it is showing the material to many orthopedic
companies. Carpenter also reported to the financial community that it is going
to take a look at how the metal works in aerospace and energy industries such as
fasteners for the aerospace industry. We expect to receive a minimum of $9
million in royalties from Carpenter during the period from 2015 to 2017. We
anticipate, however, that we will receive additional royalties before 2015,
NANOMEDICINE
Our subsidiary, Scientific Nanomedicine holds patented technologies that can use
biosafe nanoparticles and sensitive magnetic sensors to detect and measure
cancer cells in biopsies or in the human body. The technology is highly specific
- it measures the exact type of cancer and does not generate false positive
results from benign growths, calcifications, or other spurious signals that
complicate current detection methods. It is also very sensitive - it can measure
tumors that are 1000-times smaller than is possible with currently available
techniques. This combination of features has the potential to transform how
cancer is detected and treated.
Conventional cancer treatment starts when a cancer has already grown to hundreds
of millions of cells - large enough to be detectable by X-rays, ultrasound, or
to cause external symptoms. Even then, distinguishing between benign conditions
and cancer is difficult, resulting in missed cancers, exploratory surgeries or
unnecessary treatment, and needless patient anxiety. Treatments tend towards
"overkill," since there are no effective methods to measure small changes in the
cancer to reliably know when all cancer cells have been eliminated, or to detect
metastases or recurrences before they are again large enough to be deadly.
Cancer is a cellular phenomena, but conventional technology does not measure
cells. The mismatch causes huge costs - we need to find and treat cancer cells,
but current technology forces us to find shapes and remove or kill all kinds of
cells. Billions of dollars each year are wasted, and many lives shattered or
lost, because cancer is essentially invisible until it is big enough to cause
problems.
We have invested approximately $2.0 million in the Senior Scientific cancer
project over the past two years. We continue to progress in advancing the
technology toward commercialization. In the past year, we have reached the
following milestones:
· On the nanoparticle front, we can now consistently produce our own
nanoparticles that are several times better for our application than those
available commercially.
· On the instrumentation front, our prototype instrument has been improved
along our planned path to market. We have also broken new ground in methods
to more specifically identify individual cancers, and to track multiple
cancers.
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We have worked closely with major cancer institutions in this regard, and have
joint programs underway with their leading researchers in ovarian cancer, breast
cancer, and prostate cancer. These programs are designed to validate our
technology for the market, which will produce value for our shareholders. Our
technology makes possible the detection of specific cancer cells. Physicians may
then select a broad range for initial diagnosis, or a single type for monitoring
therapy or detecting metastases. Small quantities of biosafe nanoparticles with
attached targeting agents are introduced into the patient where they "stick"
only to the targeted cancer cells. A weak magnetic field is applied to magnetize
the particles, and sensitive magnetic detectors count the number of particles
that have stuck to cancer cells. Due to the highly specialized nature of both
the nanoparticles and our detection device, only those particles stuck to their
targeted cells are detected, making the results highly specific, objective (the
results depend only on the cells, not a human interpretation of an image), and
sensitive (only a few thousand cells are required, instead of hundreds of
millions for conventional techniques).
Our technology makes possible improvements across a wide range of cancer
fighting areas: detection of cancers years earlier; noninvasive, specific
diagnosis after conventional screening; earlier, faster discovery of drugs;
precise, personalized monitoring of therapy; detection of metastases while still
treatable; and accurate monitoring of new therapies. Our technology has been
proven in animal models using human cancer cells, in human trials using bone
marrow biopsy samples, and is the subject of over 20 patent applications and14
peer-reviewed publications. Our success will depend in part on its ability to
obtain regulatory approvals required for human application of its technologies,
both in the United States and other countries. There can be no assurance that
such approvals will be obtained.
Our next step is placing instruments into operation. We have the instruments
designed, and the cancer institutes are preparing to receive them. We need
capital to produce the instruments, support the first users, and get the
validation results. This will take about 12 months, and, at the end, we will
have the technology ready for launch into significant non-FDA markets, or
license for use in human applications, or both. Our technology is a platform
technology that has many possible applications. Our business model has been
designed to fit these several applications, but, generally, the instrument will
be placed at low cost, and recurring revenue realized on consumable targeted
nanoparticles. Overall, we anticipate that our technology will be acquired or
licensed by a large company once the first few applications are approved and in
the market (if not before).
We are now at an important juncture in our program. We have met with major
medical device companies, and they have posed specific technology validation
questions that we will answer. Leading physicians at various cancer institutes
are eager to get started with studies that will provide that
validation. Regulatory approvals are required for applications of the technology
in humans. Regulatory approval for in vivo applications may require
demonstration that the targeted nanoparticles are safe for injection into
humans, that the instrument is also safe, and that the resulting measurement
provides information useful in assessing the state of a patient. We believe that
the constituent parts of the targeted nanoparticles have already been approved
for injection in humans in other applications. Initial toxicology studies in
cell cultures suggest that the combination of the parts into targeted
nanoparticles is not toxic. Significant effort is still required to document
these results under the laboratory and manufacturing practices that the FDA is
likely to require. The instrument comprises passive sensors and a magnetizing
system, which applies a magnetic field much less powerful than that already
approved in other instruments. The correlation of the instrument reading to the
underlying biological phenomena has been demonstrated in preclinical studies for
selected cancer/antibody combinations. Significant effort is still required to
demonstrate the translation of the preclinical results to human pilot studies.
We are currently working on defining the projects required to secure regulatory
approval.
The total market for all applications of our technology is hard to estimate,
given the breadth of the platform and our ability to develop the commercial
application. Our expected development model anticipates market entries in the
United States may include the following (estimated number of procedures and
market opportunities calculated from both publicly available sources and
discussions with industry experts):
Gross
Estimated
Annual
Annual Number Market
Procedure of Procedures Opportunity
Noninvasive biopsy for breast cancer follow-up 600,000 $300 million
Noninvasive biopsy for ovarian cancer diagnosis 200,000 $100 million
Prostate cancer metastases tracking 240,000 $200 million
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Our first markets may be the use of our technology for in vitro laboratory
measurements, preclinical research and ex vivo disease monitoring. We have
received interest from clinicians in applying our technology to other cancers
and other stages of cancer therapy. The selection of the initial market entries
will be informed by size of market, and by time and risk of regulatory
requirements. More than 100 million screening tests for cancer are performed
each year in the US at a cost of over $14 billion. Ultimately, our technology,
after development, has the potential to replace these screening tests or the
more expensive, invasive tests that follow a positive screening result.
To develop our technology, we are seeking $3-$5 million in additional financing
to: possibly place and support instruments at the request of collaborators at
two of the leading cancer research and treatment centers in the United States;
perform studies demonstrating the application of our technology to specific
clinical needs; perfect and protect the intellectual property surrounding our
instrument, our nanoparticles, and our clinical applications; and initiate the
process of regulatory approval.
Available cash has been used to refine and improve the cancer detection
technology system. The new system will give us the ability to detect down to a
few hundred cells, 100 times more sensitive in detecting cancer cells than the
present instrument which is already 1,000 times more sensitive than a mammogram.
This is extremely important in detecting cancer that has metastasized. The
technology has now been used to increase the sensitivity and specificity for
finding ovarian cancer at an early stage. Results of experiments on ovarian
cancer cell has shown this technology can easily identify the different types of
ovarian cells and is now being used to do research on new markers for ovarian
disease. These very important results will lead to earlier identification of
ovarian cancer as well as identification of new methods for determining it is
ovarian cancer and not a benign cyst in the ovaries. These results will shortly
be submitted for publication in a peer-reviewed publication.
INTELLECTUAL PROPERTY / RESEARCH AND DEVELOPMENT
In 2008, we purchased Metallicum to acquire its licensed rights to patented
technology. The technology is comprised of three US Patents (US Patent numbers
7152448, 6197129 and 6399215) for which Metallicum (subsequently, Manhattan) had
been assigned an exclusive license rights by Los Alamos National Security LLC
(LANL). Under the license rights, Metallicum had all rights, title and interest
throughout the world in and to any and all inventions, original works of
authorship, developments, concepts, know-how, improvements on the patents or
trade secrets whether or not patentable or registerable under copyright or
similar laws. The purchase price paid for these licenses was $305,000, which
represents its fair value. The Company obtained an exclusive license on two
patents and a non-exclusive license on the third patent. The value attributable
to license agreements is being amortized over the period of its estimated
benefit period of 10 years.
On May 31, 2011, we entered into an Agreement and Plan of Reorganization to
acquire Senior Scientific and Scientific Nanomedicine. With the acquisition, we
now have:
• 3 U.S. patents issued/allowed;
• 4 PCT applications for:
• Cell detection using targeted nanoparticles and magnetic properties
thereof,
• Detection, measurement, and imaging of cells such as cancer and other
biologic substances using targeted ,nanoparticles and magnetic
properties thereof,
• Nonsurgical determination of organ transplant condition, and
• Methods and apparatuses for the localization and treatment of cancer;
• 3 U.S. utility applications;
• 19 U.S. provisional applications;
• Confidential nanoparticle production, marker conjugation methods, and
analysis techniques; and
• Analysis and data acquisition software copyrights
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Our ability to compete depends in part on the protection of and our ability to
defend our proprietary technology and on the goodwill associated with our trade
names, service marks and other proprietary rights. However, we do not know if
current laws will provide us with sufficient enough protection that others will
not develop technologies similar or superior to ours, or that third parties will
not copy or otherwise obtain or use our technologies without our authorization.
The success of our business will depend, in part, to identify technology, obtain
patents, protect and enforce patents once issued and operate without infringing
on the proprietary rights of others. Our success will also depend on our ability
to maintain exclusive rights to trade secrets and proprietary technology we own,
are currently developing and will develop. We can give no assurance that any
issued patents will provide us with competitive advantages or will not be
challenged by others, or that the patents of others will not restrict our
ability to conduct business.
In addition, we rely on certain technology licensed with a perpetual term from
the Los Alamos National Laboratory and may be required to license additional
technologies in the future. We do not know if these third-party licenses will be
available or will continue to be available to us on acceptable commercial terms
or at all. The inability to enter into and maintain any of these licenses could
have a material adverse effect on our business, financial condition or results
of our operations.
Policing unauthorized use of our proprietary technology and other intellectual
property rights could entail significant expense. In addition, we do not know if
third parties will bring claims of copyright or trademark infringement against
us or claim that our use of certain technologies violates a patent or other
intellectual property. Any claims of infringement, with or without merit, could
be time consuming and expensive to defend, result in costly litigation, divert
management attention, require us to enter into costly royalty or licensing
arrangements or prevent us from using important technologies or methods, any of
which could have a material adverse effect on our business, financial condition
or results of our operations.
SALES AND MARKETING
Although our technologies presently are in the development stage, we are engaged
in an early commercialization program intended to facilitate the transition from
development to licensing, manufacturing and/or sale. This program consists of
preliminary dialogues with potential strategic partners, investors,
manufacturers, potential licensees and/or purchasers.
COMPETITION
As a result of our licensed technology, we do not have any direct competitors in
our advanced materials operations. We may, however, face competition from
leading researchers and manufacturers worldwide that develop competing
technology.
With respect to our nanomedicine technology, our cancer detection technology
will face competition primarily from companies such as Abbott Laboratories Inc.,
Cepheid Inc., Philips, GE Healthcare, Siemens, Gen-Probe Incorporated, MDxHealth
SA, EpiGenomics AG, Roche Diagnostics and Sequenom, Inc. We plan, however, to
enter into partnerships with the aforementioned companies to develop our
technology
Competitors may successfully challenge our licensed technology, produce similar
products that do not infringe our licensed technology or produce products in
countries where we have not applied for intellectual property protection. Many
of these competitors may have longer operating histories and significantly
greater financial, marketing and other resources than we have. Furthermore,
competitors may introduce new products that address our potential markets.
Competition could have a material adverse effect on our business, financial
condition and results of our operations.
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The markets in which we compete are highly competitive and constantly evolving.
We believe that the principal competitive factors in our technology markets
include without limitation:
· capitalization;
· cost of product;
· first to market with product in market segment;
· strong intellectual portfolio;
· product reliability;
· strong customer base; and
· strong manufacturing and supplier relationships.
CUSTOMERS AND SUPPLIERS
For the nine months ended September 30, 2012 and 2011, significantly all of our
revenue was generated by one customer, Carpenter Technology Corporation. We did
not have any significant suppliers.
RESULTS OF OPERATIONS
NINE MONTHS ENDED SEPTEMBER 30, 2012 COMPARED TO NINE MONTHS ENDED SEPTEMBER 30,
2011.
GROSS PROFIT. The $516,000 of revenue recognized for the nine months ended
September 30, 2012 related to service income and is nearly equivalent to the
$514,000 in revenue earned during the nine months ended September 30, 2011. The
fees earned pursuant to the agreement with Carpenter are being proportionately
recognized as revenue based upon the total fees to be collected over a 42 month
period. The 42 month period is based on the time periods described in the
Agreement (6 months after the Effective Date), (12 months after the Effective
Date), and (each of the first 3 anniversaries of Annuity date where the "Annuity
date" is March 12, 2011. The cost of revenue totaling $84,000 for the nine
months ended September 30, 2011 represents consulting fees paid during the
period.
GENERAL AND ADMINISTRATIVE. General and administrative expenses consist of
consultants, contractors, accounting, legal, travel, rent, telephone and other
day to day operating expenses. General and administrative expenses were
$1,696,000 for the nine months ended September 30, 2012 compared with $2,208,000
for the nine months ended September 30, 2011. General and administrative
expenses decreased primarily as a result of costs incurred for common stock
issued for services and stock based compensation related to vesting of warrants
in 2011 partially offset by higher costs incurred related to research, patent
applications for Senior Scientific technology and costs associated with investor
relations.
NET LOSS. Our net loss was $1,607,000 for nine months ended September 30, 2012
compared to a net loss of $1,815,000 for the nine months ended September 30,
2011. The decrease in net loss resulted from lower general and administrative
costs in 2011.
COMPREHENSIVE LOSS: Our comprehensive loss was $1,596,000 for nine months ended
September 30, 2012 compared to comprehensive loss of $1,837,000 for the nine
months ended September 30, 2011. The comprehensive loss was the result of a net
loss in the first nine months of September 2012 and 2011 offset by $11,000 and
$(22,000) in 2012 and 2011, respectively, related to unrealized gain (loss) in
the market value of our shares of Novint Technologies, Inc. ("Novint"). As of
September 30, 2012 and September 30, 2011, we owned 1,075,648 shares of common
stock of Novint.
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THREE MONTHS ENDED SEPTEMBER 30, 2012 COMPARED TO THREE MONTHS ENDED SEPTEMBER
30, 2011.
GROSS PROFIT. The $171,000 of revenue recognized for the three months ended
September 30, 2012 related to service income and is nearly equivalent to the
$173,000 in revenue earned during the three months ended September 30, 2011. The
fees earned pursuant to the agreement with Carpenter are being proportionately
recognized as revenue based upon the total fees to be collected over a 42 month
period. The 42 month period is based on the time periods described in the
Agreement (6 months after the Effective Date), (12 months after the Effective
Date), and (each of the first 3 anniversaries of Annuity date where the "Annuity
date" is March 12, 2011. The cost of revenue totaling $28,000 for the three
months ended September 30, 2011 represents consulting fees paid during the
period.
GENERAL AND ADMINISTRATIVE. General and administrative expenses consist of
consultants, contractors, accounting, legal, travel, rent, telephone and other
day to day operating expenses. General and administrative expenses were $518,000
for the three months ended September 30, 2012 compared with $1,196,000 for the
three months ended September 30, 2011. General and administrative expenses
decreased primarily as a result of costs incurred for common stock issued for
services and stock based compensation related to vesting of warrants in 2011
partially offset by higher costs incurred related to research, patent
applications for Senior Scientific technology and costs associated with investor
relations.
NET LOSS. Our net loss was $324,000 for three months ended September 30, 2012
compared to a net loss of $1,065,000 for the three months ended September 30,
2011. The increase in net loss resulted from higher general and administrative
costs and higher interest cost associated with our convertible debt.
COMPREHENSIVE LOSS: Our comprehensive loss was $302,000 for three months ended
September 30, 2012 compared to comprehensive loss of $1,097,000 for the three
months ended September 30, 2011. The comprehensive loss was the result of net
losses in the first quarter of 2012 and 2011, offset by a $(32,000) unrealized
gain (loss) in the market value of our shares of Novint Technologies, Inc.
("Novint") during the third quarter of 2011.
LIQUIDITY AND PLAN OF OPERATIONS
Stockholders' deficit totaled $632,000 on September 30, 2012 and the working
capital deficit was $1,241,000 on such date. We anticipate we will sell
additional common stock and issue shares and/or options in exchange for
services. While we anticipate that our 2012 revenues received from our
technology sales and service agreement will cover the cash needs of our
overhead, we need to raise fund for the costs incurred related to research and
patents for Senior Scientific technology.
At September 30, 2012, our significant assets include our portfolio of
intellectual property relating to the various technologies, our contracts with
third parties pertaining to technology development, acquisition, and licensing,
and 1,075,648 shares of common stock of Novint; our cash on hand; and our
strategic alliances with various scientific laboratories, educational
institutions, scientists and leaders in industry and government.
We had an increase of $308,000 in cash and cash equivalents for the nine months
ended September 30, 2012, as a result of cash provided by financing activities
offset by our net loss. For the nine months ended September 30, 2012, cash used
by operating activities was $704,000 compared to $796,000 used by operating
activities for the nine months ended September 30, 2011. Cash used by operating
activities in 2012 was primarily as a result of our net loss which was offset by
non-cash expenditures related to stock-based expenses totaling $102,000, debt
discount and original issue discount of $422,000, and depreciation and
amortization expense of $136,000. There was no cash used in investing activities
in either the first quarters of 2012 and nominal amount in 2011. There was
$1,012,000 of cash provided by financing activities in the nine months of 2012
as the result of issuance of common stock and a promissory note in 2012 compared
to no cash provided or used by financing activities during the same period of
2011.
Based upon current projections, our principal cash requirements for the next 12
months consists of (1) fixed expenses, including payroll, investor relations
services, public relations services, bookkeeping services, consultant services,
and rent; and (2) variable expenses, including technology research and
development, milestone payments and intellectual property protection, and
additional scientific consultants. As of September 30, 2012, we had $465,000 in
cash. We intend to satisfy our capital requirements for the next 12 months from
our cash on hand and cash generated from our technology transfer agreements
which we anticipate will cover the cash needs of our overhead and the cost of
our operations.
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CRITICAL ACCOUNTING POLICIES AND ESTIMATES
Our discussion and analysis of our financial condition and results of operations
are based upon our consolidated financial statements, which have been prepared
in accordance with accounting principles generally accepted in the United States
of America.
Our discussion and analysis of our financial condition and results of operations
are based upon our consolidated financial statements, which have been prepared
in accordance with accounting principles generally accepted in the United States
of America.
Use of Estimates
The preparation of financial statements in conformity with accounting principles
generally accepted in the United States of America requires management to make
estimates and assumptions that affect the amount of assets and liabilities and
disclosures of contingent assets and liabilities at the date of the financial
statements and the reported amounts of revenue and expenses during the reporting
period. A significant estimate includes the carrying value of our patents, fair
value of our common stock, assumptions used in calculating the value of stock
options, depreciation and amortization.
Impairment of Long-Lived Assets:
We assess the impairment of our long-lived assets periodically in accordance
with Financial Accounting Standards Board ("FAS") Accounting Standard
Codification ("ASC") Topic 10. Whenever events or changes in circumstances
indicate that the carrying amounts of long-lived assets may not be recoverable,
we will compare undiscounted net cash flows estimated to be generated by those
assets to the carrying amount of those assets. When these undiscounted cash
flows are less than the carrying amounts of the assets, we will record
impairment losses to write the asset down to fair value, measured by the
discounted estimated net future cash flows expected to be generated from the
assets. To date there has been no impairment.
License Agreements
In 2008, the Company obtained licenses to the rights of certain patents
regarding nano-structured materials developed by another company as a result of
the acquisition of Metallicum. The purchase price paid for these licenses was
$305,000, which represents its fair value. The Company obtained an exclusive
license on two patents and a non-exclusive license on the third patent. The
value attributable to license agreements is being amortized over the period of
its estimated benefit period of 10 years. Under the terms of the agreement, the
Company may be required to pay royalties, as defined, to the licensors.
In 2009, the Company entered into a patent license agreement with Los Alamos
National Security LLC for the exclusive use of certain technology relating to
the manufacture and application of nanostructuring metals and alloys. The value
attributable to license agreements is being amortized over the period of its
estimated benefit period of 10 years. Under the terms of the agreement the
Company is required to pay an annual license fee of $10,000 and, may be required
to pay royalties, as defined, to the licensors.
On May 31, 2011, we entered into an Agreement and Plan of Reorganization to
acquire Senior Scientific and Scientific Nanomedicine. The total purchase price
was 21,668,000 restricted shares of our common stock (less 7,667,000 shares
previously issued pursuant to an option agreement. As a result of this
acquisition, we own patented technologies that can use biosafe nanoparticles and
sensitive magnetic sensors to detect and measure cancer cells in biopsies or in
the human body with the potential to revolutionize how cancer is detected and
treated.
Revenue Recognition
Revenue is recognized when the four basic criteria of revenue recognition are
met: (i) a contractual agreement exists; (ii) transfer of technology
(intellectual property) has been completed or services have been rendered; (iii)
the fee is fixed or determinable, and (iv) collectability is reasonably assured.
Service revenue is recognized when specific milestones are reached or as service
is provided if there are no discernable milestones.
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Investments: Available-for-Sale Investments
Investments that we designate as available-for-sale are reported at fair value,
with unrealized gains and losses, net of tax, recorded in accumulated other
comprehensive income (loss). We determine the cost of the investment sold based
on the specific identification method. Our available-for-sale investments
include Marketable equity securities. We acquire these equity investments for
the promotion of business and strategic objectives. We record the realized gains
or losses on the sale or exchange of marketable equity securities in gains
(losses) on other equity investments, net.
Stock-Based Compensation:
The Company follows the provision of FASB ASC Topic 718 for the measurement and
recognition of compensation expense for all share-based payment awards to
employees, directors and non-employees. Additionally, the Company follows the
SEC's Staff Accounting Bulletin No. 107 "Share-Based Payment" ("SAB 107"), as
amended by Staff Accounting Bulletin No. 110 ("SAB 110"), which provides
supplemental application guidance based on the views of the SEC. The Company
estimates the expected term, which represents the period of time from the grant
date that the Company expects its stock options to remain outstanding, using the
simplified method as permitted by SAB 107 and SAB 110. Under this method, the
expected term is estimated as the mid-point between the time the options vest
and their contractual terms. The Company continues to apply the simplified
method because it does not have sufficient historical exercise data to provide a
reasonable basis upon which to estimate the expected terms due to the limited
period of time its equity shares have been publicly traded and the limited
number of its options which have so far vested and become eligible for exercise.
The estimated fair value of grants of stock options and warrants to our
nonemployees is charged to expense, if applicable, in the financial statements.
These options vest in the same manner as the employee options granted under each
of the option plans as described above.
OFF BALANCE SHEET ARRANGEMENTS
We have not entered into any off-balance sheet arrangements that have or are
reasonably likely to have a current or future effect on our financial condition,
changes in financial condition, revenues or expenses, results of operations
liquidity, capital expenditures or capital resources and would be considered
material to investors.
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
Not applicable
ITEM 4T. CONTROLS AND PROCEDURES
(a) Evaluation of Disclosure Controls and Procedures
We conducted an evaluation under the supervision and with the participation of
our management, of the effectiveness of the design and operation of our
disclosure controls and procedures. The term "disclosure controls and
procedures," as defined in Rules 13a-15(e) and 15d-15(e) under the Securities
and Exchange Act of 1934, as amended ("Exchange Act"), means controls and other
procedures of a company that are designed to ensure that information required to
be disclosed by the company in the reports it files or submits under the
Exchange Act is recorded, processed, summarized and reported, within the time
periods specified in the Securities and Exchange Commission's rules and forms.
Disclosure controls and procedures also include, without limitation, controls
and procedures designed to ensure that information required to be disclosed by a
company in the reports that it files or submits under the Exchange Act is
accumulated and communicated to the company's management, including its
principal executive and principal financial officers, or persons performing
similar functions, as appropriate, to allow timely decisions regarding required
disclosure. Based on this evaluation, our principal executive and principal
financial officers concluded as of September 30, 2012 that our disclosure
controls and procedures were not effective at the reasonable assurance level due
to the material weaknesses in our internal controls over financial reporting
discussed immediately below.
This quarterly report does not include an attestation report of our registered
public accounting firm regarding internal control over financial reporting.
Management's report was not subject to attestation by our registered public
accounting firm pursuant to temporary rules of the Securities and Exchange
Commission that permits us to provide only management's report in this quarterly
report.
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Management's Report on Internal Control Over Financial Reporting
Our management is responsible for establishing and maintaining adequate internal
control over financial reporting as defined in Rules 13a-15(f) and 15d-15(f)
under the Exchange Act. Our internal control over financial reporting is
designed to provide reasonable assurance regarding the reliability of financial
reporting and the preparation of financial statements for external purposes in
accordance with generally accepted accounting principles. Our internal control
over financial reporting includes those policies and procedures that:
1. Pertain to the maintenance of records that in reasonable detail accurately
and fairly reflect the transactions and dispositions of our assets;
2. Provide reasonable assurance that transactions are recorded as necessary
to permit preparation of financial statements in accordance with U.S.
GAAP, and that our receipts and expenditures are being made only in
accordance with the authorization of our management and directors; and
3. Provide reasonable assurance regarding prevention or timely detection of
unauthorized acquisition, use or disposition of our assets that could have
a material effect on the financial statements.
Because of its inherent limitations, internal control over financial reporting
may not prevent or detect misstatements. Also, projections of any evaluation of
effectiveness to future periods are subject to the risk that controls may become
inadequate because of changes in conditions, or that the degree of compliance
with the policies or procedures may deteriorate.
Management assessed the effectiveness of our internal control over financial
reporting as of September 30, 2012. Based on this assessment, management
concluded that the Company did not maintain effective internal controls over
financial reporting as a result of the identified material weakness in our
internal control over financial reporting described below. In making this
assessment, management used the framework set forth in the report entitled
Internal Control-Integrated Framework issued by the Committee of Sponsoring
Organizations of the Treadway Commission, or COSO. The COSO framework summarizes
each of the components of a company's internal control system, including (i) the
control environment, (ii) risk assessment, (iii) control activities, (iv)
information and communication, and (v) monitoring.
Identified Material Weakness
A material weakness in our internal control over financial reporting is a
control deficiency, or combination of control deficiencies, that results in more
than a remote likelihood that a material misstatement of the financial
statements will not be prevented or detected.
Management identified the following material weakness during its assessment of
internal controls over financial reporting:
Resources: We had one full-time employee in general management and no full-time
employees with the requisite expertise in the key functional areas of finance
and accounting. As a result, there is a lack of proper segregation of duties
necessary to insure that all transactions are accounted for accurately and in a
timely manner.
Written Policies & Procedures: We need to prepare written policies and
procedures for accounting and financial reporting to establish a formal process
to close our books monthly on an accrual basis and account for all transactions,
including equity transactions, and prepare, review and submit SEC filings in a
timely manner.
Audit Committee: We do not have, and are not required, to have an audit
committee. An audit committee would improve oversight in the establishment and
monitoring of required internal controls and procedures.
(b) Changes In Internal Control Over Financial Reporting
During the quarter ended September 30, 2012, there were no changes in our
internal controls over financial reporting during this fiscal quarter that
materially affected, or is reasonably likely to have a materially affect, on our
internal control over financial reporting.
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PART II
ITEM 1. LEGAL PROCEEDINGS
We are subject from time to time to litigation, claims and suits arising in the
ordinary course of business. As of September 30, 2012, we were not a party to
any material litigation, claim or suit whose outcome could have a material
effect on our financial statements.
ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
For the nine months ended September 30, 2012, the Company issued 12,600,000
shares of common stocks and warrants for 6,300,000 shares for a total
consideration of $630,000 to seven individuals. Further, the Company issued
2,983,871 shares to an attorney for legal services for the Company totaling
$124,000, and 300,000 shares to another consultant for services to satisfy an
outstanding obligation totaling $21,000. Additionally, the Company issued
200,000 shares and warrants for 100,000 shares to a consultant for services
rendered to the Company totaling $10,000.
We issued convertible notes for $400,000 (the "Convertible Notes") of which
$100,000 was issued on January 31, 2012 and $300,000 was issued on April 26,
2012. The non-interest bearing notes can be converted into the Company's common
stock, at any date after six months from the issuance of each Note, at a
conversion price of 67% of the fair value of the Company's common stock upon the
date of conversion notice, subject to a floor price of approximately $0.044 for
the note issued in January 2012 and approximately $0.034 for the note issued in
April 2012. The holder of the notes has not converted any portion of the notes
as of June 30, 2012. Additionally, the note holder was issued warrants for
6,000,000 shares of the Company's common stock with an exercise price of $0.05
that expire on October 15, 2015.
The issuances were not public offerings based upon the following factors: (i)
the issuance of the securities was an isolated private transaction; (ii) a
limited number of securities were issued to a limited number of offerees; (iii)
there was no public solicitation; (iv) each offeree was an "accredited
investor," (v) the investment intent of the offerees; and (vi) the restriction
on transferability of the securities issued. There no underwriter used in any
transaction. The proceeds from the private offerings will be used for working
capital, general corporate expenses and the acquisition and exploration of
properties. No underwriters were used for any offering. All of the foregoing
securities were issued in reliance upon the exemption from registration pursuant
to Section 4(2) of the Securities Act and/or Rule 506 of Regulation D or Rule
903 of Regulation S. Cash proceeds raised will be used for working capital and
general corporate purposes.
ITEM 3. DEFAULTS UPON SENIOR SECURITIES
Not Applicable
ITEM 4. MINE SAFETY DISCLOSURES
Not Applicable
ITEM 5. OTHER INFORMATION
Not Applicable.
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ITEM 6. EXHIBITS
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