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0000950134-07-006581.txt : 20070326
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20070326161145
ACCESSION NUMBER: 0000950134-07-006581
CONFORMED SUBMISSION TYPE: 10KSB
PUBLIC DOCUMENT COUNT: 11
CONFORMED PERIOD OF REPORT: 20061231
FILED AS OF DATE: 20070326
DATE AS OF CHANGE: 20070326
FILER:
COMPANY DATA:
COMPANY CONFORMED NAME: HELIX BIOMEDIX INC
CENTRAL INDEX KEY: 0000831749
STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834]
IRS NUMBER: 912099117
STATE OF INCORPORATION: DE
FISCAL YEAR END: 1231
FILING VALUES:
FORM TYPE: 10KSB
SEC ACT: 1934 Act
SEC FILE NUMBER: 033-20897
FILM NUMBER: 07718263
BUSINESS ADDRESS:
STREET 1: 22122 20TH AVE SE
CITY: BOTHELL
STATE: WA
ZIP: 98021
BUSINESS PHONE: 425 402 8400
MAIL ADDRESS:
STREET 1: 22122 20TH AVE SE
CITY: BOTHELL
STATE: WA
ZIP: 98021
FORMER COMPANY:
FORMER CONFORMED NAME: CARTEL ACQUISITIONS INC
DATE OF NAME CHANGE: 19890718
FORMER COMPANY:
FORMER CONFORMED NAME: CARIBBEAN ACQUISTIONS INC
DATE OF NAME CHANGE: 19880725
10KSB
1
v26497e10ksb.htm
FORM 10KSB
e10ksb
UNITED
STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C.
20549
Form 10-KSB
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(Mark One)
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ANNUAL REPORT UNDER SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934
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For the fiscal year ended
December 31, 2006
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TRANSITION REPORT UNDER SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934
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For the transition period
from to
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Commission File
No. 33-20897-D
HELIX BIOMEDIX, INC.
(Name of small business issuer
in its charter)
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Delaware
(State or other
jurisdiction of
incorporation or organization)
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91-2099117
(I.R.S. Employer
Identification No.)
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22118-20th Avenue
Southeast, Suite 204, Bothell, Washington 98021
(Address of principal executive
offices)
(425) 402-8400
(Issuers telephone
number)
Securities registered under Section 12(b) of the
Exchange Act:
Not Applicable
Securities registered under Section 12(g) of the
Exchange Act:
None
Check whether the issuer (1) filed all reports required to
be filed by Section 13 or 15(d) of the Exchange Act during
the past 12 months (or for such shorter period that the
registrant was required to file such reports) and (2) has
been subject to such filing requirements for the past
90 days. Yes þ No o
Check if there is no disclosure of delinquent filers in response
to Item 405 of
Regulation S-B
contained in this form and no disclosure will be contained, to
the best of registrants knowledge, in definitive proxy or
information statements incorporated by reference in
Part III of this
Form 10-KSB
or any amendment to this
Form 10-KSB. þ
Indicate by check mark whether the registrant is a shell company
(as defined in
Rule 12b-2
of the Exchange
Act). Yes o No þ
State issuers revenues for its most recent fiscal year.
$70,940
As of March 8, 2007, there were 22,788,514 shares of
common stock, $0.001 par value, of Helix
BioMedix, Inc. issued and outstanding. Based on the closing
sales price on March 8, 2007, the aggregate market value of
the common stock held by non-affiliates of the registrant was
$11,630,258.
DOCUMENTS
INCORPORATED BY REFERENCE
Portions of the registrants Proxy Statement relating to
the registrants 2007 Annual Meeting of Stockholders to be
held on May 17, 2007 are incorporated by reference into
Part III of this Annual Report.
Transitional Small Business Disclosure Format (Check
one): Yes o No þ
HELIX
BIOMEDIX, INC.
FORM 10-KSB
TABLE OF CONTENTS
PART I
Forward-Looking
Statements
Our disclosure and analysis in this Annual Report and in the
documents incorporated by reference contain forward-looking
statements, which provide our current expectations or forecasts
of future events. Forward-looking statements include, without
limitation:
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statements concerning possible or assumed future results of
operations, trends in financial results and business plans,
including those relating to earnings growth and revenue growth;
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statements about our product development schedule;
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statements about our future capital requirements and the
sufficiency of our cash, cash equivalents, investments, and any
other sources to meet these requirements;
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statements about our plans, objectives, expectations, and
intentions; and
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other statements that are not historical facts.
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Words such as believes, anticipates,
expects, and intends, and similar
expressions may identify forward-looking statements, but the
absence of these words does not necessarily mean that a
statement is not forward-looking. Forward-looking statements are
subject to known and unknown risks and uncertainties and are
based on potentially inaccurate assumptions that could cause
actual results to differ materially from those expected or
implied by the forward-looking statements. Our actual results
could differ materially from those anticipated in the
forward-looking statements for many reasons, including the
factors described in Item 1, Business
Certain Factors That May Affect Our Business and Future
Results in this Annual Report. Other factors besides those
described in this Annual Report could also affect actual
results. You should carefully consider the factors described in
Item 1, Business Certain Factors That May
Affect Our Business and Future Results in evaluating our
forward-looking statements.
You should not unduly rely on these forward-looking statements,
which speak only as of the date of this Annual Report. We
undertake no obligation to publicly revise any forward-looking
statement to reflect circumstances or events after the date of
this Annual Report or to reflect the occurrence of unanticipated
events. You should, however, review the factors and risks we
describe in the reports we file from time to time with the
Securities and Exchange Commission, or SEC, after the date of
this Annual Report.
Overview
We are a bioactive peptide-based biopharmaceutical company. Our
objective is to develop and commercialize consumer and
pharmaceutical products containing our high value peptides and
peptide fragments that have proven cosmetic and therapeutic
potential carefully selected from our extensive library of
patented bioactive peptides.
We have initially targeted using small chain or short amino acid
fragments of our peptides with anti-infective,
anti-inflammatory, cell proliferation, and migration properties
as ingredients in cosmetics and potential topical therapeutics.
Possible uses include anti-aging skin care, acne treatment,
wound healing, and treatment of athletes foot and other
fungal infections of the skin and hair including the management
of various dermatoses.
To establish a foundation for our initial commercialization
efforts, we successfully identified and isolated a number of
peptides in the innate human immune system that have potential
cosmetic and therapeutic benefits. However, peptides of the
innate immune system are molecularly inappropriate for direct
application in personal care or pharmaceutical products. By
re-engineering these peptides using bioactive, synthetic small
amino sequences, we believe that we have created commercially
attractive alternatives that provide even greater benefits than
those peptides found in nature.
In addition to our primary focus on peptides for use in cosmetic
skin care and dermatological therapies, we believe our peptide
library also promises new opportunities in certain therapeutic
and industrial product categories
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such as oral care, biocides, and animal health. We view these
additional applications as out-licensing opportunities with
commercial or academic entities that specialize in those fields.
Our business was incorporated on February 2, 1988, and
until 2000, we operated primarily as a technology development
company, generating a portfolio of intellectual property focused
on identifying and developing synthetic bioactive peptides. In
2000, we entered the commercialization stage of our business
development plan with an increased emphasis on applying and
commercializing the extensive library of patented bioactive
peptides that we have developed.
Our website is located at www.helixbiomedix.com.
Information contained on our website is not part of, and is not
incorporated into, this Annual Report. Our filings with the SEC
are available without charge on our website.
Consumer
Programs
In 2004, we initiated license agreements with personal care
contract manufacturers and materials suppliers for inclusion of
certain of our proprietary cosmetics peptides in anti-acne and
anti-aging skin care products. We rely on these industry
supplier licensees to develop new product opportunities that
incorporate our peptides and to create both awareness and demand
for our technology among their personal care customer companies.
We believe our peptide technology further holds potential as a
technology platform for personal care industry leaders. We
collaborate directly with leading personal care companies to
identify opportunities for strengthening their brand position
with proprietary products featuring our peptide technology.
In 2006, we initiated our first efforts to create turn-key,
validated products containing our peptide technology. We plan to
introduce these new products into the marketplace through
partnerships with personal care marketing companies. The first
such product is scheduled for launch in the second half of 2007.
Anti-Acne
Programs
We believe one of our lead cosmetic peptides promises
significant advantages for skin care competitors in the
over-the-counter
acne treatment market. This proprietary peptide may be
formulated into products with certain
over-the-counter
anti-acne ingredients for improvement in blemish-clearing
benefits. The skin care benefits of this peptide derive from its
ability to bind to a pro-inflammatory substance on the cell wall
of the acne-causing bacteria. This pro-inflammatory substance is
known to cause much of the redness associated with acne
breakouts but, when bound to our peptide, is rendered inactive.
Laboratory and clinical testing confirm the additional treatment
benefits and higher level of consumer satisfaction associated
with formulations that contain our peptide.
There are currently a number of product development initiatives
incorporating our peptide into anti-acne formulations. We
believe the use of this peptide is advantageous for globally
marketed anti-acne products, not only because it supports more
favorable outcomes with salicylic acid based
treatment products, but because it obviates the need for benzyol
peroxide, an ingredient that is limited in application due to
regulatory restrictions in certain markets as well as its
potential harshness on sensitive skin.
Anti-Aging
Programs
We have identified and qualified a number of peptides that
target changes in the appearance of skin associated with the
aging process. Because there are anti-aging skin benefits that
derive from the skins natural healing process, much of the
anti-aging aspect of our peptide library has been derived from
the screening processes associated with our pharmaceutical wound
healing programs.
Peptides that target improvement in the appearance of aging skin
may affect one or more of the age-related skin characteristics:
lines and wrinkles, loss of elasticity, loss of firmness and
definition, appearance of darkened areas or general unevenness
of skin tone, rough texture, and thinning of the skin.
One of our lead anti-aging peptides targets several aspects of
support for the skins structural matrix. This peptide has
been demonstrated to accelerate the migration of cells from the
skins uppermost layer to strengthen areas prone to lines
and wrinkles and to impart a smoother, firmer appearance. This
peptide has been clinically demonstrated to provide equivalent
benefits to the leading prescription anti-aging products, but
without the risk of
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irritation associated with aggressive retinoids. This peptide is
being formulated into various cosmetic skin care products that
are anticipated to launch in the second half of 2007.
We believe that, through the isolation of peptides derived from
naturally recurring sequences that we call
Replikinestm,
and specific combinations of those
Replikinestm
that we call
Combikinestm,
we can increase the benefits derived from peptide applications
in cosmetic anti-aging skin products. We have entered into an
evaluation and development initiative with a leading supplier of
cosmetic ingredients to qualify these new peptide technologies
and hope to bring them to market in 2008. Recently identified
peptide opportunities for our anti-aging portfolio include a
group of synthetic peptides that we have branded as
Modukinestm.
These peptides work to interrupt processes that accelerate the
undesirable changes in skin associated with aging, including the
accelerated breakdown of collagen and elastin, the skins
key structural components. We believe several of these
Modukinestm
hold commercial promise beyond the area of anti-aging skin care
as they support the skins resiliency.
We are also working to identify opportunities for peptides to
interrupt the pathways that lead to undesirable discoloring and
mottled skin tone. This effort is especially timely as
hydroquinone, one of the key ingredients used for such cosmetic
benefits in the United States, has recently been withdrawn from
the market, creating a need that we believe may be safely and
effectively addressed with peptides that we are currently
developing.
We have identified numerous opportunities for the addition of
peptides into therapeutic moisturizers and shampoos in support
of the healthy appearance and comfort of skin and scalp.
Potential benefits of adding certain peptides to cosmetically
therapeutic moisturizers and hair care products include
resistance to secondary infection associated with compromised
skin, restoration of healthy appearance to cracked, flaky feet
that do not respond to ordinary moisturizers, reduced flaking,
and improved comfort associated with conditions of the scalp.
While our primary product focus is currently on advanced
cosmetic and
over-the-counter
treatment of skin and hair, we have also identified other
categories where our peptides may offer product benefits. For
example, we continue to seek partnership opportunities for
development and licensing opportunities in the areas of oral
care and odor management.
Pharmaceutical
Programs
We are developing a novel, broad-spectrum, topical
anti-infective for the treatment of skin and wound infections
and the prevention of Staphylococcus aureus (S. aureus)
infections including those caused by MRSA (Methicillin Resistant
S. aureus). These programs are based upon a
first-in-class
family of molecules known as lipohexapeptides (or small molecule
peptides) that we developed to specifically combine the
attributes of small molecule natural products with the
advantages of antimicrobial peptides. This new class of
anti-infective peptide has demonstrated significant improvement
in activity, both in vitro and in vivo, over
traditional antimicrobial peptides.
As with traditional antimicrobial peptides, our lead
lipohexapeptides are rapidly cidal, fail to engender resistance
in vitro, are readily synthesized and do not exhibit
cross-resistance with other antibiotics. However, these
molecules also have the advantage of being more stable, more
active, safer, and more cost-effective to manufacture than
traditional antimicrobial peptides. In addition, primarily due
to acylation (addition of a lipid), these molecules are
significantly more active in complex biological environments
such as serum or wound fluid. As a result, lipohexapeptides
exhibit potent activity in animal infection models.
In pre-clinical testing our lead molecules exhibited
broad-spectrum antimicrobial activity against significant
bacterial pathogens such as S. aureus, Streptococcus
pyogenes, and Pseudomonas aeruginosa, and also
pathogenic fungi such as Candida and Trichophyton species. This
activity was maintained against antibiotic-resistant organisms
such as MRSA and Vancomycin Resistant Enterococci. Our lead
molecules have demonstrated significant activity in both
bacterial and fungal animal infection models. In a S. aureus
abraded skin infection model, our lead lipohexapeptides
significantly reduced the number of bacteria following three
days of once-daily dosing, and in many cases, our peptide
eradicated the pathogen. In a guinea pig dermatophytosis model,
our lead peptide candidates significantly reduced pathogen count
and delivered clinical benefits comparable to Terbinafine, a
drug approved by the Food and Drug Administration (FDA) for
onchomycosis. In both animal models, toxicity was not
significantly different from that without peptides.
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Acne
Anti-infective
The National Institute of Arthritis, Musculoskeletal and Skin
Disorders estimate that 17 million people are affected by
acne in the United States every year. Acne is the most common
skin disorder of adolescence and early adulthood
(ages 11-30),
affecting 80% of that demographic. Generally, mild to moderate
cases are treated with topical medications, with more severe
cases being treated with systemic or a combination of topical
and systemic therapies. The global market for prescription
anti-acne products is currently estimated to be
$2.0 billion, and the largest segment of this is attributed
to topical medications. While topical antibiotics such as
Clindamycin make up a large part of this market, providing
significant clinical benefit, the emergence of resistance to
antibiotics such as Clindamycin occurred as early as 1979.
Our lipohexapeptide program is specifically directed at
developing small, stable, and highly potent antimicrobials
capable of delivering therapeutic benefit within the clinical
environment. These molecules overcome the specific challenges
typically associated with acne such as the ability to work in an
oil and serum environment and the ability to kill organisms deep
within a pore. The efficacy observed in the dermatophytosis
model described above demonstrates the penetration and
antimicrobial effects of these molecules in the hair follicle of
the host.
MRSA
There is an ever-increasing global problem of antimicrobial
resistance. This phenomenon has been well documented by the
Centers for Disease Control and Prevention, which recently
identified a 28.5% increase in S.aureus oxacillin (methicillin)
resistance in hospitals taking part in the National Nosocomial
Infections Surveillance system from
1992-2003.
Their report concludes that action is necessary to control the
spread of this organism, and, to this end, several European
countries have been successful in identifying and treating
colonized patients quickly. The ability of lipohexapeptides to
safely and effectively kill S.aureus in an abraded skin
infection model, and the fact that this class of molecule
exhibits potent activity against both methicillin and mupirocin
(current therapy) resistant strains, support its development
potential. The broad spectrum of activity exhibited by
lipohexapeptides also enables possible application to chronic
wounds, burn wounds, and trauma wounds in which multiple
pathogens can cause significant morbidity and mortality. The
market for such topical anti-infectives is currently estimated
to be $1.5 billion per year.
Topical
fungal infections
Trichophyton species are the major cause of a significant number
of fungal skin infections including, athletes foot, tinea
capitis (scalp ringworm), and onychomycosis (nail fungus). Up to
70% of Americans have athletes foot at any given time, 13%
of US school children (85% of children in many other countries)
test positive for tinea capitis, and
22-40% of
Americans
51-100 years
of age have onychomycosis. These disease conditions have
contributed to the worldwide sales for prescription topical
antifungals exceeding $1 billion in 2006, with a similar
level of sales for
over-the-counter
products addressing these conditions. Our pre-clinical data have
shown that our lead molecules are capable of treating
Trichophyton infections and hold great promise for multiple
dermatological indications.
Competition
The cosmetic, biotechnology, and pharmaceutical industries are
characterized by rapidly advancing technologies, intense
competition, and a strong emphasis on proprietary products. Many
participants in these industries, as well as academic
institutions and other research organizations, are actively
engaged in the discovery, research and development of products
that could compete with our products under development. They may
also compete with us in recruiting and retaining skilled
scientific talent.
We believe that we face two broad classes of competitors:
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other companies developing therapies based upon peptide
technology; and
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companies using other technologies to address the same disease
conditions that we are targeting.
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We are currently aware of several companies that are utilizing
peptide-based technologies for antimicrobial applications
including: Agennix, Inc., AM Pharma Holdings, Genarea
Corporation, Inimex Pharmaceuticals, and Migenix, Inc.
Even if our peptide technology proves successful, we might not
be able to be competitive in this rapidly advancing area of
technology. Some of our potential competitors have more
financial and other resources, larger research and development
staffs, and more experience than we do in researching,
developing, and testing products. Some of these companies also
have more experience than we do in conducting clinical trials,
obtaining FDA and other regulatory approvals, and manufacturing,
marketing, and distributing medical and consumer products.
Smaller companies may successfully compete with us by
establishing collaborative relationships with larger companies
or academic institutions. Our competitors may succeed in
developing, obtaining patent protection for or commercializing
their products more rapidly than us. A competing company
developing, or acquiring rights to, a more effective therapeutic
product for the same diseases targeted by us, or one that offers
significantly lower costs of treatment, could render our
products noncompetitive or obsolete.
Suppliers
We believe that there are several readily available sources of
amino acids used for our peptides. We do not plan to manufacture
peptides on a commercial scale. However, in support of the
development process required to advance our licensing strategy,
we have produced and maintain a small, inexpensive peptide
inventory. In planning for commercial-scale production, we have
sought collaborations with several credible, experienced
manufacturers specializing in the production of peptides. With
their assistance, we have developed production and cost plans
that will support the inclusion of our peptides in a wide range
of both consumer and clinical products. We believe several of
these contract manufacturers are capable of scaling peptide
synthesis to support all of our projected volume and
configuration requirements.
Intellectual
Property Rights
We have developed a proprietary library containing a broad and
diverse array of synthetic bioactive peptides. Our peptide
library not only includes multiple proprietary peptides, but
also includes various compositions of and methods of using those
peptides. We believe that our patents and patent applications
provide broad and early patent coverage that offers important
competitive advantages that no other competitor can provide.
We currently hold nine patents issued in the United States, two
provisional United States applications, and three
non-provisional United States applications. We also have ten
issued foreign patents and two Patent Cooperation Treaty (PCT)
applications pending. These patents and patent applications
describe six distinct classes of peptides, comprising more than
100,000 unique peptide sequences. The control of a
patent-protected library comprising several distinct classes of
peptides distinguishes us from our competitors, many of whom are
attempting to develop only a single class of peptides for
multiple applications. The breadth of our library offers
scientists an exceptionally wide range of options in matching
optimal peptides with individual product or therapeutic
requirements.
We rely on a combination of patent, trademark, copyright, and
trade secret laws to protect our proprietary technologies and
products. We aggressively seek U.S. and international
patent protection applicable to our peptide technologies. We
also rely on trade secret protection for our confidential and
proprietary information and in-license technologies we view as
necessary to our business plan.
With respect to proprietary know-how that is not patentable, we
have chosen to rely on trade secret protection and
confidentiality agreements to protect our interests. We have
taken security measures to protect our proprietary know-how,
technologies, and confidential data, and continue to explore
further methods of protection. We require all employees,
consultants, and collaborators to enter into confidentiality
agreements, and employees and consultants enter into invention
assignment agreements with us. We cannot assure you, however,
that these agreements will provide meaningful protection or
adequate remedies for any breach or that our trade secrets will
not otherwise become known or be independently discovered by our
competitors.
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In the case of a strategic partnership or other collaborative
arrangement which requires the sharing of data, our policy is to
disclose to our partner, under controlled circumstances, only
data that is relevant to the partnership or arrangement during
the contractual term of the strategic partnership or
collaborative arrangement, subject to a duty of confidentiality
on the part of our partner or collaborator. Disputes may arise
as to the ownership and corresponding rights to know-how and
inventions resulting from research by us, and our corporate
partners, licensors, scientific collaborators, and consultants.
We cannot assure you that we will be able to maintain our
proprietary position or that third parties will not circumvent
any proprietary protection we have. Our failure to maintain
exclusive or other rights to these technologies could harm our
competitive position.
To continue developing and commercializing our current and
future products, we may license intellectual property from
commercial or academic entities to obtain the rights to
technology that is required for our discovery, research,
development, and commercialization activities.
Regulation
Federal, state and local governmental authorities in the United
States and other countries regulate, among other things, the
testing, production, distribution and sale of prescription and
over-the-counter
drugs and cosmetics. In the United States, the Food and Drug
Administration, or the FDA, acting under the Food Drug and
Cosmetic Act, or FDCA, and other federal statutes and FDA
implementing regulations, regulates products primarily on the
basis of their intended use, as determined by the labeling
claims made for the product.
Although under our licensing strategy our collaborators will
bear the majority of regulatory compliance burden, our ability
to successfully out-license and collaborate with others on our
product candidates requires that we understand the regulations
and restrictions on commercialization of cosmetic and drug
products.
FDA
regulation of cosmetics
The FDCA defines cosmetics as products and their components
intended to be rubbed, poured, sprinkled, or sprayed on,
introduced into, or otherwise applied to the human body or any
part thereof for cleansing, beautifying, promoting
attractiveness, or altering the appearance. Cosmetic products
are not subject to FDA pre-market approval authority, although
the FDA can take enforcement action for marketed cosmetic
products that are adulterated or misbranded, including
violations of product safety requirements, use and quantity of
ingredients, labeling and promotion and methods of manufacture.
Additionally, the FDA monitors compliance of cosmetic products
through random inspections of cosmetic manufacturers and
distributors. The labeling of cosmetic products is subject to
the requirements of the FDCA, the Fair Packaging and Labeling
Act and other FDA regulations.
Our licensing strategy with cosmetics manufacturers requires
that we operate within the confines of cosmetic intended uses
when developing and partnering for the commercialization of
relevant products.
FDA
regulation of drug products
The FDCA defines drugs as products intended to cure, mitigate,
treat or prevent a disease or to affect the structure or any
function of the human body. In comparison to cosmetics, drug
products are subject to more comprehensive safety and
effectiveness requirements of the FDCA and its implementing
regulations. The FDA and its counterparts in other countries
extensively regulate the pre-clinical and clinical testing,
approval, manufacturing, labeling, storage, record-keeping,
reporting, advertising, promotion, import, export, marketing,
and distribution, among other things, of drug products. If we or
our collaborators do not comply with applicable requirements, we
may be fined, our products may be recalled or seized, our
clinical trials may be suspended or terminated, our production
may be partially or totally suspended, the government may refuse
to approve related marketing applications, and we may be subject
to an injunction,
and/or
criminally prosecuted.
The steps required before a new drug may be marketed in the
United States include (i) pre-clinical laboratory and
animal testing, (ii) submission to the FDA of an
Investigational New Drug, or IND, application which must become
effective before clinical trials may commence,
(iii) adequate and well-controlled clinical trials to
establish the safety and efficacy of the drug,
(iv) submission to the FDA of a New Drug Application, or
NDA, and (v) FDA approval of the NDA prior to any
commercial sale or shipment of the drug. Pre-clinical testing is
generally
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conducted on laboratory animals to evaluate the potential safety
and the efficacy of a drug. The results of these studies are
submitted to the FDA as a part of an IND, which must be approved
before clinical trials in humans can begin. Typically, clinical
evaluation involves a time consuming and costly three-phase
process. In Phase I, clinical trials are conducted with a
small number of subjects to determine the early safety profile,
the pattern of drug distribution and metabolism. In
Phase II, clinical trials are conducted with groups of
patients afflicted with a specific disease to determine
preliminary efficacy, optimal dosages and expanded evidence of
safety. In Phase III, large-scale, multi-center,
comparative trials are conducted with patients afflicted with a
target disease to provide sufficient data to demonstrate the
efficacy and safety required by the FDA. The FDA closely
monitors the progress of each of the three phases of clinical
trials and may, at its discretion, re-evaluate, alter, suspend
or terminate the testing based upon the data that have been
accumulated to that point and its assessment of the risk/benefit
ratio to the patient.
This testing, the preparation of necessary applications, the
processing of those applications by the FDA, and potential
review of the applications by an FDA advisory panel of outside
experts are expensive, and typically take many years to
complete. The FDA may not act quickly or favorably in reviewing
these applications, or may deny approval altogether, and we or
our collaborators may encounter significant difficulties or
costs in our efforts to obtain FDA approval.
We believe that certain of our lipohexapeptide product
candidates for treatment of topical skin infections may require
complete NDA preparation by our collaborators, as may certain of
our Over The Counter (OTC) drug product candidates. To date, we
have not conducted human clinical trials of our lipohexapeptides.
The
OTC monograph system
While FDA approval is generally required before a new drug
product may be marketed in the U.S., many OTC drugs are exempt
from the FDAs pre-marketing approval requirements. In
1972, the FDA instituted the ongoing OTC Drug Review to evaluate
the safety and effectiveness of OTC drug ingredients in the
market. Through this process, the FDA issues monographs for
therapeutic product categories that set forth the specific
active ingredients, dosages, strengths, indications for use,
warnings and labeling statements for OTC drug ingredients that
the FDA will consider generally recognized as safe and effective
for OTC use and therefore not subject to pre-market approval.
For most categories of OTC drugs not yet subject to a final
monograph, the FDA usually permits such drugs to continue to be
marketed until a final monograph becomes effective, unless the
drug will pose a potential health hazard to consumers.
Drugs subject to final monographs, as well as drugs that are
subject only to proposed monographs, are subject to various FDA
regulations concerning, for example, manufacturing in accordance
with cGMPs, general and specific labeling requirements and
prohibitions against promotion for conditions other than those
stated in the labeling. Drug manufacturing facilities are
subject to FDA inspection, and failure to comply with applicable
regulatory requirements may lead to administrative or judicially
imposed penalties.
Our anti-acne and certain topical antimicrobial product
candidates may be regulated under the OTC monograph system by
the FDA.
We are also subject to regulation by the Occupational
Safety & Health Administration (OSHA), and the
Environmental Protection Agency (EPA), and to various laws, and
regulations relating to safe working conditions, laboratory, and
manufacturing practices, and the use, and disposal of hazardous
or potentially hazardous substances, including radioactive
compounds used in connection with our research, and development
activities, and we may in the future be subject to other
federal, state or local laws or regulations. OSHA, the EPA or
other regulatory agencies may promulgate regulations that may
affect our research and development programs. We are also
subject to regulation by the Department of Transportation, and
to various laws and regulations relating to the shipping of
cells, and other similar items. We are unable to predict whether
any agency will adopt any regulation that could limit or impede
our operations.
Depending on the circumstances, failure to meet these other
applicable regulatory requirements can result in criminal
prosecution, fines or other penalties, injunctions, recall or
seizure of products, partial or total suspension of
8
production, denial or withdrawal of pre-marketing product
approval or refusal to allow us to enter into supply contracts,
including government contracts.
Sales of cosmetics and drug products outside the United States
are subject to foreign regulatory requirements that vary widely
from country to country. Whether or not we or our collaborators
have obtained FDA approval, we must obtain approval of a product
by comparable regulatory authorities of foreign countries prior
to the commencement of marketing the product in those countries.
The time required to obtain this approval may be longer or
shorter than that required for FDA approval. The foreign
regulatory approval process includes all the risks associated
with FDA regulation set forth above, as well as country-specific
regulations, including in some countries price controls.
During the fiscal years ended December 31, 2005 and 2006,
we expended approximately $834,200 and $988,500, respectively,
on our research and development programs.
To date, we have not incurred any substantial costs to comply
with environmental laws or regulations.
Personnel
As of December 31, 2006, we employed eight personnel, all
on a full-time basis, including three employees involved in
research. None of our employees is covered by a collective
bargaining agreement. We have never experienced
employment-related work stoppages and consider our employee
relations to be positive.
Certain
Factors That May Affect Our Business and Future
Results
You should carefully consider the risks described below,
together with all other information included in this Annual
Report on
Form 10-KSB,
in evaluating our company. If any of the following risks
actually occur, our financial condition or operating results
could be harmed. In such case, investors may lose part or all of
their investment.
We
will need to raise additional capital to fund our operations and
our failure to obtain funding when needed may force us to delay,
reduce or eliminate our product development programs or
collaboration efforts.
Developing products and conducting pre-clinical testing of
antimicrobial peptide technologies requires substantial amounts
of capital. To date, we have raised capital primarily through
private equity financings. If we are unable to timely obtain
additional funding, we may never obtain the results necessary to
commercialize any of our products. We will need to raise
additional capital to, among other things:
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commercialize our product candidates;
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fund our pre-clinical studies;
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continue our research and development activities;
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finance our general and administrative expenses; and
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prepare, file, prosecute, maintain, enforce, and defend patent
and other proprietary rights.
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Our net cash used in operations has exceeded our cash generated
from operations for each year since our inception. For example,
we used approximately $3.0 million in operating activities
for the year ended December 31, 2006, and approximately
$2.8 million in 2005. After giving effect to our recent
private placements of common stock which raised approximately
$2.0 million and $148,750 and closed on March 5, 2007, and
March 26, 2007, respectively, we believe that based upon
the current status of our product development, and collaboration
plans, our cash and cash equivalents and marketable securities
should be adequate to satisfy our capital needs through at least
the next twelve months. However, our future funding requirements
will depend on many factors, including, among other things:
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our ability to enter into revenue producing agreements;
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the progress, expansion, and cost of our pre-clinical, and
research and development activities;
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9
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any future decisions we may make about the scope and
prioritization of the programs we pursue;
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the development of new product candidates or uses for our
antimicrobial peptide technologies;
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changes in regulatory policies or laws that affect our
operations; and
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competing technological and market developments.
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If we raise additional funds by issuing equity securities,
further dilution to stockholders may result, and new investors
could have rights superior to holders of shares of our currently
issued, and outstanding common stock. In addition, debt
financing, if available, may include restrictive covenants. If
adequate funds are not available to us, we may have to liquidate
some or all of our assets or delay, reduce the scope of or
eliminate some portion or all of our development programs. We
also may have to license to other companies our products or
technologies that we would prefer to develop, and commercialize
ourselves.
We
expect to continue to incur substantial losses and we may never
achieve profitability.
We are a development stage company and have incurred significant
operating losses since we began operations in November 1988,
including a net loss of approximately $3.8 million for the
year ended December 31, 2006, and we may never become
profitable. As of December 31, 2006, we had a deficit
accumulated during the development stage of approximately
$24.1 million. These losses have resulted principally from
costs incurred in our research and development programs, and
from our general and administrative expenses. We intend to make
substantial expenditures to further develop and commercialize
our product candidates, and expect that our rate of spending may
accelerate as the result of the increased costs, and expenses
associated with expanded in-house research and development of
our lead candidates, out-licensing initiatives, clinical trials,
regulatory approvals, and commercialization of our antimicrobial
peptide technologies. We plan to identify lead peptides
demonstrating the potential for commercially viable products.
Development of these products will require extensive in-vitro
and in-vivo testing. This testing, as well as the
extension of existing pre-clinical testing, will require the
establishment of strategic partnerships with third parties.
Because of the numerous risks and uncertainties associated with
our product development efforts, we are unable to predict when
we may become profitable, if at all. If we are unable to achieve
and then maintain profitability, the market value of our common
stock will likely decline.
We are
at an early stage of product development and do not yet have
commercially marketable products to provide material
revenue.
Although we have been developing our antimicrobial peptide
technology since 1988, we remain a development stage company and
to date have generated no material revenue from product sales.
Our strategic plan contemplates the development of both
pharmaceutical and non-pharmaceutical products, and applications
for our proprietary peptides. However, there can be no assurance
that products will be commercialized in either field as a result
of continued development programs or from joint efforts with any
future collaborative partner. The failure to develop safe,
commercially viable pharmaceutical or non-pharmaceutical
applications for our technology will have a material adverse
effect on our business, operating results, and financial
condition.
We
need to enter strategic alliances with third parties to develop,
test, and produce commercially viable products.
A key element of our strategy is to enhance development programs
and fund capital requirements, in part, by entering into
collaborative agreements with cosmetic, pharmaceutical, and
other biotechnology companies. We also plan to explore
collaborations with non-pharmaceutical companies, and
opportunities for incorporating our antimicrobial peptides into
non-clinical applications such as cosmetics and biocides.
Although the development of such alliances is one of our
objectives, there can be no assurance that we will succeed in
attracting substantial collaborative partners who can materially
assist in the development and commercialization of our
technology. The development of commercially viable products from
our technology will likely require the technical collaboration
and financial assistance of other, significantly larger third
parties, to bear most of the costs of pre-clinical and clinical
testing, regulatory approval, manufacturing, and marketing prior
to commercial sale. Even if we are successful in attracting
collaborative partners, and those collaborations yield
commercially viable products, our
10
receipt of revenue will be substantially dependent upon the
decisions made by, and the manufacturing, and marketing
resources of these strategic partners. Further, there can be no
assurance that our interests will coincide with those of any
future collaborative partner, that such a partner will not
develop, independently or with third parties, products that
could compete with those products contemplated by any agreement
we may have with that partner, or that disagreements over
rights, technology or other proprietary interests will not
occur. The failure to develop strategic business alliances that
facilitate the development, testing, and commercialization of
our products will have a material adverse effect on its
business, operating results, and financial condition.
Because
of the specialized nature of our business, the termination of
relationships with key management and scientific personnel or
the inability to recruit and retain additional personnel could
prevent us from developing our technologies and obtaining
financing.
The competition for qualified personnel in the biotechnology
field is intense, and we rely heavily on our ability to attract,
and retain qualified scientific, technical, and managerial
personnel. We are highly dependent upon R. Stephen Beatty,
our President and Chief Executive Officer, Dr. Timothy
Falla, our Vice President and Chief Scientific Officer, and Lori
Bush, our Chief Operating Officer. Our future success depends,
in part, upon our ability to attract, retain, and motivate
highly skilled employees. In order to commercialize our products
successfully, we will be required to expand our workforce,
possibly in the areas of business development, and sales and
marketing. These activities will require the addition of new
personnel, including management, and the development of
additional expertise by existing management personnel. We face
competition for qualified individuals from numerous
biotechnology companies, as well as academic, and other research
institutions. To the extent we are unable to attract and retain
any of these individuals on favorable terms, our business may be
adversely affected.
We
rely on collaborators to assist in the research and development
activities necessary for the commercialization of our product
candidates. If our collaborators do not perform as expected, we
may not be able to commercialize our product
candidates.
We intend to continue to develop alliances with third-party
collaborators to develop and market our current and future
product candidates. We may not be able to attract third-party
collaborators to develop and market product candidates, and may
lack the capital and resources necessary to develop its product
candidates alone. If we are unable to locate collaborators, or
if our collaborators do not prioritize and commit substantial
resources to programs associated with our product candidates, we
may be unable to commercialize its product candidates, which
would limit our ability to generate revenue and become
profitable.
We
face substantial competition in our product development efforts
from personal care, pharmaceutical and biotechnology companies,
universities and other
not-for-profit
institutions.
We face significant competition in our attempts to develop
applications of our antimicrobial peptide technology from
entities that have substantially greater research and product
development capabilities, and financial, scientific, marketing,
and human resources. These entities include cosmetic,
pharmaceutical and biotechnology companies, as well as
universities and
not-for-profit
institutions. We expect that competition in the development of
products analogous to our antimicrobial peptide technology will
intensify. Our competitors may succeed in developing products
earlier than we do, entering into successful collaborations
before us, obtaining approvals from the U.S. Food and Drug
Administration (FDA) or other regulatory agencies for such
products before us, or developing products that are more
effective than those we develop or propose to develop. The
success of any one competitor in these or other respects will
have a material adverse effect on our business, operating
results, and financial condition.
We
face product liability risks and may not be able to obtain
adequate insurance to protect against losses.
The current use of any of our products, including in
pre-clinical trials, and the sale of any of our products exposes
us to liability claims. These claims might be made directly by
consumers and our corporate collaborators or others selling such
products. We may experience financial losses in the future due
to product liability claims. We have expanded our insurance
coverage to include the sale of commercial products. However, we
may be unable to maintain insurance coverage at a reasonable
cost or in sufficient amounts to protect against losses. If a
successful
11
product liability claim or a series of claims is brought against
us for uninsured liabilities or in excess of insured
liabilities, our assets may be insufficient to cover such claims
and our business operations could be impaired.
If we
are unable to protect our proprietary rights, we may not be able
to compete effectively.
Our success depends in part on obtaining, maintaining, and
enforcing our patents and other proprietary rights. We believe
we own, or have rights under licenses to, issued patents and
pending patent applications that are necessary to commercialize
our antimicrobial peptides. However, the patents on which we
rely may be challenged and invalidated, and our patent
applications may not result in issued patents. Moreover, our
patents and patent applications may not be sufficiently broad to
prevent others from practicing our technologies or developing
competing products. We also face the risk that others may
independently develop similar or alternative technologies or may
design around our proprietary and patented technologies.
The patent positions of pharmaceutical and biotechnology
companies can be highly uncertain and involve complex legal and
factual questions for which important legal principles remain
unresolved. No consistent policy regarding the breadth of claims
allowed in biotechnology patents has emerged to date in the
United States. Furthermore, the application, and enforcement of
patent laws and regulations in foreign countries is even more
uncertain. Accordingly, we cannot assure you that we will be
able to effectively file, protect or defend our proprietary
rights in the United States or in foreign jurisdictions on a
consistent basis.
Third parties may successfully challenge the validity of our
patents. We will only be able to protect our technologies from
unauthorized use by third parties to the extent that valid and
enforceable patents or other proprietary rights cover them.
Because the issuance of a patent is not conclusive of its
validity or enforceability, we cannot assure you how much
protection, if any, will be given to our patents if we attempt
to enforce them or if others challenge their validity in court.
It is possible that a competitor may successfully challenge our
patents or that a challenge will result in limiting the coverage
of our patents. If the outcome of litigation is adverse to us,
third parties may be able to use our technologies without
payment to us.
In addition, it is possible that competitors may infringe upon
our patents or successfully avoid them through design
innovation. We may initiate litigation to police unauthorized
use of our proprietary rights. However, the cost of litigation
to uphold the validity of our patents and to prevent
infringement could be substantial, and the litigation will
consume time and other resources. Some of our competitors may be
better able to sustain the costs of complex patent litigation
because they have substantially greater resources. Moreover, if
a court decides that our patents are not valid, we will not have
the right to stop others from using our inventions. There is
also the risk that, even if the validity of our patents were
upheld, a court may refuse to stop others on the ground that
their activities do not infringe upon our patents. Because
protecting our intellectual property is difficult and expensive,
we may be unable to prevent misappropriation of our proprietary
rights.
We also rely on certain proprietary trade secrets and know-how,
especially where we believe patent protection is not appropriate
or obtainable. Trade secrets and know-how, however, are
difficult to protect. We have taken measures to protect our
unpatented trade secrets and know-how, including the use of
confidentiality and invention assignment agreements with our
employees, consultants and contractors. It is possible, however,
that these persons may unintentionally or willingly breach the
agreements or that our competitors may independently develop or
otherwise discover our trade secrets and know-how.
If the
use of our technologies conflicts with the rights of others, we
could be subject to expensive litigation or be required to
obtain licenses from others to develop or market antimicrobial
peptides.
Our competitors or others may have or acquire patent rights that
they could enforce against us. If they do so, we may be required
to alter our antimicrobial peptide technology, pay licensing
fees or cease activities. If our antimicrobial peptide
technology conflicts with patent rights of others, third parties
could bring legal action against us or our licensees, suppliers,
customers or potential collaborators, claiming damages, and
seeking to enjoin manufacturing and marketing of the affected
products. If these legal actions are successful, in addition to
any potential liability for damages, we might have to obtain a
license in order to continue to manufacture or market the
affected products. A required license under the related patent
may not be available on acceptable terms, if at all.
12
We may be unaware that the use of our technology conflicts with
pending or issued patents. Because patent applications can take
many years to issue, there may be currently pending
applications, unknown to us, that may later result in issued
patents upon which our antimicrobial peptide technology or
antimicrobial peptides may infringe. There could also be
existing patents of which we are unaware upon which our
antimicrobial peptide technology or antimicrobial peptides may
infringe. In addition, if third parties file patent applications
or obtain patents claiming technology also claimed by us in
pending applications, we may have to participate in interference
proceedings in the U.S. Patent and Trademark Office to
determine priority of invention. If third parties file
oppositions in foreign countries, we may also have to
participate in opposition proceedings in foreign tribunals to
defend the patentability of the filed foreign patent
applications. We may have to participate in interference
proceedings involving our issued patents or our pending
applications.
A
third party may claim that we infringe upon its proprietary
rights.
If a third party claims that we infringe upon its proprietary
rights, any of the following may occur:
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we may become liable for substantial damages for past
infringement if a court decides that our technology infringes
upon a competitors patent;
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a court may prohibit us from selling or licensing our product
without a license from the patent holder, which may not be
available on commercially acceptable terms, if at all, or which
may require us to pay substantial royalties or grant cross
licenses to our patents; and
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we may have to redesign our technology or product candidate so
that it does not infringe upon others patent rights, which
may not be possible or could require substantial funds or time.
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If any of these events occurs, our business will suffer and the
market price of our common stock will likely decline.
Our
rights to use peptides and technologies licensed to us by third
parties are not within our control and we may not be able to
implement our antimicrobial peptide technology without these
peptides and technologies.
We have licensed patents and other rights, which are necessary
to our antimicrobial peptide technology and antimicrobial
peptides. Our business will significantly suffer if these
licenses terminate, if the licensors fail to abide by the terms
of the license or fail to prevent infringement by third parties
or if the licensed patents or other rights are found to be
invalid. We have in-licensed several peptide patents and patent
applications from the University of British Columbia. These
licenses terminate upon the expiration of the last licensed
patent, and may also be terminated in the event of a material
breach.
If we violate the terms of our licenses, or otherwise lose our
rights to these peptides, patents or patent applications, we may
be unable to continue development of our antimicrobial peptide
technology. Our licensors or others may dispute the scope of our
rights under any of these licenses. Additionally, the licensors
under these licenses might breach the terms of their respective
agreements or fail to prevent infringement of the licensed
patents by third parties. Loss of any of these licenses for any
reason could materially harm our financial condition and
operating results.
If our
principal stockholders, executive officers and directors choose
to act together, they may be able to control our management and
operations, acting in their own best interests and not
necessarily those of other stockholders.
Our executive officers, directors, principal stockholders, and
entities affiliated with them, beneficially own in the aggregate
approximately 38.9% of our outstanding common stock and common
stock equivalents as of December 31, 2006. This significant
concentration of share ownership may adversely affect the
trading price for our common stock because investors often
perceive disadvantages in owning stock in companies with
controlling stockholders. These stockholders, acting together,
will have the ability to exert substantial influence over all
matters requiring approval by our stockholders, including the
election and removal of directors, and any proposed merger,
13
consolidation or sale of all or substantially all of our assets.
In addition, they could dictate the management of our business
and affairs.
This concentration of ownership could have the effect of
delaying, deferring or preventing a change in control or
impeding a merger or consolidation, takeover or other business
combination that could be favorable to you.
Future
sales of our common stock could negatively affect our stock
price.
If our common stockholders sell substantial amounts of common
stock in the public market, or the market perceives that such
sales may occur, the market price of our common stock could
decline.
In addition, we will need to raise substantial additional
capital in the future to fund our operations. If we raise
additional funds by issuing equity securities, our stock price
may decline and our existing stockholders may experience
significant dilution.
Our
common stock may experience extreme price and volume
fluctuations, which could lead to costly litigation for us and
make an investment in us less appealing.
The market price of our common stock has and may continue to
fluctuate substantially due to a variety of factors, including:
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announcements about our collaborators or licensees;
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announcements of technological innovations or new products or
services by us or our competitors;
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announcements concerning our competitors or the biotechnology
industry in general;
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new regulatory pronouncements and changes in regulatory
guidelines;
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general and industry-specific economic conditions;
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additions or departures of our key personnel;
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changes in financial estimates or recommendations by securities
analysts;
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variations in our quarterly results; and
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changes in accounting principles.
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The market prices of the securities of biotechnology companies,
particularly companies like ours without consistent product
revenue and earnings, have been highly volatile, and are likely
to remain highly volatile in the future. This volatility has
often been unrelated to the operating performance of particular
companies. In the past, companies that experience volatility in
the market price of their securities have often faced class
action securities litigation. Moreover, market prices for stocks
of biotechnology-related and technology companies frequently
reach levels that bear no relationship to the operating
performance of these companies. These market prices generally
are not sustainable, and are highly volatile. Whether or not
meritorious, litigation brought against us could result in
substantial costs, divert our managements attention and
resources, and harm our financial condition and results of
operations.
Our
certificate of incorporation, bylaws, and stockholder rights
agreement may delay or prevent a change in our
management.
Our amended and restated certificate of incorporation, bylaws,
and stockholder rights agreement contain provisions that could
delay or prevent a change in our board of directors and
management teams. Some of these provisions:
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authorize the issuance of preferred stock that can be created
and issued by the board of directors without prior stockholder
approval, commonly referred to as blank check
preferred stock, with rights senior to those of our common stock;
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authorize our board of directors to issue dilutive shares of
common stock upon certain events; and
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provide for a classified board of directors.
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These provisions could make it more difficult for common
stockholders to replace members of the board of directors.
Because our board of directors is responsible for appointing the
members of our management team, these provisions could in turn
affect any attempt to replace the current management team.
Executive
Officers
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Name
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Age
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Position
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R. Stephen Beatty
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57
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President and Chief Executive
Officer
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Lori H. Bush
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Chief Operating Officer
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Timothy J. Falla, Ph.D.
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41
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Vice President and Chief
Scientific Officer
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David H. Kirske
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53
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Vice President and Chief Financial
Officer
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R. Stephen Beatty has served as our President and
Chief Executive Officer and as a member of our board of
directors since May 1999. Prior to joining us, Mr. Beatty
established and operated Beatty Finance, Inc., a private
financial services company (Beatty Finance).
Mr. Beatty is currently President and a director of Beatty
Finance but does not have
day-to-day
responsibilities in those capacities. Mr. Beatty holds a
B.S. in Mathematics from the University of South Alabama and an
M.B.A. from the University of New Orleans.
Lori H. Bush joined us in October 2006 and serves as our
Chief Operating Officer. Prior to joining the company,
Ms. Bush was President of Nu Skin, the multi-national
personal care products division of Nu Skin Enterprises where she
continues to chair their Professional Advisory Board. Prior to
her position at Nu Skin, Ms. Bush held the positions of
Executive Director, Worldwide Skin Care Ventures for the Johnson
and Johnson Consumer Products Companies, and Vice President,
Professional Marketing for Neutrogena, a Johnson and Johnson
Company. She currently sits on the board of directors of Matrixx
Initiatives, Inc. Ms. Bush earned her B.S. from The Ohio
State University and M.B.A. from Temple University.
Timothy J. Falla, Ph.D. has served as our Vice
President and Chief Scientific Officer since June 2001. From
1998 until 2001, Dr. Falla was Principal Scientist with
IntraBiotics Pharmaceuticals, Inc. where he led a
multi-disciplinary
scientific research team focused on antibacterial drug discovery
and development. Dr. Falla holds a B.S. in Applied Biology
from the University of Wales, and a Ph.D. in Molecular Biology
and Infectious Disease from Oxford University and the University
of Wales.
David H. Kirske has served as our Vice President and
Chief Financial Officer since July 2004. From June 2001 to
December 2003, Mr. Kirske served as an independent
consultant to several biotechnology companies. From January 1999
to June 2001, he was the Corporate Controller for F5 Networks,
Inc., a provider of integrated Internet traffic management
solutions. Mr. Kirske was the Corporate Controller and
Treasurer for Redhook Ale Brewery, Incorporated, a specialty
manufacturer of craft beers, from 1993 to January 1999.
Mr. Kirske holds a B.A. in Business Administration from the
University of Puget Sound.
Other
Information
We make available on our website, free of charge, copies of our
annual report on
Form 10-KSB,
quarterly reports on
Form 10-QSB,
current reports on
Form 8-K,
and amendments to those reports filed or furnished pursuant to
Section 13(a) or 15(d) of the Securities Exchange Act of
1934 as soon as reasonably practicable after filing or
furnishing the information to the SEC. The Internet address for
the information is www.helixbiomedix.com.
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ITEM 2.
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DESCRIPTION
OF PROPERTY
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We currently lease approximately 8,500 square feet of
laboratory and office space in Bothell, Washington. The lease
expires in November 2009 and includes an option to extend the
term of the lease for three years.
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ITEM 3.
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LEGAL
PROCEEDINGS
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None
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ITEM 4.
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SUBMISSIONS
OF MATTERS TO A VOTE OF SECURITY HOLDERS
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None
PART II
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ITEM 5.
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MARKET
FOR COMMON EQUITY AND RELATED STOCKHOLDER MATTERS
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Market
Information
Our common stock has been quoted on the OTC Bulletin Board
under the symbol HXBM since 1999. Prior to this date
our common stock did not trade publicly. The following table
summarizes our common stocks high and low sales prices for
the periods indicated as reported by the OTC
Bulletin Board. These quotations reflect
inter-dealer
prices, without retail markups, markdowns or commissions, and
may not represent actual transactions.
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Year Ended December 31,
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2006
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2005
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High
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Low
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High
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Low
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First Quarter
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$
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1.01
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$
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0.72
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$
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2.05
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$
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1.45
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Second Quarter
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$
|
1.46
|
|
|
$
|
0.86
|
|
|
$
|
1.75
|
|
|
$
|
1.40
|
|
|
Third Quarter
|
|
$
|
1.10
|
|
|
$
|
0.85
|
|
|
$
|
1.50
|
|
|
$
|
0.90
|
|
|
Fourth Quarter
|
|
$
|
1.01
|
|
|
$
|
0.70
|
|
|
$
|
1.07
|
|
|
$
|
0.65
|
|
As of February 28, 2007, we had 905 holders of record, and
approximately 1,200 beneficial stockholders of our common stock.
Such holders include any brokers or clearing agencies as holders
of record but exclude the individual stockholders whose shares
are held by brokers or clearing agencies.
Dividend
Policy
We have never declared or paid cash dividends on our capital
stock. We currently intend to retain any future earnings to fund
the development and growth of our business, and do not
anticipate paying any cash dividends in the foreseeable future.
Any future determination relating to our dividend policy will be
made by our board of directors.
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|
|
ITEM 6.
|
MANAGEMENTS
DISCUSSION AND ANALYSIS OR PLAN OF OPERATION
|
For a discussion of forward-looking statements and important
factors that could cause results to differ materially from the
forward-looking statements in this Annual Report, see
Part I, Forward-Looking Statements, and
Item 1, Business Certain Factors That May
Affect Our Business and Future Results.
Management
Discussion and Analysis Overview
In Managements Discussion and Analysis or Plan of
Operation, we explain the financial condition, changes in
financial condition and results of operations of our company,
including, among other things:
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|
|
| |
|
an overview of our business;
|
| |
| |
|
results of operations and why those results are different from
prior years; and
|
| |
| |
|
the capital resources that we currently have and possible
sources of additional funding for future capital requirements.
|
Business
Overview
Our mission is to become an industry leader in developing and
commercializing small proteins known as bioactive peptides. We
have a proprietary library containing a broad array of these
synthetic bioactive peptides. All
16
of our pharmaceutical products are currently in the preclinical
stage of development. We do not separately track costs
associated with our preclinical projects due to the cost burden
associated with accounting at such levels of detail and our
limited resources. However, the majority of our research and
development spending is on the two areas of application
discussed below. Our business strategy is to develop and
out-license the rights to use proprietary peptides in distinct
fields of application to third parties. We have developed
several peptide sequences in two broad areas of application,
which consist of:
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| |
|
Skin care we have developed a number of peptides
capable of stimulating aspects of the skins innate ability
to regenerate.
|
| |
| |
|
Pharmaceutical our peptides have demonstrated
promising results in the areas of topical anti-infectives and
wound healing.
|
Due to the early stage of development of each of our peptide
sequences in our pharmaceutical programs, we are unable to
estimate the total costs and timing to complete development.
Additionally, we currently anticipate
out-licensing
our product candidates and the final development will depend on
the efforts of third parties. The timing of our being able to
enter into any licensing agreements resulting in significant
payments to us is uncertain. Thus we lack the experience
necessary to determine when material cash flows from our
projects will materialize, if at all.
Results
of Operations
As of December 31, 2006, our accumulated deficit was
approximately $24.1 million. We may incur substantial
additional operating losses over the next several years. Such
losses have been and may continue to be principally the result
of various costs associated with our discovery, research and
development programs and the purchase of technology.
Substantially all of our working capital in recent years has
resulted from equity financings. Our ability to achieve a
consistent, profitable level of operations depends in large part
on our ability to enter into revenue generating out-license
arrangements. Even if we are successful in the aforementioned
activities, our operations may not be profitable. In addition,
payments under licensing arrangements are subject to significant
fluctuations in both timing and amount. Therefore, our operating
results for any period may fluctuate significantly and may not
be comparable to the operating results for any other period.
Years
Ended December 31, 2006 and December 31,
2005
Revenue for the year ended December 31, 2006 was
approximately $70,900 compared to approximately $108,400 in the
prior year, a decrease of 34.6%. The decrease in revenue is
primarily attributable to a decrease in peptide sales. Revenues
in 2007 will be dependent on our ability to enter into
collaborative and licensing arrangements with third parties.
Cost of sales for the year ended December 31, 2006 was
approximately $163,000 compared to approximately $84,300 in the
prior year, an increase of 93.4%. The increase in cost of sales
is primarily attributable to inventory being written down
approximately $151,400 to net realizable value in 2006.
Research and development expenses were approximately $988,500
for the year ended December 31, 2006 compared to
approximately $834,200 in the prior year, an increase of 18.5%.
The increase is attributable primarily to the adoption of
FAS123R in 2006, which resulted in approximately $87,100 of
incremental expense, and certain external studies conducted in
2006 which were not conducted in 2005.
Depreciation and amortization expenses were approximately
$180,800 for the year ended December 31, 2006 compared to
approximately $175,100 in the prior year, an increase of 3.3%.
The increase is primarily attributable to additional equipment
purchased in 2006 to support our research and development
efforts.
Accounting, legal, and professional expenses were approximately
$318,100 for the year ended December 31, 2006 compared to
approximately $300,900 in the prior year, an increase of 5.7%.
The increase is primarily attributable to legal fees associated
with the protection of existing patents and the application for
new patents.
Consulting fees were approximately $14,800 for the year ended
December 31, 2006 compared to approximately $133,500 in the
prior year, a decrease of 88.9%. The decrease in consulting fees
is associated
17
primarily with services required in 2005 relating to the
implementation of a new financial reporting system and to
services provided to support financing for the company.
General and administrative expenses were approximately
$2.3 million for the year ended December 31, 2006
compared to approximately $1.9 million in the prior year,
an increase of 21.2%. The increase in general and administrative
expenses is primarily attributable to costs associated with the
addition of two board members, stock compensation expense
required under FAS123R, which resulted in approximately $304,100
of incremental expense, the hiring of a Chief Operating Officer,
and severance payments related to the departure of the Vice
President of Business Development as of October 15, 2006.
Interest income was approximately $74,600 for the year ended
December 31, 2006 compared to approximately $46,100 for the
prior year, an increase of 61.8%. The increase in interest
income was primarily due to a higher average cash balance and a
higher average interest rate in 2006.
Years
Ended December 31, 2005 and December 31,
2004
Revenue for the year ended December 31, 2005 was
approximately $108,400 compared to approximately $93,700 in the
prior year, an increase of 15.7%. The increase in revenue was
primarily attributable to peptide sales, at cost.
Cost of sales for the year ended December 31, 2005 was
approximately $84,300 compared to no cost of sales in 2004. This
was primarily attributable to the sale of peptides to two
customers in 2005.
Research and development expenses were approximately $834,200
for the year ended December 31, 2005 compared to
approximately $915,200 in the prior year, a decrease of 8.9%.
The decrease was primarily attributable to the costs of certain
external studies conducted in 2004, which were not conducted in
2005.
Depreciation and amortization expenses were approximately
$175,100 for the year ended December 31, 2005 compared to
approximately $160,600 in the prior year, an increase of 9.0%.
The increase was primarily attributable to additional equipment
purchased in 2005 to support our research and development
efforts.
Accounting, legal, and professional expenses were approximately
$300,900 for the year ended December 31, 2005 compared to
approximately $312,600 in the prior year, a decrease of 3.7%.
The decrease was attributable to lower professional fees in 2005.
Consulting fees were approximately $133,500 for the year ended
December 31, 2005 compared to approximately $128,000 in the
prior year, an increase of 4.3%. The increase in consulting fees
was associated primarily with services required in 2005 relating
to the implementation of a new financial reporting system.
General and administrative expenses were approximately
$1.9 million for the year ended December 31, 2005
compared to approximately $1.7 million in the prior year,
an increase of 11.0%. The increase in general and administrative
expenses was primarily attributable to costs associated with
bonuses paid to certain officers in 2005 totaling $120,000 in
consideration of services rendered for the two prior years.
Interest income was approximately $46,100 for the year ended
December 31, 2005 compared to approximately $22,100 for the
prior year, an increase of 108.6%. The increase in interest
income was primarily due to higher levels of cash invested
during 2005 compared to 2004.
Liquidity
and Capital Resources
Since inception, we have financed our operations primarily
through the private sale of debt and equity securities. On
March 5, 2007, we closed a private equity financing,
receiving cash of approximately $2.0 million in exchange
for 2,666,666 shares of $0.001 par value common stock.
In a second closing held on March 26, 2007, we received
cash of approximately $148,750 in exchange for
198,332 shares of $0.001 par value common stock.
18
On March 3, 2006, we closed a private equity financing,
receiving cash of approximately $2.4 million in exchange
for 2,383,000 shares of $0.001 par value common stock
and warrants to purchase up to 238,300 shares of
$0.001 par value common stock. The warrants have a
5-year term
and a per share purchase price of $1.00.
In a second closing held on March 10, 2006, we received
$215,000 in exchange for 215,000 shares of $0.001 par
value common stock and warrant to purchase up to
21,500 shares of $0.001 par value common stock. The
warrants have a
5-year term
and a per share purchase price of $1.00.
On February 28, 2005, we announced that we closed the
initial closing of a private equity financing, receiving cash of
approximately $2.3 million in exchange for
1,548,501 shares of common stock and warrants to purchase
up to 125,000 additional shares of common stock. The warrants
have a
5-year term
and a per share purchase price of $1.50. In a second closing
held on March 2, 2005, we received $175,000 in exchange for
116,666 shares of common stock.
On March 1, 2005, we commenced a tender offer to holders of
certain of our warrants that were purchased in four private
placement financings to exchange their warrants as follows:
|
|
|
| |
|
2001/2002
Warrants (warrants to purchase shares of our common stock
issued as part of the units described in the private placement
memorandum dated May 2001): We offered to issue either
(a) 0.82 shares of common stock for each warrant share
tendered; or (b) 1.0 share of common stock for each
warrant share tendered upon payment of $0.25 for each warrant
share tendered.
|
| |
| |
|
2002/2003
Warrants (warrants to purchase shares of our common stock
issued as part of the units described in the private placement
memorandum dated September 2002, and amended December 2002): We
offered to issue either (a) 0.84 shares of common
stock for each warrant share tendered; or
(b) 1.0 share of common stock for each warrant share
tendered upon payment of $0.25 for each warrant share tendered.
|
| |
| |
|
2003 Warrants (warrants to purchase shares of our common
stock issued as part of the units described in the private
placement memorandum dated November 2003): We offered to issue
either (a) 0.37 shares of common stock for each
warrant share tendered; or (b) 1.0 share of common
stock for each warrant share tendered upon payment of $0.56 for
each warrant share tendered.
|
| |
| |
|
2004 Warrants (warrants to purchase shares of our common
stock issued as part of the units described in the private
placement memorandum dated March 2004): We offered to issue
either (a) 0.60 shares of common stock for each
warrant share tendered; or (b) 1.0 share of common
stock for each warrant share tendered upon payment of $0.50 for
each warrant share tendered.
|
On May 31, 2005, we closed the tender offer to exchange
certain of our outstanding warrants. In this transaction, we
received proceeds in the amount of approximately
$1.3 million and issued 4,960,918 million shares of
common stock in exchange for the cancellation of warrants that
provided for the purchase of approximately 5.5 million
shares of its common stock.
We will need to raise additional capital in order to grow our
business operations. As of December 31, 2006, we had cash
and cash equivalents and marketable securities of approximately
$2.3 million, compared to approximately $2.8 million
as of December 31, 2005. Our net cash used in operations
has exceeded our cash generated from operations for every year
since our inception. Based on our current operating plan, we
estimate that existing cash and cash equivalents and marketable
securities will be sufficient to meet our cash requirements
through 2007 based on current expense levels. We will need
substantial additional funding to further develop our existing
programs, including our pharmaceutical program. Accordingly, we
intend to seek additional funding through available means, which
may include debt
and/or
equity financing.
Our future capital requirements depend on many factors including:
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|
|
| |
|
the ability to attract collaborative agreement partners;
|
| |
| |
|
the ability to generate revenue under licensing
agreements; and
|
| |
| |
|
the costs of filing, prosecuting, enforcing, and defending
patents, patent applications, patent claims, and trademarks.
|
19
The availability of additional capital to us is highly
uncertain. We are actively pursuing out-licensing opportunities
but do not expect those efforts to produce significant capital
during the next twelve months. Any equity financing would likely
result in dilution to our existing stockholders and debt
financing, if available, would likely include restrictive
covenants.
Critical
Accounting Policies and Estimates
The preparation of our financial statements requires us to make
estimates and assumptions that affect the reported amounts of
liabilities at the date of the financial statements and the
reported amounts of revenue and expenses during the reporting
period. On an ongoing basis, our management evaluates its
estimates and judgments, including those related to revenue
recognition, research and development costs, capitalized patent
costs and valuation of stock options and warrants. We base our
estimates and judgments on historical experience and on various
other factors that are believed to be reasonable under the
circumstances. Actual results may differ from these estimates
under different assumptions or conditions.
|
|
|
| |
|
Revenue Recognition. We recognize revenue from
the sale of peptides when title transfers to the customer,
typically upon shipment. We recognize revenue from licensing
fees when delivery has occurred and no future obligations exist.
Royalties from licensees, if any, are based on third-party sales
and recorded as earned in accordance with contract terms when
third-party results are reliably measured and collection is
reasonably assured. Payments received for which the earnings
process is not complete are classified as deferred revenue.
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| |
| |
|
Research and Development Costs. These costs,
including personnel costs, supplies, and other indirect research
and development costs are expensed as incurred. In instances
where we enter into agreements with third parties for research
and development activities, which may include personnel costs,
supplies and other costs associated with such collaborative
agreements, we expense these items as incurred.
|
| |
| |
|
Capitalization of Patent Costs. We capitalize
the third party costs associated with filing patents or entering
into licenses associated with our underlying technology. Our
policy for the capitalization of patent costs is to begin
amortization of these costs at the time they are incurred. We
review our patent portfolio to determine whether any such costs
have been impaired and are no longer being used in our research
and development activities. To the extent we no longer use
certain patents, the associated costs will be written-off at
that time.
|
| |
| |
|
Valuation of Stock Options and Warrants. On
January 1, 2006, we adopted the fair value recognition
provisions of Financial Accounting Standards Board
(FASB) Statement No. 123(R), Share-Based
Payment (SFAS 123R). Prior to
January 1, 2006, we accounted for share-based payments
under the recognition and measurement provisions of APB Opinion
No. 25, Accounting for Stock Issued to Employees
(APB 25), and related Interpretations, as
permitted by FASB Statement No. 123, Accounting for
Stock-Based
Compensation (SFAS 123). In accordance with
APB 25, no compensation cost was required to be recognized
for options granted that had an exercise price equal to the
market value of the underlying common stock on the date of grant.
|
Stock options and warrants issued to non-employees are accounted
for using the fair value method prescribed by Emerging Issues
Task Force (EITF) Issue
No. 96-18
and EITF Issue
No. 00-18.
We adopted SFAS 123R using the
modified-prospective-transition method. Under this method,
compensation cost recognized for the year ended
December 31, 2006 includes: a) compensation cost for
all share-based payments granted prior to, but not yet vested as
of, December 31, 2005, based on the grant-date fair value
estimated in accordance with the original provisions of
SFAS 123, and b) compensation cost for all
share-based
payments granted subsequent to December 31, 2005, based on
the grant-date fair value estimated in accordance with the
provisions of SFAS 123R. The results for the prior periods
have not been restated.
Effective January 1, 2006, we adopted the fair value
attribution method for recognizing compensation expense.
Previously under the disclosure-only provisions of
SFAS 123, we accounted for stock compensation using the
intrinsic value method prescribed in APB 25. For all
unvested options outstanding as of January 1, 2006, the
previously measured but unrecognized compensation expense, based
on the fair value at the original grant date, will be recognized
ratably over the remaining vesting period. For
20
share-based
payments granted subsequent to January 1, 2006,
compensation expense, based on the fair value on the date of
grant, will be recognized on a straight-line basis over the
vesting period.
Recent
Accounting Pronouncements
In June 2006, the FASB issued Interpretation (FIN) No. 48,
Accounting for Income Tax Uncertainties, which clarifies
the accounting for uncertainty in income taxes recognized in the
financial statements in accordance with SFAS No. 109,
Accounting for Income Taxes. The Interpretation
prescribes a recognition threshold of
more-likely-than-not
and a measurement attribute on all tax positions taken or
expected to be taken in a tax return in order to be recognized
in the financial statements. In making this assessment, a
company must determine whether it is more-likely-than-not that a
tax position will be sustained upon examination, including
resolution of any related appeals or litigation processes, based
solely on the technical merits of the position and that the tax
position will be examined by appropriate taxing authority that
would have full knowledge of all relevant information. Once the
recognition threshold is met, the tax position is then measured
to determine the actual amount of benefit to recognize in the
financial statements. In addition, the recognition threshold of
more-likely-than-not must continue to be met in each reporting
period to support continued recognition of the tax benefit. Tax
positions that previously failed to meet the
more-likely-than-not recognition threshold should be recognized
in the first financial reporting period in which that threshold
is met. Previously recognized tax positions that no longer meet
the more-likely-than-not recognition threshold should be
derecognized in the financial reporting period in which that
threshold is no longer met. We are currently assessing the
expected impact of this Interpretation on our financial
statements.
In the fourth quarter of 2006, we adopted the
U.S. Securities and Exchange Commission (SEC) Staff
Accounting Bulletin (SAB) No. 108, Quantifying
Misstatements in Current Year Financial Statements, which
provides interpretive guidance on how the effects of prior year
misstatements should be considered in quantifying current year
financial statement misstatements. The interpretations in
SAB No. 108, which expresses the SECs staff
views, were issued to address the diversity in the practice of
quantifying financial statement misstatements and the potential
under current practice for a build up of improper amounts on the
balance sheet. The SEC staff indicated that companies should
quantify errors using both a balance sheet and an income
statement approach and evaluate whether either approach results
in material misstatement. The adoption of this interpretation
did not have an impact on our financial statements.
21
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ITEM 7.
|
FINANCIAL
STATEMENTS
|
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Page
|
|
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|
|
Index to Financial
Statements
|
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|
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23
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|
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24
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|
|
|
|
25
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|
|
|
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|
26
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|
|
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|
27
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|
|
|
|
|
30
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|
|
|
|
|
31
|
|
22
REPORT OF
INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
The Board of Directors
Helix BioMedix, Inc.
We have audited the accompanying balance sheets of Helix
BioMedix, Inc. (a development stage company) as of
December 31, 2006 and 2005, and the related statements of
operations, stockholders equity (deficit), and cash flows
for the years then ended and for the period from
November 7, 1988 (inception) to December 31, 2006.
These financial statements are the responsibility of the
Companys management. Our responsibility is to express an
opinion on these financial statements based on our audits. The
cumulative statements of operations, stockholders equity
(deficit), and cash flows for the period November 7, 1988
(inception) to December 31, 2006 include amounts for the
period from November 7, 1988 (inception) to
December 31, 1988 and for each of the years in the
thirteen-year period ending December 31, 2001, which were
audited by other auditors whose report has been furnished to us,
and our opinion, insofar as it relates to the amounts included
for the period November 7, 1988 through December 31,
2001, is based solely on the report of other auditors.
We conducted our audits in accordance with the auditing
standards of the Public Company Accounting Oversight Board
(United States). Those standards require that we plan and
perform the audit to obtain reasonable assurance about whether
the financial statements are free of material misstatement. An
audit includes examining, on a test basis, evidence supporting
the amounts and disclosures in the financial statements. An
audit also includes assessing the accounting principles used and
significant estimates made by management, as well as evaluating
the overall financial statement presentation. We believe that
our audits provide a reasonable basis for our opinion.
In our opinion, based on our audits and the report of other
auditors, the financial statements referred to above present
fairly, in all material respects, the financial position of
Helix BioMedix, Inc. (a development stage company) as of
December 31, 2006 and 2005, and the results of its
operations and its cash flows for the years then ended and for
the period November 7, 1988 (inception) to
December 31, 2006, in conformity with accounting principles
generally accepted in the United States of America.
As discussed in Note 1 to the financial statements, Helix
BioMedix, Inc. (a development stage company) adopted Financial
Accounting Standards Board Statement of Financial Accounting
Standards No. 123(R), Share-Based Payment, effective
January 1, 2006.
Seattle, Washington
March 26, 2007
23
REPORT OF
INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
The Board of Directors
Helix BioMedix, Inc.
Bothell, Washington
We have audited the accompanying statements of operations, cash
flows, and changes in stockholders equity (deficit) of
Helix BioMedix, Inc. (a development stage company) related to
the period from inception (November 7, 1988) to
December 31, 2001. These financial statements are the
responsibility of the Companys management. Our
responsibility is to express an opinion on these financial
statements based on our audits.
We conducted our audits in accordance with the auditing
standards of the Public Company Accounting Oversight Board
(United States). Those standards require that we plan and
perform the audit to obtain reasonable assurance that the
financial statements are free of material misstatement. An audit
includes examining, on a test basis, evidence supporting the
amounts and disclosures in the financial statements. An audit
also includes assessing the accounting principles used and
significant estimates made by management, as well as evaluating
the overall financial statement presentation. We believe that
our audits provide a reasonable basis for our opinion.
In our opinion, the financial statements referred to above
present fairly, in all material respects the results of
operations, cash flows, and changes in stockholders equity
(deficit) of Helix BioMedix, Inc. for the period from inception
(November 7, 1988) to December 31, 2001, in
conformity with accounting principles generally accepted in the
United States of America.
PROFESSIONAL CORPORATION
Denver, Colorado
February 1, 2002
24
HELIX
BIOMEDIX, INC.
(A DEVELOPMENT STAGE COMPANY)
BALANCE SHEETS
| |
|
|
|
|
|
|
|
|
|
|
|
December 31,
|
|
|
|
|
2006
|
|
|
2005
|
|
|
|
|
ASSETS
|
|
Current assets:
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
$
|
1,276,901
|
|
|
$
|
2,827,959
|
|
|
Marketable securities
|
|
|
980,000
|
|
|
|
|
|
|
Accounts receivable
|
|
|
|
|
|
|
18,988
|
|
|
Inventory
|
|
|
|
|
|
|
35,316
|
|
|
Prepaid expenses and other current
assets
|
|
|
86,732
|
|
|
|
101,363
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current assets
|
|
|
2,343,633
|
|
|
|
2,983,626
|
|
|
|
|
|
|
|
|
|
|
|
|
Property and equipment:
|
|
|
|
|
|
|
|
|
|
Machinery and equipment
|
|
|
523,797
|
|
|
|
448,883
|
|
|
Furniture and fixtures
|
|
|
46,734
|
|
|
|
14,627
|
|
|
Leasehold improvements
|
|
|
43,993
|
|
|
|
28,215
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
614,524
|
|
|
|
491,725
|
|
|
Less: accumulated depreciation
|
|
|
(419,796
|
)
|
|
|
(323,662
|
)
|
|
|
|
|
|
|
|
|
|
|
|
Property and equipment, net
|
|
|
194,728
|
|
|
|
168,063
|
|
|
|
|
|
|
|
|
|
|
|
|
Other assets:
|
|
|
|
|
|
|
|
|
|
Deposits
|
|
|
4,211
|
|
|
|
10
|
|
|
Antimicrobial technology, net
|
|
|
26,213
|
|
|
|
37,322
|
|
|
Licensing agreements, net
|
|
|
43,416
|
|
|
|
47,011
|
|
|
Patents pending and approved, net
|
|
|
441,733
|
|
|
|
505,908
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
515,573
|
|
|
|
590,251
|
|
|
|
|
|
|
|
|
|
|
|
|
Total assets
|
|
$
|
3,053,934
|
|
|
$
|
3,741,940
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS EQUITY
|
|
Current liabilities:
|
|
|
|
|
|
|
|
|
|
Accounts payable
|
|
$
|
65,549
|
|
|
$
|
57,993
|
|
|
Accrued payroll
|
|
|
59,000
|
|
|
|
|
|
|
Accrued expenses
|
|
|
76,918
|
|
|
|
166,366
|
|
|
Deferred revenue
|
|
|
54,390
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current liabilities
|
|
|
255,857
|
|
|
|
224,359
|
|
|
|
|
|
|
|
|
|
|
|
|
Commitments and contingencies
|
|
|
|
|
|
|
|
|
|
Stockholders equity:
|
|
|
|
|
|
|
|
|
|
Preferred stock, $0.001 par
value, 25,000,000 shares authorized; no shares issued or
outstanding
|
|
|
|
|
|
|
|
|
|
Common stock, $0.001 par
value, 100,000,000 shares authorized;
22,788,514 shares outstanding at December 31, 2006;
20,190,514 shares outstanding at December 31, 2005
|
|
|
22,788
|
|
|
|
20,190
|
|
|
Additional paid-in capital
|
|
|
26,908,198
|
|
|
|
23,906,974
|
|
|
Deferred stock compensation
|
|
|
|
|
|
|
(105,000
|
)
|
|
Deficit accumulated during the
development stage
|
|
|
(24,132,909
|
)
|
|
|
(20,304,583
|
)
|
|
|
|
|
|
|
|
|
|
|
|
Total stockholders equity
|
|
|
2,798,077
|
|
|
|
3,517,581
|
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities and
stockholders equity
|
|
$
|
3,053,934
|
|
|
$
|
3,741,940
|
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes to financial statements.
25
HELIX
BIOMEDIX, INC.
(A DEVELOPMENT STAGE COMPANY)
STATEMENTS OF OPERATIONS
For the Years ended December 31, 2006 and 2005
and
for the Period from Inception (November 7, 1988) to
December 31, 2006
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Inception
|
|
|
|
|
|
|
|
|
|
|
(November 7, 1988)
|
|
|
For the Years Ended
|
|
|
|
|
to December 31,
|
|
|
December 31,
|
|
|
|
|
2006
|
|
|
2006
|
|
|
2005
|
|
|
|
|
Revenue
|
|
$
|
450,974
|
|
|
$
|
70,940
|
|
|
$
|
108,408
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of peptide sales
|
|
|
247,329
|
|
|
|
162,991
|
|
|
|
84,338
|
|
|
Research and development
|
|
|
6,518,697
|
|
|
|
988,451
|
|
|
|
834,231
|
|
|
Depreciation and amortization
|
|
|
1,081,313
|
|
|
|
180,755
|
|
|
|
175,136
|
|
|
Accounting, legal and professional
|
|
|
2,492,137
|
|
|
|
318,113
|
|
|
|
300,895
|
|
|
Consulting fees
|
|
|
2,879,146
|
|
|
|
14,767
|
|
|
|
133,518
|
|
|
General and administrative
|
|
|
10,204,473
|
|
|
|
2,307,620
|
|
|
|
1,903,615
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses
|
|
|
23,423,095
|
|
|
|
3,972,697
|
|
|
|
3,431,733
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations
|
|
|
(22,972,121
|
)
|
|
|
(3,901,757
|
)
|
|
|
(3,323,325
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other (income) expense:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gain on settlement of lawsuit
|
|
|
(48,574
|
)
|
|
|
|
|
|
|
|
|
|
(Gain) loss on sale of equipment
|
|
|
(5,276
|
)
|
|
|
1,177
|
|
|
|
|
|
|
Interest expense
|
|
|
1,459,442
|
|
|
|
|
|
|
|
|
|
|
Interest income
|
|
|
(244,804
|
)
|
|
|
(74,608
|
)
|
|
|
(46,086
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,160,788
|
|
|
|
(73,431
|
)
|
|
|
(46,086
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(24,132,909
|
)
|
|
$
|
(3,828,326
|
)
|
|
$
|
(3,277,239
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per
share
|
|
|
|
|
|
$
|
(0.17
|
)
|
|
$
|
(0.18
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares outstanding
|
|
|
|
|
|
|
22,343,087
|
|
|
|
17,858,807
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes to financial statements.
26
HELIX
BIOMEDIX, INC.
(A DEVELOPMENT STAGE COMPANY)
STATEMENTS OF STOCKHOLDERS EQUITY (DEFICIT)
For the Years ended December 31, 2006 and 2005
and
for the Period from Inception (November 7, 1988) to
December 31, 2006
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deficit
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated
|
|
|
|
|
|
|
|
|
|
Common Stock
|
|
|
Additional
|
|
|
Deferred
|
|
|
Stock
|
|
|
During the
|
|
|
Stockholders
|
|
|
|
|
|
|
Number
|
|
|
|
|
|
Paid-in
|
|
|
Stock
|
|
|
Subscription
|
|
|
Development
|
|
|
Equity
|
|
|
|
|
|
|
of Shares
|
|
|
Amount
|
|
|
Capital
|
|
|
Compensation
|
|
|
Receivable
|
|
|
Stage
|
|
|
(Deficit)
|
|
|
|
|
Initial capitalization on
November 7, 1988
|
|
|
1,000,000
|
|
|
$
|
66,486
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
66,486
|
|
|
Restated for recapitalization of
the private company
|
|
|
(370,000
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Reverse acquisition of Helix
BioMedix, Inc. by Cartel Acquisitions, Inc. on March 20,
1989
|
|
|
151,262
|
|
|
|
855,292
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
855,292
|
|
|
Issuance of stock for current or
prior services:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Per Share
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Period
|
|
Amount
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 1992
|
|
$2.50
|
|
|
5,600
|
|
|
|
14,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
14,000
|
|
|
May 1993
|
|
$5.00
|
|
|
8,000
|
|
|
|
40,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
40,000
|
|
|
December 1993
|
|
$2.50
|
|
|
9,490
|
|
|
|
23,724
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
23,724
|
|
|
March 1998
|
|
$1.00
|
|
|
4,900
|
|
|
|
4,900
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
4,900
|
|
|
December 1998
|
|
$1.00
|
|
|
3,100
|
|
|
|
3,100
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3,100
|
|
|
September 1999
|
|
$0.70
|
|
|
40,000
|
|
|
|
28,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
28,000
|
|
|
September 1999
|
|
$1.25
|
|
|
73,215
|
|
|
|
91,519
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
91,519
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
144,305
|
|
|
|
205,243
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
205,243
|
|
|
Issuance of stock for settlement of
debt on account payable:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Per Share
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Period
|
|
Amount
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
May 1993
|
|
$5.00
|
|
|
4,000
|
|
|
|
20,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
20,000
|
|
|
September 1993
|
|
$2.50
|
|
|
184,000
|
|
|
|
460,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
460,000
|
|
|
April 1995
|
|
$2.50
|
|
|
41,732
|
|
|
|
104,331
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
104,331
|
|
|
April 1995
|
|
$2.41
|
|
|
80,000
|
|
|
|
192,943
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
192,943
|
|
|
September 1995
|
|
$2.50
|
|
|
14,731
|
|
|
|
36,828
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
36,828
|
|
|
September 1997
|
|
$1.00
|
|
|
110,976
|
|
|
|
110,976
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
110,976
|
|
|
December 1997
|
|
$1.00-$2.50
|
|
|
326,785
|
|
|
|
780,025
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
780,025
|
|
|
March 1998
|
|
$1.00
|
|
|
3,100
|
|
|
|
3,100
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3,100
|
|
|
June 1998
|
|
$1.00
|
|
|
1,395
|
|
|
|
1,395
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,395
|
|
|
September 1998
|
|
$1.00
|
|
|
2,500
|
|
|
|
2,500
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,500
|
|
|
September 1999
|
|
$1.25
|
|
|
2,000
|
|
|
|
2,500
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,500
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
771,219
|
|
|
|
1,714,598
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,714,598
|
|
|
Fractional shares issued in
connection with 1 for 500 reverse split
|
|
|
29
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of stock for cash:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Per Share
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Period
|
|
Amount
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March & December 1994
|
|
$2.50
|
|
|
16,000
|
|
|
|
40,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
40,000
|
|
|
April 1995
|
|
$2.50
|
|
|
4,800
|
|
|
|
12,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
12,000
|
|
|
March 1998
|
|
$1.00
|
|
|
10,000
|
|
|
|
10,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
10,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
30,800
|
|
|
|
62,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
62,000
|
|
|
Issuance of common stock as
consideration in cooperative endeavor agreement, in November 1995
|
|
|
10,000
|
|
|
|
25,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
25,000
|
|
|
Issuance of stock options in 1995
|
|
|
|
|
|
|
|
|
|
|
137,400
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
137,400
|
|
|
Issuance of stock for cash in
private placement, during July-September 1999, at $0.70 per
share, net of offering costs of $107,195
|
|
|
2,890,643
|
|
|
|
1,916,255
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,916,255
|
|
|
Escrow of stock for consulting
agreement, in September 1999, at $0.70 per share
|
|
|
|
|
|
|
42,000
|
|
|
|
|
|
|
|
(42,000
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Compensation and deferred
compensation recorded for options granted, in December 1999
|
|
|
|
|
|
|
|
|
|
|
50,875
|
|
|
|
(44,000
|
)
|
|
|
|
|
|
|
|
|
|
|
6,875
|
|
|
Deferred compensation for stock
awards in December 1999
|
|
|
|
|
|
|
87,225
|
|
|
|
|
|
|
|
(87,225
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes to financial statements.
27
HELIX
BIOMEDIX, INC.
(A DEVELOPMENT STAGE COMPANY)
STATEMENTS OF STOCKHOLDERS EQUITY
(DEFICIT) (Continued)
For the Years ended December 31, 2006 and 2005 and
for the Period from Inception (November 7, 1988) to
December 31, 2006
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deficit
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated
|
|
|
|
|
|
|
|
|
|
Common Stock
|
|
|
Additional
|
|
|
Deferred
|
|
|
Stock
|
|
|
During the
|
|
|
Stockholders
|
|
|
|
|
|
|
Number
|
|
|
|
|
|
Paid-in
|
|
|
Stock
|
|
|
Subscription
|
|
|
Development
|
|
|
Equity
|
|
|
|
|
|
|
of Shares
|
|
|
Amount
|
|
|
Capital
|
|
|
Compensation
|
|
|
Receivable
|
|
|
Stage
|
|
|
(Deficit)
|
|
|
|
|
Stock and options issued for
services in January 2000
|
|
|
1,250
|
|
|
|
3,125
|
|
|
|
4,500
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
7,625
|
|
|
Amortization of deferred
compensation costs
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
21,000
|
|
|
|
|
|
|
|
|
|
|
|
21,000
|
|
|
Retirement of share issued in
December 1999
|
|
|
|
|
(250
|
)
|
|
|
(313
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(313
|
)
|
|
Shares issued and options vested in
connection with employment agreements, March 2000
|
|
|
267,445
|
|
|
|
700,000
|
|
|
|
|
|
|
|
41,306
|
|
|
|
|
|
|
|
|
|
|
|
741,306
|
|
|
Director shares and options issued:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Per Share
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Period
|
|
Amount
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 2000
|
|
$4.05
|
|
|
7,747
|
|
|
|
18,399
|
|
|
|
12,976
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
31,375
|
|
|
June 2000
|
|
$3.17
|
|
|
8,750
|
|
|
|
16,953
|
|
|
|
10,828
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
27,781
|
|
|
September 2000
|
|
$4.61
|
|
|
8,750
|
|
|
|
24,063
|
|
|
|
16,297
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
40,360
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
25,247
|
|
|
|
59,415
|
|
|
|
40,101
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
99,516
|
|
|
Revaluation of deferred
compensation and options vested in connection with employment
agreement in June 2000
|
|
|
|
|
|
|
(27,919
|
)
|
|
|
33,784
|
|
|
|
16,396
|
|
|
|
|
|
|
|
|
|
|
|
22,261
|
|
|
Options vested in connection with
employment agreement, shares issued for services, and
revaluation of options due to suspension of exercise date, in
September 2000
|
|
|
41,000
|
|
|
|
2,313
|
|
|
|
85,000
|
|
|
|
51,012
|
|
|
|
|
|
|
|
|
|
|
|
138,325
|
|
|
Options issued in connection with
two consulting agreements, in October 2000
|
|
|
|
|
|
|
|
|
|
|
100,000
|
|
|
|
(75,000
|
)
|
|
|
|
|
|
|
|
|
|
|
25,000
|
|
|
Directors shares and options issued
in September 2000, at $2.36 per share
|
|
|
8,659
|
|
|
|
13,259
|
|
|
|
7,197
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
20,456
|
|
|
Options vested in connection with
employment agreements, and shares issued for services, in
September 2000
|
|
|
4,987
|
|
|
|
8,104
|
|
|
|
4,613
|
|
|
|
43,511
|
|
|
|
|
|
|
|
|
|
|
|
56,228
|
|
|
Compensation adjustment to variable
plan options in December 2000
|
|
|
|
|
|
|
|
|
|
|
(83,828
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(83,828
|
)
|
|
Exercise of options at
$1.00 per share
|
|
|
45,000
|
|
|
|
112,500
|
|
|
|
(67,500
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
45,000
|
|
|
Exercise of option at
$0.50 per share
|
|
|
600
|
|
|
|
1,500
|
|
|
|
(1,200
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
300
|
|
|
Adjustment to par value stock for
Delaware
re-incorporation
|
|
|
|
|
|
|
(5,841,061
|
)
|
|
|
5,841,061
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amortization of deferred
compensation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
75,000
|
|
|
|
|
|
|
|
|
|
|
|
75,000
|
|
|
Issuance of stock for services, in
October 2001, at $2.00 per share
|
|
|
25,000
|
|
|
|
25
|
|
|
|
49,975
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
50,000
|
|
|
Issuance of stock for licensing
arrangement October 2001, at $0.75 per share
|
|
|
97,500
|
|
|
|
98
|
|
|
|
73,027
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
73,125
|
|
|
Compensation adjustment for options
and warrants in 2001
|
|
|
|
|
|
|
|
|
|
|
328,310
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
328,310
|
|
|
Value of detachable warrants issued
with convertible notes payable
|
|
|
|
|
|
|
|
|
|
|
216,100
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
216,100
|
|
|
Net loss for the period from
inception on November 7, 1988 to December 31, 2001
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(7,560,663
|
)
|
|
|
(7,560,663
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2001
|
|
|
5,144,696
|
|
|
|
5,145
|
|
|
|
6,819,415
|
|
|
|
|
|
|
|
|
|
|
|
(7,560,663
|
)
|
|
|
(736,103
|
)
|
See accompanying notes to financial statements.
28
HELIX
BIOMEDIX, INC.
(A DEVELOPMENT STAGE COMPANY)
STATEMENTS OF STOCKHOLDERS EQUITY
(DEFICIT) (Continued)
For the Years ended December 31, 2006 and 2005 and
for the Period from Inception (November 7, 1988) to
December 31, 2006
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deficit
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated
|
|
|
|
|
|
|
|
Common Stock
|
|
|
Additional
|
|
|
Deferred
|
|
|
Stock
|
|
|
During the
|
|
|
Stockholders
|
|
|
|
|
Number
|
|
|
|
|
|
Paid-in
|
|
|
Stock
|
|
|
Subscription
|
|
|
Development
|
|
|
Equity
|
|
|
|
|
of Shares
|
|
|
Amount
|
|
|
Capital
|
|
|
Compensation
|
|
|
Receivable
|
|
|
Stage
|
|
|
(Deficit)
|
|
|
|
|
Issuance of common stock for
services rendered, at $0.80 per share on November 21,
2002
|
|
|
18,000
|
|
|
|
18
|
|
|
|
14,382
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
14,400
|
|
|
Conversion of convertible notes
payable into equity, at $1.00 per share Principle
|
|
|
3,082,500
|
|
|
|
3,083
|
|
|
|
3,079,417
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3,082,500
|
|
|
Accrued interest
|
|
|
231,180
|
|
|
|
231
|
|
|
|
230,949
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
231,180
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
8,476,376
|
|
|
|
8,477
|
|
|
|
10,144,163
|
|
|
|
|
|
|
|
|
|
|
|
(7,560,663
|
)
|
|
|
2,591,977
|
|
|
Private placement of common stock
(with common stock warrants equal to 60%), at $1.00 per
share, September to December 2002
|
|
|
1,560,000
|
|
|
|
1,560
|
|
|
|
1,558,440
|
|
|
|
|
|
|
|
(135,000
|
)
|
|
|
|
|
|
|
1,425,000
|
|
|
Compensation adjustments for
warrants in 2002
|
|
|
|
|
|
|
|
|
|
|
440,331
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
440,331
|
|
|
Value of detachable warrants issued
with convertible notes payable
|
|
|
|
|
|
|
|
|
|
|
512,452
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
512,452
|
|
|
Net loss for the year
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(3,161,904
|
)
|
|
|
(3,161,904
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2002
|
|
|
10,036,376
|
|
|
|
10,037
|
|
|
|
12,655,386
|
|
|
|
|
|
|
|
(135,000
|
)
|
|
|
(10,722,567
|
)
|
|
|
1,807,856
|
|
|
Exercise of warrants at
$1.00 per share
|
|
|
80,500
|
|
|
|
81
|
|
|
|
80,419
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
80,500
|
|
|
Private placement of common stock
(with common stock warrants, equal to 60%) at $1.00 per
share, net of issuance costs, January to March 2003
|
|
|
2,172,494
|
|
|
|
2,172
|
|
|
|
2,159,213
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,161,385
|
|
|
Deferred stock compensation, net
|
|
|
|
|
|
|
|
|
|
|
630,000
|
|
|
|
(525,000
|
)
|
|
|
|
|
|
|
|
|
|
|
105,000
|
|
|
Proceeds from warrant exchange at
$0.50 per warrant
|
|
|
|
|
|
|
|
|
|
|
1,176,550
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,176,550
|
|
|
Repayment of subscription receivable
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
135,000
|
|
|
|
|
|
|
|
135,000
|
|
|
Options and warrants issued for
services
|
|
|
|
|
|
|
|
|
|
|
663,407
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
663,407
|
|
|
Net loss for the year
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(3,195,503
|
)
|
|
|
(3,195,503
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2003
|
|
|
12,289,370
|
|
|
|
12,290
|
|
|
|
17,364,975
|
|
|
|
(525,000
|
)
|
|
|
|
|
|
|
(13,918,070
|
)
|
|
|
2,934,195
|
|
|
Exercise of warrants at
$0.25 per share
|
|
|
60,000
|
|
|
|
60
|
|
|
|
14,940
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
15,000
|
|
|
Private placement of common stock
(with common stock warrants equal to 35% at $2.00 per
share, net of issuance cost), March to May 2004
|
|
|
1,184,000
|
|
|
|
1,183
|
|
|
|
2,346,793
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,347,976
|
|
|
Proceeds from 2003 warrant exchange
at $0.50 per warrant
|
|
|
|
|
|
|
|
|
|
|
30,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
30,000
|
|
|
Deferred stock compensation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
210,000
|
|
|
|
|
|
|
|
|
|
|
|
210,000
|
|
|
Options issued for services
|
|
|
|
|
|
|
|
|
|
|
251,137
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
251,137
|
|
|
Net loss for the year
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(3,109,274
|
)
|
|
|
(3,109,274
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2004
|
|
|
13,533,370
|
|
|
|
13,533
|
|
|
|
20,007,845
|
|
|
|
(315,000
|
)
|
|
|
|
|
|
|
(17,027,344
|
)
|
|
|
2,679,034
|
|
|
Exercise of warrants issued for
services at $1.00 per share
|
|
|
16,050
|
|
|
|
16
|
|
|
|
(16
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrant Exchange, net
|
|
|
4,960,918
|
|
|
|
4,961
|
|
|
|
1,332,124
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,337,085
|
|
|
Proceeds from 2005 Private
Placement, net
|
|
|
1,665,167
|
|
|
|
1,665
|
|
|
|
2,478,324
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,479,989
|
|
|
Deferred stock compensation, stock
and stock options issued for services
|
|
|
15,009
|
|
|
|
15
|
|
|
|
88,697
|
|
|
|
210,000
|
|
|
|
|
|
|
|
|
|
|
|
298,712
|
|
|
Net loss for the year
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(3,277,239
|
)
|
|
|
(3,277,239
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2005
|
|
|
20,190,514
|
|
|
|
20,190
|
|
|
|
23,906,974
|
|
|
|
(105,000
|
)
|
|
|
|
|
|
|
(20,304,583
|
)
|
|
|
3,517,581
|
|
|
Adjustment to reclassify deferred
compensation to additional paid in capital upon adoption of
FAS123R
|
|
|
|
|
|
|
|
|
|
|
(105,000
|
)
|
|
|
105,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Proceeds from 2006 Private
Placement, net
|
|
|
2,598,000
|
|
|
|
2,598
|
|
|
|
2,581,423
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,584,021
|
|
|
Stock based compensation
|
|
|
|
|
|
|
|
|
|
|
524,801
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
524,801
|
|
|
Net loss for the year
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(3,828,326
|
)
|
|
|
(3,828,326
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2006
|
|
|
22,788,514
|
|
|
$
|
22,788
|
|
|
$
|
26,908,198
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
(24,132,909
|
)
|
|
$
|
2,798,077
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes to financial statements.
29
HELIX
BIOMEDIX, INC.
(A DEVELOPMENT STAGE COMPANY)
STATEMENTS OF CASH FLOWS
For the Years ended December 31, 2006 and 2005
and
For the Period from Inception (November 7, 1988) to
December 31, 2006
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Inception
|
|
|
|
|
|
|
|
|
|
|
(November 7, 1988)
|
|
|
For the Years Ended
|
|
|
|
|
to December 31,
|
|
|
December 31,
|
|
|
|
|
2006
|
|
|
2006
|
|
|
2005
|
|
|
|
|
Cash Flows from Operating
Activities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(24,132,909
|
)
|
|
$
|
(3,828,326
|
)
|
|
$
|
(3,277,239
|
)
|
|
Adjustments to reconcile net loss
to net cash used in operating activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Depreciation and amortization
|
|
|
1,081,493
|
|
|
|
180,755
|
|
|
|
175,136
|
|
|
Amortization of debt discount
|
|
|
728,552
|
|
|
|
|
|
|
|
|
|
|
Stock-based compensation costs
|
|
|
4,603,307
|
|
|
|
524,801
|
|
|
|
298,712
|
|
|
Interest expense converted to
common stock
|
|
|
231,180
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
|
53,000
|
|
|
|
|
|
|
|
|
|
|
(Gain) loss on sale of assets
|
|
|
(5,276
|
)
|
|
|
1,177
|
|
|
|
|
|
|
Changes in operating assets and
liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accounts receivable
|
|
|
8,700
|
|
|
|
18,988
|
|
|
|
(10,288
|
)
|
|
Inventory
|
|
|
|
|
|
|
35,316
|
|
|
|
(35,316
|
)
|
|
Prepaid expenses and other current
assets
|
|
|
(80,722
|
)
|
|
|
14,631
|
|
|
|
(10,292
|
)
|
|
Other assets
|
|
|
(71,601
|
)
|
|
|
(4,201
|
)
|
|
|
|
|
|
Accounts payable
related party
|
|
|
341,602
|
|
|
|
|
|
|
|
|
|
|
Accounts payable
|
|
|
67,883
|
|
|
|
7,556
|
|
|
|
(4,060
|
)
|
|
Accrued payroll
|
|
|
59,000
|
|
|
|
59,000
|
|
|
|
|
|
|
Accrued expenses
|
|
|
151,196
|
|
|
|
(89,448
|
)
|
|
|
40,373
|
|
|
Deferred revenue
|
|
|
54,390
|
|
|
|
54,390
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash used in operating
activities
|
|
|
(16,910,205
|
)
|
|
|
(3,025,361
|
)
|
|
|
(2,822,974
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash Flows from Investing
Activities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Investment in Helix Delaware
|
|
|
(10
|
)
|
|
|
|
|
|
|
|
|
|
Purchases of marketable securities
|
|
|
(980,000
|
)
|
|
|
(980,000
|
)
|
|
|
|
|
|
Proceeds from sale of assets
|
|
|
9,435
|
|
|
|
535
|
|
|
|
1,500
|
|
|
Purchase of property and equipment
|
|
|
(753,196
|
)
|
|
|
(130,253
|
)
|
|
|
(53,144
|
)
|
|
Increase in capitalized patents
|
|
|
(654,944
|
)
|
|
|
|
|
|
|
(22,525
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash used in investing
activities
|
|
|
(2,378,715
|
)
|
|
|
(1,109,718
|
)
|
|
|
(74,169
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash Flows from Financing
Activities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash received in reverse
acquisition
|
|
|
634,497
|
|
|
|
|
|
|
|
|
|
|
Proceeds from notes payable
|
|
|
3,089,894
|
|
|
|
|
|
|
|
|
|
|
Proceeds from notes
payable related party
|
|
|
379,579
|
|
|
|
|
|
|
|
|
|
|
Repayments from notes
payable related party
|
|
|
(163,154
|
)
|
|
|
|
|
|
|
|
|
|
Issuance of stock and warrants for
cash, net
|
|
|
16,625,005
|
|
|
|
2,584,021
|
|
|
|
3,817,074
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by financing
activities
|
|
|
20,565,821
|
|
|
|
2,584,021
|
|
|
|
3,817,074
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net (decrease) increase in cash
and cash equivalents
|
|
|
1,276,901
|
|
|
|
(1,551,058
|
)
|
|
|
919,931
|
|
|
Cash and cash equivalents at
beginning of period
|
|
|
|
|
|
|
2,827,959
|
|
|
|
1,908,028
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at
end of period
|
|
$
|
1,276,901
|
|
|
$
|
1,276,901
|
|
|
$
|
2,827,959
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes to financial statements.
30
HELIX
BIOMEDIX, INC.
(A DEVELOPMENT STAGE COMPANY)
NOTES TO FINANCIAL STATEMENTS
for the Period from Inception (November 7,
1988) to December 31, 2006
|
|
|
Note 1.
|
Summary
of Significant Accounting Policies
|
Description
of Entity
Helix BioMedix, Inc. was originally formed under the laws of the
State of Colorado on February 2, 1988 under the name Cartel
Acquisitions, Inc. On March 20, 1989, the Company acquired
100% of the outstanding shares of Helix BioMedix, Inc., a
Louisiana corporation (BioMedix of Louisiana), in
exchange for 151,262 shares of the Companys common
stock. Cartel Acquisitions, Inc. acquired the shares of BioMedix
of Louisiana from Helix International Corporation
(Helix). BioMedix of Louisiana was incorporated on
November 7, 1988 as a separate corporate entity from Helix
International, Inc. to develop therapeutic biopharmaceuticals
for animal and human health care. On November 1, 2000, the
Company incorporated, as a wholly owned subsidiary, Helix
BioMedix, Inc., in the State of Delaware
(Helix-Delaware) for the purpose of merging into
Helix-Delaware, with Helix-Delaware as the surviving
corporation. This merger is reflected in the accompanying
financial statements with an effective date of December 29,
2000.
Unless otherwise noted, all references herein to the
Company refer to Helix BioMedix, Inc., a Delaware
corporation, and its predecessors.
Development
Stage Activities
Since 1988, the Company has been engaged in conducting research
in the field of antimicrobial peptides, both internally and in
conjunction with research and development arrangements with
various academic and commercial organizations. During this
period, the Company acquired the ownership and rights to various
peptide patents and related technology. The Company is
developing diverse commercial (non-FDA) and clinical (FDA)
applications for its library of peptides.
Prior to September 1999, the Companys research and
development activities were constrained by patent related
uncertainties and by limited working capital, with most of its
financing during that time being advanced by its majority
shareholder. In September 1999, the Company raised
$2.0 million in an equity private placement through the
sale of approximately 2.9 million common shares and stock
purchase warrants.
Shortly thereafter, the Company entered into various employment
and consulting agreements and a restructuring of the board of
directors occurred. The Company granted various compensatory
options and share issuances to employees and consultants during
the fourth quarter of 1999 and the year 2000.
During 2001, the Company raised approximately $2.0 million
in a private placement of convertible debt and detachable common
stock warrants. The Company relocated its corporate headquarters
from Louisiana to Bothell, Washington, leasing both office and
laboratory facilities in the new location. The Company also
hired research and administrative personnel, assembled a
Scientific Advisory Board and entered into a license agreement
with the University of British Columbia.
During 2002, the Company amended the terms of its 2001 private
placement of debt. Among other changes, the notes were amended
to require automatic conversion into shares of common stock in
the event of an equity financing of at least $1.5 million
by December 31, 2002. The Company raised an additional
$1.1 million through the first half of 2002 by issuing
notes with detachable warrants under the amended private
placement of debt. Beginning in September 2002, the Company
began an equity financing consisting of a private placement of
common stock, with detachable warrants equal to 60% of the
common stock investments, raising a total of $1.6 million
by year end. This amount included $135,000 of stock
subscriptions receivable. The convertible notes and accrued
interest totaling $3.3 million were converted into
3,313,680 shares of common stock at a per share price of
$1.00 on December 31, 2002. As a continuation of the
September 2002 equity financing and under the same terms, the
Company raised an additional $2.2 million through
March 31, 2003.
31
HELIX
BIOMEDIX, INC.
(A DEVELOPMENT STAGE COMPANY)
NOTES TO FINANCIAL
STATEMENTS (Continued)
In December 2003, the Company initiated a warrant exchange
program pursuant to which holders of certain warrants issued by
the Company in October 1999, and expiring on October 18,
2004, and having a per share exercise price of $3.25 could
exchange such warrants for new warrants that (i) expire on
October 31, 2006; (ii) provide for cashless exercises;
and (iii) reduce the per share exercise price from $3.25 to
$2.25. Consideration for the exchange was $0.50 per warrant
share and surrender of the old warrants prior to
December 26, 2003. The exchange program generated proceeds
to the Company of $1.2 million.
During 2004, in a private placement of common stock, the Company
received $2.3 million in exchange for 1,184,000 shares
of common stock and detachable warrants for the purchase of an
additional 414,400 shares of common stock. The warrants
issued in this financing have a term of five years and are
exercisable at $2.00 per share.
On February 28, 2005, the Company announced that it has
closed the initial closing of a private placement of common
stock, receiving cash of $2.3 million in exchange for
1,548,501 shares of common stock and warrants to purchase
up to 125,000 shares of common stock. The warrants have a
5-year term
and a per share exercise price of $1.50.
In a second closing held on March 2, 2005, the Company
received $175,000 in exchange for 116,666 shares of common
stock. The Company received a total of $2.5 million in this
private placement financing for 1,665,167 shares of common
stock and detachable warrants for the purchase of an additional
125,000 shares of common stock.
On March 1, 2005, the Company commenced a tender offer to
holders of certain of its warrants that were purchased in four
private placement financings to exchange their warrants as
follows:
|
|
|
| |
|
2001/2002
Warrants (warrants to purchase shares of the Companys
common stock issued as part of the units described in the
private placement memorandum dated May 2001): The Company
offered to issue either (a) 0.82 shares of common
stock for each warrant share tendered; or
(b) 1.0 share of common stock for each warrant share
tendered upon payment of $0.25 for each warrant share tendered.
|
| |
| |
|
2002/2003
Warrants (warrants to purchase shares of the Companys
common stock issued as part of the units described in the
private placement memorandum dated September 2002, and amended
December 2002): The Company offered to issue either
(a) 0.84 shares of common stock for each warrant share
tendered; or (b) 1.0 share of common stock for each
warrant share tendered upon payment of $0.25 for each warrant
share tendered.
|
| |
| |
|
2003 Warrants (warrants to purchase shares of the
Companys common stock issued as part of the units
described in the private placement memorandum dated November
2003): The Company offered to issue either
(a) 0.37 shares of common stock for each warrant share
tendered; or (b) 1.0 share of common stock for each
warrant share tendered upon payment of $0.56 for each warrant
share tendered.
|
| |
| |
|
2004 Warrants (warrants to purchase shares of the
Companys common stock issued as part of the units
described in the private placement memorandum dated March 2004):
The Company offered to issue either (a) 0.60 shares of
common stock for each warrant share tendered; or
(b) 1.0 share of common stock for each warrant share
tendered upon payment of $0.50 for each warrant share tendered.
|
On May 31, 2005, the Company closed the tender offer to
exchange certain of its outstanding warrants. In this
transaction, the Company received proceeds in the amount of
$1.3 million and issued 4,960,918 shares of common
stock in exchange for the cancellation of warrants that provided
for the purchase of approximately 5.5 million shares of its
common stock.
On March 3, 2006, the Company closed a private equity
financing, receiving cash of $2.4 million in exchange for
2,383,000 shares of $0.001 par value common stock and
warrants to purchase up to 238,300 shares of
$0.001 par value common stock. The warrants have a
5-year term
and a per share purchase price of $1.00.
32
HELIX
BIOMEDIX, INC.
(A DEVELOPMENT STAGE COMPANY)
NOTES TO FINANCIAL
STATEMENTS (Continued)
In a second closing held on March 10, 2006, the Company
received $215,000 in exchange for 215,000 shares of
$0.001 par value common stock and warrant to purchase up to
21,500 shares of $0.001 par value common stock. The
warrants have a
5-year term
and a per share purchase price of $1.00. The Company received a
total of $2.6 million in this private placement financing
for 2,598,000 shares of common stock and detachable
warrants for the purchase of an additional 259,800 shares
of common stock.
On March 5, 2007, the Company closed a private equity
financing, receiving cash of approximately $2.0 million in
exchange for 2,666,666 shares of $0.001 par value
common stock.
In a second closing held on March 26, 2007, the Company
received cash of approximately $148,750 in exchange for
198,332 shares of $0.001 par value common stock.
The proceeds of these offerings are being used to continue
ongoing research and development efforts, to fund the
Companys out-licensing initiatives for its peptides and
for general corporate purposes.
Management believes progress has been made with respect to the
licensing of the Companys peptide technology and business
development efforts. However, the Companys cost to license
its peptide technology and conduct its business development
efforts and other operating activities have exceeded its
revenues each year since inception. Also, the Companys net
cash used in operations has exceeded its cash generated from
operations for each year since its inception. For example, the
Company used approximately $3.0 million of cash in
operating activities for the year ended December 31, 2006
and approximately $2.8 million in 2005. Based upon the
private placement offering discussed above and the current
status of the Companys product development and
collaboration plans, its cash and cash equivalents should be
adequate to satisfy the Companys capital needs through
2007. However, additional funding through equity securities or
other means will be necessary to meet the Companys cash
requirements beyond 2007.
Use of
Estimates
The preparation of the Companys financial statements in
conformity with accounting principles generally accepted in the
United States of America requires the Companys management
to make estimates and assumptions that affect the amounts
reported in these financial statements and accompanying notes.
Significant items subject to such estimates and assumptions
include the carrying amount of property, plant and equipment,
and intangibles; valuation allowances for receivables,
inventories and deferred income tax assets; and valuation of
share-based compensation. Actual results could differ from those
estimates.
Cash
and Cash Equivalents
The Company considers all highly liquid debt instruments with a
maturity at date of purchase of three months or less to be cash
equivalents. The Company regularly maintains cash balances in
excess of the FDIC insured limitation of $100,000. As of
December 31, 2006, the Companys cash balances
exceeded the FDIC insured limit by approximately
$1.2 million.
Marketable
Securities
The Company classifies the marketable securities as
available-for-sale.
Marketable securities, consisting of corporate and municipal
auction or floating rate securities, are reported at fair value
with the related unrealized gains and losses included as a
component of accumulated other comprehensive income (loss) in
stockholders equity. Realized gains, losses, and declines
in value of securities judged to be other than temporary are
included in other income (expense). The cost of investments for
purposes of computing realized and unrealized gains and losses
is based on the specific identification method. Auction or
floating rate securities are classified as current assets
because they represent investments that are available to fund
current operations.
33
HELIX
BIOMEDIX, INC.
(A DEVELOPMENT STAGE COMPANY)
NOTES TO FINANCIAL
STATEMENTS (Continued)
Property
and Equipment
Property and equipment, which includes laboratory equipment,
furniture and leasehold improvements, are stated at cost.
Depreciation of equipment is provided using the straight-line
basis over three to five years. Leasehold improvements are
amortized over the lesser of the economic useful lives of the
improvements or the term of the related lease. Repair and
maintenance costs are expensed as incurred.
Intangibles
Acquired patents and costs for issued patents, consisting
primarily of legal fees, are capitalized. Amortization is taken
on the straight-line method over the life of the patents of 17
to 20 years.
Antimicrobial technology, which was purchased in conjunction
with the patents, has been capitalized at the basis of the debt
issued for it. This technology is being amortized ratably over
twenty years.
Impairment
of Long-Lived Assets
Long-lived assets including property and equipment are reviewed
for possible impairment whenever significant events or changes
in circumstances, including changes in the Companys
business strategy and plans, indicate that an impairment may
have occurred. An impairment is indicated when the sum of the
expected future undiscounted net cash flows identifiable to that
asset or asset group is less than its carrying value. Impairment
losses are determined from actual or estimated fair values,
which are based on market values, net realizable values or
projections of discounted net cash flows, as appropriate. No
impairment of long-lived assets has been recognized in the
accompanying financial statements.
Revenue
Recognition
The Company has generated limited revenue from the sale and
licensing of peptides. Revenue from the sale of peptides is
generally recognized when title transfers to the customer,
typically upon shipment. Revenue is recognized from licensing
fees when delivery has occurred and no future obligations exist.
Revenue may occur from royalties from licensees and are recorded
as earned in accordance with the contract terms when third-party
results are reliably measured and collection is reasonably
assured. Nonrefundable fees received from companies that enter
into a contract for the purpose of evaluating our peptides are
deferred until the terms of the contract has been satisfied.
Research
and Development
Research and development costs, including personnel costs,
supplies, and other indirect costs and costs associated with
collaborative agreements, are expensed as incurred. In instances
where the Company enters into agreements with third parties for
research and development activities, costs are expensed as
incurred.
Income
Taxes
Deferred income taxes are provided based on the estimated future
tax effects of carryforwards and temporary differences between
the financial statement carrying amounts of existing assets and
liabilities and their respective tax basis. Deferred tax assets
and liabilities are measured using enacted tax rates expected to
apply to taxable income in the years in which those
carryforwards and temporary differences are expected to be
recovered or settled. The effect on deferred tax assets and
liabilities of a change in tax rates is recognized in the period
that includes the enactment date. A valuation allowance is
recorded for deferred tax assets when it is more likely than not
that such deferred tax assets will not be realized. Primary
temporary differences relate to net operating loss carryforwards
and research and development credit carryforwards, which are
subject to a full valuation allowance.
34
HELIX
BIOMEDIX, INC.
(A DEVELOPMENT STAGE COMPANY)
NOTES TO FINANCIAL
STATEMENTS (Continued)
Loss
per Share
Loss per share has been computed using the weighted average
number of shares outstanding during the period. Diluted per
share amounts reflect potential dilution from the exercise or
conversion of securities into common stock or from other
contracts to issue common stock. The Companys capital
structure includes common stock options and common stock
warrants, all of which have been excluded from net loss per
share calculations as they are antidilutive, as follows:
| |
|
|
|
|
|
|
|
|
|
|
|
December 31,
|
|
|
|
2006
|
|
2005
|
|
|
|
Weighted average outstanding
options
|
|
|
2,709,728
|
|
|
|
2,592,000
|
|
|
Weighted average outstanding
warrants
|
|
|
2,777,811
|
|
|
|
2,580,744
|
|
Fair
Value of Financial Instruments
The fair value of all reported assets and liabilities
representing financial instruments (none of which is held for
trading purposes) approximates the carrying value of such
instruments due to their short-term maturity or repricing.
Stock-Based
Compensation
On January 1, 2006, the Company adopted the fair value
recognition provisions of Financial Accounting Standards Board
(FASB) Statement No. 123(R), Share-Based
Payment (SFAS 123R). Prior to
January 1, 2006, the Company accounted for share-based
payments to employees under the recognition and measurement
provisions of APB Opinion No. 25, Accounting for Stock
Issued to Employees (APB 25), and related
Interpretations, as permitted by FASB Statement No. 123,
Accounting for Stock-Based Compensation
(SFAS 123). In accordance with APB 25,
no compensation cost was required to be recognized for options
granted to employees that had an exercise price equal to the
market value of the underlying common stock on the date of grant.
Stock options and warrants issued to non-employees are accounted
for using the fair value method prescribed by Emerging Issues
Task Force (EITF) Issue
No. 96-18
and EITF Issue
No. 00-18.
The Company adopted SFAS 123R using the
modified-prospective-transition method. Under this method,
compensation cost recognized for the year ended
December 31, 2006 includes: a) compensation cost for
all share-based payments granted prior to, but not yet vested as
of, December 31, 2005, based on the grant-date fair value
estimated in accordance with the original provisions of
SFAS 123, and b) compensation cost for all share-based
payments granted subsequent to December 31, 2005, based on
the grant-date fair value estimated in accordance with the
provisions of SFAS 123R. Deferred stock compensation in the
amount of $105,000 related to nonvested options was eliminated
against additional paid-in capital upon adoption of
SFAS 123R. The results for the prior periods have not been
restated.
For all unvested options outstanding as of January 1, 2006,
the previously measured but unrecognized compensation expense,
based on the fair value at the original grant date, will be
recognized ratably over the remaining vesting period. For
share-based payments granted subsequent to January 1, 2006,
compensation expense, based on the fair value on the date of
grant, will be recognized on a straight-line basis over the
vesting period. As a result of the adoption of SFAS 123R,
incremental stock-based compensation of approximately $391,200
was recognized in the statement of operations for the year ended
December 31, 2006.
35
HELIX
BIOMEDIX, INC.
(A DEVELOPMENT STAGE COMPANY)
NOTES TO FINANCIAL
STATEMENTS (Continued)
The following table presents the impact of the Companys
adoption of FAS 123R on selected line items from the
Companys financial statements for the year ended
December 31, 2006:
| |
|
|
|
|
|
|
|
|
|
|
|
Year Ended
|
|
|
|
|
December 31, 2006
|
|
|
|
|
As Reported
|
|
|
If Reported
|
|
|
|
|
Following
|
|
|
Following
|
|
|
|
|
FAS123(R)
|
|
|
APB 25
|
|
|
|
|
Loss from operations
|
|
$
|
(3,901,757
|
)
|
|
$
|
(3,510,511
|
)
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(3,828,326
|
)
|
|
$
|
(3,437,080
|
)
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per
share
|
|
$
|
(0.17
|
)
|
|
$
|
(0.15
|
)
|
|
|
|
|
|
|
|
|
|
|
There were 415,000 and 245,000 stock options granted during the
years ended December 31, 2006 and 2005, respectively. The
per share weighted-average grant date fair value of stock
options granted during the years ended December 31, 2006
and 2005 was $0.68 and $1.38, respectively, using the
Black-Scholes option pricing model with the following
assumptions:
| |
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31,
|
|
|
|
|
2006
|
|
|
2005
|
|
|
|
|
Risk-free interest rate
|
|
|
4.83
|
%
|
|
|
4.29
|
%
|
|
Expected dividend yield
|
|
|
0
|
|
|
|
0
|
|
|
Expected term in years
|
|
|
6.25
|
|
|
|
6.25
|
|
|
Expected volatility
|
|
|
100
|
%
|
|
|
100
|
%
|
The risk-free interest rate is based on the implied yield
available on U.S. Treasury zero coupon issues
with an equivalent remaining term. The Company does not
anticipate declaring dividends in the foreseeable future. For
the year ended December 31, 2006, expected volatility is
based on implied volatility of outstanding warrants to purchase
the Companys common stock, annualized daily historical
volatility of its stock price commensurate with the expected
term of the option, and other factors, including peer company
data. For the year ended December 31, 2006, the expected
term of the options represents the estimated period of time from
grant until exercise, and is based on historical experience of
similar awards, contractual terms, vesting schedules, and
expectations of future employee behavior. The Companys
stock price volatility and option term involves
managements best estimates at that time, both of which
impact the fair value of the option calculated under the
Black-Scholes methodology and, ultimately, the expense that will
be recognized over the life of the option. SFAS 123R also
requires that the Company recognize compensation expense for
only the portion of options or stock units that are expected to
vest. Therefore, the Company applies an estimated forfeiture
rate that is derived from historical employee termination
behavior.
36
HELIX
BIOMEDIX, INC.
(A DEVELOPMENT STAGE COMPANY)
NOTES TO FINANCIAL
STATEMENTS (Continued)
The following table shows the pro forma effect on the
Companys net loss and net loss per share for the year
ended December 31, 2005 had compensation expense been
determined based upon the fair value at the grant date for
awards consistent with the methodology prescribed by
SFAS 123. The pro forma effect may not be representative of
expense in future periods since the estimated fair value of
stock options on the date of grant is amortized over the vesting
period, and additional options may be granted or options may be
cancelled in future years:
| |
|
|
|
|
|
|
|
Year Ended
|
|
|
|
|
December 31,
|
|
|
|
|
2005
|
|
|
|
|
Net loss
|
|
|
|
|
|
As reported
|
|
$
|
(3,277,239
|
)
|
|
Add: Stock-based employee
compensation expense included in reported net loss
|
|
|
210,000
|
|
|
Deduct: Stock-based employee
compensation expense determined under fair value based method
for all awards
|
|
|
(724,898
|
)
|
|
|
|
|
|
|
|
Pro forma net loss
|
|
$
|
(3,792,137
|
)
|
|
|
|
|
|
|
|
Net loss per share-basic and
diluted
|
|
|
|
|
|
As reported
|
|
$
|
(0.18
|
)
|
|
|
|
|
|
|
|
Pro forma net loss
|
|
$
|
(0.21
|
)
|
|
|
|
|
|
|
Recently
Issued Accounting Pronouncements
In June 2006, the Financial Accounting Standards Board issued
Interpretation (FIN) No. 48, Accounting for Income Tax
Uncertainties, which clarifies the accounting for
uncertainty in income taxes recognized in the financial
statements in accordance with SFAS No. 109,
Accounting for Income Taxes. The Interpretation
prescribes a recognition threshold of more-likely-than-not and a
measurement attribute on all tax positions taken or expected to
be taken in a tax return in order to be recognized in the
financial statements. In making this assessment, a company must
determine whether it is more-likely-than-not that a tax position
will be sustained upon examination, including resolution of any
related appeals or litigation processes, based solely on the
technical merits of the position and that the tax position will
be examined by appropriate taxing authority that would have full
knowledge of all relevant information. Once the recognition
threshold is met, the tax position is then measured to determine
the actual amount of benefit to recognize in the financial
statements. In addition, the recognition threshold of
more-likely-than-not must continue to be met in each reporting
period to support continued recognition of the tax benefit. Tax
positions that previously failed to meet the
more-likely-than-not recognition threshold should be recognized
in the first financial reporting period in which that threshold
is met. Previously recognized tax positions that no longer meet
the more-likely-than-not recognition threshold should be
derecognized in the financial reporting period in which that
threshold is no longer met. The Company is currently assessing
the expected impact of this Interpretation on its financial
statements.
In the fourth quarter of 2006, we adopted the
U.S. Securities and Exchange Commission (SEC) Staff
Accounting Bulletin (SAB) No. 108, Quantifying
Misstatements in Current Year Financial Statements, which
provides interpretive guidance on how the effects of prior year
misstatements should be considered in quantifying current year
financial statement misstatements. The interpretations in
SAB No. 108, which expresses the SECs staff
views, were issued to address the diversity in the practice of
quantifying financial statement misstatements and the potential
under current practice for a build up of improper amounts on the
balance sheet. The SEC staff indicated that companies should
quantify errors using both a balance sheet and an income
statement approach and evaluate whether either approach results
in material misstatement. The adoption of this interpretation
did not have an impact on the Companys financial
statements.
37
HELIX
BIOMEDIX, INC.
(A DEVELOPMENT STAGE COMPANY)
NOTES TO FINANCIAL
STATEMENTS (Continued)
Note 2. Notes Payable
In June 2001, the Company commenced the sale of 6% unsecured
promissory notes. The notes had an initial maturity date of
May 31, 2002 at which time the holder had the option of
converting principal and interest to stock. The offering of
promissory notes included warrants to purchase common shares
initially having a total value of 25% of the principal amount of
the notes based on a per share purchase price of the lower of
either (a) $1.50 per share or (b) the per share
price of the next equity offering. The warrants have a term of
ten years. As of December 31, 2001, the Company raised
proceeds of $1,980,000 and had recorded $216,100 in paid in
capital from the issuance of related common stock purchase
warrants, which is considered a debt discount. The effective
interest rate on the outstanding promissory notes, when compared
to the valuation of the common stock purchase warrant incentives
and debt issue cost, was 16.9% for the year ended
December 31, 2001.
In March 2002, the Company amended the terms of the existing
debt offering as follows: (a) the offering size was
increased from 2.8 million to $3.5 million;
(b) the maturity date of the notes was extended to
December 31, 2002; (c) the notes were amended to
require conversion into shares of common stock in the event of
an equity financing in a single or series of related
transactions of at least $1.5 million (the subsequent
financing) on or before December 31, 2002; and
(d) the warrant coverage was increased to a minimum of 35%
of the principal amount in the event the subsequent financing
was completed before August 31, 2002; 40% in the event the
subsequent financing was completed before December 31,
2002; and 45% in the event the subsequent financing was
completed after December 31, 2002. Purchasers prior to the
date of the offering changes were given an opportunity to
rescind their agreement and obtain a refund of principal plus
accrued interest or accept the revised terms. Refunds for
approximately $55,000 were subsequently made. During the year
ended December 31, 2002, the Company raised an additional
$1,157,500 from the convertible debt offering. As noted below,
the Company also raised $1.6 million in an equity financing
as of December 31, 2002. Accordingly, the convertible
notes, totaling $3.1 million, together with the related
accrued interest of $231,180, were converted into
3,313,680 shares of common stock, at a per share price of
$1.00, on December 31, 2002.
The number of warrants from the convertible debt financing
totaled 1,233,000 shares, equaling 40% of the total
principal balance of $3,082,500. The warrants were originally
valued based on the $1.50 strike price and were revalued at the
time of conversion based on the final strike price of $1.00. The
total value of the warrants during 2002 resulted in additional
debt discount of approximately $512,000. The total amortization
of debt discount to interest expense during 2002 totaled
$643,000. The effective interest rate on the outstanding
promissory notes, when compared to the valuation of the common
stock purchase warrant incentives and debt issue cost, was 24.4%
for the year ended December 31, 2002.
Note 3. Marketable
securities
Marketable securities consisted of the following as of
December 31, 2006:
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross
|
|
|
Gross
|
|
|
|
|
|
|
|
Market
|
|
|
Unrealized
|
|
|
Unrealized
|
|
|
Amortized
|
|
|
|
|
Value
|
|
|
Gains
|
|
|
Losses
|
|
|
Cost
|
|
|
|
|
Corporate and municipal auction or
floating rate securities with contractual maturities of
9 years to 38 years
|
|
$
|
980,000
|
|
|
|
|
|
|
|
|
|
|
$
|
980,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The Company held no marketable securities as of
December 31, 2005.
38
HELIX
BIOMEDIX, INC.
(A DEVELOPMENT STAGE COMPANY)
NOTES TO FINANCIAL
STATEMENTS (Continued)
Note 4. Identifiable
Intangible Assets
Identifiable intangible assets, which are included in other
assets, consisted of the following as of December 31, 2006
and 2005:
| |
|
|
|
|
|
|
|
|
|
|
|
2006
|
|
|
2005
|
|
|
|
|
Antimicrobial technology
|
|
$
|
222,187
|
|
|
$
|
222,187
|
|
|
Licensing agreements
|
|
|
61,391
|
|
|
|
61,391
|
|
|
Patents pending and approved
|
|
|
834,301
|
|
|
|
834,301
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,117,879
|
|
|
|
1,117,879
|
|
|
Less accumulated amortization
|
|
|
(606,517
|
)
|
|
|
(527,638
|
)
|
|
|
|
|
|
|
|
|
|
|
|
Identifiable intangible assets, net
|
|
$
|
511,362
|
|
|
$
|
590,241
|
|
|
|
|
|
|
|
|
|
|
|
Aggregate amortization for identifiable intangible assets was
$78,879 and $78,339 for 2006 and 2005, respectively. Scheduled
amortization charges from identifiable assets as of
December 31, 2006 are as follows:
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Antimicrobial
|
|
|
Licensing
|
|
|
Patents Pending
|
|
|
|
|
|
Year
|
|
Technology
|
|
|
Agreements
|
|
|
and Approved
|
|
|
Total
|
|
|
|
|
2007
|
|
|
11,109
|
|
|
|
3,595
|
|
|
|
64,175
|
|
|
|
78,879
|
|
|
2008
|
|
|
11,109
|
|
|
|
3,595
|
|
|
|
64,175
|
|
|
|
78,879
|
|
|
2009
|
|
|
3,995
|
|
|
|
3,595
|
|
|
|
64,175
|
|
|
|
71,765
|
|
|
2010
|
|
|
|
|
|
|
3,595
|
|
|
|
64,175
|
|
|
|
67,770
|
|
|
2011
|
|
|
|
|
|
|
3,595
|
|
|
|
64,175
|
|
|
|
67,770
|
|
|
Thereafter
|
|
$
|
|
|
|
$
|
25,441
|
|
|
$
|
120,858
|
|
|
$
|
146,299
|
|
Note 5. Stockholders
Equity
Preferred
Stock
The board of directors (the Board) may authorize the
issuance of preferred stock from time to time in one or more
series and each series shall have such voting, redemption,
liquidation and dividend rights as the Board may deem advisable.
As of December 31, 2006, no preferred series shares had
been designated by the Board.
Stock
Split
On December 29, 1993, the Company underwent a
1-for-500
reverse stock split. All share and per share amounts in these
financial statements have been retroactively restated to reflect
this reverse split.
Stockholder
Rights Agreement
On August 15, 2003, the Board approved the adoption of a
Stockholder Rights Agreement pursuant to which all of the
Companys stockholders as of September 15, 2003 (the
Record Date) received rights to purchase shares of a
new series of Preferred Stock. The rights will be distributed as
a non-taxable dividend and will expire ten years from the record
date. The rights will be exercisable only if a person or group
acquires 15 percent or more of the Companys common
stock or announces a tender offer for 15 percent or more of
the common stock. If a person acquires 15 percent or more
of common stock, all rights holders, except the buyer, will be
entitled to acquire the Companys common stock at a
discount. The effect will be to discourage acquisitions of more
than 15 percent of the Companys common stock without
negotiations with the Board.
39
HELIX
BIOMEDIX, INC.
(A DEVELOPMENT STAGE COMPANY)
NOTES TO FINANCIAL
STATEMENTS (Continued)
Options
Stock
Option Plan
On December 15, 2000, the stockholders of the Company
approved the Helix BioMedix 2000 Stock Option Plan (the
2000 Plan). The 2000 Plan is to be administered by
non-employee directors who shall be authorized to grant stock
options to the Companys employees, consultants, and
directors. These options may be either Incentive Stock Options
as defined and governed by Section 422 of the Internal
Revenue Code or Nonqualified Stock Options. The 2000 Plan
specifically provides the Company with the ability to
repurchase, upon termination of an optionees employment,
up to 10,000 shares acquired by the optionee through the
exercise of options granted thereunder at the then-current fair
market value of such shares.
Stock options to purchase the Companys common stock are
granted at the fair market value on the date of grant. Options
generally become exercisable beginning one year from the date of
grant and expire 10 years from the date of grant. Options
granted to non-employee directors become exercisable ranging
from immediately upon grant to quarterly over one year. Stock
options granted to employees are typically incentive stock
options and options granted to non-employee directors are
non-qualified stock options.
The fair value of each stock option granted is estimated on the
date of grant using the Black-Scholes option valuation model.
The assumptions used to calculate the fair value of options
granted are evaluated and revised, as necessary, to reflect
market conditions and the Companys experience. Options
granted are valued using the single option valuation approach,
and the resulting expense is recognized using the cliff,
straight-line attribution method, consistent with the single
option valuation approach. Compensation expense is recognized
only for those options expected to vest.
There were 250,000 employee stock options granted and 165,000
non-employee director stock options granted during the year
ended December 31, 2006. There were 50,000 employee stock
options granted and 195,000
non-employee
direction stock options granted during the year ended
December 31, 2005. A summary of the Companys stock
option activity for the years ended December 31, 2006 and
2005 is presented in the following table:
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted
|
|
|
|
|
|
|
|
|
|
|
Weighted
|
|
|
Average
|
|
|
|
|
|
|
|
|
|
|
Average
|
|
|
Remaining
|
|
|
Aggregate
|
|
|
|
|
Shares Subject
|
|
|
Exercise Price
|
|
|
Contractual
|
|
|
Intrinsic
|
|
|
|
|
to Options
|
|
|
per Share
|
|
|
Life
|
|
|
Value
|
|
|
|
|
Outstanding, December 31, 2004
|
|
|
2,426,166
|
|
|
$
|
1.35
|
|
|
|
|
|
|
|
|
|
|
Granted
|
|
|
245,000
|
|
|
$
|
1.66
|
|
|
|
|
|
|
|
|
|
|
Exercised
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Forfeited
|
|
|
(79,166
|
)
|
|
$
|
1.38
|
|
|
|
|
|
|
|
|
|
|
Expired
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding, December 31, 2005
|
|
|
2,592,000
|
|
|
$
|
1.38
|
|
|
|
|
|
|
|
|
|
|
Granted
|
|
|
415,000
|
|
|
$
|
0.83
|
|
|
|
|
|
|
|
|
|
|
Exercised
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Forfeited
|
|
|
(88,056
|
)
|
|
$
|
1.80
|
|
|
|
|
|
|
|
|
|
|
Expired
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding, December 31, 2006
|
|
|
2,918,944
|
|
|
$
|
1.29
|
|
|
|
5.82
|
|
|
$
|
60,435
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercisable, December 31, 2006
|
|
|
2,503,248
|
|
|
$
|
1.32
|
|
|
|
5.25
|
|
|
$
|
29,985
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
40
HELIX
BIOMEDIX, INC.
(A DEVELOPMENT STAGE COMPANY)
NOTES TO FINANCIAL
STATEMENTS (Continued)
The aggregate intrinsic value in the table above is based on the
Companys closing stock price of $0.87 on December 29,
2006, which would have been received by the optionees had all of
the options with exercise prices less than $0.87 been exercised
on that date. As of December 31, 2006, total unrecognized
stock-based compensation related to nonvested stock options was
approximately $277,445, which is expected to be recognized over
a weighted average period of approximately 1.66 years. The
Company has a policy of issuing new shares to satisfy share
option exercises.
As of December 31, 2006, there were 5,355,000 shares
of common stock reserved for issuance pursuant to the 2000 Plan.
As of December 31, 2006, 2,436,056 shares remained
available for grants. Additional information regarding options
outstanding as of December 31, 2006, is as follows:
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options Outstanding
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted
|
|
|
|
|
|
Options Exercisable
|
|
|
|
|
|
|
|
|
Average
|
|
|
Weighted
|
|
|
|
|
|
Weighted
|
|
|
|
|
|
|
|
|
Remaining
|
|
|
Average
|
|
|
|
|
|
Average
|
|
|
|
|
|
|
|
|
Contractual
|
|
|
Exercise
|
|
|
|
|
|
Exercise
|
|
|
Range of Exercise Prices
|
|
|
Shares
|
|
|
Life (Years)
|
|
|
Price
|
|
|
Shares
|
|
|
Price
|
|
|
|
|
$
|
0.70 - $0.85
|
|
|
|
530,500
|
|
|
|
7.80
|
|
|
$
|
0.76
|
|
|
|
258,000
|
|
|
$
|
0.75
|
|
|
$
|
1.00 - $1.00
|
|
|
|
899,000
|
|
|
|
5.50
|
|
|
$
|
1.00
|
|
|
|
899,000
|
|
|
$
|
1.00
|
|
|
$
|
1.20 - $1.75
|
|
|
|
797,500
|
|
|
|
6.00
|
|
|
$
|
1.50
|
|
|
|
769,722
|
|
|
$
|
1.50
|
|
|
$
|
1.80 - $2.00
|
|
|
|
691,944
|
|
|
|
4.50
|
|
|
$
|
1.82
|
|
|
|
576,527
|
|
|
$
|
1.82
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
0.70 - $2.00
|
|
|
|
2,918,944
|
|
|
|
5.82
|
|
|
$
|
1.29
|
|
|
|
2,503,248
|
|
|
$
|
1.32
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
41
HELIX
BIOMEDIX, INC.
(A DEVELOPMENT STAGE COMPANY)
NOTES TO FINANCIAL
STATEMENTS (Continued)
Common
Stock Purchase Warrants
Information concerning outstanding common stock purchase
warrants is set forth below:
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31,
|
|
|
|
|
2006
|
|
|
2005
|
|
|
|
|
|
|
|
Price
|
|
|
Wghtd.
|
|
|
|
|
|
Price
|
|
|
Wghtd.
|
|
|
|
|
Number
|
|
|
Range
|
|
|
Avg.
|
|
|
Number
|
|
|
Range
|
|
|
Avg.
|
|
|
|
|
Warrants issued to employees and
non-employees for services
|
|
|
1,713,669
|
|
|
$
|
0.25-$6.00
|
|
|
$
|
1.54
|
|
|
|
1,723,669
|
|
|
$
|
0.25-$6.00
|
|
|
$
|
1.54
|
|
|
Granted
|
|
|
25,000
|
|
|
$
|
1.20
|
|
|
$
|
1.20
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercised
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(10,000
|
)
|
|
$
|
1.00
|
|
|
$
|
1.00
|
|
|
Expired/Cancelled
|
|
|
(18,750
|
)
|
|
$
|
1.20
|
|
|
$
|
1.20
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Remaining warrants issued in
connection with 1999 equity financing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Expired 2004
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exchanged
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Remaining warrants issued in
connection with 2003 warrant exchange
|
|
|
146,250
|
|
|
$
|
2.25
|
|
|
$
|
2.25
|
|
|
|
2,413,100
|
|
|
$
|
2.25
|
|
|
$
|
2.25
|
|
|
Expired 2006
|
|
|
(146,250
|
)
|
|
$
|
2.25
|
|
|
$
|
2.25
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exchanged in the 2005 Warrant
Exchange
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(2,266,850
|
)
|
|
$
|
2.25
|
|
|
$
|
2.25
|
|
|
Remaining warrants issued in
connection with 2001 convertible debt financing
|
|
|
308,000
|
|
|
$
|
1.00
|
|
|
$
|
1.00
|
|
|
|
1,153,000
|
|
|
$
|
1.00
|
|
|
$
|
1.00
|
|
|
Exchanged in the 2005 Warrant
Exchange
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(845,000
|
)
|
|
$
|
1.00
|
|
|
$
|
1.00
|
|
|
Remaining warrants issued in
connection with 2002 and 2003 equity financings
|
|
|
258,600
|
|
|
$
|
1.00
|
|
|
$
|
1.00
|
|
|
|
2,248,200
|
|
|
$
|
1.00
|
|
|
$
|
1.00
|
|
|
Exercised
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(12,000
|
)
|
|
$
|
1.00
|
|
|
$
|
1.00
|
|
|
Exchanged in the 2005 Warrant
Exchange
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1,977,600
|
)
|
|
$
|
1.00
|
|
|
$
|
1.00
|
|
|
Remaining warrants issued in
connection with 2004 equity financing
|
|
|
29,225
|
|
|
$
|
2.00
|
|
|
$
|
2.00
|
|
|
|
414,400
|
|
|
$
|
2.00
|
|
|
$
|
2.00
|
|
|
Exchanged in the 2005 Warrant
Exchange
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(385,175
|
)
|
|
$
|
2.00
|
|
|
$
|
2.00
|
|
|
Warrants issued in connection with
2005 equity financing
|
|
|
125,000
|
|
|
$
|
1.50
|
|
|
$
|
1.50
|
|
|
|
125,000
|
|
|
$
|
1.50
|
|
|
$
|
1.50
|
|
|
Warrants issued in connection with
2006 equity financing
|
|
|
259,800
|
|
|
$
|
1.00
|
|
|
$
|
1.00
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total outstanding warrants
|
|
|
2,700,544
|
|
|
$
|
0.25-$6.00
|
|
|
$
|
1.38
|
|
|
|
2,580,744
|
|
|
$
|
0.25-$6.00
|
|
|
$
|
1.47
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
In 2006, the Company granted warrants to purchase up to
25,000 shares of common stock to a consultant for services,
and warrants with respect to 18,750 of these shares were
cancelled during 2006. In 2006, approximately $4,700 of expense
was recognized as general and administrative expenses related to
the warrants.
Stock
Offerings
In December 2003, the Company initiated a warrant exchange
program pursuant to which holders of certain warrants issued by
the Company in October 1999 and expiring on October 18,
2004, and having a per share exercise price of $3.25 could
exchange such warrants for new warrants that (i) expire on
October 31, 2006; (ii) provide for cashless exercises;
and (iii) reduce the per share exercise price from $3.25 to
$2.25. Consideration for the exchange
42
HELIX
BIOMEDIX, INC.
(A DEVELOPMENT STAGE COMPANY)
NOTES TO FINANCIAL
STATEMENTS (Continued)
was $0.50 per warrant share and surrender of the old warrants
prior to December 26, 2003. The exchange program generated
proceeds to the Company of $1.2 million.
During 2004, in a private placement equity financing, the
Company received $2.3 million in exchange for
1,184,000 shares of common stock and detachable warrants
for the purchase of an additional 414,400 shares of common
stock. The warrants issued in this financing have a term of five
years and are exercisable at $2.00 per share.
On February 28, 2005, the Company closed the initial
closing of a private equity financing, receiving cash of
$2.3 million in exchange for 1,548,501 shares of
common stock and warrants to purchase up to 125,000 shares
of common stock. The warrants have a
5-year term
and a per share purchase price of $1.50.
In a second closing held on March 2, 2005, the Company
received $175,000 in exchange for 116,666 shares of common
stock. The Company received a total of $2.5 million in this
private placement financing for 1,665,167 shares of common
stock and detachable warrants for the purchase of an additional
125,000 shares of common stock.
On May 31, 2005, the Company closed a tender offer to
redeem certain of its outstanding warrants. In this transaction
the Company received proceeds of a$1.3 million and issued
4,960,918 shares of common stock in exchange for the
cancellation of warrants that provided for the purchase of
5.5 million shares of common stock.
On March 3, 2006, the Company closed a private equity
financing, receiving cash of $2.4 million in exchange for
2,383,000 shares of $0.001 par value common stock and
warrants to purchase up to 238,300 shares of
$0.001 par value common stock. The warrants have a
5-year term
and a per share purchase price of $1.00.
In a second closing held on March 10, 2006, the Company
received $215,000 in exchange for 215,000 shares of
$0.001 par value common stock and warrant to purchase up to
21,500 shares of $0.001 par value common stock. The
warrants have a
5-year term
and a per share purchase price of $1.00. The Company received a
total of $2.6 million in this private placement financing
for 2,598,000 shares of common stock and detachable
warrants for the purchase of an additional 259,800 shares
of common stock.
On March 5, 2007, the Company closed a private equity
financing, receiving cash of approximately $2.0 million in
exchange for 2,666,666 shares of $0.001 par value
common stock.
In a second closing held on March 26, 2007, the Company
received cash of approximately $148,750 in exchange for
198,332 shares of $0.001 par value common stock.
401(k)
Plan
Effective June 30, 2005, the Company implemented a defined
contribution plan, which includes a matching contribution from
the Company, which totaled $33,790 and $28,351, respectively, in
2006 and 2005.
Employee
Equity Compensation Costs
In 2003, certain employment contracts previously approved by the
board of directors resulted in a compensation charge of
$386,920, as they granted variable options. In December 2003,
the Company revised substantially all agreements to fix the
option terms. Remaining deferred compensation related to these
options totaled $0 at December 31, 2006.
Stockholders
Equity and Comprehensive Income
SFAS No. 130 requires companies to present
comprehensive income (consisting primarily of net income items
plus other direct equity changes and credits) and its components
as part of the basic financial statements. The Companys
financial statements do not contain any changes in equity that
are required to be reported separately in comprehensive income.
43
HELIX
BIOMEDIX, INC.
(A DEVELOPMENT STAGE COMPANY)
NOTES TO FINANCIAL
STATEMENTS (Continued)
Significant components of the Companys gross deferred tax
assets and liabilities as of December 31, 2006 and 2005 are
as follows:
| |
|
|
|
|
|
|
|
|
|
|
|
2006
|
|
|
2005
|
|
|
|
|
Gross deferred tax assets
(liabilities):
|
|
|
|
|
|
|
|
|
|
Net operating loss carry forwards
|
|
$
|
6,154,000
|
|
|
$
|
5,109,400
|
|
|
Research and development credits
|
|
|
86,100
|
|
|
|
97,400
|
|
|
Stock compensation
|
|
|
533,100
|
|
|
|
482,300
|
|
|
Accrued expenses
|
|
|
9,500
|
|
|
|
14,700
|
|
|
Fixed and intangible assets
|
|
|
4,200
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross deferred tax assets
|
|
|
6,786,900
|
|
|
|
5,703,800
|
|
|
Less valuation allowance
|
|
|
(6,786,900
|
)
|
|
|
(5,690,400
|
)
|
|
|
|
|
|
|
|
|
|
|
|
Net deferred tax assets
|
|
|
|
|
|
|
13,400
|
|
|
Deferred tax liabilities
|
|
|
|
|
|
|
|
|
|
Fixed and intangible assets
|
|
|
|
|
|
|
(13,400
|
)
|
|
|
|
|
|
|
|
|
|
|
|
Net deferred tax assets/liabilities
|
|
$
|
|
|
|
$
|
|
|
|
|
|
|
|
|
|
|
|
|
Due to the uncertainty of the Companys ability to generate
taxable income to realize its net deferred tax assets at
December 31, 2006 and 2005, a full valuation allowance has
been recognized for financial reporting purposes. The
Companys valuation allowance for deferred tax assets
increased by $1,096,500 during the year ended December 31,
2006. The increase in the deferred tax assets in 2006 was
primarily the result of increasing net operating loss carry
forwards during the year.
At December 31, 2006, the Company had federal net operating
loss carryforwards of approximately $18.1 million for
income tax reporting purposes, which expire from 2007 to 2026
and research and development tax credit carryforwards of
approximately $86,100, which expire from 2007 to 2021. The
decrease in research and development tax credit carryforwards is
the result of these credits beginning to expire in 2005. The
Companys ability to utilize the carry forwards may be
limited in the event of an ownership change as defined in
current income tax regulations.
Note 7. Related
Party Transactions
The Company has entered into certain contractual agreements as
follows:
|
|
|
(a)
|
With
University of British Columbia
|
The Company entered into a License Agreement
(License) with the University of British Columbia
(UBC) commencing October 1, 2001 (the
Commencement Date) whereby UBC granted to the
Company an exclusive, worldwide license to use and sublicense
certain defined Technology and any improvements
within a specified field of use and including the right to
manufacture, distribute and sell products utilizing the
Technology. The License terminates on October 1, 2021 or
upon the expiration of the last patent applied for and obtained
pursuant to certain provisions of the License, unless terminated
earlier in accordance with the terms of the License.
Dr. Robert E.W. Hancock, Ph.D., a member of the
Companys Scientific Advisory Board, is the lead
investigator and inventor of the UBC patents and patent
applications. The Technology is comprised primarily of three
broad patents for antimicrobial peptides and related methods of
use. The License extends to the Companys affiliates. In
exchange for the exclusive, worldwide license granted under the
License, the Company agreed to pay UBC a royalty of 3.5% of
44
HELIX
BIOMEDIX, INC.
(A DEVELOPMENT STAGE COMPANY)
NOTES TO FINANCIAL
STATEMENTS (Continued)
revenue generated from the Technology and any improvements
related thereto. The Company agreed to pay graduated minimum
annual royalties of $10,000 upon the fifth anniversary, $20,000
upon the 6th anniversary, and $25,000 upon the 7th and
all subsequent anniversaries of the Commencement Date. As called
for by the License, the Company has issued to UBC or its assigns
97,500 shares of the Companys common stock, options
to purchase up to 152,500 common shares at $1.50 per share,
and $61,391 in cash, such cash payment constituting
reimbursement of UBC for expenses related to the licensed
patents. The options have a term of ten years and were fully
vested upon grant. The agreement also requires the Company to
reimburse UBC for all further costs incurred with respect to the
patents, including maintenance fees.
|
|
|
(b)
|
With
Katz-Miller Ventures, LLC
|
Katz-Miller Ventures, LLC (Katz-Miller) is a former
consultant to the Company. The principal members of Katz-Miller
are Ralph Katz and Jeffrey Miller. Mr. Katz is a former
director of the Company and Mr. Miller is a current
director of the Company. The Company first entered into a
consulting agreement with Katz-Miller on October 1, 1999.
In May 2001, the Company entered into an Amended and Restated
Consulting Agreement with Katz-Miller. The Amended and Restated
Consulting Agreement modifies the terms of compensation for
services rendered under the prior agreement by providing for a
cash payment of $80,000, a short term loan of $80,000, and
issuance of warrants to purchase shares of common stock as
follows: (i) up to 50,000 at $1.50 per share;
(ii) up to 50,000 at $3.00 per share; (iii) up to
50,000 at $4.50 per share; and (iv) up to 50,000 at
$6.00 per share. All warrants were fully vested upon
issuance and will expire on June 30, 2011. In the aggregate
under the consulting agreements described in this paragraph, the
Company has paid Katz-Miller $80,000, and issued Katz-Miller
280,000 shares of its common stock and 200,000 warrants as
described above. The Company did not pay any consideration under
the consulting agreements described in this paragraph in 2005 or
2006. See also Ralph Katz, below.
|
|
|
(c)
|
With
Dunsford Hill Capital Partners, Inc.
|
Dunsford Hill Capital Partners, Inc. (Dunsford Hill)
is owned and controlled by Randall L-W. Caudill, Ph.D.
Dr. Caudill also serves as a Director of the Company.
Dunsford Hill provides consulting services to the Company on
strategic, management and financial issues. The Company first
entered into a consulting agreement with Dunsford Hill in
October 2000. Under this agreement, the Company issued to
Dunsford Hill a warrant to purchase up to 80,000 shares of
common stock at $1.50 per share, which was fully vested
upon grant. This warrant expires on November 27, 2011. The
original consulting agreement has been amended and extended by
subsequent agreements, which extend the term of the original
agreement and provide for additional compensation. Under the
May 30, 2001 Amended and Restated Consulting Agreement with
Dunsford Hill, the Company paid additional compensation in the
form of warrants to purchase an aggregate of up to
120,000 shares of common stock at $1.50 per share,
thereby eliminating certain conditions precedent that were
contained in the earlier agreement. These warrants were fully
vested upon grant and expire on May 30, 2011. Under the
August 15, 2002 Second Amended and Restated Consulting
Agreement, the Company agreed to make cash payments totaling
$72,000 payable in installments and issue warrants to purchase
up to 50,000 shares of common stock at the lower of $1.50
or the price of the next equity financing; a warrant to purchase
50,000 shares of common stock at $1.00 per share was
issued to Dunsford Hill in accordance with this provision, and
was fully vested upon issuance. This warrant expires on
August 15, 2012. The Company did not pay any consideration
under the agreements described in this paragraph in 2005 or 2006.
|
|
|
(d)
|
With
Paisley Group, LLC
|
Carlyn J. Steiner, who served as a member of the Companys
board of directors from December 2000 until April 2004, controls
the activities of the Paisley Group, LLC. The Paisley Group has
provided the Company with financial consulting services,
including consulting in conjunction with the Companys 2001
private placement of convertible debt and detachable common
stock warrants. The Company first entered into a consulting
agreement with the Paisley Group in October 2000. Under this
agreement, the Company issued to the Paisley Group a warrant
45
HELIX
BIOMEDIX, INC.
(A DEVELOPMENT STAGE COMPANY)
NOTES TO FINANCIAL
STATEMENTS (Continued)
to purchase up to 80,000 shares of common stock at
$1.50 per share, which was fully vested upon grant. This
warrant expires on November 27, 2011. The original
consulting agreement has been amended and extended by subsequent
agreements, which extend the term of the original agreement and
provide for additional compensation. Under the May 30, 2001
Amended and Restated Consulting Agreement with the Paisley
Group, the Company agreed to pay additional compensation in the
form of warrants to purchase an aggregate of 120,000 shares
of common stock at $1.50 per share, thereby eliminating
certain conditions precedent that were contained in the earlier
agreement. These warrants were fully vested upon grant, and
expire on May 30, 2011. Under the August 15, 2002
Second Amended and Restated Consulting Agreement, the Company
agreed to cash payments totaling $72,000 payable in installments
and warrants to purchase an up to 100,000 shares of common
stock at the lower of $1.50 or the price of the next equity
financing; a warrant to purchase 100,000 shares of common
stock at $1.00 per share was issued to the Paisley Group in
accordance with this provision, and was fully vested upon
issuance. This warrant expires on August 15, 2012. The
Company did not pay any consideration under the agreements
described in this paragraph in 2005 or 2006.
|
|
|
(e)
|
With
Robert E.W. Hancock, Ph.D.
|
On June 18, 2001, the Company entered into a consulting
agreement with Dr. Robert E.W. Hancock, Ph.D. Under
this agreement, Dr. Hancock was engaged to serve as a
member of the Companys Scientific Advisory Board for a
period of three years, as an expert consultant in the area of
antimicrobial peptides. Additionally, under this agreement
Dr. Hancock was engaged to assist the Company in its
efforts to license certain intellectual property from the
University of British Columbia. Dr. Hancock is the lead
investigator and inventor of the UBC patents and patent
applications. The Company entered into a license agreement with
UBC in October 2001, as described above. Pursuant to the
June 18, 2001 agreement, the Company paid $2,000 to
Dr. Hancock for each month of services thereunder, or
$86,000 in the aggregate, $24,000 of which was paid for services
provided in 2004. Also pursuant to this agreement, the Company
granted Dr. Hancock warrants to purchase: (i) up to
10,000 shares of common stock at $1.50 per share,
which warrant expires on June 19, 2011; (ii) up to
10,000 shares of common stock at $1.00 per share,
which warrant expires on June 1, 2012; (iii) up to
10,000 shares of common stock at $1.00 per share,
which warrant expires on June 1, 2013; and (iv) a
warrant to purchase up to 250,000 shares of common stock at
$1.50 per share, which warrant expires on June 18,
2011 and was issued in consideration for Dr. Hancocks
efforts in connection with the execution of the agreement with
UBC described above. Each warrant to purchase up to
10,000 shares described in this paragraph was fully vested
upon grant, and the warrant to purchase up to
250,000 shares has vested in full.
On January 17, 2005, the Company entered into a new
agreement with Dr. Hancock under which he serves on the
Scientific Advisory Board and in a consulting capacity. This
agreement terminates on December 31, 2008 unless terminated
earlier in accordance with its terms. Either party on
10 days written notice may terminate it at any time.
Pursuant to this agreement, the Company agreed to pay
Dr. Hancock $2,000 per month for each month of
services provided in 2005, and paid Dr. Hancock $24,000 for
those services. Also pursuant to this agreement, the Company
granted Dr. Hancock an option to purchase up to
30,000 shares of common stock at $1.85 per share. This
option vests quarterly in equal installments over a three-year
period, commencing January 18, 2005, and the option expires
on January 18, 2015.
On July 1, 2006, the Company entered into a new agreement
with Dr. Hancock under which he serves on the Scientific
Advisory Board and in a consulting capacity. This agreement
terminates on July 1, 2007 unless terminated earlier in
accordance with its terms. It may be terminated at any time by
either party on 10 days written notice. Pursuant to
this agreement, the Company agreed to pay Dr. Hancock
$2,000 per month for each month of services provided in
2006, and paid Dr. Hancock $12,000 for those services.
46
HELIX
BIOMEDIX, INC.
(A DEVELOPMENT STAGE COMPANY)
NOTES TO FINANCIAL
STATEMENTS (Continued)
Ralph Katz served on the Companys board of directors from
December 2000 until his resignation in May 2002. From October
2002 through March 2004, the Company engaged Mr. Katz as a
consultant to provide professional services in the areas of
strategic and financial planning. In return for services
performed, he was issued a warrant to purchase up to
100,000 shares of common stock at an exercise price of
$1.00 per share, which was fully vested upon issuance. This
option expires on October 1, 2012.
In August 2004, the Company engaged Mr. Katz to provide
advice regarding financing initiatives, to identify and develop
out-licensing opportunities and to design and implement an
investor relations program. Pursuant to that agreement
Mr. Katz was granted an option to purchase up to
75,000 shares of common stock, with an exercise price of
$1.80; 25,000 shares thereunder were fully vested upon
grant, and 50,000 vested one year later. This option expires on
August 12, 2009. In addition to the foregoing and in
connection with the same services, Mr. Katz was granted an
option to purchase up to 25,000 shares of common stock at
$2.00 per share, which was fully vested upon grant. This
option expires on March 17, 2009. No consideration was paid
to Mr. Katz under the agreement described in this paragraph
in 2005 or 2006.
|
|
|
(g)
|
Employment
Agreements
|
As of December 31, 2006, the Company had employment
contracts with four executive officers. The Company entered into
a three-year employment contract with R. Stephen Beatty as
President and Chief Executive Officer, commencing July 1,
2003.
Pursuant to the agreement, Mr. Beatty receives an annual
base salary in the amount of $340,000, and was issued an option
to purchase up to 324,000 shares of common stock at
$1.00 per share, vesting in six equal installments on
January 1, 2004, July 1, 2004, January 1, 2005,
July 1, 2005, January 1, 2006, and July 1, 2006.
This option expires on June 30, 2013. Pursuant to the
agreement, he was also issued a warrant to purchase up to
60,000 shares of common stock at $0.25 per share,
which he has since exercised in full. Upon termination of the
employment relationship by the Company without cause or by
Mr. Beatty with good reason (each as defined in the
employment agreement), the Company is obligated to pay to
Mr. Beatty any unpaid annual base salary, any amount due
but not paid under any of our incentive compensation plans,
earned but unused vacation and bonuses due, if any, for services
already performed to the effective date of termination of the
employment relationship, and monthly severance payments
equivalent to six (6) months base salary.
The Company entered into a three-year employment agreement with
Dr. Timothy Falla, its Chief Scientific Officer, commencing
July 1, 2003. Pursuant to the agreement Dr. Falla
receives an annual base salary in the amount of $240,000 and was
issued an option to purchase 180,000 shares of common stock
at $1.00 per share, vesting in six equal installments on
January 1, 2004, July 1, 2004, January 1, 2005,
July 1, 2005, January 1, 2006, and July 1, 2006.
This option expires on June 30, 2013. Pursuant to the
agreement, he was also issued a warrant to purchase up to
50,000 shares of common stock at $0.25 per share. This
warrant is exercisable so long as Dr. Falla is an employee
of the Company. Upon termination of the employment relationship
by the Company without cause or by Dr. Falla for good
reason (each as defined in the employment agreement), the
Company is obligated to pay to Dr. Falla any unpaid annual
base salary, any amount due but not paid under any of our
incentive compensation plans, earned but unused vacation and
bonuses due, if any, for services already performed to the
effective date of termination of employment, and monthly
severance payments equivalent to three (3) months
base salary.
Effective as of July 1, 2004, the Company entered into an
employment letter agreement with David Kirske, its Vice
President and Chief Financial Officer. Pursuant to the
agreement, Mr. Kirske is paid an annual base salary in the
amount of $180,000. Also pursuant to this agreement,
Mr. Kirske was granted an option to purchase
180,000 shares of common stock at $1.80 per share,
vesting every six months, in six equal installments, with the
first installment vesting on December 31, 2004. This option
expires on August 12, 2014. Upon termination of the
47
HELIX
BIOMEDIX, INC.
(A DEVELOPMENT STAGE COMPANY)
NOTES TO FINANCIAL
STATEMENTS (Continued)
employment relationship by the Company without cause (as defined
in the letter agreement) during the first three years of
Mr. Kirskes employment, the Company is obligated to
pay to Mr. Kirske monthly severance payments equivalent to
six (6) months base salary.
Effective as of October 1, 2006, the Company entered into
an employment letter agreement with Lori Bush, its Chief
Operating Officer. Pursuant to the agreement, Ms. Bush is
paid an annual base salary in the amount of $250,000. Also
pursuant to this agreement, Ms. Bush was granted an option
to purchase 250,000 shares of common stock at
$0.75 per share. These option shares will vest over a
three-year period in six equal installments of
41,667 shares on the last day of each six-month period
commencing on April 1, 2007. This option expires on
December 21, 2016. Ms. Bush is also eligible to
receive, pursuant to this agreement, options to purchase up to
an additional 250,000 shares of the Companys common
stock upon achievement by the Company of certain revenue
targets. Those revenue targets were not deemed probable of
achievement as of December 31, 2006. Upon termination of
the employment relationship under this agreement by the Company
without cause (as defined in the letter agreement) during the
first three years of Ms. Bushs employment, the
Company is obligated to pay to Ms. Bush monthly severance
payments equivalent to six (6) months base salary.
Effective as of July 1, 2004, the Company entered into an
employment letter agreement with David Drajeske, its Vice
President of Business Development. Pursuant to the agreement,
Mr. Drajeske was paid an annual base salary equal to
$150,000, and received a $25,000 signing bonus. Also pursuant to
this agreement, Mr. Drajeske was granted an option to
purchase 180,000 shares of common stock at $1.80 per
share, vesting every six months, in six equal installments, with
the first installment vesting on December 31, 2004. This
option expires on August 12, 2014. Upon termination of the
employment relationship under this agreement by the Company
without cause (as defined in the letter agreement), the Company
is obligated to pay to Mr. Drajeske monthly severance
payments equivalent to six (6) months base salary.
On October 12, 2006, the Company entered into a Separation
Agreement and Release (the Separation Agreement)
with Mr. Drajeske whereby the Company and Mr. Drajeske
agreed to (a) terminate the employment letter and
(b) discontinue Mr. Drajeskes employment
relationship effective as of October 13, 2006 (the
Resignation Date). Pursuant to the terms of the
Separation Agreement, the Company agreed to pay
Mr. Drajeske a severance payment in the aggregate amount of
$100,000, payable in six equal monthly installments. In
exchange, pursuant to the Companys standard separation
policy, Mr. Drajeske agreed, among other things, to release
the Company from certain claims and for a period of one year
following the Resignation Date, to not solicit any licensor to
or customer of the Company or any licensee of the Companys
products, in each case that is known to Mr., Drajeske, with
respect to any business, products or services that are
competitive to the products or services offered by the Company
or under development as of the Resignation Date. In addition,
Mr. Drajeske agreed to not solicit any of the
Companys employees for a period of two years following the
Resignation Date.
48
HELIX
BIOMEDIX, INC.
(A DEVELOPMENT STAGE COMPANY)
NOTES TO FINANCIAL
STATEMENTS (Continued)
|
|
|
Note 8.
|
Supplemental
Disclosure of Cash Flow Information
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Inception
|
|
|
|
|
|
|
|
(November 7,
|
|
|
|
|
|
|
|
1988) to
|
|
|
|
|
|
|
|
December 31,
|
|
|
Years Ended December 31,
|
|
|
|
|
2006
|
|
|
2006
|
|
|
2005
|
|
|
|
|
Deferred stock compensation
|
|
$
|
525,000
|
|
|
|
|
|
|
$
|
|
|
|
Stock issued to acquire patents
|
|
|
66,486
|
|
|
|
|
|
|
|
|
|
|
Debt issued to acquire technology
|
|
|
200,000
|
|
|
|
|
|
|
|
|
|
|
Bridge loans outstanding at
acquisition
|
|
|
200,000
|
|
|
|
|
|
|
|
|
|
|
Patent costs included in accounts
payable
|
|
|
99,859
|
|
|
|
|
|
|
|
|
|
|
Accounts payable converted to notes
|
|
|
704,559
|
|
|
|
|
|
|
|
|
|
|
Accrued interest converted to notes
|
|
|
403,453
|
|
|
|
|
|
|
|
|
|
|
Notes converted to equity
|
|
|
4,722,048
|
|
|
|
|
|
|
|
|
|
|
Accrued interest converted to
equity
|
|
|
231,180
|
|
|
|
|
|
|
|
|
|
|
Detachable warrants issued with
notes payable
|
|
|
728,552
|
|
|
|
|
|
|
|
|
|
|
Issuance of stock for services
provided
|
|
|
14,400
|
|
|
|
|
|
|
|
|
|
|
Purchase of property included in
accrued expenses
|
|
|
224,458
|
|
|
|
|
|
|
|
|
|
|
Stock subscription receivable
|
|
|
135,000
|
|
|
|
|
|
|
|
|
|
|
Cash paid for interest
|
|
|
105,430
|
|
|
|
|
|
|
|
|
|
|
Accounts receivable from sale of
equipment
|
|
|
10,200
|
|
|
|
|
|
|
|
|
|
The Company leases office and laboratory space under an
operating lease expiring in November 2009 which includes an
option to extend the term of the lease for three years. Rent
expense including operating costs for the years ended
December 31, 2006 and 2005 was $67,475 and $59,253,
respectively. The following is a schedule of future annual
minimum lease payments under the lease obligations as of
December 31, 2006:
| |
|
|
|
|
|
2007
|
|
$
|
72,950
|
|
|
2008
|
|
$
|
75,139
|
|
|
2009
|
|
$
|
70,763
|
|
|
|
|
|
|
|
|
Total
|
|
$
|
218,852
|
|
|
|
|
|
|
|
|
|
|
Note 10.
|
License
Agreement
|
The Company entered into a License Agreement
(License) with the University of British Columbia
(UBC) commencing October 1, 2001, (the
Commencement Date), whereby UBC granted to the
Company an exclusive, worldwide license to use and sublicense
certain defined Technology and any improvements
within a specified field of use and including the right to
manufacture, distribute and sell products utilizing the
Technology. The License terminates on October 1, 2021 or
upon the expiration of the last patent applied for and obtained
pursuant to certain provisions of the License, unless terminated
earlier in accordance with the terms of the License.
Dr. Robert E.W. Hancock, Ph.D., a member of the
Companys Scientific Advisory Board, is the lead
investigator and inventor of the UBC patents and patent
applications. The Technology is comprised primarily of three
broad patents for antimicrobial peptides and related methods of
use. The License extends to the Companys affiliates. In
exchange for the exclusive, worldwide license granted under the
License, the Company agreed to pay UBC a royalty of 3.5% of
revenue generated from the Technology and any improvements
related thereto. The Company agreed to pay
49
HELIX
BIOMEDIX, INC.
(A DEVELOPMENT STAGE COMPANY)
NOTES TO FINANCIAL
STATEMENTS (Continued)
graduated minimum annual royalties of $10,000 upon the
5th anniversary, $20,000 upon the 6th anniversary, and
$25,000 upon the 7th and all subsequent anniversaries of
the Commencement Date. As called for by the License, the Company
has issued to UBC or its assigns 97,500 shares of the
Companys common stock, options to purchase up to 152,500
common shares at $1.50 per share, and $61,391 in cash, such
cash payment constituting reimbursement of UBC for expenses
related to the licensed patents. The options have a term of ten
years and were fully vested upon grant. The agreement also
requires the Company to reimburse UBC for all further costs
incurred with respect to the patents, including maintenance fees.
50
|
|
|
ITEM 8.
|
CHANGES
IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND
FINANCIAL DISCLOSURE
|
None
|
|
|
ITEM 8A.
|
CONTROLS
AND PROCEDURES
|
As of the end of the period covered by this Annual Report, we
carried out an evaluation, under the supervision and
participation of management, including our Chief Executive
Officer and Chief Financial Officer, of the effectiveness of the
design and operation of our disclosure controls and procedures
pursuant to Exchange Act
Rule 13a-15.
Based upon that evaluation, our Chief Executive Officer and
Chief Financial Officer concluded that our disclosure controls
and procedures are effective in timely alerting them to material
information required to be included in our periodic SEC filings.
There has been no change during the last fiscal quarter in our
internal control over financial reporting that has materially
affected, or is reasonably likely to materially affect, our
internal control over financial reporting.
|
|
|
ITEM 8B.
|
OTHER
INFORMATION
|
None
PART III
|
|
|
ITEM 9.
|
DIRECTORS,
EXECUTIVE OFFICERS, PROMOTERS, CONTROL PERSONS AND CORPORATE
GOVERNANCE; COMPLIANCE WITH SECTION 16(a) OF THE EXCHANGE
ACT
|
Certain information required by this Item is contained in part
in the section captioned
Proposal No. 1 Election of
Directors in the Proxy Statement for the Helix BioMedix,
Inc. Annual Meeting of Stockholders scheduled to be held on
May 17, 2007, and such information is incorporated herein
by reference.
The remaining information required by this Item is set forth in
Part I of this report under Item 1,
Business Executive Officers.
|
|
|
ITEM 10.
|
EXECUTIVE
COMPENSATION
|
The information required by this Item is incorporated by
reference from the information contained in the sections
captioned Compensation of Executive Officers and
Proposal No. 1 Election of
Directors of the Proxy Statement for the Helix BioMedix,
Inc. Annual Meeting of Stockholders scheduled to be held on
May 17, 2007.
|
|
|
ITEM 11.
|
SECURITY
OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND
RELATED STOCKHOLDER MATTERS
|
Certain information required by this Item is incorporated by
reference from the information contained in the section
captioned Security Ownership of Certain Beneficial Owners
and Management of the Proxy Statement for the Helix
BioMedix, Inc. Annual Meeting of Stockholders scheduled to be
held on May 17, 2007.
51
Securities
Authorized For Issuance Under Equity Compensation
Plans
The following table lists our equity compensation plans,
including individual compensation arrangements, under which
equity securities are authorized for issuance as of
December 31, 2006:
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Number of Securities
|
|
|
|
|
|
|
|
Weighted-Average
|
|
|
Remaining Available for Future
|
|
|
|
|
Number of Securities to be
|
|
|
Exercise
|
|
|
Issuance Under Equity
|
|
|
|
|
Issued Upon Exercise of
|
|
|
Price of Outstanding
|
|
|
Compensation Plans (Excluding
|
|
|
|
|
Outstanding Options,
|
|
|
Options,
|
|
|
Securities Reflected
|
|
|
|
|
Warrants and Rights
|
|
|
Warrants and Rights
|
|
|
in Column(a))
|
|
|
|
|
Equity compensation plans approved
by security holders
|
|
|
2,918,944
|
|
|
$
|
1.29
|
|
|
|
2,436,056
|
|
|
Equity compensation plans not
approved by security holders(1)
|
|
|
2,700,544
|
|
|
$
|
1.38
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
|
5,619,488
|
|
|
$
|
1.33
|
|
|
|
2,436,056
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
Consists of warrants to purchase common stock issued to certain
employees and consultants in connection with services rendered
and to certain shareholders in connection with financing
activities. |
|
|
|
ITEM 12.
|
CERTAIN
RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR
INDEPENDENCE
|
The information required by this Item is incorporated by
reference from the information contained in the sections
captioned Certain Relationships and Related
Transactions and
Proposal No. 1 Election of
Directors of the Proxy Statement for the Helix BioMedix,
Inc. Annual Meeting of Stockholders scheduled to be held on
May 17, 2007.
52
| |
|
|
|
|
Exhibit
|
|
|
|
No.
|
|
Description and Location
|
|
|
|
|
2
|
.1
|
|
Proposal for Approval of
Reincorporation of Helix BioMedix, Inc., a Colorado corporation,
from Colorado to Delaware (incorporated by reference from
Exhibit 2 to the Companys
Form 10-KSB
for the year ended December 31, 2000)
|
|
|
3
|
.1
|
|
Certificate of Ownership and
Merger of Helix BioMedix, Inc. a Delaware corporation and Helix
BioMedix, Inc., a Louisiana corporation (incorporated by
reference from Exhibit 2 to the Companys
Form 10-KSB
for the year ended December 31, 2000)
|
|
|
3
|
.2
|
|
Certificate of Incorporation of
Helix BioMedix, Inc. (incorporated by reference from
Exhibit 3-a
to the Companys
Form 10-KSB
for the year ended December 31, 2000)
|
|
|
3
|
.3
|
|
Certificate of Amendment to the
Certificate of Incorporation of Helix BioMedix, Inc.
(incorporated by reference from Exhibit 3.3 to the
Companys
Form 10-KSB/A
for the year ended December 31, 2002)
|
|
|
3
|
.4
|
|
Bylaws of Helix BioMedix, Inc.
(incorporated by reference from
Exhibit 3-b
to the Companys
Form 10-KSB
for the year ended December 31, 2000)
|
|
|
10
|
.1
|
|
R. Stephen Beatty Employment
Agreement dated July 1, 2001 (incorporated by reference
from Exhibit 10.1 to the Companys
Form 10-KSB
for the year ended December 31, 2001)
|
|
|
10
|
.2
|
|
Tim Falla Employment Agreement
dated June 15, 2001 (incorporated by reference from
Exhibit 10.3 to the Companys
Form 10-KSB
for the year ended December 31, 2001)
|
|
|
10
|
.3
|
|
Helix BioMedix, Inc. Amended and
Restated 2000 Stock Option Plan (incorporated by reference from
Exhibit 10.3 to the Companys
Form 10-KSB/A
for the year ended December 31, 2002)
|
|
|
10
|
.4
|
|
Employment Agreement dated
September 24, 2003, effective July 1, 2003, between
the Company and Tim Falla (incorporated by reference from
Exhibit 10.8 to the Companys
Form 10-KSB
for the year ended December 31, 2003)
|
|
|
10
|
.5
|
|
Employment Agreement dated
September 24, 2003, effective July 1, 2003, between
the Company and R. Stephen Beatty (incorporated by reference
from Exhibit 10.9 to the Companys
Form 10-KSB
for the year ended December 31, 2003)
|
|
|
10
|
.6
|
|
Letter Agreement dated
May 19, 2003 between the Company and Parker Sroufe
(incorporated by reference from Exhibit 10.10 to the
Companys
Form 10-KSB
for the year ended December 31, 2003)
|
|
|
10
|
.7
|
|
Separation Agreement and Release
dated November 26, 2003 between the Company and Kerry
Palmer (incorporated by reference from Exhibit 10.11 to the
Companys
Form 10-KSB
for the year ended December 31, 2003)
|
|
|
10
|
.8
|
|
Amendment to Employment Agreement
dated December 10, 2003 between the Company and Timothy
Falla (incorporated by reference from Exhibit 10.12 to the
Companys
Form 10-KSB
for the year ended December 31, 2003)
|
|
|
10
|
.8(a)
|
|
Second Amendment to Employment
Agreement dated effective as of June 30, 2006 between the
Company and Timothy Falla (incorporated by reference from
Exhibit 10.8(a) to the Companys
Form 10-QSB
for the fiscal quarter ended September 30, 2006)
|
|
|
10
|
.9
|
|
Amendment to Employment Agreement
dated December 10, 2003 between the Company and
R. Stephen Beatty (incorporated by reference from
Exhibit 10.12 to the Companys
Form 10-KSB
for the year ended December 31, 2003)
|
|
|
10
|
.9(a)
|
|
Second Amendment to Employment
Agreement dated effective as of June 30, 2006 between the
Company and R. Stephen Beatty (incorporated by reference from
Exhibit 10.9(a) to the Companys
Form 10-QSB
for the fiscal quarter ended September 30, 2006)
|
|
|
10
|
.10
|
|
Employment Agreement between David
H. Kirske dated July 2, 2004 (incorporated by reference
from Exhibit 10.1 to the Companys
Form 10-QSB
for the fiscal quarter ended September 30, 2004)
|
|
|
10
|
.11
|
|
Employment Agreement between David
Drajeske dated August 12 (incorporated by reference from
Exhibit 10.2 to the Companys
Form 10-QSB
for the fiscal quarter ended September 30, 2004)
|
|
|
10
|
.12
|
|
TPI Licensing Agreement dated
September 5, 2001 (incorporated by reference from
Exhibit 10.4 to the Companys
Form 10-KSB
for the year ended December 31, 2001)
|
|
|
10
|
.13
|
|
University of British Columbia
License Agreement dated October 1, 2001 (incorporated by
reference from Exhibit 10.5 to the Companys
Form 10-KSB
for the year ended December 31, 2001)
|
53
| |
|
|
|
|
Exhibit
|
|
|
|
No.
|
|
Description and Location
|
|
|
|
|
10
|
.14
|
|
Amended and Restated Consulting
Agreement between the Company and Dunsford Hill Capital Partners
dated May 30, 2001 (incorporated by reference from
Exhibit 10.7 to the Companys
Form 10-KSB
for the year ended December 31, 2001)
|
|
|
10
|
.15
|
|
Second Amended and Restated
Consulting Agreement between the Company and Dunsford Hill
Capital Partners dated August 15, 2002 (incorporated by
reference from Exhibit 10.13 to the Companys
Form 10-KSB/A
for the year ended December 31, 2002)
|
|
|
10
|
.16
|
|
Hancock Consulting Agreement dated
June 18, 2001 (incorporated by reference from
Exhibit 10.9 to the Companys
Form 10-KSB
for the year ended December 31, 2001)
|
|
|
10
|
.17
|
|
Lease between the Company and
Teachers Insurance & Annuity Association of America,
Inc. dated August 14, 2001 (incorporated by reference from
Exhibit 10.11 to the Companys
Form 10-KSB
for the year ended December 31, 2001)
|
|
|
10
|
.17(a)
|
|
First Amendment to Lease between
the Company and Teachers Insurance and Annuity Association of
America, Inc. dated December 6, 2005 (incorporated by
reference from Exhibit 10.17(a) to the Companys
Form 10-KSB
for the year ended December 31, 2005)
|
|
|
10
|
.17(b)
|
|
Second Amendment to Lease between
the Company and Teachers Insurance and Annuity Association of
America, Inc. dated October 4, 2006
|
|
|
10
|
.18
|
|
Rights Agreement dated
August 21, 2003 (incorporated by reference from
Exhibit 10.27 to the Companys
Form 10-KSB
for the year ended December 31, 2003)
|
|
|
10
|
.19
|
|
Acceptance and Acknowledgement of
Appointment dated January 4, 2004 (incorporated by
reference from Exhibit 10.28 to the Companys
Form 10-KSB
for the year ended December 31, 2003)
|
|
|
10
|
.20
|
|
License Agreement between the
Company and E.I. du Pont de Nemours dated March 9, 2004
(incorporated by reference from Exhibit 99.1 to the
Companys
Form 8-K
dated March 16, 2004)
|
|
|
10
|
.21*
|
|
Joint Marketing Agreement between
the Company and Body Blue Inc. dated November 2, 2004
(incorporated by reference from Exhibit 10.21 to the
Companys
Form 10-KSB
for the year ended December 31, 2004)
|
|
|
10
|
.21(a)*
|
|
First Amendment to Joint Marketing
Agreement between the Company and Body Blue Inc. dated
February 13, 2006 (incorporated by reference from
Exhibit 10.21(a) to the Companys
Form 10-KSB
for the year ended December 31, 2005)
|
|
|
10
|
.22
|
|
Employment letter agreement dated
effective as of October 1, 2006 between the Company and
Lori Bush (incorporated by reference from
Exhibit 10.22 to the Companys
Form 10-QSB
for the fiscal quarter ended September 30, 2006)
|
|
|
10
|
.23
|
|
Separation Agreement and Release
dated October 12, 2006 between the Company and David
Drajeske (incorporated by reference from Exhibit 10.23 to
the Companys
Form 10-QSB
for the fiscal quarter ended September 30, 2006)
|
|
|
10
|
.24*
|
|
Non-Exclusive License Agreement
between the Company and Grant Industries, Inc. dated
December 12, 2006
|
|
|
14
|
.0
|
|
Code of Ethics adopted
August 11, 2003 (incorporated by reference from
Exhibit 14.0 to the Companys
Form 10-KSB
for the year ended December 31, 2003)
|
|
|
23
|
.1
|
|
Consent of KPMG LLP
|
|
|
23
|
.2
|
|
Consent of Comiskey and Company
|
|
|
31
|
.1
|
|
Certification of the
Companys Chief Executive Officer Pursuant to
Rule 13a-14(a)
or
Rule 15d-14(a)
of the Securities Exchange Act of 1934
|
|
|
31
|
.2
|
|
Certification of the
Companys Chief Financial Officer Pursuant to
Rule 13a-14(a)
or
Rule 15d-14(a)
of the Securities Exchange Act of 1934
|
|
|
32
|
.1
|
|
Certification of the
Companys Chief Executive Officer Pursuant to
18 U.S.C. Section 1350
|
|
|
32
|
.2
|
|
Certification of the
Companys Chief Financial Officer Pursuant to
18 U.S.C. Section 1350
|
|
|
|
|
* |
|
Confidential treatment has been requested for confidential
commercial and financial information, pursuant to
Rule 24b-2
under the Securities Exchange Act of 1934, as amended. |
54
|
|
|
ITEM 14.
|
PRINCIPAL
ACCOUNTANT FEES AND SERVICES
|
The information required by this Item is incorporated by
reference from the information contained in the section
captioned Principal Accountant Fees and Services of
the Proxy Statement for the Helix BioMedix, Inc. Annual Meeting
of Stockholders scheduled to be held on May 17, 2007.
55
SIGNATURES
In accordance with Section 13 or 15(d) of the Exchange Act,
the registrant caused this report to be signed on its behalf by
the undersigned, thereunto duly authorized.
HELIX BIOMEDIX, INC.
(Registrant)
|
|
|
| |
By:
|
/s/ R.
Stephen Beatty
|
R. Stephen Beatty
President, Chief Executive Officer
(Principal Executive Officer)
Date: March 26, 2007
David H. Kirske
Vice President and Chief Financial Officer
(Principal Financial Officer and Principal
Accounting Officer)
Date: March 26, 2007
POWER OF
ATTORNEY
Each person whose signature appears below hereby constitutes and
appoints each of R. Stephen Beatty and David H. Kirske his or
her true and lawful
attorney-in-fact
and agent, with full power to act, and with full power of
substitution and resubstitution, to execute in his or her name
and on his or her behalf, individually and in each capacity
stated below, any and all amendments and supplements to this
Annual Report, and any and all other instruments necessary or
incidental in connection herewith, and to file the same with the
Securities and Exchange Commission.
In accordance with the Exchange Act, this report has been signed
below by the following persons on behalf of the registrant and
in the capacities and on the dates indicated.
| |
|
|
|
|
|
|
|
Signature
|
|
Title
|
|
Date
|
|
|
|
/s/ R.
STEPHEN
BEATTY
R.
Stephen Beatty
|
|
President, Chief Executive
Officer
and Director
|
|
March 26, 2007
|
|
|
|
|
|
|
|
/s/ WESTON
ANSON
Weston
Anson
|
|
Director
|
|
March 26, 2007
|
|
|
|
|
|
|
|
/s/ RANDALL
L-W. CAUDILL,
PH.D.
Randall
L-W. Caudill, Ph.D.
|
|
Director
|
|
March 26, 2007
|
|
|
|
|
|
|
|
/s/ RICHARD
M. COHEN
Richard
M. Cohen
|
|
Director
|
|
March 26, 2007
|
|
|
|
|
|
|
|
/s/ JOHN
C. FIDDES,
PH.D.
John
C. Fiddes, Ph.D.
|
|
Director
|
|
March 26, 2007
|
56
| |
|
|
|
|
|
|
|
Signature
|
|
Title
|
|
Date
|
|
|
|
/s/ JEFFREY
A. MILLER,
PH.D.
Jeffrey
A. Miller, Ph.D.
|
|
Director
|
|
March 26, 2007
|
|
|
|
|
|
|
|
/s/ DAVID
OCONNOR
David
OConnor
|
|
Director
|
|
March 26, 2007
|
|
|
|
|
|
|
|
/s/ BARRY
L. SEIDMAN
Barry
L. Seidman
|
|
Director
|
|
March 26, 2007
|
|
|
|
|
|
|
|
/s/ DANIEL
O. WILDS
Daniel
O. Wilds
|
|
Director
|
|
March 26, 2007
|
57
EX-10.17B
2
v26497exv10w17b.htm
EXHIBIT 10.17(B)
exv10w17b
Exhibit 10.17b
SECOND AMENDMENT TO LEASE
This SECOND AMENDMENT TO LEASE (this Second Amendment) is made as of October 4th, 2006 by
and between Teachers Insurance & Annuity Association of America, Inc., a New York corporation
(Landlord), and Helix BioMedix, Inc., a Delaware corporation (Tenant).
RECITALS
Landlord is the landlord and Tenant is the tenant under that certain Lease dated August 14,
2001 (the Initial Lease), as modified by First Amendment to Lease dated for reference purposes
December 6, 2005 (the First Amendment), for premises located at 22122 20th Avenue SE, Bothell,
Washington, 98021, Building H, Unit 148 (the Initial Premises or H/148). The Initial
Premises consists of 3,038 rentable square feet (being 2,378 rsf office and 660 rsf warehouse).
As used herein the Amended Lease shall mean the Initial Lease as amended by First Amendment,
and the Lease shall mean the Amended Lease as modified by this Second Amendment.
The parties desire to amend the Lease as follows (all on the terms and conditions set forth
in this Second Amendment):
A. Add to the Initial Premises that certain space consisting of an agreed 2,246
rentable square feet (being 2,246 rsf of office) and located at 22118 20th Avenue
SE, Bothell, Washington, Building G, Unit 204, as shown in the attached Exhibit
A, which is incorporated herein by reference (Expansion Space or G/204)). The Initial
Premises
and Expansion Space are located in the Project that is legally described and
depicted on
the attached Exhibit B;
B. Extend the Lease Term for approximately an additional thirty-six (36) full
calendar months;
C. Make certain other modifications to the Lease, all on the following terras
and conditions.
Except as otherwise specifically defined herein all capitalized terms shall have the
meanings assigned in the Initial Lease.
AGREEMENT
In furtherance of the Recitals set forth above, which are incorporated herein by reference,
and in consideration of the mutual promises and covenants set forth below, and for other good
and valuable consideration, the receipt of which is hereby acknowledged, the parties acknowledge
and agree to the following:
1. Addition of Expansion Space. On December 1, 2006 (Expansion Space Addition Date), the
Expansion Space shall be added to the Initial Premises. Notwithstanding anything to the contrary
in the Lease, the Expansion Space shall be used by Tenant only for general office and
administrative use for a company specializing in the research and development of
biopharmaceutical products involving bioactive peptides. From and after the Expansion Space
Addition Date, (i) the term Premises as used in the Lease shall include both the Initial
Premises and the Expansion Space, (ii) Section l(e) of the Amended Lease shall be revised such
that the total Premises shall consist of an agreed 5,284 rentable square feet, and (iii)
Tenants Share of Expenses shall be recalculated to reflect the increased rentable square
footage of the Premises. If the Expansion Space is not delivered to Tenant with Landlords Work
in the Expansion Space (as defined in Section 9 below) substantially complete by December 1,
2006, this Second Amendment shall not be void or voidable, nor shall
Landlord be liable to Tenant for any loss or damage resulting therefrom. However, if the
Expansion Space is not delivered by Landlord to Tenant on or before December 1, 2006 with
Landlords Work in the Expansion Space substantially completed, then the Expansion Space
Addition Date shall be the first to occur of the following events: (i) the date on which
Landlord notifies Tenant that Landlords Work in the Expansion
Space is substantially complete (Landlord agrees to use reasonable efforts to provide three (3)
business days prior notice to Tenant of such date), (ii) the date on which Tenant takes
possession or commences beneficial occupancy of the Expansion Space, or (iii) if substantial
completion of Landlords Work in the Expansion Space is delayed due to (a) Tenants failure to
perform its obligations under this Second Amendment, the Work Letter Agreement or the Lease, (b)
changes to the Tenant Improvement Plans required by Tenant or (c) elements of the Tenant
Improvements that are required by Tenant but that cannot reasonably be performed in the
timeframes set forth in Landlords Work Schedule, then the date determined by Landlord as the
date upon which Landlords Work would have been substantially completed, but for the occurrence
of the same.
2. Extended Term of the Lease. Section l(g) of the Initial Lease is hereby
amended to extend the Term of the Lease for an additional term (Second Extended Term)
commencing on December 1, 2006 (Second Extended Term Commencement Date) and
terminating on the last day of the thirty-sixth (36th) full calendar month
following the Expansion
Space Addition Date (Expiration Date or Second
Extended Term Expiration Date).
3. Base Monthly Rent. From and after the Second Extended Term Commencement
Date, Section l (h) of the Initial Lease is hereby modified such that the Base Monthly Rent
for the
Initial Premises shall be as follows: (Month refers to the period through the full
applicable
calendar month)
| |
|
|
| H/148 |
| Time Period |
|
Base Monthly Rent |
Second Extended Term Commencement Date Month
12 |
|
$3,369.00 |
Month 13 Month 24 |
|
$3,470.00 |
Month 25 Second Extended Term Expiration Date |
|
$3,574.00 |
From and after the Expansion Space Addition Date, Section l (h) of the Initial Lease is
hereby modified such that the Base Monthly Rent for the Expansion Space shall be as follows:
(Month refers to the period through the full applicable calendar month). Base Monthly Rent for
the Expansion Space shall be in addition to Base Monthly Rent for the Initial Premises.
| |
|
|
| G/204 |
| Time Period |
|
Base Monthly Rent |
Expansion Space Addition Date Month 12 |
|
$2,695.00 |
Month 13 Month 24 |
|
$2,776.00 |
Month 25 Second Extended Term Expiration Date |
|
$2,859.00 |
4. Security Deposit. At the same time as it signs and delivers this Second
Amendment, Tenant shall deliver an additional $4,201.00 as a Security Deposit under the Lease
(such that the total Security Deposit shall be $8,512) and an additional nonrefundable
cleaning
fee of $125.
5. Parking.
From and after the Expansion Space Addition Date, the first
(1st)
sentence of Section 11 of the Initial Lease hereby is deleted and replaced with the following
sentences: Landlord grants to Tenant and Tenants customers, suppliers, employees and
invitees, a
non-exclusive license to use up to nineteen (19) surface, unreserved parking stalls in the
designated
parking areas in the Project, for the use of motor vehicles during the term of this Lease.
6. Cable. Section 26 of the Initial Lease hereby is modified by placing an (a) at
the beginning of the first (1st) paragraph and a (b) at the beginning of the
second (2nd)
paragraph. The following new Section 26(c) hereby is added to the Initial Lease:
c. Cable.
| |
(1) |
|
Within thirty (30) days after the expiration or sooner
termination of the Lease or at any time that any of the Wires (as defined
below) are no longer in active use by Tenant, Landlord may elect by written
notice to Tenant to: |
| |
(a) |
|
Retain any or all wires, cables, and similar installations
appurtenant thereto (Wires) installed by Tenant within the
Premises or anywhere in the Building outside the Premises,
including, without limitation, the plenums or risers of the Building; |
| |
| |
(b) |
|
Remove any or all of the Wires and restore the Premises or the
Building, as the case maybe, to their condition existing prior to the
installation of the Wires (Wire Restoration Work). Landlord, at
its option, may perform such Wire Restoration Work at Tenants
sole (but reasonable) cost and expense; or |
| |
| |
(c) |
|
Require Tenant to perform all or part of the Wire Restoration Work
at Tenants sole cost and expense. |
| |
(2) |
|
In the event that Tenant discontinues the use of all or any part of the Wires
or is no longer using all or any part of the Wires, Tenant shall within thirty
(30) days thereafter notify Landlord of same in writing, accompanied by a
plan or other reasonable description of the current type, quantity, points of
commencement and termination, and routes of the Wires to allow
Landlord to determine if Landlord desires to retain same. |
| |
| |
(3) |
|
In the event Landlord elects to retain any or all of the Wires, Tenant
covenants that: |
| |
(a) |
|
Tenant shall be the sole owner of the Wires, Tenant shall have the
sole right to surrender the Wires, and the Wires shall be free of all
liens and encumbrances; and |
| |
| |
(b) |
|
All Wires shall be left in good condition, working order, properly
labeled and capped or sealed at each end and in each
telecommunications/electrical closet and junction box, and in safe
condition. |
| |
(4) |
|
Notwithstanding anything to the contrary in this Lease, Landlord may
retain Tenants Security Deposit after the expiration or sooner termination
of the Lease until one of the following events has occurred with respect to
all of the Wires: |
| |
(a) |
|
Landlord elects to retain the Wires pursuant to Paragraph (l)(a)
above; |
| |
| |
(b) |
|
Landlord elects to perform the Wire Restoration Work pursuant to
Paragraph (1 )(b) above and the Wire Restoration Work is complete
and Tenant has fully reimbursed Landlord for all reasonable costs
related thereto; or |
| |
| |
(c) |
|
Landlord elects to require Tenant to perform the Wire Restoration
Work pursuant to Paragraph (l)(c) above and the Wire Restoration
Work is complete and Tenant has paid for all reasonable costs
related thereto. |
| |
(5) |
|
In the event that Tenant fails or refuses to pay all reasonable costs of the
Wire Restoration Work within thirty (30) days of Tenants receipt of
Landlords notice requesting Tenants reimbursement for or payment of such
costs or otherwise fails to comply with the provisions of this Clause,
Landlord may apply all or any portion of Tenants Security Deposit toward
the payment of any reasonable costs or expenses relative to the Wire
Restoration Work or Tenants obligations under this Clause. The retention
or application of such Security Deposit by Landlord pursuant to this Clause
does not constitute a limitation on or waiver of Landlords right to seek
further remedy under law or equity. |
| |
| |
(6) |
|
The provisions of this Section 26(c) shall survive the expiration or sooner
termination of the Lease. |
7. Limitation of Landlords Liability. Section 27 of the Initial Lease is hereby
deleted in its entirety and the following language set in its place:
27. limitation of landlords liability. notwithstanding anything to the contrary in
this lease, and in consideration of the benefits accruing hereunder, tenant agrees that, in
the event of any actual or alleged failure, breach or default of this lease by landlord,
landlords liability under this lease shall be limited to, and tenant shall look only to
the interest of landlord in the building, including all rents, proceeds and profits
therefrom. tenant shall look solely to landlords interest in the building, including all
rents, proceeds and profits therefrom, for the recovery of any judgment or award against
landlord. landlord shall not be personally liable for any judgment or deficiency, and in no
event shall landlord be liable to tenant for any lost profit, damage to or loss of business
or any form of special, indirect or consequential damage. before filing suit for an alleged
default by landlord, tenant shall give landlord notice and reasonable time to cure the
alleged default.
8. Miscellaneous Provisions. Section 29(h) of the Initial Lease hereby is deleted in
its entirety and the following language set in its place:
h. Landlords Successors. In the event of a sale or conveyance by Landlord of the
Project, the same shall operate to release Landlord from any liability under this Lease,
and in such event Landlords successor in interest shall be solely responsible for all
obligations of Landlord under this Lease. If only a portion of the Project is sold, this
Lease shall run with the portion of the Project on which the Building is located, and
Tenants Share shall be equitably adjusted based on the ratio of Tenants square footage to
the total square footage of premises in the Project so as to reflect the deletion of any
other buildings from the Project.
9. As Is; Landlords Work. Tenant leases the Initial Premises and Expansion
Space in their as-is, where-is-condition and acknowledges that Landlord has not agreed to and
shall not be required to make any improvements or alterations to the same, except for the work
set forth in the attached Exhibit C (Landlords Work or Tenant Improvements). Tenant
agrees to cooperate with Landlord with respect to Landlords performance of such Tenant
Improvements.
10. Brokers. Tenant was represented in this Second Amendment transaction by Bill
Neil of GVA Kidder Mathews, who shall be compensated by Landlord pursuant to a separate
written agreement. Except for the broker set forth in the preceding sentence, each party
shall
indemnify, defend and hold the other party harmless from and against all costs, expenses,
attorneys fees, liens and other liability for commissions or other compensation claimed by
any
broker or agent claiming the same by, through, or under that party.
11. OPTION TO RENEW. Tenant is hereby granted the right to extend the Term
of this Lease only with respect to H/148 (and not with respect to G/204) beyond the Expiration
Date of the Second Extended Term for one (1) successive period of thirty-six (36) months (the
Third Extended Term). This right to extend may be exercised by Tenant only by giving
Landlord written notice (Notice) no sooner than twelve (12) months and no later than
nine (9)
months prior to the Expiration Date of the Second Extended Term. If at the time of Tenants
notice, Tenant is in default of its obligations under the Lease beyond any applicable cure
period, then Tenants Notice to extend the Lease for the Third Extended Term shall be invalid. Tenants
right to extend the Lease for the Third Extended Term is personal to Tenant and may not be
exercised by any subtenant or assignee of Tenant. From and after the commencement of the
Third Extended Term, all of the terms, covenants, and conditions of the Lease shall continue
in full force and effect as written, except that Section 11 of this Second Amendment shall be
deleted in its entirety and Base Monthly Rent for the Third Extended Term shall be at the rate
then being paid under new leases for similarly improved and situated premises in the Canyon Park
Business Center of which this Project is a part, but not less than the Base Monthly Rent in effect
for the last month of the Second Extended Term. Tenant shall include with its Notice copies of
Tenants then-current financial statement as well as financial statements from the three (3) years
prior to the current financial statement year, and shall provide Landlord with such other financial
information regarding Tenant as Landlord may require. Tenants right to extend the Term of this
Lease for the Third Extended Term is contingent upon Landlords approval, in its reasonable
discretion, of such financial statements and information. Tenant shall have no options to renew the
Lease beyond the Second Extended Term except as set forth in this paragraph; Section 5 of the First
Amendment hereby is deleted in its entirety and of no further force and effect.
12. Full Force and Effect. Except as modified herein, all other terms and conditions
of the Lease shall remain in full force and effect. Tenant confirms that Landlord is not now
and has not in the past been in default under the Lease, and Tenant has no claim against Landlord
for damages or offset of any type.
13. Entire Agreement. This Second Amendment and the Amended Lease constitute
the entire agreement between Landlord and Tenant with respect to the subject matter of this
Second Amendment.
Landlord:
Teachers Insurance & Annuity Association of America. Inc., a New York
corporation
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/s/ Derek Landry
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Derek Landry |
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Director |
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Tenant:
Helix BioMedix, Inc., a Delaware corporation
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By:
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/s/ David Kirske
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David Kirske |
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CFO |
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Exhibit A
The Expansion Space
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Office = 2,246
Warehouse = 0
Total = 2,246 rsf
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Exhibit B
(The Project)
LEGAL
DESCRIPTION -PHASE II (Buildings G H)
THAT PORTION OF THE WEST HALF OF SECTION 29 AND OF THE EAST HALF OF SECTION 30, TOWNSHIP 27 NORTH,
RANGE 5 EAST, W.M., SNOHOMISH COUNTY, WASHINGTON. DESCRIBED AS FOLLOWS:
BEGINNING AT A POINT ON THE NORTH LINE OF THE AMENDED PLAT OF VILLAGE SQUARE,
ACCORDING TO THE PLAT RECORDED IN VOLUME 42 OF PLATS, PAGES 193 THROUGH 198,
INCLUSIVE, RECORDS OF SAID COUNTY, SAID POINT BEING NORTH 88 47 26 EAST 627.20 FEET
FROM THE NORTHWEST CORNER OF SAID PLAT;
THENCE NORTH 88 47 26 EAST 363.00 FEET ALONG SAID NORTH
LINE TO THE NORTHEAST
CORNER OF SAID PLAT;
THENCE NORTH 46 29 12 EAST 547.38 FEET TO A POINT ON A 325 FOOT RADIUS CURVE CONCAVE
TO THE NORTHEAST, A RADIAL THROUGH SAID POINT BEARING NORTH 46 29 12 EAST;
THENCE NORTHWESTERLY ALONG SAID CURVE AN ARC DISTANCE OF 196.99 FEET TO A POINT OF
REVERSE CURVE WITH A 775.00 FOOT RADIUS CURVE TO THE LEFT;
THENCE NORTHERLY ALONG SAID 775.00 FOOT RADIUS CURVE AN ARC DISTANCE
OF 112.88 FEET;
THENCE SOUTH 70 40 00 WEST 272.00 FEET TO THE POINT OF CURVE OF A 450.00 FOOT RADIUS
CURVE TO THE LEFT;
THENCE WESTERLY ALONG SAID CURVE AN ARC DISTANCE OF 160.66 FEET;
THENCE SOUTH 80 52 00 WEST 170.32 FEET;
THENCE SOUTH 68 59 47 WEST 110.41 FEET;
THENCE SOUTH 14 04 41 EAST 278.91 FEET;
THENCE SOUTH 17 06 43 WEST 170.08 FEET TO THE POINT OF BEGINNING;
TOGETHER WITH AN EASEMENT FOR INGRESS, EGRESS AND UTILITIES 25.00 FEET WIDE, BEING 12.50 FEET ON
EACH SIDE OF THE FOLLOWING DESCRIBED CENTERLINE;
BEGINNING AT THE NORTHEAST CORNER OF THE ABOVE DESCRIBED PARCEL;
THENCE SOUTH 70 40 00 WEST 272.00 FEET TO THE POINT OF A CURVE OF A 450.00 FOOT RADIUS
CURVE TO THE LEFT;
THENCE WESTERLY ALONG SAID CURVE AN ARC DISTANCE OF 160.66 FEET TO THE TERMINUS OF
SAID CENTERLINE AND EASEMENT.
SITUATE IN THE COUNTY OF SNOHOMISH, STATE OF WASHINGTON.
Cross hatched area denotes Project.
EXHIBIT C
WORK LETTER AGREEMENT
This Work Letter Agreement is entered into in conjunction with that certain Second
Amendment to Lease Agreement dated by and between Teachers Insurance &
Annuity Association of America, Inc., a New York corporation (Landlord), and Helix BioMedix, Inc.
a Delaware corporation (Tenant).
RECITALS
A. Concurrently with the execution of this Work Letter Agreement, Landlord and
Tenant have entered into a Second Amendment to Lease (the Second Amendment) under
which, among other things, Tenant has leased certain additional space (Expansion Space) from
Landlord, as more particularly described in the Second Amendment. Capitalized terms not
defined in this Exhibit C shall have the meaning ascribed to them in the Second Amendment and
Amended Lease.
B. In order to induce Tenant to enter into the Second Amendment and in
consideration of the mutual covenants hereinafter contained, Landlord and Tenant hereby agree
as follows:
1. COMPLETION SCHEDULE.
Following the execution of the Second Amendment, Landlord shall deliver to Tenant a schedule
(the Work Schedule) setting forth a timetable for the planning and completion of the
installation of the Tenant Improvements to be constructed in the Premises. The Work Schedule shall
set forth each of the various items of work to be done by or approval to be given by Landlord and
Tenant in connection with the completion of the Tenant Improvements. Such Schedule shall be the
basis for completing the Tenant Improvement work. Tenant agrees to act reasonably and promptly in
reviewing and responding to all schedules, drawings, specifications, budgets and other such items
related to Landlords Work.
2. TENANT IMPROVEMENTS.
The terms Tenant Improvements and Landlords Work shall include all work to be done in
the Premises pursuant to the Tenant Improvement Plans described in Paragraph 3 below, including,
but not limited to, partitioning, doors, ceilings, floor coverings, wall finishes (including paint
and wallcovering), electrical (including lighting, switching, telephones, outlets, etc.) and
plumbing.
3. TENANT IMPROVEMENT PLANS.
Upon Landlords request, Tenant agrees to meet with Landlords architect and/or space
planner for the purpose of preparing a space plan for the layout of the Premises. Based upon such
space plan, which must be approved of by both Landlord and Tenant, Landlords architect shall
prepare final working drawings and specifications for the Tenant Improvements. Such final working
drawings and specifications may be referred to herein as the Tenant Improvement Plans. The
Tenant Improvement Plans must be approved of by both Landlord and Tenant, and must be consistent
with Landlords standard specifications (the Standards) for tenant improvements for the
Building, as the same may be changed from time to time by Landlord. Both Landlord and Tenant agree
to act reasonably and promptly in reviewing and responding to requests for approval of the space
plan and the Tenant Improvement Plans.
4. NON-STANDARD TENANT IMPROVEMENTS.
Landlord shall permit Tenant to deviate from the Standards for the Tenant Improvements;
provided that (a) the deviations shall not be of a lesser quality than the Standards; (b) the
total lighting for the Premises shall not exceed 1.65 watts per rentable square foot; (c) the
deviations conform to applicable governmental regulations and necessary governmental permits and
approvals have been secured; (d) the deviations do not require building service beyond the level
normally provided to other tenants in the Building and do not overload the floors; (e) Landlord
has
reasonably determined that the deviations are of a nature and quality that are consistent
with the overall objectives of the Landlord for the Building; and (f) any costs related to such
deviations shall be borne by Tenant.
5. FINAL PRICING AND DRAWING SCHEDULE.
After the preparation of the space plan and after Tenants written approval thereof, in
accordance with the Work Schedule, Landlord shall cause its architect to prepare and submit to
Tenant the final working drawings and specifications referred to in Paragraph 3 hereof. Such
working drawings shall be approved by Landlord and Tenant in accordance with the Work Schedule and
shall thereafter be submitted to the appropriate governmental body by Landlords architect for
plan checking and the issuance of a building permit. Landlord, with Tenants cooperation, shall
cause to be made any changes in the plans and specifications necessary to obtain the building
permit. Concurrent with the plan checking, Landlord shall have prepared a final pricing for
Tenants approval, in accordance with the Work Schedule, taking into account any modifications
which may be required to reflect changes in the plans and specifications required by the City or
County in which the Premises are located. After final approval of the working drawings, no further
changes to the Tenant Improvement Plans may be made without the prior written approval from both
Landlord and Tenant, and then only after agreement by Tenant to pay any excess costs resulting
from the design and/or construction of such changes. Tenant hereby acknowledges that any such
changes shall be subject to the terms of Paragraph 7 hereof.
6. CONSTRUCTION OF TENANT IMPROVEMENTS.
After the Tenant Improvement Plans have been prepared and approved, the final pricing has
been approved and a building permit for the Tenant Improvements has been issued, Landlord shall
enter into a construction contract with its contractor for the installation of the Tenant
Improvements in accordance with the Tenant Improvement Plans. Landlord shall supervise the
completion of such work and shall use commercially reasonable efforts to secure substantial
completion of the work in accordance with the Work Schedule. The cost of such work shall be paid
as provided in Paragraph 7 hereof. Landlord shall not be liable for any direct or indirect damages
as a result of delays in construction beyond Landlords reasonable control, including, but not
limited to, acts of God, inability to secure governmental approvals or permits, governmental
restrictions, strikes, availability of materials or labor or delays by Tenant (or its architect or
anyone performing services on behalf of Tenant).
7. PAYMENT OF COST OF THE TENANT IMPROVEMENTS.
a.
Landlord hereby grants to Tenant (1) a G/204 Tenant Allowance up to and not to exceed
Twenty-Four Thousand Seven Hundred Six Dollars ($24,706.00) to be applied towards Tenant
Improvements to G/204; and (2) an H/148 Tenant Allowance up to and not to exceed Nine Thousand
One Hundred Fourteen Dollars ($9,114) to be applied towards Tenant Improvements to H/148. The
G/204 Tenant Allowance and H/148 Tenant Allowance may each be referred to herein as a Tenant
Allowance and are collectively referred to as the Tenant
Allowances. The Tenant Allowances
shall be used only for:
(1) Payment of the cost of preparing the space plan and the final working drawings and
specifications, including electrical, plumbing and structural drawings and of all other
aspects of the Tenant Improvement Plans. Without limitation, the Tenant Allowances will not be used for the
payment of (i) relocation costs; (ii) security access control equipment; (iii) interior
signage or graphics; and/or (iv) extraordinary design work not included within the scope of Landlords
building standard improvements or for payments to any other consultants, designers or
architects other than Landlords architect and/or space planner.
(2) The payment of plan check, permit and license fees relating to construction of the
Tenant Improvements.
(3) Construction of the Tenant Improvements, including, without limitation, the
following:
(a) Installation
within the Premises of all partitioning, doors, floor coverings, ceilings, wall coverings and painting, millwork and similar items.
(b) All electrical wiring, lighting fixtures, outlets and switches, and other
electrical work to be installed within the Premises.
(c) The furnishing and installation of all duct work, terminal boxes, diffusers
and accessories required for the completion of the heating, ventilation and air conditioning
systems within the Premises, including the cost of meter and key control for after-hour air
conditioning.
(d) Any additional Tenant requirements including, but not limited to, odor
control, special heating, ventilation and air conditioning, noise or vibration control or
other special systems.
(e) All fire and life safety control systems such as fire walls, sprinklers, halon,
fire alarms, including piping, wiring and accessories installed within the Premises.
(f) All plumbing, fixtures, pipes and accessories to be installed within the
Premises.
(g) Testing and inspection costs.
(h) Contractors fees, including but not limited to any fees based on general
conditions.
(4) All other costs to be expended by Landlord in the construction of the Tenant
Improvements, including those costs incurred by Landlord for construction of elements of the
Tenant Improvements in the Premises.
b. The cost of each item of the Tenant Improvements shall be charged against the applicable
Tenant Allowance. In the event that the cost of designing and constructing the Tenant
Improvements, as established by Landlords final pricing schedule, shall exceed the applicable
Tenant Allowance, or if any of the Tenant Improvements are not to be paid out of the Tenant
Allowance as provided in Paragraph 7a above, the excess shall be paid or bonded by Tenant to
Landlord prior to the commencement of construction of the Tenant Improvements.
c. In the event that, after the Tenant Improvement Plans have been prepared and a price
therefore established by Landlord, Tenant shall require any changes or substitutions to the Tenant
Improvement Plans, any additional costs thereof shall be paid by Tenant to Landlord prior to the
commencement of such work. Landlord shall have the right to decline Tenants request for a
change to the Tenant Improvement Plans it such changes are inconsistent with Paragraphs 3 and 4
above, or if the change would, in Landlords opinion, unreasonably delay construction of the Tenant
Improvements.
d. In the event that the cost of the Tenant Improvements increases as set forth in Landlords
final pricing schedule for any reason whatsoever, including without limitation the requirements of
any governmental agency, Tenant shall pay Landlord the amount of such increase within ten (10)
days of Landlords written notice; provided, however, that Landlord shall first apply toward such
increase any remaining balance in the applicable Tenant Allowance; and further provided that,
unless such cost is not covered by the available Tenant Allowance and is not received within such
ten (10) day period, Landlord will not delay its construction of the Tenant Improvements because of
such increase.
e. Any portion(s) of the Tenant Allowances that is not used by the Expansion Space Addition
Date shall be retained by Landlord; provided only that if Tenant does not use the entire G/204
Tenant Allowance, then Tenant may apply up to $4,492 of such unused portion towards the costs of
telephone and data cabling in G/204.
8. MISCELLANEOUS
Either partys default or failure to perform under this Work Letter Agreement shall be
a default under the Lease, and without limiting any other rights, the non-defaulting party shall be
entitled to all of its remedies under the Lease with respect to such default. Any amounts owed by
Tenant to Landlord under this Work Letter Agreement shall be Additional Rent owed under the Lease.
STATE OF California )
)ss.
COUNTY OF Orange )
I certify that I know or have satisfactory evidence that Derek Landry is the person who
appeared before me, and said person acknowledged that he/she signed this instrument, on oath stated
that he/she was authorized to execute the instrument and acknowledged it as the Director of
Teachers Insurance & Annuity Association of America. Inc. to be the free and voluntary act of such
party for the uses and purposes mentioned in the instrument.
Dated: 10/04/04
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/s/ Kari Mcgowan |
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(SEAL)
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(Signature) |
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Kari Mcgowan |
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(Print Name)
Notary Public, in and for the State of, CA
residing at Newport Beach
My Commission Expires 12/02/09 |
STATE OF Washington )
)ss.
COUNTY OF )
I certify that I know or have satisfactory evidence that David Kirske is the
person who appeared before me, and said person acknowledged that he/she signed this instrument,
on oath stated that he/she was authorized to execute the instrument and
acknowledged it as the CFO of Helix BioMedix, Inc. to be the free and voluntary act of
such party for the uses and purposes mentioned in the instrument.
Dated: 9-21-06
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/s/ Karen A. Martinez |
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(SEAL)
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Karen A. Maitiner |
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Notary Public, in and for the State of WA,
residing at Snohomish WA
My Commission Expires 7-17-10 |
EX-10.24
3
v26497exv10w24.htm
EXHIBIT 10.24
exv10w24
Exhibit 10.24
NON-EXCLUSIVE LICENSE AGREEMENT
This Non-Exclusive License Agreement (the Agreement) is entered into and effective as of
December 12, 2006 (Effective Date), by and between Helix BioMedix, Inc. a Delaware corporation
with its principal place of business at 22122 20th Avenue SE, Bothell, WA 98021 (Licensor), and
Grant Industries, Inc. a New Jersey corporation with its principal place of business at 103 Main
Avenue, Elmwood Park, NJ 07407 (Licensee). Licensor and Licensee each may be referred to in this
Agreement individually as a Party or collectively as the Parties.
RECITALS
WHEREAS, Licensor has developed a library of proprietary bioactive peptides; and
WHEREAS, Licensee desires to obtain a non-exclusive license to market, sell and distribute
certain of such peptides, either alone or in conjunction with other products, upon the terms and
conditions hereinafter set forth.
AGREEMENT
NOW, THEREFORE, in consideration of the premises and the mutual covenants contained herein and
other good and valuable consideration, the receipt and sufficiency of which are hereby
acknowledged, the Parties, intending to be legally bound, do agree as follows:
1 DEFINITIONS
For the purposes of this Agreement, the following words and phrases shall have the following
meanings:
1.1 Affiliate means any entity that directly or indirectly through one or more
intermediaries, controls, is controlled by or is under common control with another entity. For
purposes of this definition only, control, and, with correlative meanings, the terms controlled
by and under common control with shall mean (a) the possession, directly or indirectly, of the
power to direct the management or policies of a party, whether through the ownership of voting
securities or by contract relating to voting rights or corporate governance, or (b) the ownership,
directly or indirectly, of more than twenty-five percent (25%) of the voting securities or other
ownership interest of a party; provided that, if local law restricts foreign ownership, control
will be established by direct or indirect ownership of the maximum ownership percentage that may,
under such local law, be owned by foreign interests.
1.2 Applicable Law means the applicable laws, rules, and regulations, including any rules,
regulations, guidelines, or other requirements of the Regulatory Authorities, that may be in effect
from time to time in the Territory.
Confidential treatment has been requested for portions of this exhibit. This exhibit omits the information subject to the confidential treatment request. Omissions are designated as [***]. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.
1
1.3 Confidential Information means the terms and conditions of this Agreement, all
non-public information related to the Peptides, all Know-How, and all other information, data,
reports and other records that a Party to this Agreement receives from the other Party to this
Agreement.
1.4 GAAP means United States generally accepted accounting principles consistently applied.
1.5 Know-How means trade secrets, knowledge, information, expertise, data, materials and
know-how that are owned, have been developed and/or created or are developed during the term of
this Agreement by or for the Licensor related to the research, development, use or manufacture of
the Peptides.
1.6 Market means the cosmetic- and over-the-counter- personal-care products market.
1.7 Net Revenue means [***].
1.8
Patents means the patents and patent applications
set forth in Exhibit A.
1.9
Peptides means Licensors proprietary bioactive peptides described in Exhibit A attached to this Agreement. Licensor may add peptides that are proprietary
to Licensor to Exhibit A at its sole discretion.
1.10 Premix means a formulation other than a final formulation that is manufactured by
Licensee and that incorporates any single Peptide (as defined above), regardless of what
ingredients (of Licensee or any third party) other than Peptide may be included in such
formulation.
1.11 Regulatory Authorities means any applicable governmental entities regulating or
otherwise exercising authority in the Territory.
1.12 Royalties means the royalties payable by Licensee set forth in Exhibit C, which
shall be paid in accordance with Section 3.
1.13 Sublicensee means any third party to which rights hereunder are sublicensed in
accordance with Section 2.2 (including any further sublicensees of a sublicensee).
1.14 Territory means the countries or other geographic areas set forth in Exhibit B,
as such exhibit may be amended from time to time pursuant to the terms hereof.
2 LICENSE GRANT
2.1 License. Subject to the terms and conditions of this Agreement, Licensor hereby
grants to Licensee a non-exclusive right and license, under the Patents and the Know-How, to (i)
purchase the Peptides in pure form, at Licensees expense, from [***] or another manufacturer
[***] Certain information has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
2
approved in advance by Licensor in writing (or from Licensor, subject to availability and on
terms as may be agreed between Licensee and Licensor); (ii) formulate the Peptides into Premix;
provided that no Premix may contain more than one Peptide; and (iii) market, sell and distribute
the Premix to manufacturers in the Market in accordance with Section 2.2, in each case in the
Territory and for commercial purposes only. The licenses granted herein shall be non-exclusive, and
Licensee acknowledges and agrees that Licensor intends to grant the same or similar rights to other
parties.
2.2 Sublicense. Subject to the terms and conditions of this Agreement, Licensee may
grant rights to third parties that purchase Premix from Licensee to (i) market, sell and distribute
such Premix to manufacturers in the Market and (ii) incorporate such Premix into final products
within the Market and market, sell and distribute such final products, in each case in the
Territory and for commercial purposes only. Licensee shall notify Licensor of the identity of each
Sublicensee promptly after any sublicense of rights is made hereunder. Licensee shall recommend in
writing to each Sublicensee that Peptide (considered in pure form) be present in any final
formulation at a concentration level not less than those set forth in Exhibit A with
respect to each Peptide, and as agreed between the Parties with respect to any Peptide that may be
added to Exhibit A pursuant to Section 1.9. Further, Licensee shall use its best efforts
to prevent any use, sale, marketing or distribution of Premix or any product containing Premix by
any third party in a manner inconsistent with the terms or intent of this Agreement, and failing
such prevention, to promptly notify Licensor of any such inconsistent use, sale, marketing or
distribution by a third party.
2.3 No Other Rights. Except as expressly set forth in this Agreement, Licensor shall
retain all right, title and interest in and to the Patents, the Peptides and all Know-How, and
nothing in this Agreement shall be construed to confer any rights upon Licensee by implication,
estoppel or otherwise other than as expressly set forth in this Agreement.
2.4 Modification of Territory. Exhibit B may be amended from time to time
upon request by Licensee and with the consent of Licensor, which consent shall not be unreasonably
withheld. Without limiting the generality of the foregoing, Licensors withholding of consent shall
be deemed reasonable as to a country or geographic region if at the time of the request by
Licensee, Licensor is or is considering doing business (directly or indirectly) with respect to
such country or geographic region, which business involves or may involve any Peptide.
2.5 No Assignment of Improvements. For avoidance of doubt, Licensee does not
assign or otherwise transfer to Licensor hereunder any right, title or interest in or to any
improvements or inventions relating to, based upon, or derived from the Peptides that may be made
by Licensee in connection with its performance under this Agreement.
3 PAYMENTS
3.1 Royalties. Within thirty (30) days after the end of each calendar month during
the term of this Agreement, Licensee shall provide to Licensor records that fairly reflect the Net
[***] Certain information has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
3
Revenue attributable to such calendar month and the concentration of Peptide in any Premix
from which such Net Revenue was derived. The Royalties owing on the basis of such records shall be
invoiced to Licensee by Licensor and shall be paid by Licensee within thirty (30) days of the date
of each invoice.
3.2 Minimum Royalties. Licensee agrees to comply with the minimum Royalty payment
obligations set forth in Exhibit C hereto during the term of this Agreement.
3.3 Payment Method. All amounts payable by Licensee to Licensor pursuant to this
Agreement shall be paid in U.S. dollars by wire transfer in immediately available funds to an
account designated by Licensor. Any payments or portions thereof due hereunder which are not paid
on the date such payments are due under this Agreement shall bear interest at a rate equal to the
lesser of (i) the prime rate as published in The Wall Street Journal, Western Edition, on the first
day of each calendar month in which such payments are overdue, plus seven percentage points, or if
less, (ii) the maximum rate permitted by law, calculated on the number of days such payment is
delinquent, compounded monthly.
4 REPORTS
4.1 Progress Reports. Each month during the term, the Parties shall discuss via
teleconference or other agreed-upon means the progress of the Agreement, in connection with which
Licensee shall (a) describe any commercialization activities with respect to the Peptides and any
other work relating to the Peptides that it has performed, or caused to be performed, since the
last such report, (b) evaluate the work performed in relation to the goals of this Agreement and
Licensees work plans and (c) provide such other information as may be required by this Agreement
or reasonably requested by Licensor relating to such activities.
4.2 Record Retention. Licensee shall maintain complete and accurate books, records
and accounts that fairly reflect Peptide concentrations and quantities sold by customer in
sufficient detail and in accordance with GAAP to confirm Licensees compliance with the terms and
conditions of this Agreement and the accuracy of any payments required hereunder, which books,
records and accounts shall be retained by Licensee until the later of (i) three (3) years after the
end of the period to which such books, records and accounts pertain and (ii) such longer period as
may be required under Applicable Law.
4.3 Audit. Licensor shall have the right to have an independent certified public
accounting firm of nationally recognized standing, reasonably acceptable to Licensee, have access
during normal business hours, and upon reasonable prior written notice, to such records of the
Licensee as may be reasonably necessary to verify compliance by Licensee with the terms and
conditions of this Agreement and the accuracy of any payments required hereunder for any calendar
month ending not more than forty-eight (48) months prior to the date of such request; provided,
however, that Licensor shall not have the right to conduct more than one such audit in any twelve
(12)-month period. Licensor shall bear the cost of such audit unless the audit reveals a variance
in any payments required hereunder of more than 5%, in which case Licensee shall bear the cost of
the audit.
[***] Certain information has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
4
4.4 Payment of Additional Amounts. If, based on the results of an audit, additional
payments are owed by Licensee, it shall make such additional payments, with interest from the date
originally due at the rate of 1% per month, within thirty (30) days after the date on which the
accounting firms written report is delivered to Licensee.
4.5 Confidentiality. Licensor shall treat all information subject to review under
this Section 4 in accordance with the confidentiality provisions of Section 6 of this Agreement.
5 INFRINGEMENT
5.1 Infringement. In the event that Licensee learns of (i) any infringement of any of
the Patents or (ii) any misappropriation of any of the Know-How, Licensee shall promptly inform
Licensor in writing and Licensor may elect to initiate and prosecute legal proceedings with respect
thereto at Licensors cost and expense. In the event that Licensor elects not to pursue such legal
proceedings, Licensee shall have the right to do so at Licensees cost and expense.
5.2 Cooperation. In any infringement suit instituted by Licensor or Licensee pursuant
to this Agreement, Licensor or Licensee as the case may be shall, at the other Partys request and
expense, cooperate in all reasonable respects and, to the extent possible, have its employees
testify when requested and make available relevant records, papers, information, samples, specimens
and the like.
6 CONFIDENTIAL INFORMATION
6.1 Confidential Information. Each Party (Receiving Party) shall treat the terms
and conditions of this Agreement and all of the Confidential Information that it receives from the
other Party (Disclosing Party) as secret, confidential, and proprietary of the Disclosing Party
and shall not disclose or use such Confidential Information of the Disclosing Party without the
prior written consent of the Disclosing Party for any purpose except as expressly permitted under
this Agreement. The Receiving Party shall develop and implement such procedures as may be required
to prevent the intentional or negligent disclosure to third parties of such Confidential
Information of the Disclosing Party, including, but not limited to, requiring each of its employees
having access to Confidential Information of the Disclosing Party to enter into a proprietary
information agreement consistent with, and no less protective of the Disclosing Partys rights in
the Confidential Information than, the terms set forth in this Section 6 and in this Agreement.
Notwithstanding the foregoing, each Party shall have the right to disclose Confidential Information
as required by law (using reasonable best efforts to redact, where permitted by law), and to its
auditors, accountants, potential investors and potential acquirers under appropriate non-disclosure
agreements.
6.2 Exclusions. Notwithstanding the foregoing, nothing in this Agreement shall
prevent the disclosure or use by the Receiving Party of the Disclosing Partys Confidential
Information that:
[***] Certain information has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
5
(a) prior to the transmittal thereof to the Receiving Party was of general public knowledge;
(b) becomes, subsequent to the time of transmittal to the Receiving Party, a matter of general
public knowledge otherwise than as a consequence of a breach by the Receiving Party of any
obligation under this Agreement;
(c) is made public by the Disclosing Party;
(d) was in the possession of the Receiving Party in documentary form prior to the time of
disclosure thereof to the Receiving Party by the Disclosing Party, and is held by the Receiving
Party free of any obligation of confidence to the Disclosing Party or any third party; or
(e) is received in good faith from a third party having the right to disclose it, who did not
obtain such Confidential Information from the Disclosing Party and who imposes no obligation of
secrecy on the Receiving Party with respect to such Confidential Information.
7 REPRESENTATIONS AND WARRANTIES
7.1 Representations and Warranties of Licensor. Licensor represents and warrants
that: (i) there are no actions or claims pending, nor to the best of its knowledge, threatened,
against Licensor alleging infringement of any patent, copyright, trademark or other intellectual
property right relative to the Peptides; (ii) the grant of rights and licenses by Licensor to
Licensee under this Agreement is not inconsistent with the terms and conditions of any obligations
of Licensor; (iii) no authorization or consent is required for Licensor to grant the rights and
licenses under this Agreement or for Licensor to enter into this Agreement; and (iv) Licensor is
duly organized and in good standing in its state of incorporation.
7.2 Representations and Warranties of Licensee. Licensee represents and warrants
that: (i) the grant of rights and licenses by Licensee to Licensor under this Agreement is not
inconsistent with the terms and conditions of any obligations of Licensee; (ii) no authorization or
consent is required for Licensee to grant the rights and licenses under this Agreement or for
Licensee to enter into this Agreement; and (iii) Licensee is duly organized and in good standing in
its state of incorporation.
8 DISCLAIMER OF WARRANTIES / LIMITATIONS OF LIABILITY
8.1 Disclaimer of Warranties. EXCEPT AS OTHERWISE EXPRESSLY SET FORTH IN THIS
AGREEMENT, NEITHER PARTY OR ITS DIRECTORS, OFFICERS, STOCKHOLDERS, EMPLOYEES, AGENTS OR AFFILIATES
MAKES ANY REPRESENTATIONS OR EXTENDS ANY WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED,
INCLUDING BUT NOT LIMITED TO WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE,
VALIDITY OF PATENTS, ISSUED OR PENDING, NON-INFRINGEMENT OR THE ABSENCE OF LATENT OR OTHER DEFECTS,
WHETHER OR NOT DISCOVERABLE. NOTHING IN
[***] Certain information has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
6
THIS AGREEMENT SHALL BE CONSTRUED AS A REPRESENTATION MADE OR WARRANTY GIVEN BY LICENSOR THAT
THE PRACTICE BY LICENSEE OF THE LICENSE GRANTED HEREUNDER SHALL NOT INFRINGE THE INTELLECTUAL
PROPERTY OF ANY THIRD PARTY.
8.2 Limitation of Remedies. EXCEPT FOR EITHER PARTYS OBLIGATIONS UNDER SECTION 9
(INDEMNIFICATION) OR A BREACH OF A PARTYS OBLIGATIONS UNDER SECTION 6 (CONFIDENTIAL INFORMATION)
IN NO EVENT SHALL EITHER PARTY OR ITS DIRECTORS, OFFICERS, STOCKHOLDERS, EMPLOYEES, AGENTS OR
AFFILIATES BE LIABLE FOR INCIDENTAL OR CONSEQUENTIAL DAMAGES OF ANY KIND, INCLUDING ECONOMIC DAMAGE
OR INJURY TO PROPERTY OR LOST PROFITS, REGARDLESS OF WHETHER SUCH PARTY SHALL BE ADVISED, SHALL
HAVE OTHER REASON TO KNOW, OR IN FACT SHALL KNOW OF THE POSSIBILITY OF THE FOREGOING.
8.3 Limitation of Liability. EXCEPT FOR EITHER PARTYS OBLIGATIONS UNDER SECTION 9
(INDEMNIFICATION) OR A BREACH OF A PARTYS OBLIGATIONS UNDER SECTION 6 (CONFIDENTIAL INFORMATION),
THE MAXIMUM TOTAL LIABILITY OF ONE PARTY TO THE OTHER FOR ANY AND ALL CLAIMS RELATING TO OR ARISING
UNDER THIS AGREEMENT WILL BE LIMITED TO THE TOTAL AMOUNTS PAID UNDER THIS AGREEMENT.
EACH PARTY ACKNOWLEDGES THAT THE OTHER PARTY RELIED UPON THE INCLUSION OF THE LIMITATIONS OF
REMEDIES AND LIABILITY SET FORTH IN THIS SECTION 8 IN CONSIDERATION OF ENTERING INTO THIS
AGREEMENT.
9 INDEMNIFICATION
9.1 By Licensee. Licensee shall at all times during the term of this Agreement and
thereafter indemnify defend and hold Licensor and its directors, officers, stockholders, employees,
agents and affiliates (collectively, Licensor Indemnitees) harmless against any and all
liabilities, losses, fines, penalties, damages, expenses of any kind whatsoever, including legal
expenses and reasonable attorneys fees (collectively, Losses) that arise out of any claim,
action, demand, suit, or proceeding brought against a Licensor Indemnitee by any third party after
the Effective Date, to the extent attributable to or resulting from Licensees production,
manufacture, testing, marketing, sale, distribution, use, consumption, advertisement or promotion
of Licensees products or services (including, without limitation, any products that contain,
incorporate or are based on Peptides). Licensees indemnification obligations under this Section
9.1 shall not apply to any Losses to the extent that they are directly attributable to the grossly
negligent activities or intentional misconduct of any of the Licensor Indemnitees.
9.2 By Licensor. Licensor shall at all times during the term of this Agreement and
thereafter indemnify defend and hold Licensee and its directors, officers, stockholders, employees,
agents and affiliates (collectively, Licensee Indemnitees) harmless against any and all Losses
that arise out of any claim, action, suit, or proceeding brought against a Licensee Indemnitee by
any third party after the Effective Date, to the extent attributable to or resulting
[***] Certain information has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
7
from personal injury or death caused by a Peptide considered in isolation (and not
attributable to or resulting from the combination of any Peptide(s) with any other substance or
material or any act or omission of Licensee or a Sublicensee). Licensors indemnification
obligations under this Section 9.2 shall not apply to any Losses to the extent that they are
directly attributable to the grossly negligent activities or intentional misconduct of any of the
Licensee Indemnitees.
9.3 Certain Procedures Regarding Indemnification. All claims for indemnification
under this Agreement shall be made as follows:
(a) In the event a third-party claim, action, suit, or proceeding is made against a party entitled
to indemnification under this Section 9 (the Indemnitee) for which the Indemnitee would be
entitled to indemnification hereunder (a Claim), the Indemnitee shall notify the Indemnitor of
such Claim, specifying the nature and the amount of the Claim (the Claim Notice). The Claim
Notice must be delivered promptly after the Indemnitee becomes aware of the Claim, provided that
the failure of the Indemnitee to comply with such requirement shall not relieve the party required
to indemnify a person under Section 9 (the Indemnitor) of its obligations hereunder unless the
Indemnitor is materially prejudiced in the defense of the Claim due to such failure on the part of
the Indemnitee. The Indemnitor shall have the right to undertake and control the defense of any
Claim at its expense through counsel of its own choosing (subject to the Indemnitees consent to
such counsel, which consent may not be unreasonably withheld or delayed). If the Indemnitor
undertakes the defense of a Claim: (i) the Indemnitor shall not permit to exist any lien,
encumbrance or other adverse charge upon any asset of the Indemnitee; (ii) the Indemnitor may not
settle such action without first obtaining the written consent of the Indemnitee, which consent
will not be unreasonably withheld or delayed, except for settlements solely covering monetary
matters for which the Indemnitor acknowledges responsibility for payment; and (iii) the Indemnitor
shall permit the Indemnitee (at the Indemnitees sole cost and expense) to participate in such
settlement or defense through counsel chosen by the Indemnitee.
(b) The Indemnitee agrees to preserve and provide access to all evidence in its possession or
control that may be useful in defending against a Claim and to provide reasonable cooperation in
the defense thereof or in the prosecution of any action against a third party in connection
therewith at the Indemnitors expense. The Indemnitors defense of any Claim or demand shall not
constitute an admission or concession of liability therefor or otherwise operate in derogation of
any rights the Indemnitor may have against the Indemnitee or any third party. So long as the
Indemnitor is reasonably contesting any such Claim in good faith, the Indemnitee shall not pay or
settle any such Claim.
(c) If the Indemnitor elects not to undertake the defense of the Claim, the Indemnitee shall have
the right to assume the defense of the Claim through counsel of its own choosing and contest,
settle or compromise the Claim in the exercise of its exclusive discretion at the expense of the
Indemnitor. All reasonable expenses incurred by the Indemnitee pursuant to this Section 9.3(c)
shall be reimbursed by the Indemnitor within twenty (20) days of receipt of competent written
evidence of such expenses.
[***] Certain information has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
8
10 INSURANCE
10.1 General Liability. During the term of this Agreement, each Party shall maintain
commercial general liability insurance in amounts not less than [***] dollars ($[***]) per
occurrence and [***] dollars ($[***]) annual aggregate from an underwriter who has an A.M. Best
rating of A-VII or better, and naming the other Party as an additional insured. Such commercial
general liability insurance shall include but not be limited to contractual and product liability
coverage for each Partys indemnification obligations under Section 9 of this Agreement. The
general liability insurance shall include worldwide coverage, including defense of claims and
incidents outside of the United States and its territories. The liability policies required under
this Section 10 shall be written as primary and non-contributing to not in excess of any coverage
the other Party may choose to maintain. The minimum amounts of insurance coverage required under
this Section 10 shall not be construed to create a limit of each Partys liability with respect to
its indemnification obligations under Section 9 of this Agreement.
10.2 Notification. Each Party shall provide the other Party with written evidence of
such insurance at any time during the term of this Agreement promptly upon the request of the other
Party. Each Party shall provide the other Party with written notice at least fifteen (15) days
prior to the cancellation, non-renewal or material change in such insurance. If a Party does not
obtain replacement insurance providing comparable coverage prior to the expiration of such fifteen
(15) day period, the other Party shall have the right to terminate this Agreement effective at the
end of such fifteen (15) day period without notice or any additional waiting periods.
10.3 Term of Insurance. Each Party shall maintain such commercial general liability
insurance beyond the expiration or termination of this Agreement during the period that any
products containing, incorporating or based on any Peptide are commercially marketed, distributed
or sold by Licensee or any Sublicensee.
11 EXPORT CONTROLS
Licensee shall comply with and shall, at Sellers request, demonstrate such compliance with,
the U.S. Foreign Corrupt Practices Act and all applicable export laws, restrictions, and
regulations of any U.S. or foreign agency or authority, and shall obtain, and bear all expenses
relating to, any necessary licenses and/or exemptions with respect to the export from the U.S. by
Licensee or its agents of any Peptide (or any product or material containing, incorporating or
based on any Peptide) or any technology or information it obtains or learns pursuant to this
Agreement (or any direct product thereof).
12 MARKS
12.1 Non-Use of Marks. Licensee shall not use the names, logos, trademarks or service
marks of Licensor nor any adaptation thereof in any advertising, promotional or sales literature
without Licensors prior written consent, except that Licensee may state that it is
[***] Certain information has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
9
licensed by Licensor hereunder and may identify the inventors of Licensors patents and/or
patent applications.
13 TERMINATION
13.1 Term. The term of the Agreement shall begin on the Effective Date and shall
continue for three (3) years, unless terminated at an earlier date pursuant to the terms and
conditions set forth below in this Section 13. This Agreement shall automatically renew for
successive one (1) year terms provided the Minimum Royalty Payment requirements set forth in
Exhibit C are achieved in the prior year and unless either Party provides written notice to
the other Party at least sixty (60) days prior to the end of the applicable term.
13.2 Termination for Breach. Upon any material breach of any provision of this
Agreement by a Party (the Breaching Party), the other Party (the Non-Breaching Party) shall
have a right to give written notice thereof (Notice of Default) to the Breaching Party. If the
Breaching Party does not cure such material breach within thirty (30) days after the date of the
Notice of Default, the Non-Breaching Party shall have the right to terminate this Agreement by a
second written notice (Notice of Termination) to the Breaching Party. If the Non-Breaching Party
sends a Notice of Termination to the Breaching Party, this Agreement will automatically terminate
on the date of such Notice of Termination. Termination of the Agreement by Licensor under this
Section 13.2 shall not relieve Licensee of its obligation to pay any Royalties or other fees owing
at the time of termination, if any, and shall not impair any accrued right of Licensor hereunder.
13.3 Termination for Bankruptcy. To the extent permitted by applicable law, each
Party shall have the right to immediately terminate this Agreement by giving written notice to the
other Party, in the event the other Party: (i) provides notice of its intent to file (or does
actually file without providing said notice) a petition in bankruptcy; (ii) attempts to make an
assignment hereof for the benefit of creditors or otherwise; (iii) discontinues or dissolves its
business; or (iv) if a receiver is appointed for it.
13.4 Effect of Termination. Upon termination or expiration of this Agreement for any
reason: (i) the rights granted to Licensee hereunder shall immediately terminate; and (ii) nothing
herein shall be construed to release any party from any obligation that matured prior to the
effective date of such termination.
13.5 Survival. Sections 2.3, 3, 4.2, 4.5, 6, 8, 9, 15 and 17 of this Agreement shall
survive the termination or expiration of this Agreement.
14 NOTICES AND OTHER COMMUNICATIONS
Any notice or other communication pursuant to this Agreement shall be sufficiently made or
given if sent to such Party by certified first class mail, return receipt requested, postage
[***] Certain information has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
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prepaid, by reputable overnight courier, or by facsimile (with confirmation emission)
addressed to it at its address below or as it shall designate by written notice given to the other
Party:
In the case of Licensor:
Helix BioMedix, Inc.
22122 20th Avenue SE
Bothell, WA 98021
Fax: (425) 806-2999
Attn: President
In the case of Licensee:
Grant Industries
103 Main Avenue
Elmwood Park, NJ 07407
Fax:
Attn: President
All notices sent by first class mail shall be deemed to have been given four (4) business days
after deposit, all notices sent by overnight courier or facsimile shall be deemed to have been
given one (1) business day after deposit or transmission, as applicable.
15 DISPUTE RESOLUTION
Any controversy or claim arising out of or relating to this Agreement, or the breach thereof,
shall be settled by arbitration conducted in New York, New York and administered by the American
Arbitration Association in accordance with its Commercial Arbitration Rules, and judgment on the
award rendered by the arbitrator(s) may be entered in any court having jurisdiction thereof.
Notwithstanding the foregoing, either Party may, without waiving any remedy under this Agreement,
seek from any court having jurisdiction thereof any interim or provisional relief that is necessary
to protect the rights or property of that Party from immediate and irreparable injury, loss, or
damage.
16 PRESS RELEASES
Neither Party shall issue any press release or other similar public communication relating to
this Agreement unless approved in advance and in writing by the other Party, which approval shall
not be unreasonably withheld or delayed, except for those communications required by Applicable
Law.
[***] Certain information has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
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17 MISCELLANEOUS PROVISIONS
18.1 Force Majeure. Neither Party shall be held liable or responsible to the other
Party or be deemed to have defaulted under or breached this Agreement for failure to delay in
fulfilling or performing any term of this Agreement when such failure of delay is caused by or
results from events beyond the reasonable control of the non-performing Party, including fires,
floods, embargoes, shortages, epidemics, quarantines, war, acts of terrorism, acts of war (whether
war be declared or not), insurrections, riots, civil commotion, strikes, lockouts or other labor
disturbances, acts of God or acts, omissions or delays in acting by any governmental authority.
The non-performing Party shall notify the other Party of such force majeure within ten (10) days
after such occurrence by giving written notice to the other Party stating the nature of the event,
its anticipated duration, and any action being taken to avoid or minimize its effect. The
suspension of performance shall be of no greater scope and no longer duration than is necessary.
18.2 Assignment. Without the prior written consent of the other Party, neither Party
shall sell, transfer, assign, delegate, pledge or otherwise dispose of, whether voluntarily,
involuntarily, by operation of law or otherwise, this Agreement or any of its rights or duties
hereunder; provided, however, that Licensor may assign or transfer this Agreement or any of its
rights or obligations hereunder without the consent of the Licensee to any third party with which
it may merge or consolidate, or to which it may transfer all or substantially all of its assets.
Any purported assignment or transfer in violation of this Section 18.2 shall be void ab initio and
of no force or effect.
18.3 Severability. If any provision of this Agreement is held to be illegal, invalid
or unenforceable under any present or future law, and if the rights or obligations of either Party
under this Agreement will not be materially and adversely affected thereby, (a) such provision
shall be fully severable, (b) this Agreement shall be construed and enforced as if such illegal,
invalid or unenforceable provision had never comprised a part hereof, (c) the remaining provisions
of this Agreement shall remain in full force and effect and shall not be affected by the illegal,
invalid or unenforceable provisions or by its severance herefrom, and (d) in lieu of such illegal,
invalid or unenforceable provision there shall be added automatically as a part of this Agreement a
legal, valid and enforceable provisions as similar in terms to such illegal, invalid, or
unenforceable provision as may be possible and reasonably acceptable to the Parties herein. To the
fullest extent permitted by applicable law, each Party hereby waives any provision of law that
would render any provision prohibited or unenforceable in any respect.
18.4 Governing Law. This Agreement shall be governed by and construed in accordance
with the laws of the State of New York, without giving effect to the conflicts of law provisions
thereof.
18.5 Entire Agreement. This Agreement sets forth and constitutes the entire agreement
and understanding between the Parties with respect to the subject matter hereof and all prior
agreements, understating, promises and representations, whether written or oral, with respect
thereto are superseded hereby. Each Party confirms that it is not relying on any representations
or warranties of the other Party except as specifically set forth herein. No amendment,
modification, release or discharge shall be binding upon the Parties unless in writing and duly
executed by authorized representatives of both Parties.
[***] Certain information has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
12
18.6 No Waiver. Any term or condition of this Agreement may be waived at any time by
the Party that is entitled to the benefit hereof, but no such waiver shall be effective unless set
forth in a written instrument duly executed by or on behalf of the Party waiving such term or
condition. The waiver by either Party hereto of any right hereunder or of the failure to perform
or of a breach by the other Party shall not be deemed a waiver of any other right hereunder or of
any other breach or failure by said other Party whether of a similar nature or otherwise.
18.7 Attorneys Fees; Equitable Remedies. If either Party brings an action to enforce
any rights arising out of or relating to this Agreement, the prevailing Party in such action shall
be entitled to recover from the losing Party its reasonable fees, costs and expenses in connection
with such action, including reasonable attorneys fees. The Parties acknowledge and agree that any
breach of this Agreement will cause irreparable harm to the non-breaching party, which shall
entitle the non-breaching Party to injunctive relief in addition to all other available legal
remedies.
18.8 No Benefit to Third Parties. The representations, warranties, covenants and
agreement set forth in this Agreement are for the sole benefit of the Parties hereto and their
successors and permitted assigns, and they shall not be construed as conferring any rights on any
other parties.
18.9 Further Assurances. Each Party shall duly execute and deliver, or cause to be
duly executed and delivered, such further instruments and do and cause to be done such further acts
and things, including the filing of such assignments, agreements, documents and instruments, as may
be necessary or as the other Party may reasonably request in connection with this Agreement or to
carry out more effectively the provisions and purposes, or to better assure and confirm unto such
other Party its rights and remedies under this Agreement.
18.10 Construction. Except where the context otherwise requires, wherever used, the
singular shall include the plural, the plural the singular, the use of any gender shall be
applicable to all genders and the word or is used in the inclusive sense (and/or). The captions
of this Agreement are for convenience of reference only and in no way define, describe, extend or
limit the scope or intent of this Agreement or the intent of any provision contained in this
Agreement. The term including as used here mean including, without limiting the generality of
any description preceding such term. The language of this Agreement shall be deemed to be the
language mutually chosen by the Parties and no rule of strict construction shall be applied against
either Party hereto.
[Signature page follows]
[***] Certain information has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
13
IN WITNESS WHEREOF, the parties have caused this Agreement to be executed by their duly
authorized representatives as of the date set forth above.
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GRANT INDUSTRIES |
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By:
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/s/ R. Stephen Beatty
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By:
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/s/ David Granatell |
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Name:
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R. Stephen Beatty
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David Granatell |
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Title:
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President
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Title:
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Executive Director |
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[SIGNATURE PAGE TO NON-EXCLUSIVE LICENSE AGREEMENT]
EXHIBIT A
Patents, Peptides, and Minimum Recommended Concentrations
Patents:
[***]
Peptides:
[***]
Minimum Recommended Concentrations (for final, marketable formulations after dilution of
Premix):
[***]
Maximum percentage of Peptide in Premix product: [***]%.
[***] Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
EXHIBIT B
Territory
[***]
[***] Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
EXHIBIT C
Royalty Rates and Minimums
Royalties
Licensee shall pay to Licensor Royalties in the amount of [***] percent ([***]%) of all Net
Revenue, in accordance with the terms set forth in the Agreement.
Minimum Royalty Payments:
Licensor
shall have the right to terminate this Agreement and/or remove a Peptide from Exhibit A (at Licensors option) if Licensee fails to make the following minimum royalty
payments for the applicable calendar year during the term of this Agreement:
[***]
Should Licensor exercise its right to terminate this Agreement or remove a Peptide from
Exhibit A due to Licensees failure to meet minimum royalty payments, Licensee may, during
the one-year period following notice from Licensor to Licensee of such termination or removal,
continue to sell Premix (or Premix containing such removed Peptide, as the case may be) solely to
Sublicensees existing as of the date of such notice, subject to the other terms of this Agreement.
[***] Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
EX-23.1
4
v26497exv23w1.htm
EXHIBIT 23.1
exv23w1
Exhibit 23.1
Consent of Independent Registered Public Accounting Firm
The Board of Directors
Helix BioMedix, Inc.
We consent to the incorporation by reference in the registration statement (No. 333-136192) on Form
S-8 of Helix BioMedix, Inc. of our report dated March 26, 2007, with respect to the balance sheets
of Helix BioMedix, Inc. (a development stage company) as of December 31, 2006 and 2005, and the
related statements of operations, stockholders equity (deficit), and cash flows for the years then
ended and for the period from November 7, 1988 (inception) to December 31, 2006, which report
appears in the December 31, 2006 annual report on Form 10-KSB of Helix BioMedix, Inc. The
cumulative statements of operations, stockholders equity (deficit), and cash flows for the period
November 7, 1988 (inception) to December 31, 2006 include amounts for the period from November 7,
1988 (inception) to December 31, 1988 and for each of the years in the thirteen-year period ending
December 31, 2001, which were audited by other auditors whose report has been furnished to us, and
our opinion, insofar as it relates to the amounts included for the period November 7, 1988 through
December 31, 2001, is based solely on the report of other auditors.
Our report refers to Helix BioMedix, Inc.s adoption of Financial Accounting
Standards Board Statement of Financial Accounting Standards No 123(R), Share-Based Payment,
effective January 1, 2006.
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KPMG LLP
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Seattle, Washington
March 26, 2007 |
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EX-23.2
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v26497exv23w2.htm
EXHIBIT 23.2
exv23w2
Exhibit 23.2
Consent of Independent Registered Public Accounting Firm
The Board of Directors
Helix BioMedix, Inc.
We consent to the incorporation by reference in the registration statement (No. 333-136192) on Form
S-8 of Helix BioMedix, Inc. of our report dated February 1, 2002, with respect to the statements of
operations, cash flows, and changes in stockholders equity (deficit) of Helix BioMedix, Inc. (a
development stage company) related to the period from inception (November 7, 1988) to December 31,
2001, which report appears in the annual report on Form 10-KSB of Helix BioMedix, Inc. for the
fiscal year ended December 31, 2006.
/S/COMISKEY & COMPANY
PROFESSIONAL CORPORATION
Denver, Colorado
March 26, 2007
EX-31.1
6
v26497exv31w1.htm
EXHIBIT 31.1
exv31w1
Exhibit 31.1
CERTIFICATION PURSUANT TO RULE 13a-14(a) OR RULE 15d-14(a) OF THE SECURITIES EXCHANGE ACT OF 1934
I, R. Stephen Beatty, certify that:
| |
1. |
|
I have reviewed this Annual Report on Form 10-KSB of Helix BioMedix, Inc.; |
| |
| |
2. |
|
Based on my knowledge, this report does not contain any untrue statement of a material
fact or omit to state a material fact necessary to make the statements made, in light of
the circumstances under which such statements were made, not misleading with respect to the
period covered by this report; |
| |
| |
3. |
|
Based on my knowledge, the financial statements, and other financial information
included in this report, fairly present in all material respects the financial condition,
results of operations and cash flows of the small business issuer as of, and for, the
periods presented in this report; |
| |
| |
4. |
|
The small business issuers other certifying officer and I are responsible for
establishing and maintaining disclosure controls and procedures (as defined in Exchange Act
Rules 13a-15(e) and 15d-15(e)) for the small business issuer and we have: |
| |
a. |
|
Designed such disclosure controls and procedures, or caused such
disclosure controls and procedures to be designed under our supervision, to ensure
that material information relating to the small business issuer, including its
consolidated subsidiaries, is made known to us by others within those entities,
particularly during the period in which this report is being prepared; |
| |
| |
b. |
|
Evaluated the effectiveness of the small business issuers disclosure
controls and procedures and presented in this report our conclusions about the
effectiveness of the disclosure controls and procedures, as of the end of the
period covered by this report based on such evaluation; and |
| |
| |
c. |
|
Disclosed in this report any change in the small business issuers
internal control over financial reporting that occurred during the small business
issuers most recent fiscal quarter (the small business issuers fourth fiscal
quarter in the case of an annual report) that has materially affected, or is
reasonably likely to materially affect, the small business issuers internal
control over financial reporting; and |
| |
5. |
|
The small business issuers other certifying officer and I have disclosed, based on our
most recent evaluation of internal control over financial reporting, to the small business
issuers auditors and the audit committee of the small business issuers board of directors
(or persons performing the equivalent functions): |
| |
a. |
|
All significant deficiencies and material weaknesses in the design or
operation of internal control over financial reporting which are reasonably likely
to adversely affect the small business issuers ability to record, process,
summarize and report financial information; and |
| |
| |
b. |
|
Any fraud, whether or not material, that involves management or other
employees who have a significant role in the small business issuers internal
control over financial reporting. |
Date: March 26, 2007
| |
|
|
|
|
| |
|
|
| |
/s/ R. Stephen Beatty
|
|
| |
R. Stephen Beatty |
|
| |
President and Chief Executive Officer |
|
| |
EX-31.2
7
v26497exv31w2.htm
EXHIBIT 31.2
exv31w2
Exhibit 31.2
CERTIFICATION PURSUANT TO RULE 13a-14(a) OR RULE 15d-14(a) OF THE SECURITIES EXCHANGE ACT OF 1934
I, David H. Kirske, certify that:
| |
1. |
|
I have reviewed this Annual Report on Form 10-KSB of Helix BioMedix, Inc.; |
| |
| |
2. |
|
Based on my knowledge, this report does not contain any untrue statement of a material
fact or omit to state a material fact necessary to make the statements made, in light of
the circumstances under which such statements were made, not misleading with respect to the
period covered by this report; |
| |
| |
3. |
|
Based on my knowledge, the financial statements, and other financial information
included in this report, fairly present in all material respects the financial condition,
results of operations and cash flows of the small business issuer as of, and for, the
periods presented in this report; |
| |
| |
4. |
|
The small business issuers other certifying officer and I are responsible for
establishing and maintaining disclosure controls and procedures (as defined in Exchange Act
Rules 13a-15(e) and 15d-15(e)) for the small business issuer and we have: |
| |
a. |
|
Designed such disclosure controls and procedures, or caused such
disclosure controls and procedures to be designed under our supervision, to ensure
that material information relating to the small business issuer, including its
consolidated subsidiaries, is made known to us by others within those entities,
particularly during the period in which this report is being prepared; |
| |
| |
b. |
|
Evaluated the effectiveness of the small business issuers disclosure
controls and procedures and presented in this report our conclusions about the
effectiveness of the disclosure controls and procedures, as of the end of the
period covered by this report based on such evaluation; and |
| |
| |
c. |
|
Disclosed in this report any change in the small business issuers
internal control over financial reporting that occurred during the small business
issuers most recent fiscal quarter (the small business issuers fourth fiscal
quarter in the case of an annual report) that has materially affected, or is
reasonably likely to materially affect, the small business issuers internal
control over financial reporting; and |
| |
5. |
|
The small business issuers other certifying officer and I have disclosed, based on our
most recent evaluation of internal control over financial reporting, to the small business
issuers auditors and the audit committee of the small business issuers board of directors
(or persons performing the equivalent functions): |
| |
a. |
|
All significant deficiencies and material weaknesses in the design or
operation of internal control over financial reporting which are reasonably likely
to adversely affect the small business issuers ability to record, process,
summarize and report financial information; and |
| |
| |
b. |
|
Any fraud, whether or not material, that involves management or other
employees who have a significant role in the small business issuers internal
control over financial reporting. |
Date: March 26, 2007
| |
|
|
|
|
| |
|
|
| |
/s/ David H. Kirske
|
|
| |
David H. Kirske |
|
| |
Vice President and Chief Financial Officer |
|
| |
EX-32.1
8
v26497exv32w1.htm
EXHIBIT 32.1
exv32w1
Exhibit 32.1
CERTIFICATION OF CHIEF EXECUTIVE OFFICER PURSUANT TO 18 U.S.C. SECTION 1350
I, R. Stephen Beatty, President and Chief Executive Officer of Helix BioMedix, Inc. (the
Company), certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002, that:
| |
1. |
|
the Annual Report on Form 10-KSB of the Company for the year ended December 31, 2006
(the Report) fully complies with the requirements of Section 13(a) or 15(d) of the
Securities Exchange Act of 1934; and |
| |
| |
2. |
|
the information contained in the Report fairly presents, in all material respects, the
financial condition and results of operations of the Company as of December 31, 2006. |
Date: March 26, 2007
| |
|
|
|
|
| |
|
|
| |
/s/ R. Stephen Beatty
|
|
| |
R. Stephen Beatty |
|
| |
President and Chief Executive Officer |
|
| |
EX-32.2
9
v26497exv32w2.htm
EXHIBIT 32.2
exv32w2
Exhibit 32.2
CERTIFICATION OF CHIEF FINANCIAL OFFICER PURSUANT TO 18 U.S.C. SECTION 1350
I, David H. Kirske, Vice President and Chief Financial Officer of Helix BioMedix, Inc. (the
Company), certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002, that:
| |
1. |
|
the Annual Report on Form 10-KSB of the Company for the year ended December 31, 2006
(the Report) fully complies with the requirements of Section 13(a) or 15(d) of the
Securities Exchange Act of 1934; and |
| |
| |
2. |
|
the information contained in the Report fairly presents, in all material respects, the
financial condition and results of operations of the Company as of December 31, 2006. |
Date: March 26, 2007
| |
|
|
|
|
| |
|
|
| |
/s/ David H. Kirske
|
|
| |
David H. Kirske |
|
| |
Vice President and Chief Financial Officer |
|
| |
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