10-K 1 v155552_10k.htm
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
 
FORM 10-K
 
(Mark One)
x           ANNUAL REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
 
For the fiscal year ended December 31, 2008
 
OR
 
¨           TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
 
For the transition period from ______________________________ to ______________________________
 
Commission file number 000-19724
 
PROTEIN POLYMER TECHNOLOGIES, INC.
(Exact name of registrant as specified in its charter)
 
Delaware
33-0311631
(State or other jurisdiction of
incorporation or organization)
(I.R.S. Employer Identification No.)

11494 Sorrento Valley Road, San Diego, CA 92121
(Address of principal executive offices) (Zip Code)
 
Issuer’s telephone number: (858) 558-6064
 
Securities registered pursuant to Section 12(b) of the Exchange Act: None
 
Securities registered pursuant to Section 12(g) of the Exchange Act:
Common Stock
(Title of Class)
 
Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act.    Yes  ¨    No  x
 
Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act.    Yes  ¨    No  x
 
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 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   x     No   ¨ 
 
Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K is not contained herein, and will not be contained, to the best of registrant’s knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to this Form 10-K.  x
 
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. (as defined in Rule 12b-2 of the Exchange Act).  Check one:
 
Large accelerated filer  ¨
Accelerated Filer  ¨
Non-accelerated filer  ¨
Smaller reporting company  x

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act).    Yes  ¨    No  x 
 
The aggregate market value of the voting common equity held by non-affiliates computed by reference to the price at which the common equity sold, or the average bid and asked price of such common equity, as of June 30, 2009, the last business day of the issuer’s most recently completed second fiscal quarter, was $974,497. Stock held by directors, officers, and shareholders owning 5% or more of the outstanding common equity (as reported on Schedules 13D and 13G) were excluded as they may be deemed to be affiliates. This determination of affiliate status is not a conclusive determination for any other purpose. The number of shares of the registrant’s common equity outstanding as of June 30, 2009 was 112,959,272.
 
Documents Incorporated by Reference: None

 

 

PROTEIN POLYMER TECHNOLOGIES, INC.
 
FORM 10-K
FOR THE FISCAL YEAR ENDED DECEMBER 31, 2008
 
TABLE OF CONTENTS
 
   
Page
     
PART I
   
 
Item 1.
Business
 
2
 
Item 1A.
Risk Factors
 
14
 
Item 1B.
Unresolved Staff Comments
 
18
 
Item 2.
Properties
 
18
 
Item 3.
Legal Proceedings
 
19
 
Item 4.
Submission of Matters to a Vote of Security Holders
 
19
     
PART II
   
 
Item 5.
Market for Common Equity, Related Stockholder Matters and Small Business Issuer Purchases of Equity Securities
  20
 
Item 6.
Selected Financial Data
 
21
 
Item 7.
Management’s Discussion and Analysis of Financial Condition and Results of Operations
 
21
 
Item 7A.
Quantitative and Qualitative Disclosures about Market Risk
 
25
 
Item 8.
Financial Statements and Supplementary Data
 
F-1
 
Item 9.
Changes in and Disagreements with Accountants on Accounting and Financial Disclosure
 
26
 
Item 9A.
Controls and Procedures
 
26
 
Item 9B.
Other Information
 
28
     
PART III
   
 
Item 10.
Directors and Executive Officers of the Registrant
 
28
 
Item 11.
Executive Compensation
 
30
 
Item 12.
Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
 
33
 
Item 13.
Certain Relationships and Related Transactions
 
36
 
Item 14.
Principal Accountant Fees and Services
 
37
         
PART IV
   
 
Item 15.
Exhibits and Financial Statement Schedules
 
38
 
 Signatures
     

 
1

 

PART I

Item 1.
Business
 
Forward Looking Statements
 
Certain statements contained or incorporated by reference in this Annual Report on Form 10-K constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause actual results, performance or achievements of the company, or industry results, to be materially different from any future results, performance or achievements expressed or implied by forward-looking statements. Such risks and uncertainties include, among others, history of operating losses, raising adequate capital for continuing operations, early stage of product development, scientific and technical uncertainties, competitive products and approaches, reliance upon collaborative partnership agreements and funding, regulatory testing and approvals, patent protection uncertainties and manufacturing scale-up and required qualifications. While these statements represent management’s current judgment and expectations for the company, such risks and uncertainties could cause actual results to differ materially from any future results suggested herein. We undertake no obligation to release publicly the results of any revisions to these forward-looking statements to reflect events or circumstances arising after the date hereof.
 
Company and Technology Background
 
Protein Polymer Technologies, Inc. (hereafter the “Company” or “we”), a Delaware corporation, is a biotechnology company incorporated on July 6, 1988. We are engaged in the research, development and production of bio-active devices to improve medical and surgical outcomes. Through our patented technology to produce proteins of unique design, biological and physical product components are integrated to provide for optimized clinical performance.
 
We are focused on developing products to improve medical and surgical outcomes, based on an extensive portfolio of proprietary biomaterials. Biomaterials are materials that are used to direct, supplement, or replace the functions of living systems. The interaction between materials and living systems is dynamic. It involves the response of the living system to the materials (e.g., biocompatibility) and the response of the materials to the living system (e.g., remodeling). The requirements for performance within this demanding biological environment have been a critical factor in limiting the possible metal, polymer, and ceramic compositions to a relatively small number that to date have been proven useful in medical devices implanted within the body.
 
The goal of biomaterials development historically has been to produce inert materials, i.e., materials that elicit little or no response from the living system. However, we believe that such conventional biomaterials are constrained by their inability to convey appropriate messages to the cells that surround them, the same messages that are conveyed by proteins in normal human tissues.
 
The products we have targeted for development are based on a new generation of biomaterials which have been designed to be recognized and accepted by human cells to aid in the natural process of bodily repair, (including the healing of tissue and the restoration or augmentation of its form and function) and, ultimately, to promote the regeneration of tissues. We believe that the successful realization of these properties will substantially expand the role that artificial devices can play in the prevention and treatment of human disability and disease, and enable the culture of native tissues for successful reimplantation.

 
2

 

Through our proprietary core technology, we produce high molecular weight polymers that can be processed into a variety of material forms such as gels, sponges, films, and fibers, with their physical strength and rate of resorption tailored to each potential product application. These polymers are constructed of the same amino acids as natural proteins found in the body. We have demonstrated that our polymers can mimic the biological and chemical functions of natural proteins and peptides, such as the attachment of cells through specific membrane receptors and the ability to participate in enzymatic reactions, thus overcoming a critical limitation of conventional biomaterials. In addition, materials made from our polymers have demonstrated excellent biocompatibility in a variety of preclinical safety studies.
 
Our patented core technology enables messages that direct activities of cells to be precisely formulated and presented in a structured environment similar to what nature has demonstrated to be essential in creating, maintaining and restoring the body’s functions. Our protein polymers are made by combining the techniques of modern biotechnology and traditional polymer science. The techniques of biotechnology are used to create synthetic genes that direct the biological synthesis of protein polymers in recombinant microorganisms. The methods of traditional polymer science are used to design novel materials for specific product applications by combining the properties of individual “building block” components in polymer form.

In contrast to natural proteins, either isolated from natural sources or produced using traditional genetic engineering techniques, our technology results in the creation of new proteins with unique properties. We have demonstrated an ability to create materials that:
 
 
 
combine properties of different proteins found in nature;
 
 
reproduce and amplify selected activities of natural proteins;
 
 
eliminate undesired properties of natural proteins; and
 
 
incorporate synthetic properties via chemical modifications
 
This ability is fundamental to our current primary product research and development focus — tissue repair and regeneration. Tissues are highly organized structures made up of specific cells arranged in relation to an extracellular matrix (“ECM”), which is principally composed of proteins. The behavior of cells is determined largely by their interactions with the ECM. Thus, the ability to structure the cells’ ECM environment allows the protein messages they receive — and their activity — to be controlled.
 
Fundamental Protein Polymers
 
Our primary products under development are based on protein polymers combining selected properties from two of the most extraordinary structural proteins found in nature: silk and elastin. Silk, based upon its crystalline structure, has long been known as an incredibly strong material, and has a long history of medical use in humans as a material for sutures. Elastin fibers are one of the most remarkable rubber-like materials ever studied. Found in human tissues such as skin, lungs and arteries, elastin fibers must expand and contract over a lifetime, and can be extended nearly three times their resting length without damaging their flexibility.

 
3

 

Despite the incredible individual properties of silk and elastin, neither of these natural protein materials is capable of being processed into forms other than what nature has provided without destroying their valuable materials properties. However, our proprietary technology has enabled the creation of polymers that combine the repeating blocks of amino acids responsible for the strength of silk and the elasticity of elastin. New combinations of properties suitable for various medical applications have been created by precisely varying the number and sequence of the different blocks in the assembled protein polymer.
 
We have also created protein polymers based on repeating blocks of amino acids found in two other classes of structural proteins found in nature: collagen and keratin. Collagen is the principal structural component of the body, found in some shape or form in virtually every tissue, ranging from shock absorbing cartilage to light transmitting corneas. Keratin is a major component in hair, nails and skin. The development of materials based on these polymers is at an early stage of research.
 
We are focused internally on developing protein polymers that are useful in products for (1) tissue augmentation, (2) tissue adhesives and sealants, and (3) drug delivery devices. Our products are based on a new generation of biomaterials designed to aid in the process of bodily repair by promoting the healing of tissue and restoration or augmentation of its form and function. These platform biomaterials are genetically engineered, high molecular weight proteins, processed into products with tailored physical structure and biological characteristics.
 
Our internal product development efforts are targeted toward a variety of markets based on a common biomaterials platform. These include: injectable disc nucleus for the treatment of injured or degenerated spinal discs, strong and fast-setting, resorbable surgical sealants for use in general and cardiovascular procedures following primary wound closure, adhesion barriers, scaffolds for wound healing and tissue engineering. Other markets of interest, which are in an earlier stage of development, include those for drug delivery devices.
 
We have also developed coating technology that can efficiently modify and improve the surface properties of traditional biomedical devices. Our primary goal is to develop medical products for use inside the body with significantly improved patient outcomes as compared to current products and practices.

Product Candidates and Anticipated Markets for Protein Polymer Technology
 
Our protein polymer technology and materials have the potential to create products useful in a variety of medical markets. Opportunities for research and development of product candidates for other medical uses continue to be evaluated.
 
All of these product candidates are subject to preclinical and clinical testing requirements for obtaining FDA and international regulatory authorities’ marketing approvals. The actual development of product candidates, if any, will depend on a number of factors, including the availability of funds required to research, develop, test and obtain necessary regulatory approvals; the anticipated time to market; the potential revenues and margins that may be generated if a product candidate is successfully developed and commercialized; and the Company’s assessment of the potential market acceptance of a product candidate.

 
4

 

Surgical Tissue Sealants (STS): Certain tissue adhesives and sealants that seek to avoid the limitations of sutures, staples, pins and screws have been developed and marketed for a number of years outside the United States by other parties. In the United States, approved products have fallen into several categories. DermaBond® (not our trademark), a synthetic cyanoacrylate adhesive, is approved for topical application to close skin incisions and lacerations. Cyanoacrylate adhesives set fast and have high strength, but form brittle plastics that do not resorb. This limitation restricts their use to bonding the outer surfaces of skin together. Tisseel® (not our trademark), a fibrin sealant, is approved for use as an adjunct to hemostasis in surgery. Fibrin sealants have excellent hemostatic properties, but are derived from human and/or animal blood products, set slowly, have low strength, and lose their strength rapidly.

A third category of tissue adhesives combines natural proteins such as collagen or albumin with synthetic cross-linking agents such as gluraraldehyde. Such products were originally marketed in Europe for limited, life-threatening indications and the FDA approved one such product, BioGlue® (not our trademark), in 2001 for use as an adjunct to sutures and staples in open surgery to repair large arteries. The aldehyde cross-linking agents employed in such products (i.e., glutaraldehyde, formaldehyde) are known to cause adverse tissue reactions. DuraSeal® (not our trademark), a sealant product composed of a synthetic polymer called polyethylene glycol, is a relatively weak sealant approved for use in neurosurgery. To date, none of the products available in the U.S. for use inside the body have found widespread acceptance among surgeons, for reasons ranging from their lack of performance based on properties such as adhesiveness, flexibility, and resorption rate, complexity of use, or concerns about the perceived benefit to risk.

We have developed surgical adhesives and sealants that are easy for the surgeon to use, and that combine the biocompatibility of fibrin glues (without the risks associated with use of blood-derived products) with the high strength and fast setting times of cyanoacrylates. Unique features include significant strength and elasticity within the adhesive matrix (to move as tissues move) and the capability of tailoring the resorption rate of the adhesive matrix to the rate at which the wound heals. A non-resorbable adhesive or sealant can only be used where the damaged tissues are not going to grow together. Otherwise, a barrier to wound healing is unavoidably created.

We have demonstrated both the adhesive performance and the biocompatibility of our product formulations in preclinical studies, including resorption of the adhesive matrix in conjunction with the progression of wound healing. As a result of our evaluations of the unmet surgeon needs, the properties achievable with our technology and the capabilities of competitive technologies, specific applications providing the most significant opportunities have been targeted.

Sealant Performance/Properties

 
 
·
Sets quickly to an adhesive hydrogel.
  
 
·
Adheres well to tissue, seals gas and fluid leaks.
  
 
·
Minimal material swelling.
 
 
·
Resorbable and non-resorbable formulations.
 
 
·
Two absorption rates.
 
 
·
Reduces post-operative adhesions.

 
5

 

Our tissue adhesive technology combines a silk-elastin polymer designed specifically to react with a biocompatible cross-linking agent under physiological conditions. Two fluid components are mixed just prior to their delivery to the treatment site, which can be accomplished through a fine gauge needle and in spray form. The material then rapidly cures to a tough, elastic hydrogel that strongly adheres to surrounding tissues.

Wound Healing & Tissue Regeneration: The current market for wound care products is highly segmented, involving a variety of different approaches to wound care. Products currently marketed and being developed by other parties includes fabric dressings (such as gauze), synthetic materials (such as polyurethane films) and biological materials (such as growth factors and living tissue skin graft substitutes). While the type of product used varies depending on the type of wound and the extent of tissue damage, we believe that a principal treatment goal in all instances is to stimulate wound healing while regenerating functional (as opposed to scar) tissue.

We have developed protein polymers that we believe may be useful in the treatment of dermal wounds, particularly chronic wounds such as decubitous ulcers, where both reconstruction of the extracellular matrix ("ECM") and re-establishment of its function are desired. These polymers, based on key ECM protein sequence blocks, are biocompatible, fully resorbable and have been processed into gels, sponges, films and fibrous sheets. We believe that such materials, if successfully developed, could improve the wound-healing process by providing physical support in situ for cell migration and tissue regeneration and as delivery systems for growth factors. Additionally, such materials may serve as scaffolds for the ex vivo production of living tissue substitutes.

Urethral Bulking Agent (UBA) - Polymer 47K: UBA effectively relieves female stress incontinence by injecting liquid that rapidly changes to long-lasting solid bulk to the tissue surrounding the urethra. Our UBA injection procedure, an alternative to surgery, most often requires only one treatment. UBA is a more effective and longer lasting bulking agent than the competition. The UBA gel is resistant to migration. A human clinical feasibility study has been completed.

Manufacturing, Marketing and Distribution

Preclinical and clinical testing of potential medical device products, where the results will be submitted to the FDA, requires compliance with the FDA’s Good Laboratory Practices (“GLP”) and other Quality System Regulations (“QSR”). We implemented polymer production and quality control procedures and made certain facilities renovations to operate in conformance with FDA requirements in our former facilities.  However, the lease on these facilities expired on April 30, 2008.  The Company did not renew the facilities lease and vacated the premises on expiration of the lease. We have relocated our administrative offices and are outsourcing our laboratory and production facilities.    See “Item 2. Properties” below.  Accordingly, we cannot assure that our polymer production capacity will be sufficient in the future to satisfy applicable regulatory requirements and/or supply our development programs with the required quality and quantity of materials needed for feasibility and preclinical testing and initial (“pilot”) clinical testing. We will require additional manufacturing capacity to expand beyond initial clinical trials.
 
We are considering several methods for increasing production of our biomedical product candidates to meet pivotal clinical trial and commercial requirements. For example, we may establish external contract manufacturing arrangements for needed quantities of materials. However, we cannot assure that such arrangements, if desired, could be entered into or maintained on acceptable terms, if at all, or that the existence or maintenance of such arrangements would not adversely affect our margins or our ability to comply with applicable governmental regulations. The actual method or combination of methods that we may ultimately pursue will depend on a number of factors, including availability, cost and our assessment of the ability of such production methods to meet our commercial objectives.

 
6

 

Research and Development
 
Local Drug Delivery: Oral delivery of drugs is the most preferred route of administration. However, for many drugs this is not possible, and alternative drug delivery routes are required. Alternative routes include transdermal, mucosal, and by implantation or injection. For implantation or injection, it is often desirable to extend the availability of the drug in order to minimize the frequency of these invasive procedures. A few materials have been commercialized which act as depots for a drug when implanted or injected, releasing the drug over periods ranging from one month to several years. Other material and drug combinations are being developed by third parties. We believe that the properties of these materials for such applications can be substantially improved upon, making available the use of depot systems for a wider range of drugs and applications.
 
Our tissue augmentation products, our surgical adhesive and sealant formulations, and our wound healing matrices all provide platforms for drug delivery applications, serving as controlled release drug depots. The protein polymer materials we have developed exhibit exceptional biocompatibility, provide for control over rates of resorption, and are fabricated using aqueous solvent systems at ambient temperatures — attributes that can be critical in maintaining the activity of the drug, particularly protein-based drugs emerging from the biotechnology industry. This program is in the preclinical research stage.

Collaborative and License Agreements
 
Because of the highly technical focus of our business, we must conduct extensive research and development prior to any commercial production of our biomedical products or the biomaterials from which they are created. During this development stage, our ability to generate revenues is limited. Because of this limitation, we do not have sufficient resources to devote to extensive testing or marketing of our products. Our primary method to expand our product development, testing and marketing capabilities is to seek to form collaborative arrangements with selected corporate partners with specific resources that we believe complement our business strategies and goals.
 
Spine Wave, Inc.

Low back pain is the leading cause for healthcare expenditures in the United States, resulting in more than $50 billion in direct and indirect medical expense, and products used to treat it are the fastest growing major segment of the orthopedic industry, with a market of $2.1 billion in revenues and a growth rate of more than 25% annually, according to a February 2000 Viscogliosi Bros., LLC., Spine Industry Analysis Series report. The leading surgical treatments for spine include spinal fusions, discectomies, and laminectomies, but the market for disc replacement and repair is expected to grow more rapidly than other treatments as new products are approved over the next five years.

We are a technology partner with Spine Wave, Inc. (hereafter “Spine Wave”). We used our patented tissue adhesive technology to create Spine Wave’s NuCoreÔ intervertebral disc repair material.

The spine supports about one-half of the body’s weight and is a highly flexible structure. The spinal disc is like a jelly-filled tire between the bony vertebrae, a key component providing for flexibility and acting as a shock absorber. It has no blood supply and thus is not able to repair itself. Exposure to heavy loads or extreme twisting motions can cause tears in the outer portion of the disc, allowing the jelly-like material (the nucleus) to extrude. Additionally, with age the disc degenerates. Injury to the disc or degeneration of the disc, results in fundamental changes in its mechanical properties, and also impacts surrounding tissues in a variety of ways, which can result in persistent pain.

 
7

 

Currently, there are no satisfactory minimally invasive surgical treatments available for chronic low back pain due to damaged or deteriorated discs. In extreme cases, a spinal fusion may be performed to limit the mobility of the joint.  In other cases, the disk maybe removed and an artificial disk implanted.  However, these procedures require invasive surgeries, and in some cases they result in restricted mobility, leading to further degeneration of the spine.

A number of products are reported to be in development, ranging from complete replacement with an artificial disc to implantation of “pillows” within the disc space. We and Spine Wave believe an injectable product that can be used in an outpatient procedure, avoiding surgery required for implants and thus minimizing additional damage to the disc and/or surrounding structures will be a preferred approach. Collaborative feasibility studies have demonstrated that the injectable disc nucleus product has physical properties mimicking those of the natural nucleus; is able to withstand the large, cyclical forces seen by the human spine; and resists expulsion under high loads due to its adherence to the disc wall.

Spine Wave’s NuCore™ Injectable Nucleus device, based on our patented tissue adhesive technology, is an injectable protein polymer formulation for repair of spinal discs damaged as a result of injury or aging. Injected in a liquid form, the NuCore™ material rapidly cures to a gel that has physical properties which mimic those of the natural nucleus. Spine Wave has enrolled patients in Degenerative Disc Disease and microdiscectomy studies of the NuCore™ Injectable Nucleus device in four countries: Switzerland, Australia, Germany and the United States.

We created this core technology and manufactured the product for Spine Wave, Inc.’s U.S. and European trials. Spine Wave has contracted to a third party, the manufacture of recombinant protein for NuCore™ Injectable Nucleus for commercial in-market supply.
  
Genencor International, Inc.
 
In December 2000, we signed a broad-based, worldwide exclusive license agreement with Genencor International, Inc. (hereafter “Genencor”) enabling Genencor, potentially, to develop a variety of new products for industrial markets. In October 2002, the license agreement was amended to provide Genencor with an additional one-year option to initiate development in the field of non-medical personal care products.
 
In March 2005, the license was amended to fully incorporate the field of personal care products into the license. As a result of the agreements, Genencor may use our patented protein polymer design and production technology, in combination with Genencor's extensive gene expression, protein design, and large-scale manufacturing technology, to design and develop new products with improved performance properties for defined industrial fields and the field of non-medical personal care products.
 
In return for the licensed rights, Genencor paid the Company an up-front license fee of $750,000, and will pay royalties on the sale of any products commercialized by Genencor under the agreement. The licensed technology was transferred to Genencor upon execution of the license agreement without any further product development obligation on our part. Future royalties on the net sales of products incorporating the technology under license and developed by Genencor will be calculated based on a royalty rate to be determined at a later date. In addition, we are entitled to receive up to $5 million in milestone payments associated with Genencor’s achievement of various industrial product development milestones incorporating the licensed technology. In March 2005 we received a second license milestone payment of $250,000 from Genencor for Genencor’s initiation of a product development project based on technology licensed from us.

 
8

 

Both warrants have subsequently expired. The agreement terminates on the date of expiration of the last remaining patent.
 
On October 9, 2006, our license agreement with Genencor was amended. The amendment essentially provided for (i) the immediate funding of a $100,000 payment under the existing agreement, (ii) modification of the royalty percentage from a variable rate concept to a single rate of 2% of Genencor's net revenues earned from the product sales subject to the license, (iii) a $100,000 payment in January, 2007 and (iv) modification of the milestone payments earned under the agreement. As amended, we are entitled to a milestone payment of $250,000 when a product attains aggregate sales of $5.0 million. We are entitled to a single milestone payment for each product.
 
Sanyo Chemical Industries, Ltd.

On June 29, 2009, the Company received from Sanyo Chemical Industries, Ltd. (“Sanyo”) a fully executed copy of a License Agreement between Sanyo and the Company.  The effective date of the Agreement is June 18, 2009.    Pursuant to the Agreement, the Company has granted a non-exclusive, world-wide license to Sanyo of its technology, know-how, and intellectual property relating to recombinant, repetitive unit proteins and peptides, for the purposes of developing and commercializing products related to Sanyo’s specific fields of business.  The Agreement remains in effect until the expiration of the last to expire of the Company’s patents licensed by Sanyo under this Agreement.  The Agreement further provides the Company with initial and ongoing license fees, technical service and training fees, and a percentage royalty on the quarterly net sales of any new products developed by Sanyo under this Agreement.

Other Agreements
 
We are discussing other potential collaboration agreements with prospective marketing partners. We cannot assure that we will continue such discussions or if we will be able to establish such agreements at all, or do so in a timely manner and on reasonable terms, or that such agreements will lead to successful product development and commercialization. From time to time, we are party to certain agreements for the evaluation of materials regarding biomedical applications of our products, polymers and technology, including applications in areas other than those identified as product candidates above. These agreements provide, or are intended to provide, for the evaluation of product feasibility. We cannot assure that we will continue to be able to establish such agreements at all, or do so in a timely manner and on reasonable terms, or that such agreements will lead to joint product development and commercialization agreements.
 
Intense Competition
 
The principal anticipated commercial uses of our biomaterials are as components of end-use products for biomedical and other specialty applications. End-use products using or incorporating our biomaterials would compete with other products that rely on the use of alternative materials.
 
The areas of business in which we engage and propose to engage are characterized by intense competition and rapidly evolving technology. Competition in the biomedical and surgical repair markets is particularly significant. Our competitors in the biomedical and surgical repair markets include major pharmaceutical, surgical product, chemical and specialized biopolymer companies, many of which have financial, technical, research and development and marketing resources significantly greater than our own. Academic institutions and other public and private research organizations are also conducting research and seeking patent protection in the same or similar application areas, and may commercialize products on their own or through joint ventures. Most of our competitors depend on synthetic polymer technology rather than protein engineering for developing products. However, we believe that DuPont, BioElastics Research, Ltd. and several university laboratories are currently conducting research into similar protein engineering technology.

 
9

 

The primary elements of competition in the biomedical and surgical repair products market are
 
 
º
performance,
 
º
cost,
 
º
safety,
 
º
reliability,
 
º
convenience, and
 
º
commercial production capabilities.
  
We believe that our ability to compete in this market will be enhanced by the breadth of our issued patent claims, our other pending patent applications, our early entry into the field and our experience in protein engineering.
 
Patents and Trade Secrets
 
We are aggressively pursuing domestic and international patent protection for our technology, making claim to an extensive range of recombinantly prepared structural and functional proteins, the DNA encoding these proteins, methods for preparing this synthetic repetitive DNA, methods for the production and purification of protein polymers, end-use products incorporating such materials and methods for their use. Due to this multi-layered patent strategy, each of our products under development is protected by multiple patents claiming different aspects of the underlying inventions.
 
We have been issued twenty-eight patents by the United States Patent and Trademark Office. Additionally, we have three U.S. patent applications pending.

We have been granted four U.S. patents that broadly cover the polymer compositions used in our product development efforts and/or the DNA encoding these polymers. These polymers are generally defined by the use of repetitive amino acid sequences found in naturally occurring proteins (e.g., silk, elastin, collagen, and keratin). The last of these patents will expire in 2015. Additionally, we have been granted two U.S. patents that specifically cover polymer compositions based on repetitive silk and elastin units and the DNA encoding these polymers. The last of these patents will expire in 2014.
 
The silk/elastin copolymers used in our tissue augmentation products and our tissue adhesive products, including the spinal disc repair product, and the genes used to produce them have amino acid and/or DNA sequences within the claims of all six of these patents. We also have been granted two U.S. patents that cover methods of using polymers such as these silk/elastin copolymers for tissue augmentation. This patent will expire in 2017.
 
We have been granted ten U.S. patents covering our tissue adhesive and sealant technology. Four of these patents cover the cross-linked polymer compositions and/or methods of using our polymers and a cross-linking agent to adhere or seal tissues, including the filling of defects in tissues. The spinal disc repair product under development, as well as other anticipated products based on our adhesive and sealant technology fall within the claims of these patents. These patents will expire in 2015. The remaining five patents cover the special case where primers are used to enhance the mechanical strength of protein-based tissue adhesives and sealants. These patents will expire in 2017.

 
10

 

We have been granted two U.S. patents covering the methods used to construct the synthetic DNA encoding proteins having repetitive amino acid sequences. The claims of these patents are not limited by the specific amino acid sequence of the polymers produced using the methods. Therefore, they provide very broad coverage of our core technology. Both of these patents will expire in 2014.
 
We have been granted ten U.S. patents that are not currently central to our product development focus. However, they either do or may support the interests of licensees of our technology or may support our future product development efforts. Three of the patents specifically cover DNA encoding polymers useful for in vitro cell culture, the last of which will expire in 2015. Two of the patents specifically cover collagen-like proteins and the DNA encoding them, both of which will expire in 2013. One of the patents specifically covers a purification method for silk-like proteins, developed for large-scale industrial use, which will expire in 2010. Two of the patents specifically cover compositions, formed objects and methods of making such objects, combining traditional thermoplastic resins and proteins providing chemical or biological activity. Both of these patents will expire in 2015. Two of the patents specifically cover our water-insoluble polymers that have been chemically modified to make them water-soluble. Both of these last two patents will expire in 2015.

Although we believe our existing issued patent claims provide a competitive advantage, we cannot assure that the scope of our patent protection is or will be adequate to protect our technology or that the validity of any patent issued will be upheld in the future. Additionally, with respect to our pending applications, we cannot assure that any patents will be issued, or that, if issued, they will provide substantial protection or be of commercial benefit to us.

Although we do not currently have any operations outside the U.S., we anticipate that our potential products will be marketed on a worldwide basis, with possible manufacturing operations outside the U.S. Additionally, current or potential products of our licensees are, or are expected to be, marketed on a worldwide basis with current or potential manufacturing operations outside the U.S. Accordingly, we have filed international patent applications corresponding to the major U.S. patents described above in foreign countries. Due to translation costs and patent office fees, international patents are significantly more expensive to obtain and maintain than U.S. patents. Additionally, there are differences in the requirements concerning novelty and the types of claims that can be obtained compared to U.S. patent laws, as well as the nature of the rights conferred by a patent grant. We carefully consider these factors in consultation with our patent counsel, as well as the size of the potential markets represented, in determining the foreign countries in which to file patents.
 
Because of the uncertainty concerning patent protection and the unavailability of patent protection for certain processes and techniques, we also rely upon trade secret protection and continuing technological innovation to maintain our competitive position. Although all our employees have signed confidentiality agreements, there can be no assurance that our proprietary technology will not be independently developed by other parties, or that secrecy will not be breached. Additionally, we are aware that substantial research efforts in protein engineering technology are taking place at universities, government laboratories and other corporations and that numerous patent applications have been filed. We cannot predict whether we may have to obtain licenses to use any technology developed by third parties or whether such licenses can be obtained on commercially reasonable terms, if at all.
 
In the course of our business, we employ various trademarks and trade names in packaging and advertising our products. We have assigned the federal registration of our ProNectin® trademark and our SmartPlastic® trademark for ProNectin F Activated Cultureware to Sanyo Chemical Industries, Ltd. in connection with the sale to Sanyo of our cell culture business in February 2000. We intend to protect and promote all of our trademarks and, where appropriate, will seek federal registration of our trademarks.

 
11

 

Regulatory Matters
 
Regulation by governmental authorities in the United States and other countries is a significant factor affecting the success of products resulting from biotechnological research. Our current operations and products are, and anticipated products and operations will be, subject to substantial regulation by a variety of agencies, particularly those products and operations related to biomedical applications. Currently, our activities are subject principally to regulation under the Occupational Safety and Health Act and the Food, Drug and Cosmetic Act (including amendments and updates) of both the U.S. and the State of California.
 
Extensive preclinical and clinical testing and pre-market approval from the FDA is required for new medical devices, drugs or vaccines, which is generally a costly and time-consuming process. To support the development of such products, we are required to be in compliance with many of the FDA’s regulations to conduct testing in support of product approvals; in particular, compliance with the FDA’s Good Laboratory Practices (GLP) and applicable Quality System Regulations (QSR). Where we have conducted such testing, our company may choose to file product approval submissions ourselves or for our partners.

We cannot assure that we, or our customers, will be able to obtain or maintain the necessary approvals from the FDA or corresponding international regulatory authorities.  Our anticipated business could be adversely affected if we are unable to obtain and maintain these approvals and/or comply with these regulations. To the extent we manufacture medical devices, or a component material supplied to a medical device manufacturer, we will be required to conform commercial manufacturing operations to the FDA’s QSR requirements. We would also be required to register our facility with the FDA as an establishment involved in the manufacture of medical devices. QSR requirements are rigorous, and there can be no assurance that compliance could be obtained in a timely manner and without the expenditure of substantial resources, if at all. International quality system requirements, (e.g., ISO 13485 issued by the International Organization for Standardization) is the quality model used by medical product manufacturers and is required for the sale of medical devices in Europe. ISO 13485 standards are similar to the FDA’s QSR.
 
Our research, development and production activities are, or may be, subject to various federal and state laws and regulations relating to environmental quality and the use, discharge, storage, transportation and disposal of toxic and hazardous substances. Our future activities may be subject to regulation under the Toxic Substances Control Act, which requires us to obtain pre-manufacturing approval for any new “chemical material” we produce for commercial use that does not fall within the FDA’s regulatory jurisdiction. We believe we are currently in substantial compliance with all applicable laws and regulations. Although we intend to use our best efforts to comply with all environmental laws and regulations in the future, we cannot assure that we will be able to fully comply with such laws, or that full compliance will not require substantial capital expenditures.
 
Product Liability and Absence of Insurance
 
Our business may expose us to potential product liability risks whenever human clinical testing is performed, or upon the use of any commercially marketed medical product. Prior to beginning human clinical testing of our investigational devices, we procured product liability insurance. Prior to shipping the products, we obtained the applicable product liability insurance. We are maintaining the insurance with coverage appropriate for the development and use of our products. We cannot assure, however, that we will be able to continue to obtain such insurance on acceptable terms or that such insurance will provide adequate coverage against potential liabilities. A successful product liability claim or series of claims could result in a material adverse effect on our business.

 
12

 

Executive Officers of the Registrant

Name
 
Age
 
Position with the Company
James B. McCarthy, M.B.A., J.D.
 
57
 
Interim Chief Executive Officer, Interim Principal Accounting Officer, and Interim Corporate Secretary
Joseph Cappello, Ph.D.
 
52
 
Vice President, Research and Development, Chief Technical Officer and Director, Clinical Research
Franco A. Ferrari, Ph.D.
 
57
 
Vice President, Laboratory Operations and Polymer Production and Director, Molecular Genetics
 
Mr. McCarthy is our Interim Chief Executive Officer, Interim Principal Accounting Officer, and Interim Corporate Secretary, positions he has held since October, 2007. Mr. McCarthy has served as a director since April 2005. Mr. McCarthy also serves as the Chairman and Chief Executive Officer of Gemini Consulting Group, Inc., a health care consulting firm, a position he has held since 1991. Mr. McCarthy is also a member of the Board of Directors for Sirigen Group Ltd., London, England, and StemCyte, Inc., Covina, CA, with offices in New Jersey, Taiwan, and India. He is also a member of the Board of Trustees of the University of San Diego, San Diego, California.

Dr. Cappello has been our Vice President, Research and Development since February 1993 and Chief Technical Officer since February 1997. He has been our Director, Clinical Research, since July 2002. From September 1988 to February 1993, he was our Senior Research Director, Protein Engineering.
 
Dr. Ferrari has been our Vice President, Laboratory Operations and Director, Molecular Genetics since February 1993. From September 1988 to February 1993, he was our Senior Research Director, Genetic Engineering.
 
All of our executive officers were appointed by the Board of Directors and serve at its discretion. No family relationships exist between any of the officers or directors of our company.
 
Employees
 
As of December 31, 2008, we had 2 full-time employees, both of whom hold Ph.D. degrees. We are highly dependent on the services of our executive officers and scientists. The loss of the services of any one of these individuals would have a material adverse effect on the achievement of our development objectives, our business opportunities and prospects. The recruitment and retention of additional qualified management and scientific personnel is also critical to our success. We cannot assure that we will be able to attract and retain required personnel on acceptable terms, due to the competition for such experienced personnel from other biotechnology, pharmaceutical, medical device and chemical companies, universities and non-profit research institutions.

 
13

 

Item 1A.
Risk Factors

Risks Related to Our Business and Industry

If we continue to incur operating losses, and are unable to raise additional operating capital, we may be unable to continue our operations at planned levels and be forced to curtail or cease our operations.

We have incurred operating losses since our inception in 1988, and will continue to do so for at least several more years. As of December 31, 2008, our accumulated deficit was approximately $73,206,000, and we have continued to incur losses since that date. The losses have resulted principally from expenses of research and development and from general and administrative expenses. If these losses continue, they could cause the value of our stock to decline.

We believe our existing available cash, cash equivalents and accounts receivable, in combination with anticipated contract research payments and revenues received from the transfer of clinical testing materials, will not be sufficient to meet our anticipated capital requirements during 2009. Substantial additional capital resources will be required to fund continuing expenditures related to our research, development, manufacturing and business development activities. If we do not raise adequate funds, we will be required to significantly curtail or cease our operations, and may have to sell or license out significant portions of our technology or potential products.

We believe there may be a number of alternatives to meeting the continuing capital requirements of our operations, including additional collaborative agreements and public or private financings. However, these alternatives may not be consummated in the necessary time frames needed for continuing operations or on terms favorable to us, if at all. From April, 2006 to September 2007, one of our stockholders provided financing to us to support our operations (see references to Szulik loan). As of January 9, 2008, we issued a new note in the principal amount of $6,415,000.  This note replaced the previous note and included the then $5,876,000 outstanding principal balance plus the then $539,000 outstanding in accrued interest on the old note.  On September 1, 2008, the scheduled maturity date of the 1/09/08 Note was extended to March 31, 2009, and on March 31, 2009, the 1/09/08 Note was extended to September 30, 2009.  In September 2007, the Company entered into a stock purchase agreement that has been used to fund operations since that time. In addition, from October 2008 through June 2009, the Company has entered into debt financing agreements to fund operations.  In the event that future funding through the stock purchase agreement or other debt financing agreements fail to materialize, on a timely basis, we will be forced to further curtail or cease operations.

Our year end audited financial statements contain a “going concern” explanatory paragraph, in which our independent auditors have expressed substantial doubt regarding our ability to continue operating as a going concern.
 
Our financial statements for the years ended December 31, 2008 and 2007 included herein have been prepared on the basis of accounting principles applicable to a going concern.  Our auditors’ report on the financial statements contained herein includes an additional explanatory paragraph following the opinion paragraph on our ability to continue as a going concern.  A note to these financial statements describes the reasons why there is substantial doubt about our ability to continue as a going concern and our plans to address this issue.  Our December 31, 2008 financial statements do not include any adjustments that might result from the outcome of this uncertainty.  Our inability to continue as a going concern will likely result in a ceasing of our operations.  See, “Part II. Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations; Liquidity and Capital Resources.”

 
14

 

If we fail to establish and manage strategic partnerships, we may be prevented from developing potential products or the time required for commercializing potential products may be increased.

Our principal strategy is to enter into partnerships or licensing arrangements with medical or pharmaceutical companies with appropriate marketing and distribution capabilities to reduce the time and costs for developing and commercializing our potential products. We may not be able to establish additional strategic partnerships or licensing arrangements, or, if available, they may not be on terms and conditions favorable to our business. Additionally, these arrangements generally may be terminated under various circumstances, including termination at the discretion of the strategic partner without cause or without prior notice. Termination of the arrangements could seriously harm our business and financial condition. Furthermore, our strategy may lead to multiple alliances regarding different product opportunities that are active at the same time. We may not be able to successfully manage multiple arrangements in various stages of development.

We are discussing other potential collaboration agreements with prospective marketing partners. Furthermore, from time to time, we are party to certain materials evaluation agreements regarding biomedical applications of our products, polymers and technology, including applications in areas other than those identified as product candidates above. These agreements provide, or are intended to provide, for the evaluation of product feasibility. We may not be able to establish these agreements at all or do so in a timely manner and on reasonable terms. In addition, these agreements may not lead to successful product development and commercialization.

We may not be able to produce commercially acceptable products because our technology is unproven. If we cannot prove our technology, we will not succeed in commercializing our products.

Our technological strategy of designing and producing unique products based on genetically engineered proteins that do not have a harmful effect on biological systems, such as the human body, is commercially unproven. The process of developing products and achieving regulatory approvals is time consuming and prone to delays. We have completed only a few products that require collaboration and marketing partners, and have not generated any significant revenues from product sales.

The products we are currently pursuing will require substantial further development, testing and regulatory approvals. Our research and development activities may not be successful and as such, we may not be able to produce commercially acceptable products.

We must prove our products' effectiveness in clinical trials. If we are unable to successfully complete clinical trials, we may not be able to produce marketable products.

Before obtaining regulatory clearance for the commercial sale of any of our products, we must demonstrate through preclinical studies and clinical trials that the potential product is safe and effective for use in humans for each particular use. Due to the inherent difficulties associated with clinical trials, we cannot guarantee that:

 
º
we will be able to complete the clinical trials successfully, if at all;

 
º
we will be able to demonstrate the safety and efficacy necessary to obtain the requisite regulatory approvals of product candidates; or

 
º
the product candidates will result in marketable products.

 
15

 

The biomedical and surgical repair industry involves intense competition and rapid technological changes. Our business may suffer if our competitors develop superior technology.

We operate in the biomedical and surgical repair markets that involve intense competition. Our competitors in those markets include major pharmaceutical, surgical product, chemical and specialized biopolymer companies, many of which have financial, technical, research and development and marketing resources significantly greater than ours. Our biomaterials are used primarily in the manufacture of end-use products for medical applications that compete with other products that rely on the use of alternative materials or components. As a result, we compete with diverse, complex and numerous rapidly changing technologies. We believe that our ability to compete will be enhanced by the breadth of our issued patent claims, our other pending patent applications and our experience in protein engineering. However, we currently do not have the resources to compete commercially without the use of collaborative agreements with third parties.

Our product technology competes for corporate development and marketing partnership opportunities with numerous other biotechnology companies, research institutes, academic institutions and established pharmaceutical companies. We also face competition from academic institutions and other public and private research organizations that are conducting research and seeking patent protection, and may commercialize products on their own or through joint ventures. Although most of our competitors depend on technology other than protein engineering for developing products, we believe that several university laboratories are currently conducting research into similar protein engineering technology. Our competitors may succeed in developing products based on our technology or other technologies that are more effective than the ones we are developing, or that would render our technology and products obsolete and non-competitive, which may harm our business.

We have not developed a process to manufacture our products on a commercially viable scale. We will lose potential revenues if we cannot manufacture products on a commercial scale.

To date, we have manufactured only limited amounts of our biomedical products for internal testing, initial human clinical testing and, in certain cases, evaluation and testing by corporate partners and other third parties. To obtain manufacturing approvals from the FDA for the development and commercialization of certain biomedical products, we would be required to upgrade our manufacturing facilities.

We have not yet developed a process to manufacture our products on a commercial scale and may not be able to, or have another party on our behalf, develop a process at a cost or in quantities necessary to become commercially viable. We may need to evaluate alternative methods to produce commercial quantities of our products. We may not be able to successfully assess the ability of other production methods or establish contract-manufacturing arrangements to meet commercial objectives.

Our business is subject to substantial regulation and may be harmed if we are unable to comply with the applicable laws.

Regulation by governmental authorities in the United States and other countries affects the success of products resulting from biotechnological research. Our current operations and products are, and anticipated products and operations will be, subject to substantial regulation by a variety of local, state, federal and foreign agencies, particularly those products and operations related to biomedical applications. A few examples of the laws that govern our products and operations are:

o
FDA’s Good Laboratory Practices;
o
FDA Quality System Regulations;
o
Food, Drug & Cosmetic Act, as amended; and
o
Occupational Safety and Health Act;

 
16

 

Compliance with the applicable laws and regulations is a costly and time-consuming process. We believe we are currently in substantial compliance with the laws and regulations applicable to our current operations. Although we intend to use our best efforts to comply with all applicable laws and regulations in the future, we may not be able to fully comply with the laws and regulations and as such, our business operations would be seriously harmed.

Our business may be harmed if we are not able to retain key employees.

As of December 31, 2008, we had two full-time employees, neither of whom have employment contracts with us, and both of whom hold Ph.D. degrees. Our success will depend largely upon the efforts of our scientists and certain of our executive officers who understand our technology and business objectives. The loss of the services of any one of these individuals would seriously harm our business opportunities and prospects. Our success also depends on the retention of scientific personnel. We may not be able to attract and retain required personnel on acceptable terms, due to the competition for experienced personnel from other biotechnology, pharmaceutical and chemical companies, universities and non-profit research institutions. We do not maintain "key-man" or similar life insurance policies with respect to these persons to compensate us in the event of their deaths, which may harm our business.

We may be sued for product liability and may not have sufficient protection under our insurance policies.

We may face product liability claims with respect to our technology or products either directly or through our strategic partners. We may also be exposed to potential product liability risks whenever human clinical testing is performed or upon the use of any commercially marketed medical product. We believe that our prior sales of SmartPlastic(R), ProNectin (R) F and ProNectin(R) L products do not pose any material product liability risk. To our knowledge no product liability claims have ever been made against us. Before initiating human clinical testing of our technology, we procured product liability insurance that is limited to coverage of $1,000,000 per occurrence and in the aggregate $5 million.  Our current product liability insurance is limited to coverage of $1,000,000 per occurrence and in the aggregate $1,000,000 and our umbrella liability insurance is limited to coverage of $2,000,000 per occurrence and in the aggregate $2,000,000. If plaintiffs succeed in their claims against us, if any, and if the coverage under our insurance policies is insufficient, our business would be seriously harmed.

If we are unable to protect our proprietary technology, we may not be able to compete as effectively.

We have been issued 28 United States patents and 14 foreign patents, and have 3 additional pending United States patent applications. We have not yet marketed, sold, or developed our products outside the United States, except for limited amounts of ProNectin(R) F, ProNectin(R) L, and SmartPlastic(R) cell culture products. The patent position of biotechnology companies, such as ours, is highly uncertain and involves complex legal, scientific, and factual factors. For example:
 
 
º
patents issued to us may be challenged, invalidated or circumvented;

 
º
patents may not issue from any of our pending patent applications or, if issued, may not be sufficiently broad to protect our technology and products or provide us with any proprietary protection or competitive advantage;

 
º
our competitors may have filed patent applications or may have obtained patents and other proprietary rights relating to products or processes similar to and competitive with ours. The scope and validity of such patents may not be known or the extent to which we may be required to obtain licenses under these patents or other proprietary rights. If required, we may not be able to obtain any licenses on acceptable terms, if at all;

 
º
certain foreign intellectual property laws may not be as protective as those of the United States; or

 
º
we may enter into collaborative research and development arrangements with our strategic partners that may result in the development of new technologies or products, but may also get us involved in a dispute over the ownership of rights to any technology or products that may be so developed.

 
17

 

If we are unable to obtain patent protection, enforce our patent rights or maintain trade secrets and other protection for our products and technology, our business may be seriously harmed.

We also seek to protect our intellectual property in part by confidentiality agreements with our employees and consultants. These agreements may be breached or terminated. We may not have an adequate remedy for any breach, and our trade secrets may otherwise become known or independently discovered by competitors, which would harm our business.

Our common stock was delisted from the NASDAQ and OTC Bulletin Board and will be difficult to sell.

Our common stock was delisted from the NASDAQ Small Cap Market on September 20, 1999, and was delisted from the OTC Bulletin Board on May 19, 2009.  Our common stock now trades on the OTC Pink Sheets.  As a consequence of the delistings, it is more difficult to dispose of, or to obtain accurate quotations as to the market value of, our common stock. In addition, the delisting made our common stock substantially less attractive as collateral for margin and purpose loans, for investment by financial institutions under their internal policies or state investment laws, or as consideration in future capital raising transactions.

Our common stock is also subject to regulation as a "penny stock." The Securities and Exchange Commission has adopted regulations that generally define "penny stock" to be any equity security that has a market price or exercise price less than $5.00 per share, subject to certain exceptions, including listing on the NASDAQ Small Cap Market. For transactions covered by the penny stock rules, the broker-dealer must consider the suitability of the purchaser, receive the purchaser's written consent before the purchase, deliver a risk disclosure document before the purchase and disclose the commission payable for the purchase. Additionally, if the broker-dealer is the sole market maker, the broker-dealer must disclose this fact and the broker-dealer's presumed control over the market. Finally, monthly statements must be sent disclosing recent price information for the penny stock held in the account and information on the limited market in penny stocks.

The requirements of the penny stock rules restrict the ability to sell our common stock in the secondary market and the price at which our common stock can be sold. Since our common stock was delisted from the NASDAQ Small Cap Market and OTC Bulletin Board, we have seen a decline in our average daily trading volume, and as a result, the trading price of our common stock has experienced wide fluctuations.

Item 1B.
Unresolved Staff Comments
                
There were no unresolved staff comments as of 12/31/08.

Item 2.
Properties

We do not own any real property.  Through April 30, 2008, we leased approximately 27,000 square feet of office and laboratory space in San Diego. The leased property included our administrative offices, which encompassed approximately 4,000 square feet, and our laboratory facilities, which encompassed approximately 23,000 square feet. The annual rent for this space was approximately $680,000. This lease expired on April 30, 2008 and our Board determined not to renew it.

We currently lease approximately 180 square feet of administrative office space in San Diego. The lease term began on June 15, 2009 and expires on February 28, 2010.  The lease can be terminated at any time with one month’s notice.  The current annual rent for this space is approximately $4,300.  We are currently outsourcing our laboratory and production facilities.

 
18

 

Item 3.
Legal Proceedings

On October 15, 2008, certain alleged noteholders instituted suit against the Company in Superior Court of California, County of Sacramento, seeking payment of outstanding notes payable allegedly owed by the Company. The name of the case is Lou Matson, Mary Matson, and Don Brandon v Protein Polymer Technologies, Inc, Case Number 34-2008-00022190.  On May 19, 2009, the plaintiffs filed a request for dismissal with prejudice of the action against the Company, and the Company paid nothing to plaintiffs in exchange for the dismissal.
 
Item 4.
Submission of Matters to a Vote of Security Holders

No matter was submitted to a vote of security holders during the fourth quarter of 2008.

 
19

 

PART II
 
Item 5.
Market for Common Equity, Related Stockholder Matters and Small Business Issuer Purchases of Equity Securities.

NASDAQ and OTC Bulletin Board Delisting
 
Prior to September 1999, our common stock traded on The NASDAQ Stock Market under the symbol “PPTI”. Our common stock was delisted from the NASDAQ Small Cap Quotation System, effective September 20, 1999. The reasons for the delisting were failure to maintain the minimum bid requirement of $1.00 per share for our common stock and failure to meet the minimum net asset requirement of $2 million.  Our common stock was then traded on the OTC Bulletin Board under the symbol “PPTI.OB”.

On May 19, 2009, the Company was delisted from the OTC Bulletin Board.  The reason for the delisting was failure to file required SEC reports in a consistently timely manner.  Our common stock is now traded on the OTC Pink Sheets.  To access the quotations for our common stock, use the call letters “PPTI.PK”.

The high and low prices set forth below represent inter-dealer prices without retail markups, markdowns or commissions, and may not represent actual transactions. The source of the high and low information set forth below was provided by Yahoo Finance (http://finance.yahoo.com).
 
   
Trade Prices
 
2008
 
High
   
Low
 
First Quarter
  $ 0.08     $ 0.04  
Second Quarter
    0.07       0.03  
Third Quarter
    0.06       0.02  
Fourth Quarter
    0.04       0.01  
                 
2007
               
First Quarter
  $ 0.18     $ 0.12  
Second Quarter
    0.19       0.10  
Third Quarter
    0.21       0.11  
Fourth Quarter
    0.16       0.06  
 
As of December 31, 2008, we had approximately 167 shareholders of record of our common stock; we estimate we had approximately nine beneficial holders as of that date. We have never paid cash dividends on our common stock. We currently intend to retain earnings, if any, for use in the operation and expansion of our business and therefore do not anticipate paying any cash dividends on our common stock in the foreseeable future
 
Recent Sales of Unregistered Securities

During the last quarter of 2008, we received an aggregate of $57,500 for the purchase of 1,545,795 common shares and 1,545,795 warrants to purchase common shares.  Additionally, we received aggregate proceeds of $230,000 from the issuance of unsecured notes during the fourth quarter of 2008.  As consideration for the notes, the Company granted 5,250,000 warrants to purchase common shares to the noteholders.  Reference is made to Liquidity and Capital resources under Management’s Discussion and Analysis of Financial Condition and Results of Operations for information relating to these sales.  The sales of common shares and issuance of notes were made pursuant to the exemption form the registration provisions of the Securities Act of 1933 provided by Section 4 (2) thereof.

 
20

 

Equity Compensation Plan Information 
 
The following table provides information as of December 31, 2008 regarding equity compensation plans (including individual compensation arrangements) under which our equity securities are authorized for issuance.

Plan Category
   
Number of
securities
to be issued upon
exercise of
outstanding
options, warrants
and
rights
 
Weighted-average
exercise price of
outstanding
options, warrants
and rights
 
Number of
securities
remaining available
for future issuance
under equity
compensation plans
(excluding
securities reflected
in column (a))
     
(a)
 
(b)
 
(c)
Equity Compensation Plans approved by security holders
             
Stock Option Plans1
   
3,333,200
 
$
0.678
 
6,380,000
Employee Stock Purchase Plan2
   
   
 
Equity Compensation Plans not approved by security holders3
   
174,300
 
$
0.749
 
n/a
 

1 Includes shares of common stock to be issued upon exercise of stock options granted under the 1989 Employee Stock Option Plan, the 1992 Employee Stock Option Plan, the 2002 Employee Stock Option Plan, and the 1996 Non-employee Director’s Stock Option Plan.
2 Includes shares of common stock available for future issuance under the Employee Stock Purchase Plan.
3 Includes shares of common stock to be issued upon exercise of out-of-plan non-qualified options granted.
 
Item 6.
Selected Financial Data

As a smaller reporting company, as defined by Rule 12b-2 of the Exchange Act and in Item 10(f)(1) of Regulation S-K, we are electing scaled disclosure reporting obligations, and therefore are not required to provide the information requested by this Item.

Item 7.
Management’s Discussion and Analysis of Financial Condition and Results of Operations

General Overview
 
Protein Polymer Technologies, Inc. is a biotechnology company engaged in the research, development, production and clinical testing of medical products based on materials created from our patented technology to produce proteins of unique design. Additionally, we are committed to the acquisition of faster-to-market medical products in certain complementary growth markets. Since 1992, we have focused primarily on developing technology and products to be used for tissue adhesives and sealants; wound healing support; and drug delivery devices.
 
Results of Operations

Operating Results for the Year Ended December 31, 2008 as compared to 2007

Revenue. We earned $25,000 in contract revenue for the year ended December 31, 2008 as compared to $287,000 for the year ended December 31, 2007.  Revenue generated in 2008 was earned through material transfer agreements with our clients, and revenue generated in 2007 was earned primarily through contract and licensing agreements.

 
21

 

Research and Development Expenses. Research and development expenses for the year ended December 31, 2008 were approximately $1,257,000, compared to $2,503,000 for 2007. The decline from 2007 resulted from our inability to raise additional capital, and the closing of our laboratory and administrative facility, and the subsequent sub-contracting of the laboratory function in 2008.  We expect our research and development expenses will increase in the future only to the extent that additional capital is obtained or future collaborative development and licensing agreements are secured.

Selling, General and Administrative Expenses. Selling, general and administrative expenses for the year ended December 31, 2008 were approximately $1,040,000, as compared to $809,000 for 2007.  The increase from 2007 was due to the reallocation of certain expenses previously associated with our research and development efforts.  To the extent possible, we continue to concentrate on controlling costs in this area. We expect our selling, general and administrative expenses will increase in the future only to the extent that additional capital is obtained or future collaborative development and licensing agreements are secured.

The following discusses items which were incurred in each year that are non-recurring or of particular significance. During 2007 we made significant changes in the operating structure of the Company in order to reduce non-core functions and focus our efforts on basic revenue and scientific results. During 2008, we continued to make significant reductions in operations and focus our attention on methods of producing revenue from the numerous patents, trade secrets and other proprietary techniques we have developed over the life of the Company.

Interest Expense.  Interest expense increased from $442,000 in 2007 to $710,000 in 2008. This increase was the direct result of interest accruals on the debt financing loans during 2007 and 2008 from a shareholder (described in Liquidity and Capital Resources below) to sustain our operations.

Operating Losses. For the year ended December 31, 2008, we recorded a net loss applicable to common shareholders of $3,147,000 or $0.03 per share, as compared to a loss of $3,538,000 or $0.05 per share for 2007. The differences in the net losses are as discussed in detail previously. The weighted average number of shares outstanding increased by approximately 29,093,000 due to the net effect of the share repurchase in the fourth quarter of 2008 and the issuance of additional shares during 2008 in connection with new equity funding used  to sustain operations.   

Liquidity and Capital Resources

As of December 31, 2008, we had cash and cash equivalents totaling approximately $1,300, as compared to $22,000 at December 31, 2007. As of December 31, 2008, we had a working capital deficit of approximately $8,870,000 compared to a working capital deficit of $7,862,000 at December 31, 2007.

We do not have any off balance sheet financing activities and do not have any special purpose entities. We had no long-term capital lease obligations as of December 31, 2008 or December 31, 2007. For the years ended December 31, 2008 and December 31, 2007, we did not have any cash expenditures for capital equipment and leasehold improvements.  We do not anticipate significant expenditures for capital equipment or leasehold improvements for 2009.

We believe our existing available cash, cash equivalents, and accounts receivable, in combination with anticipated contract research payments and revenues received from the transfer of clinical testing materials, will not be sufficient to meet our anticipated capital requirements during 2009. Substantial additional capital resources are required to fund continuing expenditures related to our operating, research, development, manufacturing and business development activities. As discussed in Note 6 to the financial statements, the Company entered into a common stock purchase agreement (hereafter “SPA”) in September 2007 and has raised $2,357,500 as of June 30, 2009, as a result of that SPA.  Pursuant to the SPA, which has been our main source of external financing since September 2007, the investors purchase shares of our common stock at the closing price of the stock on the day the investment is made. In addition, we issued a five-year warrant to each investor to purchase the same number of shares as those purchased by such investor at 110% of the price at which the shares are purchased.  As of November 28, 2007, the SPA was amended so that warrants issued on and after that date are exercisable at 100% of the price at which the shares are purchased.  We have also granted the investors demand and piggy-back registration rights covering the shares purchased and the sharers issuable upon exercise of the warrants.

 
22

 

Prior to the SPA, required funding was provided to us through a note payable agreement (known as the Szulik Loan) by Matthew Szulik, one of our stockholders. This loan was outlined in previous filings and is further described in Note 5 to the financial statements. As with the Escrow Agreement relating to the Szulik Loan, the Stock Purchase Agreement provides that TAG Virgin Islands, Inc. (hereafter “TAG”), as agent for the equity investors, will advise the Board as to which of the Company’s expenses will be paid with the funds invested by these investors.

On January 9, 2008, we replaced the Szulik Loan by issuing to Mr. Szulik a new note in the principal amount of $6,415,000.  This amount included the then $5,876,000 outstanding principal balance plus the then outstanding $539,000 in accrued interest on the old note.  The new note bears annual interest at the rate 8%, the same as did the old note, matures on September 1, 2008 and is secured in the same manner as was the old note.  On September 1, 2008, the scheduled maturity date of the 1/09/08 Note was extended to March 31, 2009, and on March 31, 2009, the scheduled maturity date was extended to September 30, 2009.  As consideration for Mr. Szulik agreeing to accept the new note, we issued him three-year warrants to purchase an aggregate of 2,438,000 shares of our common stock at $0.061 per share and lowered the exercise price of warrants to purchase 500,000 shares of our common stock that we had previously issued to him from $0.30 per share to $0.061 per share.

Between October 2, 2008 and June 5, 2009, the Company received proceeds of $645,000 as loans from clients of TAG.  These loans are represented by unsecured notes issued by the Company.  These notes are due one year after issuance and bear an annual interest rate of 8%.  The interest and principal are payable on the maturity dates, either in cash or common stock, at the discretion of the Company, at rates ranging from $0.02 to $0.05 per share.  As consideration for the loans, the Company granted warrants to the noteholders to purchase an aggregate of 25,423,077 shares of the Company’s common stock at exercise prices ranging from $0.02 to $0.05 per share.

TAG is a registered investment advisor and advises a number of our stockholders, including certain members of our Board of Directors, in investment decisions, including decisions about whether to invest in our stock.  Based upon our stock records and data supplied to us by our stockholders, we believe that clients of TAG beneficially own approximately 67.8% of our common stock as of June 30, 2009.  TAG has discretionary authority to vote or dispose of the shares of our common stock held in its client accounts and, therefore, may be deemed to be the beneficial owner of such shares in accordance with the Commission's Rules.  TAG has informed us that James Tagliaferri is the natural person at TAG with such discretionary authority.  TAG expressly disclaims beneficial ownership of any shares owned by its clients.
 
As noted above, we believe our existing available cash as of December 31, 2008 will not be sufficient to meet our anticipated capital requirements during 2009.  We are unable to pay certain vendors in a timely manner and remain over 90 days past due with certain critical vendors, such as outside laboratories and law firms. Additionally, we are currently outsourcing administrative and accounting functions as a result of cutbacks necessitated by insufficient monetary resources. We are attempting to remedy this problem. Our ability to continue operating is dependent on the receipt of additional funding and substantial additional capital resources will be required to fund continuing expenditures related to our research, development, manufacturing and business development activities. If adequate funds are not available, we will be required to significantly curtail our operating plans and most likely cease operations. We are still in discussions with other potential financing sources and collaborative partners, and are seeking additional funding in the form of equity investments, license fees, loans, milestone payments or research and development payments. We cannot assure that any of these other sources of funding will be consummated in the timeframes needed for continuing operations or on terms favorable to us, if at all.

Inflation

To date, we believe that inflation and changing prices have not had a material impact on our continuing operations. However, we have experienced increased general and product liability insurance costs over the past two years, and these increases are expected to continue for the foreseeable future.

 
23

 
Use of Estimates and Critical Accounting Policies

We have identified the policies below as critical to our business operations and to understanding our results of operations. Our accounting policies are more fully described in our financial statements and related notes located in “Item 8. Financial Statements and Supplementary Data.”

The preparation of our financial statements requires management to make estimates and assumptions that affect reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. On an ongoing basis, management evaluates its estimates and assumptions. Management bases its estimates and judgments on historical experience of operations and on various other factors that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.

Revenue Recognition.  Research and development contract revenues are recorded as earned in accordance with the terms and performance requirements of the contracts. If the research and development activities are not successful, the Company is not obligated to refund payments previously received. Fees from the sale or license of technology are recognized on a straight-line basis over the term required to complete the transfer of technology or the substantial satisfaction of any performance related responsibilities. License fee payments received in advance of amounts earned are recorded as deferred revenue. Milestone payments are recorded as revenue based upon the completion of certain contract specified events that measure progress toward completion under certain long-term contracts. Royalty revenue related to licensed technology is recorded when earned and in accordance with the terms of the license agreement.

Stock-Based Compensation.  On January 1, 2006 the Company adopted Statement of Financial Accounting Standards (“SFAS”) No. 123 (Revised 2004), Share-Based Payment, (“SFAS No. 123R”), using the modified prospective method. In accordance with SFAS No. 123R, the Company measures the cost of employee services received in exchange for an award of equity instruments based on the grant-date fair value of the award. That cost is recognized over the period during which an employee is required to provide service in exchange for the award - the requisite service period. The Company determines the grant-date fair value of employee share options using the Black-Scholes option-pricing model.

Impairment of Long Lived Assets. Long-lived assets and certain identifiable intangibles are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount may not be recoverable. If the fair value is less than the carrying amount of the asset, a loss is recognized for the difference. Fair value is determined based on market quotes, if available, or is based on valuation techniques.

Cost-Method Investment. The investment balance at December 31, 2008 and 2007 represents shares of common stock owned by the Company in a privately held company which were acquired pursuant to a license agreement.  Based on the Company’s limited ownership percentage, the investment is reported using the cost method.  Under the cost method, the Company does not record its proportional share of earnings and losses of the investee, and income on the investment is only recorded to the extent of dividends distributed from earnings of the investee received subsequent to the date of acquisition.

The Company reviews the carrying value of its cost-method investment for impairment each reporting period unless i) the investment’s fair value has not been estimated for any purpose, including estimates of fair value used to satisfy other financial reporting requirements and ii) there are no impairment indicators present for the investment during the period under review which would indicate there has been an event or change in circumstances that could have a negative effect on the investment’s fair value.

 
24

 

When an impairment test demonstrates that the fair value of an investment is less than its cost, Company management will determine whether the impairment is either temporary or other-than-temporary.  Examples of factors which may be indicative of an other-than-temporary impairment include i) the length of time and extent to which market value has been less than cost, ii) the financial condition and near-term prospects of the issuer, iii) and the intent and ability of the Company to retain its investment in the issuer for a period of time sufficient to allow for any anticipated recovery in market value.

If the decline in fair value is determined by management to be other-than-temporary, the cost basis of the investment is written down to its estimated fair value as of the balance sheet date of the reporting period which the assessment is made. This fair value becomes the investment’s new cost basis, which is not changed for subsequent recoveries in fair value.  Any recorded impairment write-down will be included in earnings as a realized loss in the period such write-down occurs

Net Loss per Common Share.  Basic loss per share is calculated using the weighted-average number of outstanding common shares during the period. Diluted loss per share is calculated using the weighted-average number of outstanding common shares and dilutive common equivalent shares outstanding during the period, using either the as-converted method for convertible notes and convertible preferred stock or the treasury stock method for options and warrants.

Excluded from diluted loss per common share as of December 31, 2008 and 2007 were 5,847,656 and 41,214,734 shares, respectively, issuable upon conversion of convertible preferred stock, and options and warrants to purchase 66,753,814 and 33,268,706 shares of common stock, respectively, because the effect of the inclusion of these shares would be anti-dilutive.  For purposes of this calculation, net loss in 2008 and 2007 has been adjusted for imputed, accumulated and/or paid dividends on the preferred stock.

Income Taxes. In determining the carrying value of our net deferred tax assets, we must assess the likelihood of sufficient future taxable income in certain tax jurisdictions, based on estimates and assumptions, to realize the benefit of these assets. If these estimates and assumptions change in the future, we may record a reduction in the valuation allowance, resulting in an income tax benefit in our Statements of Operations. Management evaluates the realizability of the deferred tax assets and assesses the valuation allowance quarterly.

Effective January 1, 2007, we adopted the provisions of Financial Accounting Standards Board (“FASB”) Interpretation No. 48 (“FIN 48”), Accounting for Uncertainty in Income Taxes - an interpretation of FASB Statement No. 109. The implementation of FIN 48 had no impact on our financial statements.

We are primarily subject to U.S. federal and state income tax. Tax years subsequent to December 31, 2003 remain open to examination by U.S. federal and state tax authorities. In addition, our policy is to recognize interest and penalties related to income tax matters in income tax expense. As of December 31, 2008, we had no accruals for interest or penalties related to income tax matters.

Recent Accounting Pronouncements

A number of new pronouncements have been issued for future implementation as discussed in the notes to our financial statements located in “Item 8. Financial Statements and Supplementary Data.” See page F-10 of our consolidated financial statements for further discussion

Item 7A.
Quantitative and Qualitative Disclosures about Market Risk 

As a smaller reporting company, as defined by Rule 12b-2 of the Exchange Act and in Item 10(f)(1) of Regulation S-K, we are electing scaled disclosure reporting obligations, and therefore are not required to provide the information requested by this Item.


 
25

 
 
Item 8. 
Financial Statements and Supplementary Data
 
Filed herewith are the following Audited Financial Statements for Protein Polymer Technologies, Inc.
 
Description
 
Page
 
Report of Independent Registered Public Accounting Firm
 
F-2
 
Balance Sheets at December 31, 2008 and 2007
 
F-3
 
Statements of Operations for the years ended December 31, 2008 and 2007
 
F-4
 
Statements of Stockholders’ Deficit for the years ended December 31, 2008 and 2007
 
F-5
 
Statements of Cash Flows for the years ended December 31, 2008 and 2007
 
F-6
 
Notes to Financial Statements
 
F-7
 

 
F-1

 

            REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

To the Board of Directors and Stockholders
Protein Polymer Technologies, Inc.

We have audited the accompanying balance sheets of Protein Polymer Technologies, Inc.  as of December 31, 2008 and 2007, and the related statements of operations, stockholders’ deficit, and cash flows for the years then ended. These financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the financial statements based on our audits.

We conducted our audits in accordance with the 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. The Company was not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. Our audits included consideration of internal control over financial reporting as a basis for designing audit procedures that were appropriate in the circumstances, but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion. An audit also includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements, assessing the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements. 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 financial position of Protein Polymer Technologies, Inc. as of December 31, 2008 and 2007, and the results of their operations and their cash flows for the years then ended, in conformity with accounting principles generally accepted in the United States of America.

The accompanying financial statements have been prepared assuming that the Company will continue as a going concern. As discussed in Note 1 to the financial statements, the Company has minimal cash balances and a significant working capital deficit as of December 31, 2008, and has incurred significant recurring net losses through December 31, 2008. These factors raise substantial doubt about the Company’s ability to continue as a going concern. Management’s plans as to these matters are described in Note 1. The accompanying financial statements do not include any adjustments that might result from the outcome of this uncertainty.

/s/ SQUAR, MILNER, PETERSON, MIRANDA & WILLIAMSON, LLP
 
San Diego, California
July 24, 2009

 
F-2

 

Protein Polymer Technologies, Inc.
Balance Sheets

   
December 31,
 
   
2008
   
2007
 
Assets
           
Current assets:
           
Cash
  $ 1,291     $ 21,936  
Prepaid expenses and other current assets
    35,011       33,419  
Total current assets
    36,302       55,355  
                 
Deposits
    29,679       29,679  
Equipment and leasehold improvements, net
    24,429       128,100  
Investment
    520,000       520,000  
Total assets
  $ 610,410     $ 733,134  
                 
Liabilities and stockholders' deficit
               
Current liabilities:
               
Accounts payable
  $ 969,435     $ 827,626  
Accrued liabilities
    844,073       794,312  
Secured note payable - related party
    6,414,837       5,876,000  
Notes payable – Surgica
    519,071       419,071  
Notes payable – other, net of unamortized debt discount
    158,589       -  
Total current liabilities
    8, 906,005       7,917,009  
                 
Notes payable, net of current maturities
    -       100,000  
                 
Commitments and contingencies (Note 9)
               
                 
Stockholders' deficit:
               
Convertible preferred stock, $0.01 par value; 5,000,000 shares authorized; 20,237 and 65,645 shares issued and outstanding at December 31, 2008 and 2007 - liquidation preference of $2,082,930 and $9,464,500 at December 31, 2008 and 2007, respectively.
    1,834,299       6,019,917  
Common stock, $0.01 par value; 1,000,000,000 authorized; 109,387,843 and 73,722,232 shares issued and outstanding at December 31, 2008 and 2007, respectively
    1,093,878       737,222  
Additional paid-in capital
    61,982,390       56,227,221  
Accumulated deficit
    (73,206,162 )     (70,268,235 )
Total stockholders' deficit
    (8,295,595 )     (7,283,875
Total liabilities and stockholders’ deficit
  $ 610,410     $ 733,134  
 
The accompanying notes are an integral part of these financial statements.

 
F-3

 

Protein Polymer Technologies, Inc.
Statements of Operations

   
Years ended December 31,
 
   
2008
   
2007
 
Revenues:
           
Contract revenue
  $ 24,868     $ 287,118  
Total revenues
    24,868       287,118  
                 
Operating Expenses:
               
Research and development
    1,256,662       2,503,035  
Selling, general and administrative
    1,040,363       809,446  
Total expenses
    2,297,025       3,312,481  
                 
Loss from operations
    (2,272,157 )     (3,025,363 )
                 
Other expense:
               
Interest and other income
    3,413       21,513  
Interest expense
    (709,829 )     (442,235 )
Gain from sale of assets
    40,646       -  
Gain on settlement of accounts payable
    -       193,917  
Total other expense
    (665,770 )     (226,805 )
                 
Net loss
    (2,937,927 )     (3,252,168 )
                 
Undeclared and imputed and/or paid dividends on preferred stock
    208,973       285,976  
                 
Net loss applicable to common shareholders
  $ (3,146,900 )   $ (3,538,144 )
                 
Basic and diluted net loss per common share
  $ (0.03 )   $ (0.05 )
                 
Shares used in computing basic and diluted net loss per common share
    97,409,563       68,316,641  
 
The accompanying notes are an integral part of these financial statements.

 
F-4

 

Protein Polymer Technologies, Inc.
Statements of Stockholders' Deficit
 
                           
Additional
         
Total
 
   
Common Stock
   
Preferred Stock
   
Paid-in
   
Accumulated
   
Stockholders'
 
    
Shares
   
Amount
   
Shares
   
Amount
   
Capital
   
Deficit
   
Deficit
 
Balance at December 31, 2006
    67,409,204       674,092       65,645       6,019,917       55,760,511       (67,007,742 )     (4,553,222 )
Share based compensation expense
                            (109,552 )           (109,552 )
Imputed dividend on extension of warrant
                            8,325       (8,325 )      
Issuance of common stock for dispute settlement
    400,000       4,000                   57,067             61,067  
Issuance of common stock pursuant to stock purchase agreement
    5,913,028       59,130                   510,870             570,000  
Net loss
                                  (3,252,168 )     (3,252,168 )
Balance at December 31, 2007
    73,722,232     $ 737,222       65,645     $ 6,019,917     $ 56,227,221     $ (70,268,235 )   $ (7,283,875 )
Share based compensation expense
                            4,255             4,255  
Imputed dividend on extension of warrant
                            18,231             18,231  
Debt discount for warrants issued
                                    196,221             196,221  
Issuance of common stock pursuant to stock purchase agreement
    36,586,091       365,861                   1,346,639             1,712,500  
Stock repurchase
    (920,480 )     (9,205 )     (45,408 )     (4,185,618 )     4,189,823             (5,000 )
Net loss
                                  (2,937,927 )     (2,937,927 )
Balance at December 31, 2008
    109,387,843     $ 1,093,878       20,237     $ 1,834,299     $ 61,982,390     $ (73,206,162 )   $ (8,295,595 )
 
The accompanying notes are an integral part of these financial statements.

 
F-5

 

Protein Polymer Technologies, Inc.
Statements of Cash Flows

   
Years ended December 31,
 
   
2008
   
2007
 
Operating activities
           
Net loss
  $ (2,937,927 )   $ (3,252,168 )
Adjustments to reconcile net loss to net cash used for operating activities:
               
Gain on sale of assets
    (40,646 )     -  
Gain on settlement of accounts payable
    -       (193,917 )
Depreciation and amortization
    43,317       100,375  
Debt discount amortization
    143,041       -  
Share-based compensation expense
    4,255       (109,552 )
Other income
    -       (21,368 )
Changes in operating assets and liabilities:
               
Contracts receivable
    -       21,068  
Rent receivable
    -       39,527  
Prepaid expenses and other current assets
    (1,593 )     16,521  
Accounts payable
    141,809       (210,127 )
Accrued liabilities
    588,599       578,047  
Deferred rent
    -       (4,449 )
Net cash used for operating activities
    (2,059,145 )     (3,036,043 )
                 
Investing activities
               
Proceeds from sale of equipment
    101,000       -  
Net cash provided by investing activities
    101,000       -  
                 
Financing activities
               
Net proceeds from sale of common stock
    1,712,500       -  
Repurchase of common and preferred stock
    (5,000 )     -  
Net proceeds from subscriptions to purchase common stock
    -       570,000  
Proceeds from issuance of debt - related party
    -       2,414,484  
Proceeds from issuance of notes payable
    230,000       -  
Net cash provided by financing activities
    1,937,500       2,984,484  
                 
Net decrease in cash
    (20,645 )     (51,559 )
Cash at beginning of the period
    21,936       73,495  
Cash at end of the period
  $ 1,291     $ 21,936  
                 
Supplemental disclosures of cash flow information
               
Interest paid
  $ 2,703     $ 5,263  
Non cash investing and financing activity
               
Imputed dividend on extension of warrants
  $ 18,231     $ 8,325  
Debt discount recorded related to warrants issued in connection with notes payable - other
  $ 79,000     $ -  
Debt discount recorded related to warrants issued in connection with extension of tern of secured note payable – related party
  $ 135,000     $ -  
Reclassification of accrued interest to secured note payable – related party
  $ 538,837     $ -  
 
The accompanying notes are an integral part of these financial statements.

 
F-6

 

Protein Polymer Technologies, Inc.
Notes to Financial Statements

1. 
Organization and Significant Accounting Policies
 
Organization and business activities

Protein Polymer Technologies, Inc. (the “Company”) is a biotechnology company focused on the design, clinical development, and commercialization of genetically engineered protein polymers for a variety of biomedical and specialty materials applications. The Company was incorporated in Delaware on July 6, 1988.

Going Concern and Liquidity

The accompanying financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. For the year ended December 31, 2008, the Company incurred net losses and negative cash flows from operating activities of approximately $2,938,000 and $2,059,000, respectively, and at December 31, 2008, the Company had a working capital deficit of approximately $8,870,000 and an accumulated deficit of approximately $73,206,000. Our cash balance as of December 31, 2008 was approximately $1,300 and, in combination with anticipated additional contract, license, and material transfer payments, are insufficient to meet our on-going capital requirements.

Between April 2006 and September 2007, the Company relied primarily on borrowings pursuant to a note payable from a related party for capital needed to fund its operations and working capital requirements (see Note 5). The maturity of the note reflecting these borrowings, for which the outstanding principal balance at December 31, 2008 was approximately $6,415,000, is September 30, 2009. There is no assurance this maturity date will be extended if required by the Company. As of the end of December 2008, additional borrowings under the Company’s existing debt financing provided by a related party are unavailable and the lender continues to hold essentially all of the Company’s assets as collateral.

Since September 27, 2007, required operating capital has been obtained primarily through proceeds totaling $2,357,500 as of June 30, 2009 from sales of common stock and warrants pursuant to a Stock Purchase Agreement entered into on that date.  During the year ended December 31, 2008 and the period ended June 30, 2009, operating capital obtained from the Stock Purchase Agreement totaled $1,712,500 and $75,000, respectively.  Additionally, during the period from October 2, 2008 and December 31, 2008 and the subsequent period ended June 30, 2009, the Company received proceeds of $230,000 and $415,000, respectively, as unsecured loans from clients of TAG Virgin Islands, Inc. (hereafter “TAG”).  There is no assurance that additional capital required to continue to fund operations will be available under these agreements. See Notes 6 and 12.

Management believes that additional required funding during 2009 may be available through either the September 27, 2007 Stock Purchase Agreement or through additional unsecured loans from clients of TAG.  In addition, Management is currently in discussions with other potential financing sources and collaborative partners and is investigating other sources of funding in the form of equity investments and license fees.  However, no assurances can be given that the Company will receive additional funding from any of these sources required to meet its liquidity needs for 2009.  If adequate funds are not available, the Company will be required to significantly curtail operations, sell or license out significant portions of its technology, or possibly cease operations.  The financial statements do not include any adjustments that might result should the Company be unable to continue as a going concern.

Cash

The Company’s cash balances are maintained in checking accounts with a bank.  As of December 31, 2008 and 2007, there were no cash equivalents.

 
F-7

 

Protein Polymer Technologies, Inc.
Notes to Financial Statements (Continued)

Equipment and Leasehold Improvements

Equipment and leasehold improvements are stated at cost, less accumulated depreciation and amortization. Equipment is depreciated over the estimated useful life of the asset, typically three to seven years, using the straight-line method. Leasehold improvements are amortized over the shorter of the lease term or the estimated useful life of the asset.

Impairment of Long-Lived Assets

Long-lived assets and certain identifiable intangibles are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount may not be recoverable. If the fair value is less than the carrying amount of the asset, a loss is recognized for the difference.

Revenue and Expense Recognition

Research and development contract revenues are recorded as earned in accordance with the terms and performance requirements of the contracts. If the research and development activities are not successful, the Company is not obligated to refund payments previously received. Fees from the sale or license of technology are recognized on a straight-line basis over the term required to complete the transfer of technology or the substantial satisfaction of any performance related responsibilities. License fee payments received in advance of amounts earned are recorded as deferred revenue. Milestone payments are recorded as revenue based upon the completion of certain contract specified events that measure progress toward completion under certain long-term contracts. Royalty revenue related to licensed technology is recorded when earned and in accordance with the terms of the license agreement. Research and development costs are expensed as incurred.

Stock-Based Compensation

On January 1, 2006 the Company adopted Statement of Financial Accounting Standards (“SFAS”) No. 123 (Revised 2004), Share-Based Payment, (“SFAS No. 123R”), using the modified prospective method. In accordance with SFAS No. 123R, the Company measures the cost of employee services received in exchange for an award of equity instruments based on the grant-date fair value of the award. That cost is recognized over the period during which an employee is required to provide service in exchange for the award - the requisite service period. The Company determines the grant-date fair value of employee share options using the Black-Scholes option-pricing model.

Under the modified prospective approach, SFAS No. 123R applies to new awards and to awards that were outstanding on January 1, 2006 that are subsequently modified, repurchased or cancelled. Under the modified prospective approach, compensation cost recognized during the years ended December 31, 2008 and 2007,, includes compensation cost for all share-based payments granted prior to, but not yet vested on, January 1, 2006, based on the grant-date fair value estimated in accordance with the pro forma provisions of SFAS No. 123R, and compensation cost for all share-based payments granted subsequent to January 1, 2006, based on the grant-date fair value estimated in accordance with the provisions of SFAS No. 123R. Periods prior to January 1, 2006 were not restated to reflect the impact of adopting the new standard.

 
F-8

 

Protein Polymer Technologies, Inc.
Notes to Financial Statements (Continued)

Fair Value Measurement

The carrying value of the Company’s cash, accounts payable and accrued expenses approximate their respective fair values because of the short maturities of these instruments. The carrying value of the Company’s notes payable obligations approximates their fair value as the stated interest rates of these instruments reflect rates currently available to the Company.

Cost Method Investment

The investment balance at December 31, 2008 and 2007 represents shares of common stock owned by the Company in a privately held company which were acquired pursuant to a license agreement.  Based on the Company’s limited ownership percentage, the investment is reported using the cost method.  Under the cost method, the Company does not record its proportional share of earnings and losses of the investee, and income on the investment is only recorded to the extent of dividends distributed from earnings of the investee received subsequent to the date of acquisition.

The Company reviews the carrying value of its cost-method investment for impairment each reporting period unless i) the investment’s fair value has not been estimated for any purpose, including estimates of fair value used to satisfy other financial reporting requirements and ii) there are no impairment indicators present for the investment during the period under review which would indicate there has been an event or change in circumstances that could have a negative effect on the investment’s fair value.

When an impairment test demonstrates that the fair value of an investment is less than its cost, Company management will determine whether the impairment is either temporary or other-than-temporary.  Examples of factors which may be indicative of an other-than-temporary impairment include i) the length of time and extent to which market value has been less than cost, ii) the financial condition and near-term prospects of the issuer, iii) and the intent and ability of the Company to retain its investment in the issuer for a period of time sufficient to allow for any anticipated recovery in market value.

If the decline in fair value is determined by management to be other-than-temporary, the cost basis of the investment is written down to its estimated fair value as of the balance sheet date of the reporting period which the assessment is made. This fair value becomes the investment’s new cost basis, which is not changed for subsequent recoveries in fair value.  Any recorded impairment write-down will be included in earnings as a realized loss in the period such write-down occurs.

Net Loss per Common Share

Basic loss per share is calculated using the weighted-average number of outstanding common shares during the period. Diluted loss per share is calculated using the weighted-average number of outstanding common shares and dilutive common equivalent shares outstanding during the period, using either the as-converted method for convertible notes and convertible preferred stock or the treasury stock method for options and warrants.

Excluded from diluted loss per common share as of December 31, 2008 and 2007 were 5,847,656 and 41,214,734 shares, respectively, issuable upon conversion of convertible preferred stock, and options and warrants to purchase 69,753,814 and 33,268,706 shares of common stock, respectively, because the effect of the inclusion of these shares would be anti-dilutive.  For purposes of this calculation, net loss in 2008 and 2007 has been adjusted for imputed, accumulated and/or paid dividends on the preferred stock.

Use of Estimates

The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the financial statements, and the amount of revenue and expense reported during the period. Actual results could differ from those estimates.

 
F-9

 

Protein Polymer Technologies, Inc.
Notes to Financial Statements (Continued)

Revenue Concentration

During the year ended December 31, 2008, the Company had material transfer agreements with two customers that accounted for 75% and 11% of contract revenue.  During the year ended December 31, 2007, the Company had material contract research agreements with four customers that accounted for 35%; 24%; 17%; and 16% of the contract revenues, respectively.   

Income Taxes

The Company records income taxes using the asset and liability method. Deferred tax assets and liabilities are recognized for the estimated future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their future respective tax bases. Deferred tax assets and liabilities are measured using enacted tax rates in effect for the year in which those temporary differences are expected to be recorded or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date.

A valuation allowance is established to reduce the deferred tax asset if it is more likely that the related tax benefits will not be realized in the future.

Reclassification

Certain reclassifications have been made to the financial statements of the prior year in order to conform to the current year presentation. These reclassifications had no effect on previously reported results of operations or accumulated deficit.

Recently Issued Accounting Pronouncements

In September 2006, the Financial Accounting Standards Board (“FASB”) issued SFAS No. 157, Fair Value Measurements (“SFAS No. 157”). SFAS No. 157 defines fair value, establishes a framework for measuring fair value, and expands disclosures about fair value measurements. This Statement focuses on creating consistency and comparability in fair value measurements. SFAS No. 157 is effective with respect to financial assets and liabilities for fiscal years beginning after November 15, 2007, and interim periods within those fiscal years.  For non-financial assets and liabilities, the effective date of SFAS No. 157 has been deferred until fiscal years beginning after November 15, 2008.  Our adoption of SFAS No. 157 with respect to financial assets and liabilities on January 1, 2008 did not have a material affect on our financial statements.  The Company is required to adopt SFAS No. 157 with respect to non-financial assets and liabilities no later than January 1, 2009. The Company does not believe that the adoption of SFAS No. 157 with respect to non-financial assets and liabilities will have a material impact on its financial position, results of operations or cash flows.

 
F-10

 

Protein Polymer Technologies, Inc.
Notes to Financial Statements (Continued)

In February 2007, the FASB issued SFAS No. 159, The Fair Value Option for Financial Assets and Financial Liabilities—including an amendment of FASB Statement No. 115 (“SFAS No. 159”), which permits entities to choose to measure many financial instruments and certain other items at fair value. The fair value option established by this Statement permits all entities to choose to measure eligible items at fair value at specified election dates. A business entity shall report unrealized gains and losses on items for which the fair value option has been elected in earnings at each subsequent reporting date. Our adoption of SFAS No. 159 on January 1, 2008 did not have a material effect on our financial statements, as the Company did not elect to measure any items at fair value.

In October 2008, the FASB issued FSP SFAS No. 157-3, Determining the Fair Value of a Financial Asset When The Market for That Asset Is Not Active (“FSP 157-3”), to clarify the application of the provisions of SFAS 157 and how an entity would determine fair value in an inactive market. FSP 157-3 is effective immediately and applies to the Company’s December 31, 2008 financial statements. The application of the provisions of FSP 157-3 did not materially impact the Company’s consolidated financial position, results of operations and cash flows as of and for the period ended December 31, 2008.

In December 2007, the FASB issued Emerging Issues Task Force (“EITF”) Issue No. 07-1, Accounting for Collaborative Arrangements, (“EITF 07-1”), which is effective for fiscal years beginning after December 15, 2008.  EITF 07-1 defines collaborative arrangements and establishes reporting requirements for transactions between participants in a collaborative arrangement and between participants in the arrangement and third parties.  EITF 07-1 also establishes the appropriate income statement presentation and classification for joint operating activities and payments between participants, as well as the sufficiency of the disclosures related to these arrangements.  EITF No 07-1 is effective for the Company on January 1, 2009. The Company has not yet determined the impact that EITF No. 07-1 may have on our financial position, results of operations, or cash flows.

In June 2007, the FASB issued EITF Issue No. 07-3, Accounting for Nonrefundable Advance Payments for Goods or Services Received for Use in Future Research and Development Activities (“EITF 07-3”), which is effective for fiscal years beginning after December 15, 2007, and interim periods within those fiscal years.  The EITF reached a conclusion that nonrefundable advance payments for goods or services that will be used or rendered for future research and development activities pursuant to an executory contractual arrangement should be deferred and capitalized.  Such amounts should be recognized as expense as the goods are delivered or the related services are performed.  Entities should continue to evaluate whether they expect the goods to be delivered or services to be rendered.  If an entity does not expect the goods to be delivered or services to be rendered, the capitalized advance payment should be charged to expense.  Our adoption of EITF 07-3 on January 1, 2008 did not have a material impact on our financial position, results of operations, or cash flows.

In December 2007, the FASB issued SFAS No. 141 (revised), Business Combinations (“SFAS No. 141(R)”). SFAS No. 141(R) changes the accounting for business combinations including the measurement of acquirer shares issued in consideration for a business combination, the recognition of contingent consideration, the accounting for pre-acquisition gain and loss contingencies, the recognition of capitalized in-process research and development, the accounting for acquisition-related restructuring cost accruals, the treatment of acquisition related transaction costs and the recognition of changes in the acquirer’s income tax valuation allowance. SFAS No. 141(R) is effective for the Company on January 1, 2009. The Company does not believe the adoption of SFAS No. 141(R) will have a material impact on its financial position, results of operations or cash flows.

 
F-11

 

Protein Polymer Technologies, Inc.
Notes to Financial Statements (Continued)

In December 2007, the FASB issued SFAS No. 160, Non-controlling Interests in Consolidated Financial Statements, an amendment of ARB No. 51 (“SFAS No. 160”). SFAS No. 160 changes the accounting for non-controlling (minority) interests in consolidated financial statements including the requirements to classify non-controlling interests as a component of consolidated stockholders’ equity, and the elimination of “minority interest” accounting in results of operations with earnings attributable to non-controlling interests reported as part of consolidated earnings. Additionally, SFAS No. 160 revises the accounting for both increases and decreases in a parent’s controlling ownership interest.  SFAS No. 160 is effective for the Company on January 1, 2009. The Company does not believe that the adoption of SFAS No. 160 will have a material impact on its financial position, results of operations or cash flows.

In March 2008, the FASB issued SFAS No. 161, Disclosures about Derivative Instruments and Hedging Activities – an amendment of FASB Statement No. 133 (“SFAS No. 161”), as amended and interpreted, which requires enhanced disclosures about an entity’s derivative and hedging activities and thereby improves the transparency of financial reporting. Disclosing the fair values of derivative instruments and their gains and losses in a tabular format provides a more complete picture of the location in an entity’s financial statements of both the derivative positions existing at period end and the effect of using derivatives during the reporting period. Entities are required to provide enhanced disclosures about (a) how and why an entity uses derivative instruments, (b) how derivative instruments and related hedged items are accounted for under Statement 133 and its related interpretations, and (c) how derivative instruments and related hedged items affect an entity’s financial position, financial performance, and cash flows. SFAS No. 161 is effective for financial statements issued for fiscal years and interim periods beginning after November 15, 2008. Early adoption is permitted.  SFAS No. 161 is effective for the Company on January 1, 2009. The Company does not believe that its adoption of SFAS No. 161 will have a material impact on its financial position, results of operations or cash flows.

In April 2008, the FASB issued FASB Staff Position (“FSP”) FAS No. 142-3, Determination of Useful Life of Intangible Assets (“FSP FAS 142-3”). FSP FAS No. 142-3 amends the factors that should be considered in developing the renewal or extension assumptions used to determine the useful life of a recognized intangible asset under SFAS No. 142, “Goodwill and Other Intangible Assets.” FSP FAS No. 142-3 also requires expanded disclosure related to the determination of intangible asset useful lives. FSP FAS No. 142-3 is effective for fiscal years beginning after December 15, 2008. FSP FAS No. 142-3 is effective for the Company on January 1, 2009. The Company does not believe that its adoption of FSP FAS No. 142-3 will have a material impact on its financial position, results of operations or cash flows.

In May 2008, the FASB issued SFAS No. 162, The Hierarchy of Generally Accepted Accounting Policies (“SFAS No. 162”), which reorganizes the GAAP hierarchy. The purpose of the new standard is to improve financial reporting by providing a consistent framework for determining what accounting principles should be used when preparing the U.S. GAAP financial statements. The standard is effective 60 days after the SEC’s approval of the PCAOB’s amendments to AU Section 411. The adoption of SFAS No. 162 will not have an impact on the Company’s financial position or results of operations.

In May 2008, the FASB issued FSP Accounting Principles Board Opinion (“APB”) No. 14-1, Accounting for Convertible Debt Instruments That May Be Settled in Cash upon Conversion (Including Partial Cash Settlement) (“FSP APB 14-1”), which requires the issuer of certain convertible debt instruments that may be settled in cash (or other assets) on conversion to separately account for the liability (debt) and equity (conversion option) components of the instrument in a manner that reflects the issuer’s nonconvertible debt borrowing rate. FSP APB 14-1 will be effective for the Company on January 1, 2009 and will require retroactive disclosure. FSP APB 14-1 is effective for the Company on January 1, 2009. The Company has not yet determined the impact FSP APB 14-1 may have on its financial position, results of operations or cash flows.

 
F-12

 

Protein Polymer Technologies, Inc.
Notes to Financial Statements (Continued)

In May 2008, the FASB issued SFAS No. 163, Accounting for Financial Guarantee Insurance Contracts—an interpretation of FASB Statement No. 60 (“SFAS No. 163”), which requires recognition of an insurance claim liability prior to an event of default when there is evidence that credit deterioration has occurred in an insured financial obligation.  SFAS No. 163 is effective for financial statements issued for fiscal years beginning after December 15, 2008, and all interim periods within those fiscal years. SFAS No. 163 is effective for the Company on January 1, 2009. The Company does not believe its adoption on SFAS No. 163 will have a material impact on its financial position, results of operations or cash flows.

In June 2008, the FASB issued FSP No. EITF 03-6-1, Determining Whether Instruments Granted in Share-Based Payment Transactions Are Participating Securities (“EITF 03-6-1”), which requires entities to apply the two-class method of computing basic and diluted earnings per share for participating securities that include awards that accrue cash dividends (whether paid or unpaid) any time common shareholders receive dividends and those dividends do not need to be returned to the entity if the employee forfeits the award. EITF 03-6-1 will be effective for the Company on January 1, 2009 and will require retroactive disclosure. EITF 03-6-1 is effective for the Company on January 1, 2009. The Company has not yet determined the impact EITF 03-6-1 may have on its financial position, results of operations or cash flows.

In June 2008, the FASB ratified the consensus reached on EITF Issue No. 07-5, Determining Whether an Instrument (or Embedded Feature) Is Indexed to an Entity's Own Stock ("EITF No. 07-5").  EITF No. 07-5 clarifies the determination of whether an instrument (or an embedded feature) is indexed to an entity's own stock, which would qualify as a scope exception under SFAS No. 133, Accounting for Derivative Instruments and Hedging Activities. EITF No. 07-5 is effective for financial statements issued for fiscal years beginning after December 15, 2008. EITF No. 07-5 is effective for the Company on January 1, 2009. The Company has not yet determined the impact EITF No. 07-5 may have on its financial position, results of operations or cash flows.

In November 2008, the FASB ratified EITF Issue No. 08-6, Equity Method Investment Accounting Considerations (EITF No. 08-6), which is effective for financial statements issued for fiscal years beginning after December 15, 2008. EITF No. 08-6 applies to all investments accounted for under the equity method and clarifies the accounting for certain transactions and impairment considerations involving equity method investments. EITF 08-6 is effective for the Company on January 1, 2009. The Company does not believe its adoption of EITF 08-6 will have a material impact on its financial position, results of operations, and cash flows.

In November 2008, the FASB ratified EITF Issue No. 08-7, Accounting for Defensive Intangible Assets (EITF No. 08-7), which is effective for intangible assets acquired by the Company on or after January 1, 2009.  EITF No. 08-7 applies to defensive intangible assets, which are acquired intangible assets that an entity does not intend to actively use but does intend to prevent others from obtaining access to the asset. EITF No. 08-7 requires an entity to account for defensive intangible assets as a separate unit of accounting. Defensive intangible assets should not be included as part of the cost of an entity’s existing intangible assets because the defensive intangible assets are separately identifiable. Defensive intangible assets must be recognized at fair value in accordance with SFAS No. 141(R) and SFAS No. 157. The Company does not believe that the adoption of EITF 08-7 will have a material impact on its financial position, results of operations, and cash flows.

In May 2009, the FASB issued SFAS No. 165, Subsequent Events (“SFAS No. 165”), which is effective for fiscal years beginning after June 15, 2009.  SFAS No. 165 establishes general standards of accounting for and disclosure of events that occur after the balance sheet date but before financial statements are issued or are available to be issued. In particular, this Statement sets forth the period after the balance sheet date during which management of a reporting entity should evaluate events or transactions that may occur for potential recognition or disclosure in the financial statements, the circumstances under which an entity should recognize events or transactions occurring after the balance sheet date in its financial statements, and the disclosures that an entity should make about events or transactions that occurred after the balance sheet date.  The Company is currently evaluating the impact that the adoption of SFAS No. 165 may have on its financial position, results of operations, and cash flows.

 
F-13

 

Protein Polymer Technologies, Inc.
Notes to Financial Statements (Continued)

2. 
Equipment and Leasehold Improvements

Equipment and leasehold improvements consist approximately of the following:
 
   
December 31,
 
   
2008
   
2007
 
Laboratory equipment
  $ 298,000     $ 1,378,000  
Office equipment
    60,000       220,000  
Leasehold improvements
    -       360,000  
      358,000       1,958,000  
Less accumulated depreciation and amortization
    (334,000 )     (1,830,000 )
    $ 24,000     $ 128,000  
 
Proceeds and gains from the sale of equipment were approximately $101,000 and $41,000, respectively, during 2008.  The Company did not sell any equipment in 2007.

Depreciation and amortization expense was approximately $43,000 and $100,000 for the years ended December 2008 and 2007, respectively.

3. 
Investment
 
The investment included on our balance sheets at December 31, 2008 and 2007 represents our cost basis in shares of common stock of Spine Wave, Inc. (“Spine Wave”), a privately held company focused on the development and commercialization of innovative products and technologies for the treatment of spinal disorders, which we acquired between 2001 and 2006 in connection with our licensing and development agreements with Spine Wave which we entered into in 2001.  Based on its limited ownership percentage, the Company accounts for its investment in Spine Wave as a cost method investment.  As a cost method investment, the Company does not record its proportional share of the earnings or losses of Spine Wave, and income related to the investment would be recognized only to the extent that dividends are distributed from earnings of Spine Wave.  To date, no such dividends have been received.

Based on adverse changes in market values of companies in the medical device/equipment industry during the second half of 2008, as evidenced by the steep declines in stock market values of publicly traded companies in this sector and in the overall stock market, the Company evaluated its investment in Spine Wave for impairment as of December 31, 2008.  Since there are no quoted prices of Spine Wave’s common stock, and since it was not practicable for the Company to otherwise estimate the fair value of Spine Wave’s common stock at December 31, 2008, the Company was unable to quantify the specific amount of potential impairment.  However, because the Company believes there may be potential impairment, it completed an evaluation to determine if the potential impairment was other-than-temporary.  This evaluation was based on a number of factors including: i) the length of time and the extent to which the market value has been less than the cost; ii) the financial condition and near term prospects of Spine Wave: and iii) the Company’s intent and ability to retain its investment in Spine Wave for a period of time sufficient to allow for a recovery in market value.  In connection with this evaluation, the Company determined that any potential impairment in its investment in Spine Wave was primarily a function of the impact on the stock market and the medical device/equipment sector of the deterioration of global economic conditions during the second half of 2008, and that any potential impairment was not a function of factors specifically relating to Spine Wave’s business or its near term prospects.  Based on the Company's evaluation of Spine Wave’s near term prospects (which the Company believes to be very strong), the partial recovery of stock market values subsequent to December 31, 2008 and on management's intention to hold the investment in Spine Wave for a sufficient period of time to allow for a recovery in the market value, the Company determined that any potential impairment was not other-than-temporary, and accordingly, no impairment was recorded at December 31, 2008.


 
F-14

 


Protein Polymer Technologies, Inc.
Notes to Financial Statements (Continued)

As of December 31, 2007 the Company was not aware of any indicators of impairment with respect to its investment in Spine Wave, and it was not practicable for the Company to estimate the fair value of this investment because of the lack of quoted market prices and the inability to otherwise estimate fair value without incurring excessive costs.  Management believed that the carrying amount of its investment in Spine Wave was not impaired at December 31, 2007.

As discussed in Note 5, a portion of the Spine Wave shares owned by the Company serve as collateral for a currently outstanding note payable.
 
4. 
Accrued Liabilities
 
Accrued liabilities consist approximately of the following:
 
   
December 31,
 
   
2008
   
2007
 
Payroll and employee benefits
  $ 67,000     $ 82,000  
Professional fees
    -       23,000  
Accrued interest
    610,000       585,000  
Insurance premium financing
    27,000       22,000  
Directors fees
    100,000       60,000  
Other
    40,000       22,000  
    $ 844,000     $ 794,000  
 
5. 
Secured Notes Payable – Related Party
  
On April 13, 2006, a shareholder loaned $1,000,000 (the “Loan”) to the Company ($500,000 in cash and an additional $500,000 deposited with an escrow agent as a line of credit) represented by a note (the “4/13/06 Note”) issued by the Company to the shareholder in the principal amount of $1,000,000 (the “Principal”). The Note was originally due on July 7, 2006 (the “Maturity Date”) and bears annual interest at the rate of 8% payable on the Maturity Date. It is secured, in accordance with the terms of a security agreement (the “Security Agreement”), by a continuing security interest in and a general lien upon (i) 2,000,000 shares of Spine Wave, Inc. common stock owned by the Company; and (ii) all U.S. patents owned by the Company. The Note and the Security Agreement are both dated April 13, 2006.

 
F-15

 

Protein Polymer Technologies, Inc.
Notes to Financial Statements (Continued)

Pursuant to the terms of the Security Agreement, the Company entered into a patent security agreement, an escrow agreement, a patent assignment, and a registration rights agreement, each dated as of April 13, 2006. According to the terms of the Security Agreement, the Company entered into the Escrow Agreement with an escrow agent for the shareholder. The Escrow Agreement provides for the disbursement of the funds held in escrow for application to Company expenses at the sole discretion of the shareholder’s designee. The Escrow Agreement terminates upon the event that the amount borrowed is paid in full and no event of default has occurred.

As consideration for the Loan, the Company granted a warrant to the shareholder to purchase an aggregate of 500,000 shares of the Company’s common stock at an exercise price of $0.30 per share. The shareholder’s counsel acts as the escrow agent and now serves as our outside general counsel.

Effective January 9, 2008, the Company replaced the 4/13/06 Note by issuing a new note (the “1/09/08 Note”) in the principal amount of $6,415,000.  This amount included the then $5,876,000 outstanding balance plus the then outstanding $539,000 of accrued interest on the 4/13/06 Note.  The 1/09/08 Note bears annual interest at the rate 8%, the same as did the 4/13/06 Note, and matures on September 1, 2008.  The 1/09/08 Note is secured in the same manner as was the 4/13/06 Note.  On September 1, 2008, the scheduled maturity date of the 1/09/08 Note was extended to March 31, 2009.  On March 31, 2009, the scheduled maturity date of the 1/09/08 Note was further extended to September 30, 2009.  As of December 31, 2008, the amount due on the 1/09/08 Note includes the original $6,415,000 outstanding balance plus $500,000 of accrued interest.

As consideration for the lender agreeing to accept the 1/09/08 Note as payment for the 4/13/06 Note, the Company i) issued the lender three-year warrants to purchase an aggregate of 2,438,000 shares of the Company’s common stock at $0.061 per share, ii) lowered the exercise price of the 4/13/06 Warrant from $0.30 per share to $0.061 per share, and iii) extended the term of the 4/13/06 Warrant from April 30, 2009 to January 31, 2011.  See Note 12.

The relative fair value of the warrants issued in connection with the 1/09/08 Note, estimated to be approximately $117,000, was recorded as debt discount. In addition, the change in fair value of the 4/13/06 Warrant resulting from the modification of the terms, estimated at $18,000, was also recorded as debt discount. The fair value of these warrants was estimated on the date of grant using the Black Scholes option valuation model with the following assumptions:

   
April 2006 
Issuance
  
January 2008 
Modification
  
January 2008 
Issuance
  
  
  
4/13/06 
Warrant
  
4/13/06 
Warrant
  
1/09/08 
Warrant
 
Expected annual dividends
   
0
%
0
%
0
%
Risk-free interest rate
   
4.9
%
3.0
%
2.7
%
Expected term (in years)
   
3.0
 
1.3
 
3.1
 
Expected Volatility
   
90.0
%
157.0
%
157.0
%

The total debt discount recorded was amortized as interest expense over the original term of the 1/09/08 Note using the effective interest method, and, as of December 31, 2008, the debt discount was fully amortized.

 
F-16

 

Protein Polymer Technologies, Inc.
Notes to Financial Statements (Continued)

6. 
 Notes Payable - Other
 
TAG Client Notes

On the following dates, the Company has received proceeds in the following amounts pursuant to note payable agreements entered into with clients of TAG:

Date
 
Amount
 
October 2, 2008
  $ 100,000  
November 3, 2008
    105,000  
December 11, 2008
    25,000  
Total
  $ 230,000  

These loans are represented by unsecured notes issued by the Company.  These notes have a maturity term of one year, and bear an annual interest rate of 8%.  The interest and principal are payable on the maturity dates.  At the Company’s option, the principal and accrued interest due at maturity may be paid in shares of its common stock based on a price per share of $0.05 with respect to the October 2, 2008 note and $0.04 with respect to the November 3, 2008 and December 11, 2008 notes.  As consideration for the loans, the Company granted warrants to the noteholders to purchase shares in the following aggregate amounts and exercise prices:

Date
 
Amount
   
Exercise
Price
 
October 2, 2008
    2,000,000     $ 0.05  
November 3, 2008
    2,625,000       0.04  
December 11, 2008
    625,000       0.04  
Total
    5,250,000          

TAG is a registered investment advisor and advises a number of our stockholders, including certain members of our Board of Directors, in investment decisions, including decisions about whether to invest in our stock.  Based upon our stock records and data supplied to us by our stockholders, we believe that clients of TAG beneficially own approximately 67.8% of our common stock. TAG has discretionary authority to vote or dispose of the shares of our common stock held in its client accounts and, therefore, may be deemed to be the beneficial owner of such shares in accordance with the Commission's Rules. TAG has informed us that James Tagliaferri is the natural person at TAG with such discretionary authority. TAG expressly disclaims beneficial ownership of any shares owned by its clients.

The relative fair values of the warrants issued in connection with these notes, estimated to be approximately $79,100, were recorded as debt discount.  The fair value of these warrants was estimated on the date of grant using the Black-Scholes option valuation model with the following assumptions:

   
10/02/08
Warrant
   
11/03/08
Warrant
   
12/11/08
Warrant
 
Expected annual dividends
    0 %     0 %     0 %
Risk-free interest rate
    1.9 %     1.5 %     1.1 %
Expected term (in years)
    3.0       3.0       3.0  
Expected Volatility
    111.9 %     63.7 %     56.7 %

The carrying value of the notes payable - other at December 31, 2008, is comprised of the following:

   
Total
 
Principal value of notes
  $ 230,000  
Less: Unamortized debt discount
    (71,400 )
    $ 158,600  

 
F-17

 

Protein Polymer Technologies, Inc.
Notes to Financial Statements (Continued)

The total debt discount recorded is being amortized as interest expense over the expected term of the notes using the effective interest method.  During 2008, the Company recorded non-cash interest expense of approximately $7,600 based on the debt discount amortization of these warrants.

Surgica Notes

In December 2005, in connection with a license agreement with Surgica Corporation for the rights to certain intellectual property, the Company assumed several notes payable agreements with an aggregate principal balance of $519,000. The notes bear interest at rates ranging from 6% to 10%, and were scheduled to mature through January 2009 as shown below:

Year Ending
December 31,
  
Notes Payable
Maturities
  
2008
  
419,000
  
2009
   
100,000
 
Total maturities
 
$
519,000
 

In March 2007, the license agreement with Surgica was terminated.  On October 15, 2008, the noteholders instituted suit against the Company in Superior Court of California, County of Sacramento seeking payment of these notes.  The name of the case is Lou Matson, Mary Matson, and Don Brandon v. Protein Polymer Technologies, Inc, Case Number 34-2008-00022190.  The Company defended this action, alleging, among other things, that it had no liability for these notes.  Until a final determination was made with respect to the disposition of the notes, the Company continued to carry them on its balance sheet.  Accordingly, as of December 31, 2008, the entire balance of the outstanding notes payable and related accrued interest of $106,000 is reflected in the accompanying financial statements as a current liability.  On May 19, 2009, the plaintiffs filed a request for dismissal with prejudice of the action against the Company, and the Company paid nothing to plaintiffs in exchange for the dismissal.

7. 
Stockholders’ Deficit

Common Stock

The Company’s Board of Directors agreed to the terms of a Stock Purchase Agreement (“SPA”) and a Registration Rights Agreement (“RRA”), each dated as of September 27, 2007, with TAG Virgin Islands, Inc.(“TAG”), as agent for certain purchasers of the Company’s common stock. TAG is a registered investment advisor and advises a number of our stockholders, including certain members of our Board of Directors, in investment decisions, including decisions about whether to invest in our stock. Based upon our stock records and data supplied to us by our stockholders, we believe that clients of TAG beneficially owned approximately 55.1% of our common stock, prior to the stock purchases subject to the SPA. The SPA essentially provides for the Company selling, from time to time, shares of its common stock, par value $0.01, to the purchasers at a purchase price determined as the closing price of the stock on sale date. As a component of the purchase of the common stock, the purchaser also will receive a warrant to purchase the same number of shares of common stock in the future. Each warrant expires in five years from the date of purchase and is exercisable at a per share price, subject to certain anti-dilution provisions, equal to 110% of the purchase price paid by the purchase.

As of November 28, 2007, the SPA was amended so that on and after that date the warrants are exercisable at 100% of the price of the shares that are purchased. The SPA can be terminated at any time by TAG. The purchasers have certain registration rights, as provided by the RRA, to require the Company, at its cost, to file an effective registration statement with the Securities and Exchange Commission.

During 2008, the Company received an aggregate of $1,712,500 in subscriptions for the purchase of 36,586,091 shares of common stock and 36,586,091 warrants, subject to the terms of the SPA and RRA.

 
F-18

 

Protein Polymer Technologies, Inc.
Notes to Financial Statements (Continued)

Convertible Preferred Stock

Series D and Series F 10% Cumulative Preferred Stock

At December 31, 2008 and 2007 there were a total of 447 and 1,344 shares, respectively, of Series D 10% Cumulative Convertible Preferred Stock (“Series D Stock”).  At December 31, 2008 and 2007 there were a total of    -0- and 26,420 shares, respectively, of Series F 10% Cumulative Convertible Preferred Stock (“Series F Stock”).    Each share of Series D and F Stock earns a cumulative dividend at the annual rate of $10 per share, payable if and when declared by the Company’s Board of Directors, in the form of cash, common stock or any combination thereof. As of December 31, 2008, the accumulated dividends were approximately $2,985,000. The Series D Stock is convertible into common stock at the holder’s option. The conversion price at the time of conversion is the lesser of $3.75 or the market price. The Series D Stock is redeemable at the Company’s option. Automatic conversion of all of the Series D Stock will occur if: (a) the Company completes a public offering of common stock at a price of $2.50 or higher; or (b) the holders of a majority thereof elect to convert. The Company has the option to demand conversion of the Series D Stock if the average market price of its common stock equals or exceeds $5.00 per share over a period of twenty business days. The Series D Stock has a liquidation preference of $100 per share plus accumulated dividends, which is senior to any outstanding share of Series G Convertible Preferred Stock, Series H Convertible Preferred Stock or common stock.  The Series D Stock has been designated as non-voting stock.

Series G Convertible Preferred Stock

At December 31, 2008 and 2007 there were a total of 11,700 shares of Series G Convertible Preferred Stock (“Series G Stock”) outstanding.  Each share of Series G Stock can be converted at any time by the holder into common stock at a price of $0.50 per share, subject to certain anti-dilution adjustments.  The Series G Stock is redeemable, in whole or in part at the Company’s option, at any time, at a redemption price of $100 per share, provided that the Company has sufficient funds available to redeem those shares of Series G Stock being redeemed.  Automatic conversion of all of the Series G Stock will occur if: (a) the Company completes a public offering of common stock at a price of $2.50 or higher in which the minimum offering is for at least $10 million; or (b) the holders of a majority thereof elect to convert. The Series G Stock has a liquidation preference of $100 per share, which is senior to any outstanding shares of common stock. Holders of Series G Stock are entitled to receive dividends, when and as declared by the Board of Directors, provided however, that no such dividends shall be declared or paid on the Series G Stock until the preferential cumulative dividends on the Series D and Series F Preferred Stock have been first fully paid or declared and set apart.

 
F-19

 

Protein Polymer Technologies, Inc.
Notes to Financial Statements (Continued)

Series H Convertible Preferred Stock

At December 31, 2008 and 2007 there were a total of 4,090 and 12,181 shares, respectively, of Series H Convertible Preferred Stock (“Series H Stock”) outstanding.  Each share of Series H Stock is convertible at any time at the election of the holder into 133.33 shares of common stock at a conversion price of $0.75 per share, subject to certain anti-dilution adjustments.  Automatic conversion of all of the Series H Stock will occur if: (a) the Company completes a public offering of common stock at a price of $5.00 or higher in which the minimum offering is for at least $10 million; or (b) the holders of a majority thereof elect to convert. The Series H Stock has a liquidation preference, which is senior to any outstanding Series G Preferred Stock or common stock, of $100 per share.  Holders of Series H Stock are entitled to receive dividends, when and as declared by the Board of Directors, provided however, that no such dividends shall be declared or paid on the Series H Stock until the preferential cumulative dividends on the Series D and Series F Preferred Stock have been first fully paid or declared and set apart.  The Series H Stock has been designated as non-voting.

Series I Convertible Preferred Stock

At December 31, 2008 and 2007 there were a total of 4,000 and 14,000 shares, respectively of Series I Convertible Preferred Stock (“Series I Stock”) outstanding.  Each share of Series I Stock is convertible at any time at the election of the holder into approximately 181 shares of common stock at a conversion price of $0.55 per share, subject to certain anti-dilution adjustments.  Automatic conversion of all of the Series H Stock will occur if: (a) the Company completes a public offering of common stock at a price of $3.00 or higher in which the minimum offering is for at least $10 million; or (b) the holders of a majority thereof elect to convert.   The Series I Stock has a liquidation preference, which is senior to any other outstanding series of preferred stock or common stock, of $100 per share.  Holders of Series I Stock are entitled to receive dividends, when and as declared by the Board of Directors, provided however, that no such dividends shall be declared or paid on the Series I Stock until the preferential cumulative dividends on the Series D and Series F Preferred Stock have been first fully paid or declared and set apart.

October 2008 Stock Re-Purchase Agreement

On October 30, 2008, the Company repurchased 920,480 common shares and a collective total of 45,408 Series D, F, H, and I preferred shares held by Johnson & Johnson Development Corporation for $5,000 (“October 2008 Stock Re-Purchase Agreement). To the Company’s knowledge, these shares represent all outstanding shares held by this shareholder.  Subject to this agreement, 897 shares of Series D Stock, 26,420 shares of Series F Stock, 8,091 shares of Series H Stock and 10,000 shares of Series I Stock were repurchased.  In connection with the repurchase of these shares, the Company recorded a reduction of the carrying values of common stock and preferred stock of $920,480 and $4,185,618, respectively,  and an aggregated increase of $4,189,823 in additional paid in capital.

Employee Stock Purchase Plan

In September 1996 the Company established the Protein Polymer Technologies, Inc., Employee Stock Purchase Plan (the “Plan”). The Plan commenced January 2, 1997, and allows for offering periods of up to two years with quarterly purchase dates occurring the last business day of each quarter. The purchase price per share is generally calculated at 85% of the lower of the fair market value on an eligible employee’s entry date or the quarterly purchase date. The maximum number of shares available for issuance under the Plan is 500,000; an eligible employee may purchase up to 5,000 shares per quarter. The Plan Administrator consists of a committee of at least two non-employee directors of the Company who are members of the Compensation Committee. The Company’s Board of Directors may modify the Plan at any time. During 2007 and 2008, no shares were purchased under the plan.  There are no additional shares available for purchase under the Plan.
 
 
F-20

 

Protein Polymer Technologies, Inc.
Notes to Financial Statements (Continued)

Stock Options

The Company adopted the 1989 Stock Option Plan, which provided for the issuance of incentive and non-statutory stock options for the purchase of up to 500,000 shares of common stock to key employees and certain other individuals. The 1989 Stock Option Plan expired as of March 17, 1999. The options granted will expire ten years from their respective dates of grant. Options granted in the plan became exercisable ratably over periods of up to five years from the date of grant. At December 31, 2008, zero options to purchase common stock had been granted under the 1989 Plan with zero options exercisable.

The Company adopted the 1992 Stock Option Plan, which provides for the issuance of incentive and non-statutory stock options for the purchase of up to 1,500,000 shares of common stock to its key employees and certain other individuals. The 1992 Stock Option Plan expired as of December 31, 2002. The options granted will expire ten years from their respective dates of grant. Options become exercisable ratably over periods of up to five years from the dates of grant. The purchase price of each option approximated the fair market value of the common stock on the date of grant. At December 31, 2008, 192,500 options to purchase common stock had been granted under the 1992 Plan with 192,500 options outstanding and exercisable.

In April 2002, the Company adopted the 2002 Stock Option Plan, which provides for the issuance of incentive and non-statutory stock options for the purchase of up to 1,500,000 shares of common stock to its key employees and certain other individuals. In April 2003, the plan was amended to increase the number of options available for grant to 9,000,000. The options will expire ten years from their respective dates of grant. Options become exercisable ratably over periods of up to three years from the dates of grant. The purchase price of each option approximated the fair market value of the common stock on the date of grant. At December 31, 2008, options to purchase 2,620,000 shares of common stock had been granted under the 2002 Plan with 2,620,000 options outstanding and exercisable.

In June 1996, the Company adopted the 1996 Non-Employee Directors Stock Option Plan (“1996 Plan”), which provides for the granting of nonqualified options to purchase up to 250,000 shares of common stock to directors of the Company. In April 2003, the 1996 Plan was amended to increase the number of options available for grant to 1,750,000, and the annual award to each Director to 80,000. Such grants of options to purchase 80,000 shares of common stock are awarded automatically on the first business day of June during each calendar year to every Participating Director then in office, subject to certain adjustments. No Participating Director is eligible to receive more than one grant per year. The purchase price of each option is set at the fair market value of the common stock on the date of grant. Each option has a duration of ten years, and becomes exercisable ratably over periods of up to three years from the date of grant. As of December, 31, 2008, the annual award to each Director of 80,000 stock options had not been issued for 2007 or 2008. In addition, the Board in their annual Proxy Statement dated August 17, 2007 stated its intent to issue shares valued at $10,000 each to Messrs. Kuhn and McCarthy as payment for outstanding directors fees for 2006. As of December 31, 2008, these shares had not been issued. The Company’s Compensation Committee administers the 1996 Plan. At December 31, 2008, 520,700 options to purchase common stock had been granted under the 1996 Plan with 498,636 options outstanding and exercisable.

Since inception, the Company has granted non-qualified options outside the option plans to employees, directors and consultants. At December 31, 2008, a total of 3,507,500 options to purchase common stock are outstanding and 3,498,587 are exercisable.

Compensation cost recorded related to the above referenced options was a charge of approximately $4,000 and a gain of approximately $110,000 for the years ended December 31, 2008 and 2007, respectively.   As of December 31, 2008, there was $2,400 of total unrecognized compensation cost related to non-vested options.  This cost is expected to be recognized during 2009.


 
F-21

 

Protein Polymer Technologies, Inc.
Notes to Financial Statements (Continued)

The Company did not grant options during the years ended December 31, 2008 or 2007.  The aggregate intrinsic value for both options outstanding and options exercisable at December 31, 2008 was $0.

Stock option activity for the year ended December 31, 20087 and 2007 is as follows:

   
Options
Outstanding
   
Weighted
Average
Exercise
Price
   
Weighted
Average
Remaining
Contractual
Term (Years)
 
Outstanding at December 31, 2006
    12,454,582       0.66       6.5  
Issued
    -       -          
Cancelled/Expired
    (957,096 )     0.52          
Exercised
                   
Outstanding at December 31, 2007
    11,497,486     $ 0.65       5.3  
Issued
    -       -          
Cancelled/Expired
    (7,989,986 )     0.64          
Exercised
                   
Outstanding at December 31, 2008
    3,507,500     $ 0.68       4.4  
Exercisable at December 31, 2008
    3,485,436     $ 0.68       4.4  

Warrants

The Company has reserved for issuance, out of currently authorized and unissued shares of common stock, shares underlying outstanding warrants to purchase common stock. Upon exercise of the warrants, shares of common stock will be issued out of currently authorized and unissued shares.

During the last quarter of 2007 and during 2008, the Company granted warrants to purchase an aggregate of 5,913,028 and 36,586,091, respectively, of the Company’s common stock pursuant to the terms of a Stock Purchase Agreement dated September 27, 2007.  Such warrants are exercisable at prices ranging from $0.17 to $0.03 per share and expire at various times through December 2013.

On January 9, 2008, we replaced the Szulik Loan and issued Mr. Szulik three-year warrants to purchase an aggregate of 2,438,000 shares of our common stock at $0.061 per share.  Additionally, we lowered the exercise price of warrants to purchase 500,000 shares of our common stock that we had previously issued to him from $0.30 per share to $0.061 per share.

During 2008, the Company granted warrants to purchase an aggregate of 5,250,000 of the Company’s common stock pursuant to the terms of unsecured note agreements.  Such warrants are exercisable at prices ranging from $0.04 to $0.05 per share and expire after one year.

During 2008 and 2007, 2,798,996 and 1,320,302 warrants, respectively, expired.  No warrants were exercised during 2007 or 2008.

 
F-22

 

Protein Polymer Technologies, Inc.
Notes to Financial Statements (Continued)

A summary of warrant activity for 2008 and 2007 is as follows:
 
   
Number of
Warrants
Outstanding
and
Exercisable
   
Weighted-
Average
Exercise
Price
 
Outstanding, December 31, 2006
    17,178,494     $ 0.55  
Granted
    5,913,028     $ 0.10  
Exercised
        $  
Expired
    (1,320,302 )   $ (0.92 )
Outstanding, December 31, 2007
    21,771,220     $ 0.41  
Granted
    44,274,091     $ 0.05  
Exercised
        $  
Expired
    (2,798,997   $ (0.64 )
Outstanding, December 31, 2008
    63,246,314     $ 0.14  
 
At December 31, 2008, the weighted-average remaining contractual life of the warrants was approximately 3.3 years.

8. 
Stockholder Protection Agreement
 
In 1997, the Company’s Board of Directors adopted a Stockholder Protection Agreement (“Rights Plan”) that distributes Rights to stockholders of record as of September 10, 1997. The Rights Plan contains provisions to protect stockholders in the event of an unsolicited attempt to acquire the Company. The Rights trade together with the common stock, and generally become exercisable ten business days after a person or group acquires or announces the intention to acquire 15% or more of the Company’s outstanding shares of common stock, with certain permitted exceptions. The Rights then generally allow the holder to acquire additional shares of the Company’s capital stock at a discounted price. The issuance of the Rights is not a taxable event, does not affect the Company’s reported earnings per share, and does not change the manner in which the Company’s common stock is traded.
 
9. 
Commitments and Contingencies
 
Facilities Lease Agreement

We currently lease approximately 180 square feet of administrative office space in San Diego. The lease term began on June 15, 2009 and expires on February 28, 2010.  The lease can be terminated at any time with one month’s notice.  The current annual rent for this space is approximately $4,300.  We are currently outsourcing our laboratory and production facilities.  Rent expense was approximately $351,000 and $672,000 for the years ended December 31, 2008 and 2007, respectively.

Annual future minimum operating lease payments are as follows:

Year Ending
December 31,
 
Operating
Leases
 
       
2009
 
$
2,340
 
2010
   
720
 
Total minimum operating lease payments
 
$
3,060
 


 
F-23

 


Protein Polymer Technologies, Inc.
Notes to Financial Statements (Continued)

In connection with our former lease for laboratory and administrative offices which expired in 2008, the Company has accrued $25,000 as of December 31, 2008 based on a claim for damages from the former landlord, which the Company is contesting.

Legal Proceedings

On October 15, 2008, holders of notes assumed by the Company in connection with the Surgica Technology License Agreement and the Supply Agreement instituted suit against the Company in Superior Court of California, County of Sacramento, seeking payment of outstanding notes payable allegedly owed by the Company. The name of the case is Lou Matson, Mary Matson, and Don Brandon v Protein Polymer Technologies, Inc, Case Number 34-2008-00022190.  On May 19, 2009, the plaintiffs filed a request for dismissal with prejudice of the action against the Company, and the Company paid nothing to plaintiffs in exchange for the dismissal.

Agreements with Surgica Corporation
 
Supply and Services Agreement
 
In March 2007, the Company received notification from Surgica’s legal counsel alleging that the Company had breached the Technology License Agreement and the Supply Agreement, and based thereon, Surgica was terminating these agreements. The Company does not believe it has breached these agreements.  Subsequently, Surgica filed for bankruptcy protection under Chapter 7 of the U.S. Bankruptcy laws.  At this time, the final discharge has not been received but court documents dated August 22, 2007 indicate that the bankruptcy will be considered a ‘no asset’ case, thus no recovery is anticipated.

 
F-24

 

Protein Polymer Technologies, Inc.
Notes to Financial Statements (Continued)

10.         Income Taxes
 
In July 2006, the FASB issued Interpretation No. 48, Accounting for Uncertainty in Income Taxes - an interpretation of FASB Statement No. 109, (“FIN 48”). FIN 48 clarifies the accounting for uncertainty in tax positions and requires that a Company recognize in its financial statements the impact of a tax position, if that position is more likely than not of being sustained upon audit by the relevant taxing authority, based on the technical merits of the position. Additionally, FIN 48 provides guidance on derecognition, measurement classification, interest and penalties, accounting in interim periods, disclosure and transition. The provisions of FIN 48 are effective for fiscal years beginning after December 15, 2006.

The Company adopted the provisions of FIN 48 on January 1, 2007, and commenced analyzing filing positions in all of the federal and state jurisdictions where it was required to file income tax returns, as well as all open tax years in these jurisdictions.  As a result of adoption, the Company has recorded no additional tax liability.  As of December 31, 2008, the Company has not yet completed its analysis of the deferred tax assets for net operating losses of $16.9 million and research and development credits of $3.2 million generated in years prior to 2008, and net operating losses of $1.4 million and research and development credits of approximately $84,000 generated in 2008.   As such, these amounts and the offsetting valuation allowance have been removed from the Company’s deferred tax assets.  Due to the existence of the valuation allowance, future changes in our unrecognized tax benefits will not impact the Company’s effective tax rate.

The Company is subject to taxation in the U.S. and state jurisdictions. The Company’s tax years for 2003 and forward are subject to examination by the U.S. and California tax authorities due to the carry-forward of unutilized net operating losses and research and development credits.  The Company is currently not under examination by any taxing authorities.

The Company’s practice is to recognize interest and/or penalties related to income tax matters in income tax expense.  During the twelve months ended December 31, 2008, the Company did not recognize any interest or penalties.  Upon adoption of FIN 48 on January 1, 2007, the Company did not record any interest or penalties.

The adoption of FIN 48 did not impact the Company’s financial condition, results of operations or cash flows.  At December 31, 2008, the Company had net deferred tax assets of $1.7 million.  The Company’s deferred tax assets are primarily composed of stock-based compensation/warrants expense, impairment of licenses, and basis differences in fixed assets. Due to uncertainties surrounding the Company’s ability to generate future taxable income to realize these assets, a full valuation has been established to offset the net deferred tax asset. Additionally, the future utilization of the company’s net operating loss to offset future taxable income may be subject to an annual limitation, pursuant to Internal Revenue Code Section 382, as a result of ownership changes that may have occurred previously or that could occur in the future.  The Company has not yet determined whether such an ownership change has occurred. Additionally, the Company has not performed a comprehensive review of the components of its research and development credit. Until this analysis and review have been completed, the Company has removed the deferred tax assets associated with these carry-forwards from its deferred tax asset schedule and has recorded a corresponding decrease to its valuation allowance. Once the appropriate analysis and review of these matters are completed, the Company plans to update its unrecognized tax benefits under FIN 48. At this time, the Company cannot estimate how much the unrecognized tax benefit may change, if any.

 
F-25

 

Protein Polymer Technologies, Inc.
Notes to Financial Statements (Continued)

Significant components of the Company's deferred tax assets as of December 31, 2008 and 2007 are shown below. A valuation allowance of $1,687,000 and $1,819,000 has been recognized to offset the deferred tax assets as of December 31 2008 and 2007, respectively, as realization of such assets is uncertain.

   
2008
   
2007
 
Deferred tax assets:
           
Allowances
    174,000       161,000  
Stock-based compensation/warrants
    511,000       509,000  
Amortization/impairment of license
    308,000       334,000  
Basis difference fixed assets
    639,000       790,000  
Accrued expenses
    40,000       -  
Other, net
    15,000       25,000  
Total deferred tax assets
    1,687,000       1,819,000  
Valuation allowance for deferred tax assets
    (1,687,000 )     (1,819,000 )
Net deferred tax assets
  $ -     $ -  

The provision for income tax on earnings subject to income taxes differs from the statutory federal income tax rate at December 31, 2008 and 2007, due to the following:

   
2008
   
2007
 
Expected federal income tax benefit
  $ (999,000 )   $ (1,105,900 )
Expected state income tax benefit, net of federal benefit
    76,000       (181,600 )
Decrease in valuation allowance
    (132,000 )     171,500  
FIN 48 adjustments
    1,006,900       1,069,100  
Stock options
    -       53,900  
Other
    48,100       (7,000 )
Provision for income taxes
  $ -     $ -  

At December 31, 2008, the Company had federal and California tax net operating loss carry-forwards of approximately $49.1 million and $25.9 million, respectively.  The federal and California tax loss carry-forwards begin to expire in 2009 and 2012, respectively, unless previously utilized.

The Company also had federal and California research and development tax credit carry-forwards of approximately $2.0 million and $1.3 million, respectively. The federal credit carry-forward began to expire in 2008. The Company also has California Manufacturers’ Investment Credit carry-forward of approximately $62,000. The California credits do not expire.

Pursuant to Internal Revenue Code Sections 382 and 383, use of the Company’s net operating loss carry-forwards may be limited if a cumulative change in ownership of more than 50% occurs within a three-year period.

 
F-26

 

Protein Polymer Technologies, Inc.
Notes to Financial Statements (Continued)

11.         Employee Benefits Plan
 
On January 1, 1993, the Company established a 401(k) Savings Plan for substantially all employees who meet certain service and age requirements. Participants may elect to defer up to 20% of their compensation per year, subject to legislated annual limits. Each year the Company may provide a discretionary matching contribution. During the year ended December 31, 2008, and 2007, the Company did not make a contribution to the 401(k) Savings Plan.

12.         Subsequent Events

Between January 1, 2009 and June 30, 2009, the Company received aggregate proceeds of $75,000 for the purchase of 3,571,429 shares of common stock and 3,571,429 warrants, subject to the terms of the SPA.

Between January 1, 2009 and June 30, 2009, the Company received proceeds of $415,000 pursuant to note payable agreements entered into with clients of TAG.  These loans are represented by unsecured notes issued by the Company.  These notes are due one year after issuance and bear an annual interest rate of 8%.  The interest and principal are payable on the maturity dates, either in cash or common stock, at the discretion of the Company, at rates ranging from $0.02 to $0.03 per share.  As consideration for the loans, the Company granted warrants to the noteholders to purchase an aggregate of 20,173,077 shares of the Company’s common stock at exercise prices ranging from $0.02 to $0.03 per share.

On June 29, 2009, the Company received from Sanyo Chemical Industries, Ltd. (“Sanyo”) a fully executed copy of a License Agreement between Sanyo and the Company.  The effective date of the Agreement is June 18, 2009.    Pursuant to the Agreement, the Company has granted a non-exclusive, world-wide license to Sanyo of its technology, know-how, and intellectual property relating to recombinant, repetitive unit proteins and peptides, for the purposes of developing and commercializing products related to Sanyo’s specific fields of business.  The Agreement remains in effect until the expiration of the last to expire of the Company’s patents licensed by Sanyo under this Agreement.  The Agreement further provides the Company with initial and ongoing license fees, technical service and training fees, and a percentage royalty on the quarterly net sales of any new products developed by Sanyo under this Agreement.

F-27

 
Item 9.      Changes in and Disagreements with Accountants on Accounting and Financial Disclosure

None.
 
Item 9A(T). Controls And Procedures

Evaluation of Disclosure Controls

As of December 31, 2008, Company management, with the participation of the Company's Interim Chief Executive Officer and Interim Principal Financial Officer, evaluated the effectiveness of the Company's disclosure controls and procedures as defined in Rules 13a-15(e) under the Securities Exchange Act of 1934, as amended (the “Exchange Act”).  Based on this evaluation, the Company's Interim Chief Executive Officer and Interim Principal Financial Officer, who is the same person, concluded that as of December 31, 2008, the Company's disclosure controls and procedures were not effective for the purposes of recording, processing, summarizing and timely reporting of material information relating to the Company required to be included in its periodic reports.

For the reasons discussed in “Management’s Report on Internal Control over Financial Reporting” below, Company management, including the Interim Chief Executive Officer and Interim Principal Financial Officer concluded that, as of December 31, 2008, the Company’s internal control over financial reporting was not effective due to material weaknesses in internal control.  Notwithstanding the identified control deficiencies, Management has concluded that the consolidated financial statements included in this annual report present fairly, in all material respects, the Company’s financial position, results of operations, and cash flows for the periods presented in conformity with accounting principles generally accepted in the United States.

Changes in Internal Control over Financial Reporting

There have been no changes in the Company’s internal control over financial reporting (as defined in Rule 13a-15(f) under the Exchange Act) that occurred during the quarter ended December 31, 2008, that have materially affected, or are reasonably likely to materially affect, the Company’s internal control over financial reporting.

Management’s Report on Internal Control Over Financial Reporting

Company management is responsible for establishing and maintaining adequate internal control over financial reporting as defined in Rule 13a-15(f) under the Securities Exchange Act of 1934.  The Company’s internal control over financial reporting is designed to provide reasonable assurance to the Company’s management and Board of Directors regarding the reliability of financial reporting and the preparation and fair presentation of financial statements for external purposes in accordance with generally accepted accounting principles.

A Company’s internal control over financial reporting includes those policies and procedures that (i) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the company; (ii) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the company are being made only in accordance with authorizations of management and directors of the company; and (iii) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the company’s assets that could have a material effect on the financial statements.

 
26

 

The effectiveness of any system of internal control over financial reporting is subject to inherent limitations, including the exercise of judgment in designing, implementing, operating and evaluating the controls and procedures.  Because of these inherent limitations, internal control over financial reporting cannot provide absolute assurance regarding the reliability of financial reporting and may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.

Company management, with the participation of the Interim Chief Executive Officer and the Interim Principal Financial Officer, assessed the effectiveness of the Company’s internal control over financial reporting as of December 31, 2008.  In making this assessment, Management used the criteria set forth by the Committee of Sponsoring Organizations of the Treadway Commission (COSO) in Internal Control – Integrated Framework.  Based on this assessment, management, with the participation of the Interim Chief Executive Officer and Interim Principal Financial Officer, believes that, as of December 31, 2008, the Company’s internal control over financial reporting was not effective based on those criteria.

A material weakness is a deficiency, or combination of deficiencies, in internal control over financial reporting such that there is a reasonable possibility that a material misstatement of the Company’s interim or annual financial statements will not be prevented or detected on a timely basis.

Specifically, Company management identified certain matters involving internal control and the Company’s operations that it considered to be material weaknesses under the standards of the Public Company Accounting Oversight Board (PCAOB), including:

 
·
Pervasive, entity-level control deficiencies across key COSO components in the Company’s control environment, including:

 
o
Controls over the period-end financial closing and reporting processes;
 
o
Controls over managerial override;
 
o
Controls to prevent or reduce the risk of fraudulent activity;
 
o
Controls to monitor other controls, including the role of the Board of Directors; and
 
o
Controls related to risk assessment.

 
·
An absence of independence and financial expertise on the Board of Directors, limiting its ability to provide effective oversight.
 
·
An absence of a formalized process to manage the Company’s internal controls over financial reporting and become compliant with Section 404 of the Sarbanes-Oxley Act.
 
·
Inadequate controls over the period-end financial close and reporting processes;
 
·
Insufficient personnel resources and technical accounting expertise within the accounting function to provide for adequate segregation of duties and to properly account for non-routine or complex accounting matters; and
 
·
Inadequate documentation of policies, procedures, and controls related to finance and accounting, including inadequate procedures for appropriately identifying, assessing, and applying accounting principles.

Company management is taking steps to remediate these weaknesses in the Company’s internal control environment, including:

 
·
Working with the Board of Directors to recruit an independent financial expert who will formalize roles and responsibilities over the Company’s internal controls over financial reporting for the Board and Management.
 
·
Implementing a formal process to manage its internal controls over financial reporting as part of its efforts to become compliant with Section 404 of the Sarbanes-Oxley Act.  Management has retained the services of a third-party consulting firm to assist Company management with compliance with Section 404 of the Sarbanes-Oxley Act of 2002 (SOX); and
 
·
Retaining the services of a third-party consulting firm with sufficient expertise to assist Company management with:

 
27

 

o
Overseeing the daily accounting function, including cash receipts and disbursements, billing, payroll, and month-end bookkeeping processes;
 
o
Identifying and resolving non-routine or complex accounting matters;
 
o
Controlling period-end financial closing and reporting processes; and
 
o
Identifying, assessing, and applying accounting principles.
 
o
Formalizing its accounting policies and procedures, including defined roles and responsibilities and required managerial reviews and approvals,

Company management will continue to monitor and evaluate the effectiveness of our disclosure controls and procedures and our internal controls over financial reporting on an ongoing basis and are committed to taking further action and implementing additional improvements, as necessary and as funds allow.

This Form 10-K does not include an attestation report of the Company’s registered public accounting firm regarding internal control over financial reporting.  Management’s report was not subject to attestation by the Company’s registered public accounting firm pursuant to temporary rules of the Securities and Exchange Commission that permit the Company to provide only management’s report in this 10-K

Item 9B.      Other Information
 
None

PART III

Item 10.      Directors and  Executive Officers of the Registrant

The table below sets forth certain information regarding our directors, our executive officers, and other significant employees as of June 30, 2009.

Name
 
Age
 
Position with the Company
James B. McCarthy, M.B.A., J.D. (2)
 
57
 
Director, Interim Chief Executive Officer, Interim Principal Accounting Officer, and Interim Corporate Secretary
Allan Farber (1)(2)
 
62
 
Director
Kerry L. Kuhn, M.D. (1)
 
59
 
Director
Richard Adelson (1)(2)
 
52
 
Director
William N. Plamondon III
 
61
 
Director
Joseph Cappello, Ph.D.
 
52
 
Vice President, Research and Development, Chief Technical Officer and Director, Clinical Research
Franco A. Ferrari, Ph.D.
 
57
 
Vice President, Laboratory Operations and Polymer Production and Director, Molecular Genetics
 

(1) Member of the Compensation Committee of Board of Directors.
(2) Member of the Audit Committee of Board of Directors.

James B. McCarthy is our Interim Chief Executive Officer, Interim Principal Accounting Officer, and Interim Corporate Secretary,  positions he has held since November 2007. He has served as a director of the Company since April 2005. Mr. McCarthy is the founder, Chairman and Chief Executive Officer of Gemini Consulting Group, Inc., a U.S. based, privately held holding company with affiliated companies in the United States and the United Kingdom. Mr. McCarthy’s areas of key expertise include the development of hospital and ambulatory surgery center joint ventures both domestically and internationally, development and implementation of hospital and physician joint venture strategies and implementation of domestic and international medical supply and equipment arrangements.

 
28

 

Mr. McCarthy received his B.A. from the University of Notre Dame, his J.D. from the Loyola University School of Law, and his M.B.A. from the Keller Graduate School of Management. He is a member of various state and national organizations, including the American Health Lawyers Association and the National Strategy Forum. He also serves on the National Advisory Council of the Keller Graduate School of Management in Chicago, IL. Mr. McCarthy is also a member of the Board of Directors for Sirigen Group Ltd., London, England, and StemCyte, Inc., Covina, CA, with offices in New Jersey, Taiwan and India. He is also a member of the Board of Trustees of the University of San Diego, San Diego, California.

Allan Farber has served as a director of the Company since January 2007. He has been a private investor for more than the past five years.

Kerry L. Kuhn, M.D. has served as a director of the Company since April 2000. Dr. Kuhn is currently a partner and Board certified practicing physician at the Omega Obstetrics and Gynecology Center in Coral Springs, Florida, a position he has held since 1986. Dr . Kuhn serves on the Board of Directors of Vital MD, a physician organization consisting of medical LLC's who employ 120 obstetricians and gynecologists.

Richard Adelson has served as a director of the Company since January 2007. He has been a private investor for more than the past five years. Mr. Adelson also served as a director of the Company from September 1999 to April 25, 2003.

William N. Plamondon III has served as a director of the Company since March 2005. Mr. Plamondon served as our President and Chief Executive Officer from April 2005 to November 2007. Mr. Plamondon also serves as the President and Chief Executive Officer of R.I. Heller & Co., LLC, a management-consulting firm, a position he has held since 1998. Previously, Mr. Plamondon served as President and CEO of ANC Rental Corporation, from October 2001 until October 2003, and as CEO of First Merchants Acceptance Corp., from May 1997 until May 1998. Mr. Plamondon is also on the Board of Trustees of North Central College. He is an eight-year member of the Executive Advisory Committee for Give Kids the World, and is an active member of the American Bankruptcy Institute and the Turnaround Management Association.

Joseph Cappello, Ph.D., has been the Company’s Vice President, Research and Development since February 1997 and Chief Technical Officer since February 1993. He has been the Company’s Director, Clinical Research, since July 2002. From September 1988 to February 1993, he was the Company’s Senior Research Director, Protein Engineering.
 
Franco Ferrari, Ph.D., has been the Company’s Vice President, Laboratory Operations and Director, Molecular Genetics since February 1993. From September 1988 to February 1993, he was the Company’s Senior Research Director, Genetic Engineering.
 
Currently, all directors hold office until the next annual meeting of stockholders and until their successors have been duly elected and qualified. Officers are elected by and serve at the discretion of the Board of Directors. There are no family relationships among our directors and officers. There currently are no legal proceedings, and during the past five years there have been no legal proceedings, that are material to the evaluation of the ability or integrity of any director or director nominee of the Company.

The Board of Directors has determined that the audit committee does not have an “audit committee financial expert” as that term is defined in Item 407(h)(2) of Regulation S-K because the Board of Directors did not believe that any of the members of the Audit Committee met the qualifications of an “audit committee financial expert.” and does not believe, given the Company's current financial condition, that the expense is warranted at this time.
 
In fiscal year ended December 31, 2008, the Board had an Audit Committee established in accordance with section 3(a)(58)(A) of the Securities Exchange Act of 1934. The Audit Committee currently consists of Messrs. McCarthy, Adelson, and Farber.

 
29

 

Section 16(a) Beneficial Ownership Reporting Compliance
 
Section 16(a) of the Securities Exchange Act of 1934 requires our officers and directors, and persons who own more than ten percent of a registered class of our equity securities (“Section 16 Participants”), to file reports of ownership and changes in ownership with the SEC. Such persons are required to furnish the Company with copies of all forms they file pursuant to Section 16(a). To our knowledge, during the fiscal year ended December 31, 2008, based solely on a review of such materials as are required by the SEC, no Section 16 Participants failed to timely file with the Securities and Exchange Commission any form or report required to be so filed pursuant to Section 16(a), except that one of our holders of more than ten percent of our common stock may have failed to file certain reports under Section 16(a).

Code of Ethics
 
We have adopted a written Code of Conduct that applies to everyone in the Company, including our Chief Executive Officer (our principal executive officer and principal financial officer).  A copy of our Code of Conduct is incorporated by reference as exhibit 14.1 to the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2008.

Item 10.      Executive Compensation

Compensation of Non-Employee Directors

Non-employee, non-affiliate directors are entitled to receive $10,000 for their services as directors during the 2008 fiscal year. All directors were reimbursed for their out-of-pocket expenses in attending meetings of the Board or committees thereof.  Neither the 2008 directors' fees payable of $10,000 each to Messrs. Adelson, Farber, Kuhn, and Plamondon nor the 2007 directors’ fee payable of $10,000 each to Messrs. Adelson, Farber, Kuhn, and McCarthy had been paid as of December 31, 2008.  We anticipate satisfying those obligations with the issuance of stock or stock options during 2009. In addition, the Board in their annual Proxy Statement dated August 17, 2007 stated its intent to issue shares valued at $10,000 each to Messrs. Kuhn and McCarthy as payment for outstanding directors fees for 2006. As of December 31, 2008, these shares had not been issued.

Directors who are also not employees of the Company are granted options to purchase Company common stock under the Company’s 1996 Non-Employee Directors’ Stock Option Plan (the "1996 Option Plan"). Under the 1996 Option Plan, each such director is granted an annual option to purchase 80,000 shares of common stock of the Company upon his or her election to the Board and on the first business day in June of each calendar year thereafter. Such options have a duration of ten years and are exercisable six months after the date of grant at a price equal to the fair market value of the Company’s common stock on the date of grant. As of December 31, 2008, the annual award to each Director of 80,000 stock options had not been issued for either 2007 or 2008.
 
Employment Agreements
 
We had an unwritten agreement with R.I. Heller & Co., LLC (hereafter “Heller”), Mr. Plamondon's affiliated consulting company, pursuant to which we paid Heller $25,000 per month for Mr. Plamondon's services. This agreement was terminated on November 29, 2007, the date of Mr. Plamondon’s resignation as our Chief Executive Officer, President, and Principal Accounting Officer.  In June 2005, we issued to Mr. Plamondon and his designees, including Erin Davis, who is now his wife, warrants to purchase an aggregate of two million shares of our common stock at $0.67 per share, subject to adjustment pursuant to anti dilution provisions. Mr. Plamondon received 1,575,000 of these warrants and Ms. Davis received 75,000 of these warrants. The warrants expired on June 30, 2008.

We have an unwritten agreement with Gemini Consulting Group, Inc., Mr. McCarthy’s affiliated consulting company, pursuant to which we pay Gemini $15,000 per month for Mr. McCarthy’s services.
 
All other employment agreements that the Company had with any of its named executive officers has expired.

 
30

 

The following table shows for the periods indicated the compensation paid to or accrued to, or for the benefit of, each of the named executive officers of the Company for services rendered to the Company for the year ended December 31, 2008.
 
Summary Compensation Table – 2008
Name and Principal
Position
 
Salary
   
Bonus
   
Stock
Award
   
Option
Award
   
Non-Equity
Incentive Plan 
Compensation
   
Change in
Pension Value
and
Nonqualified
Deferred
Compensation
Earnings
   
All Other
Compensation
   
Total
 
                                       
 
       
James B. McCarthy, Interim Chief Executive Officer/ Interim Principal Accounting Officer/ Interim Corporate Secretary, effective November 29, 2007
    -       -       -       -       -       -       180,000 (1)     180,000  
                                                                 
Joseph Cappello, Ph.D, VP, Research and Development, Chief Technical Officer and Director, Clinical Research
    167,860       -       -       -       -       -       -       167,860  
                                                                 
Franco A. Ferrari, Ph.D, VP, Laboratory Operations and Polymer Production and Director, Molecular Genetics
    154,780       -       -       -       -       -       -       154,780  
 
(1)
Mr. McCarthy’s compensation for the year ended December 31, 2008 consisted of consulting fees payable to Gemini Consulting Group, Inc., of which he is the chief executive officer. The monthly fee is $15,000 of which the entire annual fee of $180,000 was paid in cash during 2008.

 
31

 

Outstanding Equity Awards at Year End - 2008

   
Option/Warrants Awards
 
Stock Awards
 
Name
 
Number of
Securities
Underlying
Unexercised
Options (#)
Exercisable
 
Number of
Securities
Underlying
Unexercised
Options (#)
Unexercisable
 
Equity
Incentive
Plan
Awards
Number of
Securities
Underlying
Unexercised
Unearned
Options (#)
 
Option
Exercise
Price
 
Option
Expiration
Date
 
Number
of
Shares
or Units
of Stock
That
Have
Not
Vested
(#)
 
Market
Value
of
Shares
or Unit
That
Have
Not
Vested
 
Equity
Incentive
Plan
Awards:
Number
of
Unearned
Shares,
Units or
Other
Rights
That
Have Not
Vested
(#)
 
Equity
Incentive
Plan
Awards:
Market
or Payout
Value of
Unearned
Shares,
Units or
Other
Rights
That
Have Not
Vested
 
James B.
McCarthy
   
80,000
 
0
   
0
 
0.77
   
6/01/2015
 
-
   
-
 
-
   
-
 
     
80,000
 
0
   
0
 
0.20
   
6/01/2016
 
-
   
-
 
-
   
-
 
                                                 
 Joseph Cappello, Ph.D.
   
10,000
 
0
   
0
 
0.88
   
9/26/2010
 
 -
   
 
-
   
 -
 
     
50,000
 
0
   
0
 
0.80
   
4/12/2011
 
 -
   
 
-
   
 -
 
     
20,000
 
0
   
0
 
0.85
   
5/29/2011
 
 -
   
 
-
   
 -
 
     
50,000
 
0
   
0
 
0.37
   
11/25/2012
 
 -
   
 
-
   
 -
 
     
1,350,000
 
0
   
0
 
0.73
   
4/25/2013
 
 -
   
 
-
   
 -
 
     
25,000 
 
0
   
0
 
 0.65
   
 1/03/2015
 
 -
   
 
-
   
 -
 
                                                 
 Franco A. Ferrari, Ph.D.
   
10,000
 
0
   
0
 
0.88
   
9/26/2010
 
-
   
-
 
-
   
-
 
     
50,000
 
0
   
0
 
0.80
   
4/12/2011
 
-
   
-
 
-
   
-
 
     
20,000
 
0
   
0
 
0.85
   
5/29/2011
 
-
   
-
 
-
   
-
 
     
50,000
 
0
   
0
 
0.37
   
11/25/2012
                     
     
1,200,000
 
0
   
0
 
0.73
   
4/25/2013
 
-
   
-
 
-
   
-
 
     
25,000
 
0
   
0
 
0.65
   
1/03/2015
                     
                                                 
 
 
32

 
 
Item 12.
Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters

The following table sets forth certain information regarding beneficial ownership as of June 30, 2009 by

(i) 
all persons known by the Company to be the beneficial owner of more than 5% of the common stock, Series D Preferred Stock (on an as converted basis), Series F Preferred Stock (on an as converted basis), Series G Preferred Stock (on an as converted basis), Series H Preferred Stock (on an as converted basis) and Series I Preferred Stock (on an as converted basis),

(ii) 
all directors and nominees for directors,

(iii) 
each executive officer named below, and

(iv) 
all directors and executive officers as a group.

As of the foregoing date, there were no other persons, individually or as a group, known to us to be deemed the beneficial owners of five percent or more of the issued and outstanding common stock.

This table is based upon information supplied by Schedules 13D and 13G, if any, filed with the Securities and Exchange Commission, and information obtained from our directors and named executives. For purposes of this table, a person or group of persons is deemed to have “beneficial ownership” of any shares of common stock that such person has the right to acquire within 60 days of June 30, 2009, including, but not limited to shares of common stock issuable upon conversion of preferred stock and/or exercise of options. For purposes of computing the percentage of outstanding shares of common stock held by each person or group of persons named in the table, any security which such person or persons has or have the right to acquire within such date is deemed to be outstanding but is not deemed to be outstanding for the purpose of computing the percentage ownership of any other person. Except as indicated in the footnotes to this table and pursuant to applicable community property laws, we believe, based on information supplied by such persons, that the persons named in this table have sole voting and investment power with respect to all shares common stock which they beneficially own. The business address of each of the Company’s directors and named executive officers is the Company’s address unless otherwise stated in the table below.

 
33

 
 
Name and Address
 
Amount & Nature
of Beneficial
   
Approximate
 
of Beneficial Owner
 
Ownership
   
Percentage*
 
             
William N. Plamondon, III(1)
    -0-       **  
                 
Richard Adelson(1)
    389,181
(3)
    **  
                 
Allan Farber(1)
    985,607
(4)
    **  
                 
Kerry L. Kuhn, MD(1)
    820,000
(5)
    **  
                 
James B. McCarthy(1)(2)
    160,000
(6)
    **  
                 
Joseph Cappello, Ph.D.(2)
    1,580,748
(7)
    1.4 %
                 
Franco A. Ferrari, Ph.D.(2)
    1,456,359
(8)
    1.3 %
                 
Redec & Associates, LLC
c/o Protein Polymer Technologies, Inc.
11494 Sorrento Valley Road
San Diego, California 92121
    11,432,036
(9)
    10.1 %
                 
Hunter & Co.
c/o Protein Polymer Technologies, Inc.
11494 Sorrento Valley Road
San Diego, California 92121
    27,940,935
(10)
    20.3 %
                 
Matthew Szulik
c/o Protein Polymer Technologies, Inc.
11494 Sorrento Valley Road
San Diego, California 92121
    89,027,350
(11)
    57.8 %
                 
All Officers and Directors as a Group
    5,391,895
(3)-(8)
    4.7 %

 
34

 


 
*
Based upon 112,959,272 shares issued and outstanding as of June 30, 2009 except as otherwise provided in the footnotes.

**
Less than 1%.

(1)
Director.

(2)
Executive Officer.

(3)
Includes i) 50,000 shares subject to options exercisable within 60 days and ii) 3,400 shares owned by the stockholder’s spouse. Excludes 1,392,372 shares of common stock held in trust for the stockholder’s mother. The stockholder disclaims beneficial ownership of the shares owned in trust for his mother.

(4)
All shares are owned by the stockholder’s spouse. Includes 45,455 shares issuable upon conversion of Series I Preferred Stock within 60 days.

(5)
Includes (i) 365,000 shares subject to options exercisable within 60 days and (ii) 80,000 shares issuable upon conversion of Series G Preferred Stock convertible within 60 days.

(6)
Includes 160,000 shares subject to options exercisable within 60 days.
 
(7)
Includes 1,505,000 shares subject to options exercisable within 60 days. 

(8)
Includes 1,355,000 shares subject to options exercisable within 60 days.

(9)
Includes 554,545 shares issuable upon conversion of shares of Series I Preferred Stock convertible within 60 days.

(10)
Includes 24,369,506 shares subject to warrants exercisable within 60 days.

(11)
Includes (i) 127,273 shares issuable upon conversion of the Company’s Series I Preferred Stock convertible within 60 days and (ii) 40,946,038 shares subject to warrants exercisable within 60 days.

 
35

 
 
Item 13.       Certain Relationships and Related Transactions

As described in Note 5 to the financial statements, the loan issued to us on April 13, 2006 by Matthew J. Szulik, one of our stockholders, (hereafter “Szulik Loan”), has been amended ten times so that as of December 31, 2008, the outstanding Principal balance was $6,415,000 and the Maturity Date September 30, 2009. At December 31, 2008, the outstanding indebtedness subject to the Note and Security Agreement was $6,415,000 and accrued interest payable was $500,000. The Szulik Loan is secured, in accordance with the terms of a security agreement (hereafter “Security Agreement”), by a continuing security interest in and a general lien upon (i) 2,000,000 shares of Spine Wave, Inc. common stock owned by the Company; and (ii) all U.S. patents owned by the Company. The original Note and the Security Agreement are both dated April 13, 2006, but the current note is dated January 9, 2008.

Pursuant to the terms of the Security Agreement, the Company entered into a patent security agreement, an escrow agreement, a patent assignment, and a registration rights agreement, each dated as of April 13, 2006. According to the terms of the Security Agreement, the Company entered into the Escrow Agreement with an escrow agent for the shareholder. The Escrow Agreement provides for the disbursement of the funds held in escrow for application to Company expenses at the sole discretion of the shareholder’s escrow agent. Mr. Szulik’s counsel was the original escrow agent and now serves as our outside general counsel. The current escrow agent is TAG Virgin Islands, Inc. (hereafter “TAG”). The Escrow Agreement terminates upon the event that the amount borrowed is paid in full and no event of default has occurred.

As consideration for Mr. Szulik agreeing to accept the new note on January 9, 2008, we issued him three-year warrants to purchase an aggregate of 2,438,000 shares of our common stock at $0.061 per share and lowered the exercise price of warrants to purchase 500,000 shares of our common stock that we had previously issued to him from $0.30 per share to $0.061 per share.

As discussed in Note 6 to the financial statements, the Company entered into a common stock purchase agreement (hereafter “SPA”) in September 2007. The SPA provides for the Company selling, from time to time, shares of its common stock, par value $0.01, to the purchasers at a purchase price determined as the closing price of the stock on the sale date. In addition, we issue a five-year warrant to each investor to purchase the same number of shares as those purchased by such investor at 110% of the price at which the shares are purchased. As of November 28, 2007, the SPA was amended so that warrants issued on and after that date are exercisable at 100% of the price at which the shares are purchased. We have also granted the investors demand and piggy-back registration rights covering the shares purchased and the sharers issuable upon exercise of the warrants.

This funding was arranged by TAG. The SPA provides that TAG, as agent for the equity investors, will advise the Board as to which of the Company’s expenses will be paid with the funds invested by these investors. TAG can terminate the SPA at any time.

Between September 27, 2007 and December 31, 2008, the Company received an aggregate of $2,282,500 in subscriptions for the purchase of 42,499,119 shares of common stock and 42,499,119 warrants, subject to the terms of the SPA.  During 2008, the Company received an aggregate of $1,712,500 in subscriptions for the purchase of 36,586,091 shares of common stock and 36,586,091 warrants, subject to the terms of the SPA and RRA. Between January 1, 2009 and June 30, 2009, the Company received proceeds of $75,000 for the purchase of 3,571,429 shares of common stock and 3,571,429 warrants, subject to the terms of the SPA. 

Between October 2, 2008 and June 5, 2009, the Company received proceeds of $645,000 as loans from clients of TAG.  These loans are represented by unsecured notes issued by the Company.  These notes are due one year after issuance and bear an annual interest rate of 8%.  The interest and principal are payable on the maturity dates, either in cash or common stock, at the discretion of the Company, at rates ranging from $0.02 to $0.05 per share.  As consideration for the loans, the Company granted warrants to the noteholders to purchase an aggregate of 25,423,077 shares of the Company’s common stock at exercise prices ranging from $0.02 to $0.05 per share.

 
36

 

Material Relationship with the Company

Mr. Szulik has no material relationship with us apart from his ownership of our securities. Based upon our stock records and data supplied to us by our stockholders, we believe that Mr. Szulik is the beneficial owner of approximately 44.1% of our common stock, including the shares underlying the warrants he has acquired from us in connection with the Szulik Loan and the SPA. We determine beneficial ownership in accordance with the Commission's rules, which generally include voting power and/or investment power with respect to securities. Our shares of common stock issuable upon conversion of debt securities or preferred stock or subject to options or warrants exercisable within 60 days after the date on which we make our filing with the Commission in which such beneficial ownership information is disclosed are deemed outstanding for computing the stock ownership percentage of a person holding such convertible debt, preferred stock, options or warrants but are not deemed outstanding for computing the percentage of any other person.

TAG Virgin Islands, Inc. is a registered investment advisor and advises a number of our stockholders in investment decisions, including decisions about whether to invest in our stock. These clients include Messrs, Adelson and Farber and Dr. Kuhn, who are members of our Board of Directors, and Mr. Szulik and Redec & Associates, LLC. Based upon our stock records and data supplied to us by our stockholders, we believe that clients of TAG beneficially own approximately 67.8% of our common stock. TAG has discretionary authority to vote or dispose of the shares of our common stock held in its client accounts and, therefore, may be deemed to be the beneficial owner of such shares in accordance with the Commission's Rules. TAG has informed us that James Tagliaferri is the natural person at TAG with such discretionary authority. TAG expressly disclaims beneficial ownership of any shares owned by its clients.
 
Item 14.       Principal Accountant Fees and Services

During the fiscal years ended December 31, 2007 and December 31, 2008, Squar, Milner, Peterson, Miranda & Williamson, LLP provided various audit and non-audit services to us as follows:

 
·
Audit Fees: Aggregate fees billed for professional services rendered for the audit of our annual financial statements for the fiscal years ended December 31, 2007 and December 31, 2008, for review of our financial statements included in our quarterly reports on Form 10-QSB or Form 10-Q for those years, and services normally provided in connection with statutory and regulatory filings and engagements for those years, were approximately $136,100 and $112,900, respectively.

 
·
Audit-Related Fees: There were no fees billed for assurance and related services reasonably related to the performance of the audit or review of our financial statements and not reported under “Audit Fees” above in the fiscal years ended December 31, 2007 and December 31, 2008.

 
·
Tax Fees. Aggregate fees billed for tax services were approximately $5,900 and $6,800 in the fiscal years ended December 31, 2007 and December 31, 2008, respectively. These fees were primarily for compliance fees for the preparation of tax returns, assistance with tax planning strategies, and tax advice.

 
·
All Other Fees: There were no fees billed for services other than those described above in the fiscal years ended December 31, 2007 and December 31, 2008.

The Audit Committee approved in advance or ratified each of the major professional services provided by Squar, Milner, Peterson, Miranda & Williamson, LLP. The Audit Committee has considered the nature and amount of the fees billed by Squar, Milner, Peterson, Miranda & Williamson, LLP and believes that the provision of the services for activities unrelated to the audit is compatible with maintaining the independence of Squar, Milner, Peterson, Miranda & Williamson, LLP.

 
37

 

PART IV

Item 15.      Exhibits

The following documents are included or incorporated by reference:

Exhibit Number
 
Description
3.1.1 (1)
 
Certificate of Incorporation of the Company, as amended through September 30, 1995.
3.1.2 (26)
 
Amendment to the Certificate of Incorporation, dated September 20, 2007.
3.2 (2)
 
Bylaws of the Company, as amended through December 31, 1998.
4.1 (26)
 
Registration Rights Agreement between the Company and TAG Virgin Islands, Inc., as Agent for the Purchasers named therein, dated as of September 27, 2007.
10.1 (3)
 
1989 Stock Option Plan, together with forms of Incentive Stock Option Agreement and Nonstatutory Option Agreement.
10.2 (4)
 
1992 Stock Option Plan of the Company, together with forms of Incentive Stock Option Agreement and Nonstatutory Option Agreement.
10.3 (3)
 
Form of Employee’s Proprietary Information and Inventions Agreement.
10.4 (3)
 
Form of Consulting Agreement.
10.5 (3)
 
Form of Indemnification Agreement.
10.6 (4)
 
License Agreement, dated as of April 15, 1992, between the Board of Trustees of the Leland Stanford Junior University and the Company.
10.7 (5)
 
Securities Purchase Agreement related to the sale of the Company’s Series D Preferred Stock.
10.8 (6)
 
1996 Non-Employee Directors’ Stock Option Plan.
10.9 (7)
 
Stockholder Protection Agreement, dated August 22, 1997, between the Company and Continental Stock Transfer & Trust Company as rights agent.
10.10 (8)
 
Employee Stock Purchase Plan, together with Form of Stock Purchase Agreement.
10.11 (9)
 
Lease, with rider and exhibits, dated April 13, 1998, between the Company and Sycamore/San Diego Investors.
10.12 (10)
 
First Amendment to Stockholder Protection Agreement dated April 24, 1998, between the Company and Continental Stock Transfer & Trust Company as rights agent.
10.13 (11)
 
Letter of Agreement dated April 13, 1998 between the Company and Johnson & Johnson Development Corporation for the exchange of up to 27,317 shares of Series D Preferred Stock for a like number of shares of Series F Preferred Stock.
10.14 (12)
 
Securities Purchase Agreement related to the sale of the Company’s Series G Convertible Preferred Stock.
10.15 (12)
 
Second Amendment to Stockholder Protection Agreement, dated July 26, 1999 between the Company and Continental Stock Transfer and Trust Company as rights agent.
10.16 (13)**
 
License and Development Agreement dated as of January 26, 2000 between the Company and Prospectivepiercing Limited, to be known as Femcare Urology Limited.
10.17 (13)**
 
Supply Agreement dated as of January 26, 2000 between the Company and Femcare Urology Limited.
10.18 (13)**
 
Escrow Agreement dated as of January 26, 2000 between the Company and Femcare Urology Limited.
10.19 (13)
 
License Agreement dated as of February 18, 2000 between the Company and Sanyo Chemical Industries, Ltd.
10.20 (14)**
 
License Agreement dated December 21, 2000 between the Company and Genencor International, Inc.

 
38

 
 
10.21 (14)
 
Form of Warrant to Purchase Common Stock issued in connection with License Agreement between the Company and Genencor International, Inc.
10.22 (15)
 
Securities Purchase Agreement related to the sale of the Company’s Series H Preferred Stock.
10.23 (17)**
 
Founder Stock Purchase Agreement dated April 12, 2001 between the Company and Spine Wave Inc.
10.24 (17)**
 
License Agreement dated April 12, 2001 between the Company and Spine Wave, Inc.
10.25 (17)**
 
Escrow Agreement dated April 12, 2001 between the Company and Spine Wave, Inc.
10.26 (17)**
 
Supply and Services Agreement dated April 12, 2001 between the Company and Spine Wave, Inc.
10.27 (18)**
 
Amendment No. 1 to Supply and Services Agreement dated February 12, 2002 between the Company and Spine Wave, Inc.
10.28 (18)**
 
Stock Purchase and Vesting Agreement dated March 21, 2002 between the Company and Spine Wave, Inc.
10.29 (16)
 
Warrant to Purchase Shares of Common Stock of Spine Wave, Inc. issued to the Company.
10.30 (19)
 
First Amendment to the License Agreement dated October 1, 2002 between the Company and Genencor International, Inc.
10.31 (19)
 
Employment Agreement, dated as of December 31, 2002, between the Company and J. Thomas Parmeter.
10.32 (19)
 
Employment Agreement, dated as of December 31, 2002, between the Company and John E. Flowers.
10.33 (19)
 
Employment Agreement, dated as of December 31, 2002, between the Company and Joseph Cappello.
10.34 (19)
 
Employment Agreement, dated as of December 31, 2002, between the Company and Franco A. Ferrari.
10.35 (20)
 
2002 Stock Option Plan, and forms of Incentive Stock Option Agreement and Non-Statutory Stock Option Agreement.
10.36 (21)**
 
Amendment No. 2 to Supply and Services Agreement dated October 1, 2003 between the Company and Spine Wave, Inc.
10.37 (22)
 
Securities Purchase Agreement, dated as of March 31, 2005, by and among the Company and certain investors.
10.38 (22)
 
Form of Warrant to Purchase Shares of Common Stock of the Company in connection with Securities Purchase Agreement dated as of March 31, 2005.
10.39 (23)
 
Form of Warrant to Purchase Shares of Common Stock of the Company issued to William N. Plamondon, III.
10.44 (24)
 
Irrevocable Proxy, dated as of November 23, 2005, executed by Louis R. Matson in favor of the Company.
10.40 (25)**
 
Asset Purchase Option Agreement, dated as of November 23, 2005, by and between the Company and Surgica Corporation.
10.41 (25)**
 
License Agreement, dated as of December 19, 2005, between the Company and Surgica Corporation.
10.42 (25)**
 
Supply and Services Agreement, dated as of December 19, 2005, between the Company and Surgica Corporation.
10.43 (25)**
 
Voting Agreement, dated as of November 23, 2005, between the Company and Louis R. Matson.
10.44 (26)
 
Common Stock Purchase Agreement between the Company and TAG Virgin Islands, Inc., as Agent for the Purchasers named therein, dated as of September 27, 2007.
10.45 (26)
 
Amendment No. 7 to Secured Promissory Note issued to Matthew J. Szulik, dated November 10, 2007.

 
39

 


10.46 (27)
Amendment 1 to the Common Stock Purchase Agreement between the Company and TAG Virgin Islands, Inc., as Agent for the Purchasers named therein, dated as of November 28, 2007.
10.47 (27)
Secured Promissory Note Replacement Agreement, dated as of January 9, 2008, between the Company and Matthew J. Szulik.
10.48 (27)
Secured Promissory Note issued to Matthew J. Szulik, dated as of January 9, 2008.
10.49 (27)
Form of Warrant to Purchase Shares of Common Stock of the Company in connection with the Secured Promissory Note issued to Matthew J. Szulik, dated as of January 9. 2008.
10.50 (28)
Form of Promissory Note issued to noteholders on October 2, 2008, November 3, 2008, December 11, 2008, February 6, 2009, March 18, 2009, April 20, 2009, May 7, 2009, and June 5, 2009.
10.51 (28)
Form of Warrant to Purchase Shares of Common Stock of the Company in connection with the Promissory Notes issued to noteholders on October 2, 2008, November 3, 2008, December 11, 2008, February 6, 2009, March 18, 2009, April 20, 2009, May 7, 2009, and June 5, 2009.
10.52**
Technology License Agreement between the Company and Sanyo Chemical Industries, Ltd., dated as of June 18,  2009.
14.1 (29)
Code of Conduct.
31.1
Certification of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
31.2
Certification of Principal Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
32.1
Certification of Chief Executive Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
32.2
Certification of Principal Financial Officer pursuant to Section 960 of the Sarbanes-Oxley Act of 2002.
 


(1)
Incorporated by reference to Registrant’s Report on Form 10-QSB for the quarter ended September 30, 1995, SEC File No. 000-19724, as filed with the Commission on October 25, 1995.

(2)
Incorporated by reference to Registrant’s Report on Form 10-KSB for the fiscal year ended December 31, 1998, as filed with the Commission on March 5, 1999.

(3)
Incorporated by reference to the Company's Registration Statement on Form S-1 (No. 33-43875), SEC File No. 033-43875, filed with the Commission on November 12, 1991, as amended by Amendments Nos. 1, File No. 033-43875, 2, SEC File No. 033-43875, 3, SEC File No. 033-43875, and 4, SEC File No. 033-43875, thereto filed on November 25, 1991, December 23, 1991, January 17, 1992 and January 21, 1992, respectively.

(4)
Incorporated by reference to Registrant’s Report on Form 10-KSB for the fiscal year ended December 31, 1992, SEC File No. 000-19724, as filed with the Commission on March 31, 1993.

(5)
Incorporated by reference to Registrant’s Report on Form 10-QSB for the quarter ended September 30, 1995, SEC File No. 000-19724, as filed with the Commission on October 25, 1995.

(6)
Incorporated by reference to Registrant’s Report on Form 10-KSB for the fiscal year ended December 31, 1996, SEC File No. 000-19724, as filed with the Commission on March 27, 1997.

 
40

 

(7)
Incorporated by reference to Registrant’s Current Report on Form 8-K, SEC File No. 000-19724, as filed with the Commission on August 27, 1997.

(8)
Incorporated by reference to Registrant’s Report on Form 10-KSB for the fiscal year ended December 31, 1997, SEC File No. 000-19724, as filed with the Commission on April 15, 1998.

(9)
Incorporated by reference to Registrant’s Report on Form 10-QSB for the quarter ended March 31, 1998, SEC File No. 000-19724, as filed with the Commission on May 15, 1998.

(10)
Incorporated by reference to Registrant’s Report on Form 10-QSB for the Quarter ended June 30, 1998, SEC File No. 000-19724, as filed with the Commission on August 14, 1998.

(11)
Incorporated by reference to Registrant’s Report on Form 10-KSB for the fiscal year ended December 31, 1998, as filed with the Commission on March 5, 1999.

(12)
Incorporated by reference to Registrant’s Report on Form 10-QSB for the quarter ended September 30, 1999, SEC File No. 000-19724, as filed with the Commission on November 12, 1999.

(13)
Incorporated by reference to Registrant’s Report on Form 10-KSB for the fiscal year ended December 31, 1999, SEC File No. 000-19724, as filed with the Commission on March 24, 2000.

(14)
Incorporated by reference to Registrant’s Report on Form 10-KSB for the fiscal year ended December 31, 2000, SEC File No. 000-19724, as filed with the Commission on February 22, 2001.

(15)
Incorporated by reference to Registrant’s Report on Form 10-QSB for the quarter ended September 30, 2001, SEC File No. 000-19724, as filed with the Commission on November 14, 2001.

(16)
Incorporated by reference to Registrant’s Report on Form 10-QSB for the quarter ended September 30, 2002, SEC File No. 000-19724, as filed with the Commission on November 13, 2002.

(17)
Incorporated by reference to Registrant’s Report on Form 10-KSB/A for the fiscal year ended December 31, 2001, SEC File No. 000-19724, as filed with the Commission on March 5, 2003.
 
(18)
Incorporated by reference to Registrant’s Report on Form 10-QSB/A for the period ended September 30, 2002, SEC File No. 000-19724, as filed with the Commission on March 5, 2003.

(19)
Incorporated by reference to Registrant’s Report on Form 10-KSB for the fiscal year ended December 31, 2002, SEC File No. 000-19724, as filed with the Commission on March 28, 2003.

(20)
Incorporated by reference to Registrant’s Report on Form 10-QSB for the period ended March 31, 2003, SEC File No. 000-19724, as filed with the Commission on May 14, 2003.

(21)
Incorporated by reference to Registrant’s Report on Form 10-KSB for the fiscal year ended December 31, 2003, SEC File No. 000-19724, as filed with the Commission on March 28, 2003.
 
(22)
Incorporated by reference to Registrant’s Current Report on Form 8-K, SEC File No. 000-19724, as filed with the Commission on April 7, 2005.

(23)
Incorporated by reference to Registrant’s Report on Form 10-QSB for the quarter ended June 30, 2005, SEC File No. 000-19724, as filed with the Commission on August 17, 2005.

(24)
Incorporated by reference to Registrant's Current Report on Form 8-K, SEC File No. 000-19724, as filed with the Commission on December 22, 2005.

 
41

 

(25)
Incorporated by reference to Registrant's Report on Form 10-KSB for the fiscal year ended December 31, 2005, SEC File No. 000-19724, as filed with the Commission on March 31, 2006.

(26)
Incorporated by reference to Registrant's Report on Form 10-QSB for the quarter ended September 30, 2007, SEC File No. 000-19724, as filed with the Commission on November 19, 2007.

27)
Incorporated by reference to Registrant’s Report on Form 10-KSB for the fiscal year ended December 31, 2007, SEC File No. 000-19724, as filed with the Commission on May 12, 2008.

(28)
Incorporated by reference to Registrant’s Report on Form 10-Q for the quarter ended September 30, 2008, SEC File No. 000-19724, as filed with the Commission on November 19, 2008.

(29)
Incorporated by reference to Registrant’s Report on Form 10-KSB for the fiscal year ended December 31, 2004, SEC File No. 000-19724, as filed with the Commission on March 31, 2005.

**
Portions of this document have been redacted pursuant to a Request for Confidential Treatment filed with the Securities and Exchange Commission.

 
42

 

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.
 
 
PROTEIN POLYMER TECHNOLOGIES, INC.
     
July 24, 2009
By:
/S/ JAMES B. MCCARTHY
   
James B. McCarthy
   
Interim Chief Executive Officer

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
 
Capacity
 
Date
         
/S/ JAMES B. MCCARTHY
 
Interim Chief Executive Officer,
 
July 24, 2009 
James B. McCarthy
 
Interim Principal Financial Officer, and
   
   
Interim Corporate Secretary
   
         
/S/ ALLAN FARBER
 
Director
 
July 24, 2009
Allan Farber
       
         
/S/ KERRY L. KUHN
 
Director
 
July 24, 2009
Kerry L. Kuhn, M.D.
       
         
/S/ RICHARD ADELSON
 
Director
 
July 24, 2009
Richard Adelson
       
         
/S/ WILLIAM N. PLAMONDON III
 
Director
 
July 24, 2009
William N. Plamondon III
       

 
43

 

EXHIBIT INDEX

10.1
Technology License Agreement between the Company and Sanyo Chemical Industries, Ltd., dated as of June 18, 2009.

31.1
Certification of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

31.2
Certification of Principal Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

32.1
Certification of Chief Executive Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

32.2
Certification of Principal Financial Officer pursuant to Section 960 of the Sarbanes-Oxley Act of 2002.

 
44