0000950159-12-000186.txt : 20120328 0000950159-12-000186.hdr.sgml : 20120328 20120328164642 ACCESSION NUMBER: 0000950159-12-000186 CONFORMED SUBMISSION TYPE: 10-K PUBLIC DOCUMENT COUNT: 16 CONFORMED PERIOD OF REPORT: 20120323 FILED AS OF DATE: 20120328 DATE AS OF CHANGE: 20120328 FILER: COMPANY DATA: COMPANY CONFORMED NAME: TENGION INC CENTRAL INDEX KEY: 0001296391 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 200214813 STATE OF INCORPORATION: DE FILING VALUES: FORM TYPE: 10-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-34688 FILM NUMBER: 12721091 BUSINESS ADDRESS: STREET 1: 3929 WESTPOINT BLVD. STREET 2: SUITE G CITY: WINSTON-SALEM STATE: NC ZIP: 27103 BUSINESS PHONE: 336-722-5855 MAIL ADDRESS: STREET 1: 3929 WESTPOINT BLVD. STREET 2: SUITE G CITY: WINSTON-SALEM STATE: NC ZIP: 27103 10-K 1 tengion10k.htm TENGION, INC. FORM 10-K tengion10k.htm

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C.  20549
 
FORM 10-K
 
(Mark One)
 
 x
ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
 
For the fiscal year ended December 31, 2011
 
OR
 
 o
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
 
For the transition period from _____ to _____
 
Commission file number 001-34688
 
 
Tengion, Inc.
(Exact name of registrant as specified in its charter)
 
Delaware
(State or other jurisdiction of
incorporation or organization)
20-0214813
(I.R.S. Employer Identification No.)
 
3929 Westpoint Boulevard, Suite G
Winston-Salem, NC 27103
(Address of principal executive offices)
(336) 722-5855
(Registrant’s telephone number, including area code)
 
 
Securities registered pursuant to Section 12(b) of the Act
 
Title of each Class   Name of Exchange on which registered
 Common Stock, par value $0.001 per share NASDAQ Global Market
 
Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act.  Yes  o   No x
 
Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or 15(d) of the Act.    Yes  o   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 o
 
Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).     Yes x    No o
 
 
 
 
 
 
 
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  o
 
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer or a non-accelerated filer, as defined in Rule 12b-2 of the Exchange Act.
 
Large accelerated filer   o Accelerated filer  o Non-accelerated filer  o Smaller reporting company x
 
Indicate by check mark whether the registrant is a shell company, as defined in Rule 12b-2 of the Exchange Act.    Yes  o   No x
 
The aggregate market value of the registrant’s common stock held by non-affiliates of the registrant as of June 30, 2011 was $19,786,913.  This calculation excludes 7,320,466 shares held on June 30, 2011 by directors and executive officers.  As of March 26, 2012, there were 24,252,519 shares of the registrant’s common stock outstanding.
 
DOCUMENTS INCORPORATED BY REFERENCE
 
Portions of the registrants definitive Proxy Statement for its 2012 Annual Meeting of Stockholders are incorporated by reference into Part II and Part III of this Form 10-K to the extent stated herein.  Such Proxy Statement will be filed with the Securities and Exchange Commission within 120 days after the end of the fiscal year to which this Form 10-K relates.
 
 
 
 
 
 
TENGION, INC.
FORM 10-K
INDEX
 
Item 1.
Business
Item 1A.
Risk Factors
Item 1B.
Unresolved Staff Comments
Item 2.
Properties
Item 3.
Legal Proceedings
Item 4.
Mine Safety Disclosures
     
PART II
     
Item 5.
Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities
Item 6.
Selected Financial Data
Item 7.
Management’s Discussion and Analysis of Financial Condition and Results of Operations.
Item 7A.
Quantitative and Qualitative Disclosures about Market Risk
Item 8.
Financial Statements and Supplementary Data
Item 9.
Changes in and Disagreements with Accountants on Accounting and Financial Disclosure
Item 9A.
Controls and Procedures
Item 9B.
Other Information
     
PART III
     
Item 10.
Directors, Executive Officers and Corporate Governance
Item 11.
Executive Compensation
Item 12.
Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
Item 13.
Certain Relationships and Related Party Transactions, and Director Independence
Item 14.
Principal Accounting Fees and Services
     
PART IV
     
Item 15.
Exhibits and Financial Statement Schedules
     
Signatures

 
Tengion® and the Tengion logo® are our registered trademarks and Tengion Neo-Urinary Conduit™, Tengion Neo-Kidney™, Tengion Neo-Kidney Augment™, Tengion Neo-Vessel™, Tengion Neo-Vessel Replacement™, Tengion Neo-Bladder Replacement™, Neo-Bladder Augment™, Tengion Organ Regeneration Platform™ and Organ Regeneration Platform™ are our trademarks. Other names are for informational purposes only and may be trademarks of their respective owners.
 
 
 
 
 
 
 

 
Item 1.  Business
 
Overview
 
Tengion is a regenerative medicine company focused on discovering, developing, manufacturing and commercializing a range of neo-organs, or products composed of living cells, with or without synthetic or natural materials, implanted or injected into the body to engraft into, regenerate, or replace a damaged tissue or organ.  Using our Organ Regeneration Platform, we create these neo-organs using a patient’s own cells, or autologous cells.  We believe our proprietary product candidates harness the intrinsic regenerative pathways of the body to regenerate a range of native-like organs and tissues.  Our product candidates are intended to delay or eliminate the need for chronic disease therapies, organ transplantation, and the administration of anti-rejection medications.  In addition, our neo-organs are designed to avoid the need to substitute other tissues of the body for a purpose to which they are poorly suited.
 
Building on our clinical and preclinical experience, we are initially leveraging our Organ Regeneration Platform to develop our Neo-Urinary Conduit for bladder cancer patients who are in need of a urinary diversion and our Neo-Kidney Augment for patients with advanced chronic kidney disease.
 
Our Neo-Urinary Conduit is intended to replace the use of bowel tissue in bladder cancer patients requiring a non-continent urinary diversion after bladder removal surgery, or cystectomy.  We are able to manufacture our Neo-Urinary Conduit using a proprietary process that takes four weeks or less and uses only smooth muscle cells derived from a routine biopsy.  We are currently conducting a Phase I clinical trial for our Neo-Urinary Conduit in bladder cancer patients to assess its safety and preliminary efficacy, as well as to translate the surgical implantation procedure utilized in preclinical studies.  This trial is an open-label, single-arm study, which is expected to enroll up to ten patients.  We enrolled our fourth patient in this trial in the first quarter of 2012 and, with this implantation, we and our clinical investigators believe that the surgical technique used successfully in animal models has been translated to this patient.  We intend to discuss with our Data Safety Monitoring Board, or DSMB, a reduction in the timelines between future patient implants, which is currently 12 weeks.  Assuming appropriate safety data, we anticipate that we will complete implantation of up to ten patients by the end of 2012.
 
Our Neo-Kidney Augment is being developed to prevent or delay dialysis by increasing renal function in patients with advanced chronic kidney disease.  Our Neo-Kidney Augment is based on our proprietary technology, which is expected to use the patient’s cells, procured by a needle biopsy of the patient’s kidney, to create an injectable product candidate that can catalyze the regeneration of functional kidney tissue.  We submitted a pre-Investigational New Drug, or pre-IND, filing with FDA for this program in February 2012 and will be meeting with FDA in March 2012 for purposes of clarifying our path to submitting an IND for our Neo-Kidney Augment.  We also continue to explore moving our Neo-Kidney Augment forward in Europe using the Advanced Therapy Medicinal Products, or ATMP, pathway, an established European regulatory route for advanced cell based therapies.  We intend to aggressively pursue our Neo-Kidney Augment development program.
 
We were incorporated in Delaware in 2003.  Our corporate headquarters are located at 3929 Westpoint Boulevard, Suite G, Winston-Salem, North Carolina and our telephone number is (336) 722-5855.
 
Our Organ Regeneration Platform
 
Our Organ Regeneration Platform involves testing different combinations of cell types and biomaterials.  We believe this approach enables us to identify accurately the mixture of various cell types and biomaterials for a specific organ necessary to elicit a regenerative response.  We own or license over 20 U.S. patents and patent applications and over 100 international patents and filings related to our Organ Regeneration Platform and product candidates.  The organ regeneration process enabled by our proprietary Organ Regeneration Platform involves the following steps:
 
 
 
2
 
 
 
·  
Isolation and expansion of progenitor cells.  Our autologous organ regeneration process begins with receipt of a small tissue sample, obtained by a biopsy from the patient.  This sample is then sent to our clinical production facility in North Carolina where our scientists engage in a specialized process to isolate the necessary committed progenitor cells that form the basis of the target organ’s or tissue’s essential function.  Committed progenitor cells have been programmed by the body to become specific cell types, but are not yet developed into a single cell type, retaining the ability to promote regeneration.  We then use our proprietary cell growth process to grow, or expand, the specifically isolated progenitor cells ex vivo, or outside of the body, until an adequate number of cells are produced.
 
·  
Seeding and growth.  Once we have completed our cell expansion process, we combine those cells with a biomaterial to stabilize and form our product candidate.  Depending upon the type of neo-organ being created, we use biomaterials that, when combined with the isolated and expanded cell populations, promote the desired regenerative outcome.  We select the type of material based upon our knowledge of the organ or tissue we are seeking to regenerate and extensive testing to determine the optimal material characteristics, treatment, and shape that will encourage cell growth and catalyze the body’s regenerative power.  Composition and design of the biomaterials are essential elements of our technology that help to ensure native-like tissue regeneration.
 
The expanded cell populations and selected biomaterial are formulated, using our proprietary bioprocesses, packaged, and then shipped to the patient’s surgeon  ready for implantation.
 
·  
Implantation.  The neo-organ is typically shipped from our manufacturing facility to the patient’s surgeon within four weeks after we receive the patient’s biopsy.  Both before and during the initial clinical trial for our product candidates, we collaborate with a small number of surgeons to translate the surgical procedure used in preclinical studies for use in humans.
 
Regeneration.  Based on data from preclinical and clinical studies, we believe that our neo-organs serve as a catalyst for the body to regenerate native-like organs and tissues.  Native tissue supporting structure, for example blood vessels, grow into the implanted neo-organ and the biomaterial is absorbed by the body.  In preclinical tests, we have observed that the newly grown tissue integrates with its surroundings and becomes substantially indistinguishable over time from the native organ.  We have also observed that, in this regenerative process, the body regulates the growth and development of the organ to ensure that it is not under- or over-developed. Similarly, the neo-organ takes on native-like functional activities.

Our Strategy
 
Our goal is to become the leading regenerative medicine company focused on the development and commercialization of neo-organs for a variety of diseases and disorders.  To achieve this objective, we intend to:
 
·  
Advance the Neo-Urinary Conduit.  We have an active IND for our Neo-Urinary Conduit and are currently conducting a Phase I clinical trial in bladder cancer patients who require removal of their bladders and are in need of a urinary diversion We enrolled our fourth patient in this trial in the first quarter of 2012.  Assuming appropriate safety data, we anticipate that we will complete implantation of up to ten patients by the end of 2012.
 
·  
Advance the Neo-Kidney Augment.  We are devoting a significant portion of our resources and business efforts to our Neo-Kidney Augment development program.  We submitted a pre- Investigational New Drug, or IND, filing with FDA for this program in February 2012 and will be meeting with FDA in March 2012 for purposes of clarifying our path to submitting an IND for our Neo-Kidney Augment.  We also continue to explore moving our Neo-Kidney Augment forward in Europe using the ATMP pathway.
 
·  
Leverage our Organ Regeneration Platform to develop additional neo-organs.  We believe our technology is broadly applicable to other indications including certain types of urologic, renal, gastrointestinal and vascular diseases.  We have generated significant proprietary know-how and intellectual property in the development and manufacture of our various product candidates.  We plan to continue to apply our technologies to other neo-organs as treatments for other conditions.
 
 
 
3
 
 
 
·  
Selectively pursue strategic partnerships to accelerate and maximize the potential of our product candidates and technology while preserving significant commercial rights.  We intend to selectively pursue strategic partnership opportunities that we believe may allow us to accelerate the development or commercialize our products to maximize the value of our product candidates.
 
Neo-Urinary Conduit
 
Our Neo-Urinary Conduit is a combination of autologous smooth muscle cells and bioabsorbable scaffold that is intended to catalyze regeneration of a native bladder tissue conduit, passively transporting urine from the ureters, through a stoma, or hole in the abdomen, into a standard ostomy bag.  We expect that it will be a safe and effective alternative to the creation of a urinary diversion from bowel tissue after bladder removal.  Our Neo-Urinary Conduit is intended to avoid complications such as bowel obstruction, urine absorption, infection and mucus secretion associated with the use of bowel tissue in the urinary tract, as well as the potential surgical issues that arise from the procedure involved in harvesting bowel tissue.  We produce our Neo-Urinary Conduit using smooth muscle cells from a routine fat biopsy and not cells from the diseased bladder, eliminating the risk of reintroducing cancerous cells from the bladder into the patient.
 
We produce our Neo-Urinary Conduit for our Phase I clinical trial at our cGMP qualified clinical production facility using our Organ Regeneration Platform.  We are able to deliver our Neo-Urinary Conduit in four weeks or less after we receive the patient’s fat biopsy.  This timing is consistent with the clinical practice of bladder removal in these patients.  To create our Neo-Urinary Conduit, we isolate the smooth muscle cells from the biopsy, expand the cells ex vivo and then seed them onto a bioabsorbable scaffold, which is composed of biomaterials similar to those used in bioabsorbable sutures.  Each surgeon implanting one of our Neo-Urinary Conduits will be trained in and receive specific procedures and protocols based on routine surgical techniques to implant our Neo-Urinary Conduit in the patient.  We have an active IND and are currently conducting a Phase I clinical trial for the treatment of bladder cancer patients who require bladder removal.
 
Market Overview
 
The following table indicates the number of urinary conduit procedures performed per year in the United States and the European Union.
 
Estimated Surgical Procedures Per Year
United States(1)
European Union(2)
Urinary Conduit
    
Cancer                                                                     
9,300
10,800
Other                                                                     
1,700
  2,300
Total Urinary Conduit Procedures                                                                         
11,000
13,100
_______________________
Sources:
(1)
US: Agency for Healthcare Research and Quality.
(2)
EU: Government data sources for the United Kingdom, France and Germany; other EU countries estimated from population census.

Bladder Cancer
 
According to the National Cancer Institute, bladder cancer is the sixth most common form of cancer in the United States.  The American Cancer Society estimates there will be 73,500 new cases of bladder cancer diagnosed in the United States in 2012, and nearly 15,000 deaths.  The European Cancer Observatory estimates that there were over 110,000 new cases of bladder cancer in Europe in 2008.  In the United States, there are approximately 10,000 cases per year of bladder cancer requiring bladder removal, according to data compiled from a 2005 National Inpatient Sample, or NIS, performed by the Healthcare Cost and Utilization Project, or HCUP, a family of healthcare databases and related software tools and projects developed through a federal-state-industry partnership and sponsored by the Agency for Healthcare Research and Quality.
 
 
 
4
 
 
 
Following removal of a bladder, patients require some form of urinary diversion.  Most patients are currently treated by using a segment of bowel tissue to construct a conduit for urine to exit from the body.  In its simplest form, the reconstruction involves creating a tubular structure out of bowel tissue and then connecting it to the ureters at one end and the skin at the other in a procedure that was pioneered in the 1930s.  Urine output is not controlled and the patient wears a collection device at all times.
 
The other diversionary option for patients is the creation of a continent reservoir which is most commonly a bladder-shaped pouch fashioned from bowel tissue, to which the ureters and urethra are connected.  We believe that less than 10% of the urinary diversions performed after bladder removal are bladder replacements and the remaining diversions are urinary conduits, based upon data compiled from a 2005 NIS performed by HCUP.  There are multiple factors that affect the decision concerning which form of post-bladder removal urinary diversion is optimal for a given patient, including stage of disease, health and mental status, manual dexterity, physique and, importantly, patient preference.
 
The following graphic illustrates two urinary diversion options for patients who require bladder removal.
 
 
Limitations of Current Therapies
 
There are many complications associated with surgery to remove or repair the bladder, such as adhesions and obstructions.  In the case of traditional surgery to construct a conduit for urine to exit from the body into an ostomy bag, complications such as ureteral detachment, ureteral stricture and hydroureter / hydronephrosis, or swelling in the ureters or kidneys resulting from the backup of urine, are related to the attachment of the ureters to the conduit.  Other complications, such as stomal stenosis, involve the attachment of the conduit to the abdominal wall.
 
While there is variation across procedures and patient types, there are risks and complications common to all procedures that rely on harvesting bowel tissue and placing it in the urinary tract.  These complications may include:
 
·  
Bowel complications.  Bowel surgery required to harvest tissue for reconstructive use can result in complications, such as prolonged recovery of bowel function, ileus (temporary bowel paralysis), obstructions, leaks and fistulas.  Because vitamin B12 is absorbed in the bowel tissue, the loss of tissue can result in anemia and neurologic abnormalities.  Additionally, malabsorption of salts and lipids can lead to diarrhea.
 
 
 
5
 
 
 
·  
Absorption issues.  Use of bowel tissue often leads to electrolyte and metabolic imbalances, which can cause bone loss.  Certain drugs taken by the patient may be reabsorbed by the implanted bowel tissue, potentially leading to unintended toxic levels.  The exposure of intestinal surface to urine also results in the inappropriate absorption of ammonium, chloride and hydrogen ions as well as potassium loss, leading to chronic metabolic imbalances or abnormalities.
 
·  
Infection.  Persistent and recurrent infections are common in patients with bowel tissue reconstruction.  For example, based upon an article entitled “Long Term Outcome of Ileal Conduit Diversion” by S. Madersbacher, et. al., which appeared in the Journal of Urology in 2003, as many as 23% of patients with bowel tissue conduits have recurrent urinary tract infections, or UTIs, and according to “Use of intestinal segments in urinary diversion” by D. M. Dahl and W. S. McDougal in Campbell-Walsh Urology in 2007, approximately 10% to 17% of bowel tissue conduit patients have UTIs that reach the kidney.  Bacteria normally found in bowel tissue can serve as a source of infection and septic complications when repositioned into the urinary tract.  One of the consequences of persistent infection is the development of stones, hard masses which can cause pain, bleeding, obstruction of urine or infections.
 
·  
Mucus.  Bowel tissue repositioned in the urinary tract secretes mucus into the urine.  Mucus increases the risk of stone formation and the viscosity of urine.
 
·  
Cancer.  Malignancy, although rare, is a well-recognized complication following enterocystoplasty and other reconstructive surgeries that incorporate bowel segments into the genitourinary tract.
 
Patients requiring some form of urinary diversion with today’s standard of care are at risk of complications associated with the use of bowel tissue as well as those associated with the surgery to harvest the bowel tissue.
 
Preclinical History and Background of the Neo-Urinary Conduit
 
Our preclinical studies utilized various large animal models for bladder removal and implantation of our product candidate.  In these studies, animals receiving our product candidate underwent bladder removal and the animals’ ureters were attached to one end of our Neo-Urinary Conduit using bioabsorbable sutures and the other end was connected to the skin in the abdominal wall, providing an outlet for urine to flow out of the body.
 
Principal observations of our Neo-Urinary Conduit in preclinical animal models have shown that:
 
·  
Implantation of our Neo-Urinary Conduit created from fat-derived smooth muscle cells results in the formation of a functional conduit.
 
·  
By three months post-implantation the scaffold is no longer present and is replaced by a tri-layered native-like bladder tissue consisting of urothelium, submucosa and smooth muscle cells.
 
·  
There is no evidence of abnormal cell growth, tissue development or adverse immune response, or adverse systemic effects in response to the biomaterials, autologous cells, or our Neo-Urinary Conduit.
 
·  
Our Neo-Urinary Conduit regenerates native-like bladder tissue with complete mucosal lining at the ureteral and skin junctions.  The function of the regenerated bladder tissue is similar to native bladder tissue in that it allows elimination of urine in a water-tight fashion and does not absorb urine or secrete mucus or electrolytes.
 
These preclinical animal studies suggest that by using current standards of clinical care and specific surgical and post-operative procedures associated with urinary conduits, our Neo-Urinary Conduit may be safe and effective for treating patients who have had their bladders removed.
 
 
 
6
 
 
 
Clinical Development Plan
 
We have an active IND for our Neo-Urinary Conduit and commenced a Phase I study in March 2010.  The program is designed to provide data to support the use of our Neo-Urinary Conduit in patients who are undergoing bladder removal due to bladder cancer.
 
This trial is designed to assess the safety and preliminary efficacy of the Neo-Urinary Conduit, as well as to translate the surgical implantation procedure utilized in preclinical studies.  This trial is an open-label, single-arm study which is currently expected to enroll up to ten patients.  We are working with clinical investigators who have expertise in the surgical treatment of bladder cancer and significant experience performing bladder removals and urinary diversions.  This study does not have a control group as the surgical procedure, post-operative care, and other clinical parameters preclude the possibility of blinding treatment options.
 
This trial is intended to allow our investigators to optimize the post-surgical care of patients.  Our clinical investigators may, as necessary, modify the surgical technique based upon the experience gained by prior patients enrolled.  A limited number of clinical centers are being utilized to minimize variations in surgical technique and provide the most controlled setting in which the surgical approach is optimized through working with a clinical investigator.  We have designed the trial to provide for at least an eight-week interval between implantations of the Neo-Urinary Conduit in the initial patients in the trial to allow for close observation and assessment of any treatment or procedure-related complications, post-operative recovery, tolerability, and safety before proceeding to the next patient.
 
To date, four patients have been enrolled and implanted in the clinical trial.  Data from three of these patients have allowed clinical investigators to design surgical modifications in an effort to address stoma patency, conduit integrity and vascular supply.  The complications that arose with each of the first three patients were resolved successfully and, following new surgeries to construct a urinary diversion using bowel tissue, all three patients have recovered well.  We enrolled our fourth patient in this trial in the first quarter of 2012 and, with this implantation, we and our clinical investigators believe that the surgical technique used successfully in animal models has been translated to this patient.  We intend to discuss with our DSMB a reduction in the timelines between future patient implants, which is currently 12 weeks.  Assuming appropriate safety data, we anticipate that we will complete implantation of up to ten patients by the end of 2012.
 
The primary safety and efficacy assessment of our Neo-Urinary Conduit will be made at 12 months post-implantation and patients will be followed for an additional 48 months in order to assess long term safety and durability.  During this first year, however, patients will be seen frequently by the study investigator and/or designated clinical team: every one to two weeks after hospital discharge through week eight, and then at month 3, 6, 9 and 12.  Imaging, either CT scan or ultrasound, will be performed at three-month intervals for the first year to examine the neo-organ’s structure, patency and identify any obstructions or other abnormalities.  This frequent evaluation and the open-label nature of this study will provide us significant ongoing feedback throughout the study.
 
The Tengion Neo-Kidney Augment
 
Our Neo-Kidney Augment is being developed to prevent or delay dialysis by increasing renal function in patients with advanced chronic kidney disease, or CKD.  Our Neo-Kidney Augment is based on our proprietary technology, which is expected to use the patient’s cells, procured by a needle biopsy of the patient’s kidney, to create an injectable product candidate that can catalyze the regeneration of functional kidney tissue.  We submitted a pre-IND filing with FDA for this program in February 2012 and will be meeting with FDA in March 2012 for purposes of clarifying our path to submitting an IND for our Neo-Kidney Augment.  We also continue to explore moving our Neo-Kidney Augment forward in Europe using the ATMP pathway, an established European regulatory route for advanced cell based therapies.  We intend to aggressively pursue our Neo-Kidney Augment development program.
 
Market Overview and Limitations of Current Therapies
 
According to the 2011 Annual Report of the United States Renal Data System, or the USRDS, which is funded by the National Institutes of Health, or NIH, there are over 40 million people in the United States with chronic kidney disease.  Patients with end stage renal disease, or ESRD, have CKD that has progressed to a point of little to no kidney function.  These patients require dialysis or a kidney transplant to survive.  According to the USRDS, $29 billion in Medicare costs each year are attributable just to ESRD patients.  ESRD is associated with an approximate 20% mortality rate per year.  In addition, bone loss and anemia is a common complication of advanced CKD, mainly due to an inability of the kidneys to produce enough Vitamin D and erythropoietin, a hormone that controls red blood cell production.
 
 
 
7
 
 
 
Dialysis extends the lives of patients with ESRD, but has many limitations, including infections, hernias and the need to undergo the procedure up to three times per week.  Kidney transplantation remains the most desirable and cost-effective form of kidney replacement therapy at this time; however, there is a chronic shortage of organs.  In 2009, only 18,000 kidney transplants were performed.  In addition to the high cost of organ procurement and the subsequent surgery, kidney transplant patients also require a lifetime of drug therapy to prevent organ rejection.  There is a clear need for a product that can prevent or delay the need for dialysis or kidney transplant in patients with advanced CKD.
 
Our Solution
 
Through our Organ Regeneration Platform, we have identified a specific combination of renal cells that provides the foundation for the Neo-Kidney Augment and are currently optimizing the formulation to achieve the desired product profile.  We obtain cells through a routine needle biopsy of the kidney and using our Organ Regeneration Platform, we are able to produce our Neo-Kidney Augment grown from these cells in as short as four weeks from biopsy receipt.
 
This product development program has demonstrated function in multiple animal models.  We have isolated and characterized the necessary cells from healthy and diseased human kidneys, which we believe supports translation of this approach to human patients. In our animal studies, diseased kidney function was improved by the selected regenerative cells that form the active biological component of our Neo-Kidney Augment.  In these studies, renal function was shown to be enhanced as early as seven weeks after implantation and was associated with improvements to functional kidney mass as indicated by improved or stabilized kidney filtration, reduced urinary protein loss, and enhanced urine concentrating ability.  Systemic functions controlled by the kidney were also improved including metabolic condition (electrolyte and mineral balance), blood pressure, weight gain and correction of anemia.  Improved survival was demonstrated in two animal models which were followed up to one year.  In one animal study, selected regenerative cells taken from human kidneys were able to improve kidney function of chronically diseased kidneys.
 
We have assessed the regenerative capabilities of the Neo-Kidney Augment in a rodent model of chronic kidney disease in which renal failure is induced by removal of approximately 80% of the kidney tissue.  These studies extend up to six months post-treatment and have demonstrated that animals implanted with our Neo-Kidney Augment have prolonged survival with no additional supportive care.  Stabilization and improvement in functional renal mass are evident within several weeks after implantation and continue for the duration of the studies.  In these studies, we have seen improvement or stabilization of various biomarkers including certain proteins, lipids, bone remodeling and vitamin levels, as well as organism-level improvements in weight gain and blood pressure.
 
We also have conducted a preclinical study in a rodent model of chronic, progressive renal failure that develops due to obesity, diabetes, and hypertension – three common co-morbid conditions often seen in patients with renal failure.  This study demonstrated that our proprietary therapeutic approach, using specific regenerative cells isolated from diseased kidney tissue, can provide increased functional kidney mass with resulting improvements in kidney filtration, urine concentration, and electrolyte balance, as well as a significant reduction in blood pressure.  At one year of age, which is approaching end-of-life in this aggressive model, the treated animals demonstrated improved kidney function, delayed disease progression, and better survival compared to the age- and disease-matched untreated control animals.
 
The rodent studies described above demonstrated the Neo-Kidney Augment offers therapeutic benefits when used in various animal models of CKD.  To further evaluate the effects of the Neo-Kidney Augment, a canine model of CKD, established via 70% surgical mass reduction of the kidney and a high salt diet, was used to evaluate potential cross-species therapeutic effects.  This model has functional kidney mass reduction similar to that of a clinical CKD Stage 3 patient.  Using this established model for CKD and multiple clinically relevant end-points (serum creatinine, blood urea nitrogen, and estimated glomerular filtration rate), the Neo-Kidney Augment was shown to provide measurable and significant improvement or stabilization of renal function. Homeostatic improvements included weight gain, and renal improvements were both functional and enhanced histological structure.
 
 
 
8
 
 
 
Additional Platform Programs
 
We believe our Organ Regeneration Platform is broadly applicable to the development of other product candidates and therapeutic indications.  The following programs have been advanced to various stages of development by us but are not currently being funded for further development as we are focusing our resources on our Neo-Urinary Conduit and Neo-Kidney Augment programs.
 
Neo-Bladder Replacement
 
Our Neo-Bladder Replacement, for which we believe we have completed all preclinical development necessary to prepare an IND, is a combination of bioabsorbable materials and autologous smooth muscle cells cultured by our scientists that we believe will serve as a functioning bladder, eliminating the need for an ostomy bag, for patients who have their bladders removed due to cancer.  Our Neo-Bladder Replacement, when implanted in the body, is intended to serve as a template that recruits other cells to develop a regenerated bladder.
 
Neo-Bladder Augment
 
Our Neo-Bladder Augment was designed for the treatment of neurogenic bladder, or dysfunctional bladder due to some form of neurologic disease or condition, for which treatment often requires an augmentation of the bladder in order to relieve high bladder pressure and incontinence.  While we have conducted two Phase II clinical trials of this product candidate – a pediatric study in children with spina bifida and an adult study in patients with spinal cord injury – we currently are not actively developing our Neo-Bladder Augment and are directing the majority of our resources toward the development of our Neo-Kidney Augment and Neo-Urinary Conduit development programs.  In April 2011, we terminated the pediatric and adult Neo-Bladder Augment clinical trials.  We subsequently withdrew the IND.
 
The Tengion Neo-GI Augment
 
Leveraging our cumulative experience from producing tubular neo-organs, such as our Neo-Urinary Conduit, we have conducted early development work on our Neo-GI Augment.  This product candidate is composed of smooth muscle cells, obtained from a routine fat biopsy, seeded on one of our proprietary bioabsorbable scaffolds, that can be used as a tubular or patch implant to accommodate patient needs.  Our objective is to demonstrate that our Neo-GI Augment regenerates esophageal and intestinal tissues.  We believe our Neo-GI Augment may offer benefits in other gastrointestinal diseases.
 
The Tengion Neo-Vessel Replacement
 
Our Neo-Vessel Replacement targets various blood vessel applications including vascular access grafts, or arterio-venous, or AV, shunts, for patients with ESRD undergoing hemodialysis treatment, and for vessel replacement for patients undergoing coronary or peripheral artery bypass procedures.  Our technology will use smooth muscle cells isolated from fat tissue and endothelial cells isolated from blood samples, which are expanded ex vivo and then seeded onto a bioabsorbable scaffold in the shape of a blood vessel.
 
Manufacturing
 
We believe our product manufacturing capability provides us with a competitive advantage.  We manufacture our product candidates in a facility specifically designed for the production of patient-specific materials and have implemented quality control systems to ensure our manufacturing processes and facilities comply with applicable current good manufacturing processes, or cGMP, current Good Tissue Practices, or cGTP, and medical device quality systems regulations, or QSR standards.  We have exercised these manufacturing and quality control processes while producing materials for preclinical and clinical studies and have established a significant knowledge base relating to the manufacture of our product candidates.  This knowledge base is maintained in a set of standard operating procedures that detail the techniques and standards for manufacturing.
 
 
 
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Manufacturing of product candidates for our existing preclinical and clinical studies is conducted in our pilot manufacturing facility in Winston-Salem, North Carolina.  The pilot manufacturing facility contains approximately 38,400 square feet of laboratories, offices, and clean room manufacturing space.  We expect to manufacture early stage product candidates through Phase II clinical trials at this facility.  The facility is designed to prevent cross-contamination of patient specific materials and to provide physical segregation while processing these materials.  Our products are manufactured as individual units using disposable processing materials for storage and containment of the product.  We do not face many of the traditional challenges of biopharmaceutical companies in maintaining batch quality as manufacturing is scaled up to commercial quantities because our batch size remains consistent at one unit and because the core manufacturing processes remain consistent regardless of production volume.
 
As our product candidates advance into later-stage clinical trials toward commercialization, we will need to either develop our own internal manufacturing capability or contract with a third-party manufacturer to conduct this manufacturing on our behalf.
 
Sales and Marketing
 
We believe the product candidates we are currently developing will be used primarily by a relatively small number of hospital-based specialty surgeons.  We intend to explore building the necessary marketing and sales infrastructure to market and sell our current product candidates, if approved by the FDA, as well as hire additional personnel to train physicians on the surgical techniques used with our product candidates.  We will also explore the possibility of entering into strategic partnerships for the development and marketing our product candidates.
 
Intellectual Property
 
We have established a patent position surrounding our technology and product candidates in regenerative medicine. As of December 31, 2011, we owned or had licenses to 15 issued U.S. patents, 12 of which are exclusive and two of which are non-exclusive.  The Company also has 20 U.S. patent and international Patent Cooperation Treaty (PCT) applications, and over 100 foreign patents and patent applications.  The patent portfolio owned by the Company relates to the composition, design and methods of manufacture for our Neo-Urinary Conduit, Neo-Bladder Replacement and Neo-Bladder Augment product candidates, as well as technological advances associated with our Neo-Kidney Augment, Neo-Vessel Replacement, and Neo-GI Augment development programs.  The licensed patent portfolio relates to technology developed by scientists and researchers associated with Children’s Medical Center Corporation and Wake Forest University Health Sciences.  Also included within our portfolio are patents that address an array of regenerative medicine and tissue engineering technologies and product candidates outside the scope of our current product pipeline.  In addition to our patent portfolio, we have developed proprietary information, trade secrets and know-how in the development and manufacture of neo-organs. We are committed to protecting our intellectual property position and to aggressively pursue our patent portfolio as well as the protection of our proprietary information, know-how and trade secrets.
 
Our Patent Portfolio
 
Our urologic product candidates currently include our Neo-Urinary Conduit, our Neo-Bladder Replacement, and our Neo-Bladder Augment. Our urologic-related patent portfolio is currently composed of 14 issued U.S. patents; 4 granted European patents, which have been validated in 12 European countries; 12 issued patents in other foreign jurisdictions; 4 pending U.S. non-provisional patent applications; 2 pending Patent Cooperation Treaty, or PCT, applications; and 14 pending foreign patent applications, all of which relate to a PCT application. We own one and have licensed 13 of the issued patents. We own 3 of the U.S. non-provisional patent applications, the PCT applications, and 11 of the foreign patent applications. We have licensed all of the other pending applications.
 
 
 
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The issued U.S. patents, which will expire between 2013 and 2029, contain claims directed to organ constructs, cell-matrix structures, organ scaffolds, and laminarly organized luminal organ or tissue structure constructs; methods of making the same, and methods of treatment using the same. If claims in the pending U.S. patent applications covering urinary conduit constructs, methods for producing the same, and methods of treatment using the same; methods of treatment using laminarly organized luminal organ or tissue structure constructs; and methods for correcting tissue defects in urological structures, are allowed, they would expire between 2018 and 2031. The granted European patents, which will expire between 2018 and 2020, contain claims directed to organ constructs, cell-matrix structures, organ scaffolds, and laminarly organized luminal organ or tissue structure constructs; and methods of making and using the same. The pending PCT, foreign and U.S. provisional applications contain claims directed to urinary conduit constructs, organ constructs, cell-matrix structures, organ scaffolds, and laminarly organized luminal organ or tissue structure constructs; methods of making and using the same; and rational design of regenerative medicine products. These patent applications, if issued, will expire between 2019 and 2031.
 
Our gastrointestinal (GI) development program is our Neo-GI Augment.  Our GI-related patent portfolio is currently composed of one pending U.S. non-provisional patent application and two PCT applications, each of which is owned by us.  If claims issue from patent applications filed claiming benefit of the provisional applications, they will expire in 2031.
 
Our renal development program is our Neo-Kidney Augment.  Our renal-related patent portfolio is currently composed of 11 issued U.S. patents; 4 granted European patents, which have been validated in 12 European countries; 10 issued patents in other foreign jurisdictions; 7 pending U.S. non-provisional patent applications; 2 pending U.S. provisional patent applications; 4 pending PCT applications; and 21 pending foreign patent applications, 18 of which relate to a PCT application. We have licensed all of the issued patents. We own 2 of the U.S. non-provisional patent applications, all 4 of the PCT applications and the U.S. provisional applications. We have licensed all of the other pending applications.
 
The issued U.S. patents, which will expire between 2011 and 2020, contain claims directed to prosthetic kidneys, organ constructs, cell-matrix structures, organ scaffolds; methods of making the same, and methods of treatment using the same. If claims in the pending U.S. patent applications covering renal cell preparations and augmentation constructs, methods for producing the same, and methods of treatment using the same, are allowed, they would expire between 2019 and 2030. The granted European patents, which will expire between 2017 and 2020, contain claims directed to prosthetic kidneys, organ constructs, cell-matrix structures, organ scaffolds; and methods of making and using the same. The pending PCT, foreign and U.S. provisional applications contain claims directed to renal cell preparations and augmentation constructs, methods for producing and using the same; rational design of regenerative medicine products, renal adipose-derived cells, and drug screening assays. These patent applications, if issued, will expire between 2019 and 2032.
 
Our vascular development program is our Neo-Vessel Replacement.  Our vessel-related patent portfolio is currently composed of 1 pending U.S. non-provisional patent application, 1 PCT application, and 7 pending foreign patent applications. We own each of the pending applications. If claims in our pending patent applications covering tissue engineering scaffolds having a mechanical response to stress and strain substantially similar to that of a response by a native blood vessel, and methods of making the same, are allowed, they would expire in 2031.
 
Confidential Information and Inventions Assignment Agreements
 
We require our employees, consultants and members of our research and development advisory board to execute confidentiality agreements upon the commencement of employment, consulting or collaborative relationships with us.  These agreements provide that all confidential information developed or made known during the course of the relationship with us be kept confidential and not disclosed to third parties except in specific circumstances.  In the case of employees, the agreements provide that all inventions resulting from work performed for us, utilizing our property or relating to our business and conceived or completed by the individual during employment shall be our exclusive property to the extent permitted by applicable law.
 
 
 
 
 
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License Agreements and Research Agreements
 
Exclusive License Agreement with Children’s Medical Center Corporation
 
In October 2003, we entered into a license agreement with Children’s Medical Center Corporation, or CMCC, for the license of certain patent rights and intellectual property rights owned or controlled by CMCC related to tissue engineering technology.  The CMCC patent rights include patent rights owned by CMCC, as well as CMCC’s right to sublicense certain patent rights owned or controlled by Massachusetts Institute of Technology, or MIT.  Under the terms of this license agreement, CMCC has granted us exclusive worldwide, sublicensable licenses under certain of CMCC’s patent rights related to implantable matrices for the development and commercialization of tissue engineered products for human and animal therapeutics in the subfields of genitourinary, vascular tissue, nervous tissue, trachea and other subfields later agreed upon by us and CMCC.  Our license from CMCC is exclusive in all subfields for patent rights related to organ constructs; cell matrix structures; laminarly organized luminal organ or tissue structure constructs; prosthetic kidneys; kidney augmenting constructs; stents; reproductive organs and tissue structure constructs; as well as methods for making and using the same.  Our license to CMCC’s patent rights related to implantable cartilaginous structures, implantable genitourinary cell-seeded matrices, and mammalian urothelial cell preparation is non-exclusive, except in the genitourinary subfield where the license is exclusive.  Our license to CMCC’s patent rights relating to organ decellularization is non-exclusive for all subfields covered by the license agreement.  Under the license agreement, we were also granted a non-exclusive, non-sublicensable, non-transferable license to certain CMCC biological materials and know-how related to unpatented manufacturing and scientific information, except that such license may be sublicensed or transferred to our affiliates and contractors for purposes specified in the license agreement.  CMCC has retained a royalty-free, non-exclusive right to practice, use and license to other academic and nonprofit research organizations to practice and/or use the patent rights and licensed products for research, educational, clinical and/or charitable purposes only.
 
We are required under the license agreement to use reasonably diligent efforts, as defined in the license agreement, to bring one or more licensed products to market as soon as practicable and to obtain all necessary government approvals for the manufacture, use, sale and distribution of licensed products.  If we fail to meet the diligence requirements set forth in the license agreement, we may be required under certain circumstances to grant a sublicense to a third party chosen by CMCC relating to the licensed product or subfield for which we have failed to meet our diligence obligations.
 
Under the license agreement, we are required to make payments to CMCC for accrued and continuing patent prosecution costs and also upon the achievement of certain development and sales milestones as well as certain consideration received from a sublicensee.  If we develop and obtain regulatory approval of a licensed product in each of the four subfields, we will be required to pay CMCC development milestones aggregating approximately $6.9 million.  Also, if cumulative net sales of all licensed products reach a certain level, we will be required to make a one-time sales milestone payment of $2.0 million.  We have previously paid a license issue fee of $175,000 and $350,000 of development milestones to CMCC and as of December 31, 2010, we did not owe any milestone payments to CMCC under the license agreement.  A portion of the milestone payments we make will be credited against our future royalty payments.  We must pay CMCC royalties in the mid-single digit range based on net sales of licensed products as defined in the agreement by us, our affiliates and our sublicensees, which royalties will be reduced for certain amounts we are required to pay to license patents or intellectual property from third parties and under certain circumstances if there is a competing product.  No royalties will be payable with respect to sales of licensed products in countries where there is no valid patent claim, unless we advised CMCC not to file for patent protection in that country and later choose to market and sell licensed products in such country.  The license agreement, and our obligation to pay royalties terminates on the later of the expiration, on a country-by-country basis, of the last patent right and October 2018.
 
Either party may terminate the license agreement upon 90 days prior written notice upon a material, unremedied breach or default of the other party.  CMCC may terminate the agreement immediately upon our insolvency or as otherwise provided in the agreement and also upon 45 days prior written notice for our failure to pay royalties due in a timely manner.  We may terminate at any time, with or without cause, upon six months prior written notice and payment to CMCC of accrued amounts due and a $50,000 termination fee.
 
 
 
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Wake Forest University Health Sciences License Agreement
 
In January 2006 we entered into a license agreement with Wake Forest University Health Sciences, or WFUHS, which was amended in May 2007, for the license of WFUHS’s intellectual property (including know-how) related to research performed by WFUHS employee, Dr. Anthony Atala, a former employee of the Children’s Hospital Boston, an affiliate of CMCC, and the inventor or co-inventor on certain inventions and patents held by CMCC, which are licensed to us under our license agreement with CMCC.
 
In January 2006, we entered into a research agreement with WFUHS, which was amended in September 2006.  Under the research agreement, WFUHS agreed to perform sponsored research in return for quarterly payments.  The sponsored research involved the experiments and studies set out in annual research plans and milestones established under the agreement.  We terminated this agreement effective December 31, 2011.
 
Under the terms of this amended license agreement, WFUHS has granted us a worldwide, exclusive, sublicensable license to make, use and sell products covered by certain of WFUHS’s patent rights that relate to improvements of the existing inventions and patents included in the patent rights licensed to us under our license agreement with CMCC, or the improvement patents, and to new development inventions and patents arising out of the performance of a separate agreement, the WFUHS Research Agreement, or the new development patents, in the fields of human and animal organs, tissues and tissue-engineered and regenerative medicine directed to their functions in the subfields of genitourinary tissue, kidney tissue, cardiovascular tissue and nervous tissue.  This license agreement also granted us a non-exclusive, worldwide, sublicensable license to certain know-how related to unpatented manufacturing and scientific information provided by WFUHS.  Our license to patents claiming inventions conceived after the expiration or other termination of the WFUHS Research Agreement may be terminated at any time by WFUHS following expiration or other termination of the WFUHS Research Agreement.  On January 11, 2012, WFUHS exercised this right to terminate our license to improvement patents claiming inventions conceived after termination of the WFUHS Research Agreement.
 
We are obligated to use commercially reasonable efforts to bring licensed products to market.  If WFUHS believes that we have failed to comply with this obligation and an arbitrator agrees with WFUHS, we will be required to enter into a sublicense for the relevant product or grant WFUHS the right to enter into a sublicense for the that product.  We are not required to make any milestone payments to WFUHS related to the development or commercialization of the licensed products.  In addition, we are required to meet certain time deadlines with respect to initiating the first human clinical trial, filing for marketing approval with the FDA and achieving the first commercial sale in the United States with respect to the first product covered by the new development patents in each subfield.  If we fail to meet any of these deadlines, WFUHS may, in its sole option, terminate our license with respect to such product covered by the new development patents.
 
Under the license agreement, we also issued WFUHS a warrant to purchase 3,200 shares of our common stock through January 1, 2016 at an exercise of $2.32 per share and are required to pay WFUHS a percentage of certain consideration received from a sublicensee.  We are required to pay certain license maintenance fees with respect to each product covered by new development patents, commencing two years after we initiate the first animal study conducted under cGLP, with respect to such product.  These license maintenance fees, which are in the low six figure range with respect to each product, will be creditable against royalties we are obligated to pay to WFUHS for such product.  In addition, we are required to pay WFUHS royalties in the low- to mid-single digit range based on net sales of licensed products in all countries.  With respect to any product covered by an improvement patent, our obligation to pay royalties to WFUHS terminates upon the later of the expiration, on a product-by-product basis, of the last to expire patent covering such product and the date that is 15 years from the first commercial sale of such product, provided that no such royalty is payable more than seven years after expiration of the last-to-expire patent covering such product.
 
With respect to any licensed product that is not covered by an improvement patent, our obligation to pay royalties to WFUHS terminates, on a product-by-product basis, on the date that is five years from the first commercial sale of such product, provided that the first commercial sale occurs prior to January 1, 2021 (for each day after January 1, 2021 that the first commercial sale does not occur, the five-year period is reduced by one day).
 
 
 
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Pursuant to the terms of the amended license agreement, we have provided $2.8 million of funding for research activities under the WFUHS research agreement through December 31, 2010.  We have made no other payments under the license agreement with WFUHS.
 
The agreement continues in effect on a country-by-country basis until the later of the expiration of the last to expire new improvement patent and January 1, 2021, unless earlier terminated as provided in the agreement.  We may terminate the license agreement at any time, with or without cause, upon 90 days prior written notice.  WFUHS may terminate the license agreement upon our default in paying a license fee or providing a report required to be provided under the license agreement, our material breach or our making a knowingly false report, upon 45 days prior written notice, provided that we may cure such default or breach within the 45-day period.
 
Medtronic Right of First Refusal and Right of First Negotiation Agreement
 
On March 1, 2011, we entered into a Right of First Refusal and Right of First Negotiation Agreement with Medtronic, Inc. pursuant to which we granted Medtronic a right of first refusal to the license, sale, assignment, transfer or other disposition by us of any material portion of intellectual property (including patents and trade secrets) or other assets related to our Neo-Kidney Augment program (an NKA transaction) until October 31, 2013.  Additionally, from November 1, 2013 through July 1, 2014, Medtronic will have a right of first negotiation with respect to an NKA transaction, with an option to convert that right of first negotiation to a right of first refusal.  Medtronic made a $7 million investment in our common stock along side other investors in a private placement consummated on March 4, 2011.  In consideration for receiving rights under the Right of First Refusal and Right of First Negotiation Agreement, Medtronic agreed to receive a warrant to purchase 25% fewer shares of common stock that otherwise would have been issued to Medtronic pursuant to the terms of the private placement.  In the event of a change in control, and without any obligation on our part, the agreement and all Medtronic’s rights pursuant thereto will automatically terminate in all respects and be of no further force and effect.
 
Competition
 
Our industry is subject to rapid and intense technological change.  While we do not believe we currently have any commercial competitors who are developing autologous organs and tissues for the target populations that we are addressing, we face, and will continue to face, intense competition from medical device, pharmaceutical, biopharmaceutical and biotechnology companies, as well as numerous academic and research institutions and governmental agencies who are generally engaged in tissue engineering and regenerative medicine activities or funding.  In addition, there are companies and academic institutions developing drugs, medical devices, and surgical techniques to treat many of the medical conditions our product candidates are designed to treat.
 
Regenerative Medicine
 
While we are, to our knowledge, the only regenerative medicine company presently developing a range of neo-organs for implant that are designed to regenerate into functional organs and tissues, there are companies that are researching and developing regenerative cell-based products or therapies, which may seek to address the medical indications that our neo-organ product candidates seek to address.  The companies include Mesoblast, Athersys, Aastrom, and Neusentis Regenerative Medicine. In addition, several large pharmaceutical companies with much greater resources have demonstrated a strategic interest in regenerative medicine, including Sanofi Aventis, Johnson & Johnson, Pfizer and Celgene.
 
Bladder Treatment
 
We expect that our Neo-Urinary Conduit will compete with the current standard of care, which is the use of bowel tissue to create a urinary diversion. Companies that are researching, developing and marketing products to treat bladder dysfunction include Allergan, which is developing Botox for bladder dysfunction; Speywood Biopharma, which is developing Dysport for bladder dysfunction; and Medtronic, which is marketing Interstim for bladder dysfunction.  Further, many large pharmaceutical companies market anticholinergenic medications, such as Detrol and Ditropan, which can be used to treat bladder dysfunction.
 
 
 
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Advanced Chronic Kidney Disease
 
There are many companies searching for therapeutics to address chronic kidney disease.  These companies include larger companies, such as Reata, Abbott, Eli Lilly, and Merck, as well as smaller biotechnology companies, such as Anexon, ProMetic, and Nile Therapeutics.
 
Many of the companies competing against us have financial and other resources substantially greater than our own.  In addition, many of our competitors have significantly greater experience in testing therapeutic products, obtaining FDA and other marketing approvals of products, and marketing and selling those products.  Accordingly, our competitors may succeed more rapidly than we will in obtaining FDA approval for products and achieving widespread market acceptance.
 
We expect to compete based upon, among other factors, our unique mechanism of action, our broad-based therapeutic impact, our intellectual property portfolio, our substantial process know-how with respect to scalable manufacturing capabilities, and the efficacy and safety profile of our product candidates.  Our ability to compete successfully will depend, in part, on our continued ability to attract and retain skilled and experienced scientific, clinical development and executive personnel, to develop viable autologous neo-organs.
 
Government Regulation
 
Regulation by governmental authorities in the United States and other countries is a significant factor in the development, manufacture, commercialization and reimbursement of our neo-organs.  All of the products we are seeking to develop will require marketing approval, or licensure, by governmental agencies prior to commercialization.  In particular, human therapeutic products are subject to rigorous preclinical and clinical testing, approval and marketing regulations promulgated by the FDA and similar regulatory authorities in other countries.  Various governmental statutes and regulations also govern or influence testing, manufacturing, quality control, safety, labeling, packaging, storage and record keeping related to such products and their marketing.  State, local and other authorities may also regulate manufacturing facilities used for our neo-organs.  The process of obtaining these approvals and the subsequent compliance with appropriate statutes and regulations require the expenditure of substantial time and money, and there can be no guarantee that approvals will be granted.
 
FDA Approval Process
 
Our neo-organs will require approval from the FDA and corresponding agencies in other countries before they can be marketed.  The FDA regulates human therapeutic products in one of three broad categories: biologics, drugs, or medical devices.  Our product candidates that are currently under development are combination products having features of both a biologic and a medical device.  The FDA has determined that the primary mode of action for our Neo-Urinary Conduit is cellular and, therefore, they will be regulated as biologics.  We currently believe other neo-organs that we develop will also be regulated as biologics and will therefore require approval via a Biologics License Application, or BLA.  The FDA regulates biological products under both the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act, and implementing regulations for both statutes.  The FDA generally requires the following steps for pre-market approval or licensure of a new biological product:
 
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preclinical laboratory and animal tests conducted in compliance with FDA’s Good Laboratory Practice, or GLP, requirements and applicable requirements for the humane use of laboratory animals, to assess a product’s biological activity, biocompatibility and to identify potential safety problems and to characterize and document the product’s manufacturing controls and stability;
 
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submission to the FDA of an IND application, which must become effective before clinical testing in humans can begin;
 
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development of clinical protocols to establish the safety and efficacy of the product in humans in clinical trials;
 
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obtaining approval of clinical protocols by institutional review boards, or IRBs, of clinical sites in order to introduce the product into humans in clinical trials;
 
 
 
 
 
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adequate and well-controlled human clinical trials to establish the safety and efficacy of the product for its intended indication conducted in compliance with the FDA’s Good Clinical Practice, or GCP, requirements, as well as any additional requirements for the protection of human research subjects and their health information;
 
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compliance with cGMP and if applicable, cGTP and QSR, regulations and standards concerning quality and the use of human cellular and tissue products;
 
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submission to the FDA of a BLA, for marketing approval that includes substantive evidence of safety and effectiveness from adequate results of preclinical testing and clinical trials;
 
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FDA review of the marketing application in order to determine, among other things, whether the product is safe and effective for its intended uses; and
 
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obtaining FDA approval of the BLA, including inspection and approval of the product manufacturing facility as compliant with cGMP and if applicable, cGTP and QSR, requirements, prior to any commercial sale or shipment of the product.
 
Once a biological product is identified for development, it enters the preclinical testing stage.  An IND sponsor must submit the results of the preclinical tests together with manufacturing information, analytical data and any available clinical data or literature to the FDA as part of the IND.  The sponsor also will include a protocol detailing, among other things, the objectives of the initial clinical trial, the parameters to be used in monitoring safety and the effectiveness criteria to be evaluated if the initial clinical trial lends itself to an efficacy evaluation.  Some preclinical testing may continue even after the IND is submitted.  The IND automatically becomes effective 30 days after receipt by the FDA, unless the FDA places the clinical trial on a clinical hold within that 30-day time period.  In such a case, the IND sponsor and the FDA must resolve any outstanding concerns before the clinical trial can begin.  Clinical holds also may be imposed by the FDA at any time before or during trials due to safety concerns or non-compliance with regulatory requirements.
 
All clinical trials must be conducted under the supervision of one or more qualified investigators in accordance with GCP regulations.  These regulations include the requirement that all research subjects provide informed consent.  Further, an IRB must review and approve the plan for any clinical trial before it commences at any institution.  An IRB considers, among other things, whether the risks to individuals participating in the trials are minimized and are reasonable in relation to anticipated benefits.  The IRB also approves the information regarding the clinical trial and the consent form that must be provided to each clinical trial subject or his or her legal representative and must monitor the clinical trial until completion.
 
Each new clinical protocol and any amendments to the protocol must be submitted under the IND for FDA review, and to the IRBs for approval.  Protocols detail, among other things, the objectives of the clinical trial, subject selection and exclusion criteria, and the parameters to be used to monitor subject safety.
 
Typically, clinical testing involves a three-phase process although the phases may overlap.  Generally, Phase I clinical trials are conducted in a small number of healthy volunteers or patients, except in circumstances where clinical testing would be not appropriate in healthy volunteers, and are designed to provide information about product safety.  In Phase II, clinical trials are conducted with groups of patients afflicted with a specific disease in order to determine optimal dose, preliminary efficacy and expanded evidence of safety.  Phase III clinical trials are generally large-scale, multi-center, comparative trials conducted with patients afflicted with a target disease in order to provide statistically valid proof of efficacy, as well as safety and potency.  In some circumstances, the FDA may require Phase IV or post-marketing trials if it feels that additional information needs to be collected about the product after it is on the market, particularly for long term safety follow up.  During all phases of clinical development, regulatory agencies require extensive monitoring and auditing of all clinical activities, clinical data and clinical trial investigators.  Progress reports detailing the results of clinical trials must be submitted at least annually to the FDA.  The FDA may, at its discretion, re-evaluate, alter, suspend, or terminate the testing based upon the data which have been accumulated to that point and its assessment of the risk/benefit ratio to the patient.  Monitoring all aspects of clinical trials to minimize risks is a continuing obligation and process.  All serious and unexpected adverse events that are deemed to be associated with the product must be reported to the FDA in written IND safety reports.
 
 
 
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The results of the preclinical and clinical testing are submitted to the FDA along with descriptions of the manufacturing process.  In the case of vaccines, gene and cell therapies and products such as our current product candidates, the results of clinical trials are submitted as a BLA.  Under the Pediatric Research Equity Act of 2003, or PREA, which was reauthorized under the FDAAA, a BLA or a supplement to a BLA must contain data to assess the safety and effectiveness of the biological product for the claimed indications in all relevant pediatric subpopulations and to support dosing and administration for each pediatric subpopulation for which the product is safe and effective.  The FDA may grant deferrals for submission of data or full or partial waivers.  Unless otherwise required by regulation, PREA does not apply to any biological product for an indication for which orphan designation has been granted.
 
The FDA reviews all BLAs submitted to ensure that they are sufficiently complete for substantive review before it accepts them for filing.  The FDA may request additional information rather than accept a BLA for filing.  In this event, the BLA must be resubmitted with the additional information.  The resubmitted application also is subject to review before the FDA accepts it for filing.  Once the submission is accepted for filing, the FDA begins an in-depth substantive review.  The FDA reviews a BLA to determine, among other things, whether the product is safe, has an acceptable purity profile and is adequately effective, and whether its manufacturing meets standards designed to assure the product’s continued identity, safety, purity, and potency.
 
The FDA may grant marketing approval, or the FDA may request additional clinical data or deny approval if the FDA determines that the application does not satisfy its marketing approval criteria.  FDA review of a BLA typically takes nine months, but may last longer, especially if the FDA asks for more information or clarification of information already provided.  The FDA may refer the BLA to an advisory committee for review, evaluation and recommendation as to whether the application should be approved and under what conditions.  An advisory committee is a panel of experts who provide advice and recommendations when requested by the FDA on matters of importance that come before the agency.  The FDA is not bound by the recommendations of the advisory committee, but it generally follows such recommendations.
 
The process of obtaining marketing approval is lengthy, uncertain, and requires the expenditure of substantial resources.  Each BLA must be accompanied by a user fee, pursuant to the requirements of the Prescription Drug User Fee Act, or PDUFA, and its amendments.  The FDA adjusts the PDUFA user fees on an annual basis.  According to the FDA’s fee schedule, effective through September 30, 2011, the user fee for an application requiring clinical data, such as a BLA, is $1,841,500.  PDUFA also imposes an annual product fee for biologics ($98,970), and an annual establishment fee ($520,100) on facilities used to manufacture prescription biologics.  Fee waivers or reductions are available in certain circumstances, including a waiver of the application fee for the first application filed by a small business.  Additionally, no user fees are assessed on BLAs for products designated as orphan drugs, unless the drug also includes a non-orphan indication.  We have applied for orphan designation for our Neo-Urinary Conduit product candidate.
 
Before FDA approves a BLA, all facilities and manufacturing techniques used for the manufacture of products must comply with applicable FDA regulations governing cGMP.  Among other things, the manufacturer must develop methods for testing the identity, potency and purity of the final product.  A local field division of the FDA is responsible for completing the pre-approval inspection and providing recommendation for or against approval.  This effort is intended to assure appropriate facility and process design to avoid potentially lengthy delays in product approvals due to inspection deficiencies.  Similarly, before approving a BLA, the FDA also may conduct pre-licensing inspections of a company, its contract research organizations and/or its clinical trial sites to ensure that clinical, safety, quality control and other regulated activities are compliant with GCP.  To assure such cGMP and GCP compliance, the applicants must incur significant expenditure of time, money and effort in the area of training, record keeping, production, and quality control.  Following approval, the manufacture, holding, and distribution of a product continues to require significant resources in order for the sponsor to maintain full compliance in these areas.  For human cellular products, cGTP requirements apply.  For a biologic/device combination product, the product must be manufactured also in compliance with QSR requirements for the device component.
 
After marketing approval has been obtained, the FDA will require post-marketing safety reporting to monitor the side effects of the product.  Further studies may be required to provide additional data on the product’s risks, benefits, and optimal use, and further clinical trials will be required to gain approval for the use of the product as a treatment for clinical indications other than those for which the product was initially tested.  Results of post-marketing programs may limit or expand the further marketing of the product.  Further, if there are any modifications to the product, including changes in indication, labeling, or a change in the manufacturing process, manufacturing facility, or product composition, a BLA supplement may be required to be submitted to the FDA.
 
 
 
 
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Other FDA Regulatory Requirements
 
Maintaining substantial compliance with applicable federal, state and local statutes and regulations requires the expenditure of substantial time and financial resources.  Any biological products manufactured or distributed by us pursuant to FDA approvals are subject to continuing regulation by the FDA, including:
 
·  
record-keeping requirements;
 
·  
reporting of adverse experiences with the biologic;
 
·  
providing the FDA with updated safety and efficacy information;
 
·  
reporting of cGMP deviations that may affect the identity, potency, purity and overall safety of a distributed product;
 
·  
reporting on advertisements and promotional labeling; and
 
·  
complying with electronic record and signature requirements.
 
In addition, the FDA strictly regulates labeling, advertising, promotion and other types of information on products that are placed on the market.  There are numerous regulations and policies that govern various means for disseminating information to health-care professionals as well as consumers, including to industry sponsored scientific and educational activities, information provided to the media and information provided over the Internet.  Prescription biologics may be promoted only for the approved indications and in accordance with the provisions of the approved label.  Biological product manufacturers and other entities involved in the manufacturing and distribution of approved biological products are required to register their establishments with the FDA and certain state agencies, and are subject to periodic unannounced inspections by the FDA and certain state agencies for compliance with cGMP and other laws.
 
The FDA has very broad enforcement authority and the failure to comply with applicable regulatory requirements can result in administrative or judicial sanctions being imposed on us or on the manufacturers and distributors of our approved products, including, without limitation, warning or untitled letters, refusals of government contracts, clinical holds, civil penalties, injunctions, restitution, disgorgement of profits, recall or seizure of products, total or partial suspension of production or distribution, withdrawal of approvals, refusal to approve pending applications, and criminal prosecution resulting in fines and incarceration.  The FDA and other agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses, and a company that is found to have improperly promoted off-label uses may be subject to significant liability.  In addition, even after marketing approval is obtained, later discovery of previously unknown problems with a product may result in restrictions on the product or even complete withdrawal of the product from the market.
 
FDA Amendments Act
 
On September 27, 2007, the President signed into law the Food and Drug Administration Amendments Act of 2007, or the FDAAA.  This new legislation grants significant new powers to the FDA, many of which are aimed at assuring the safety of drugs and biologics after approval.  In particular, the new law authorizes the FDA to, among other things, require post-approval studies and clinical trials, mandate changes to drug and biologic labeling to reflect new safety information, and require risk evaluation and mitigation strategies for certain drugs and biologics.  In addition, the new law significantly expands the federal government’s clinical trial registry and results databank and creates new restrictions on the advertising and promotion of drugs and biologics.  Under the FDAAA, companies that violate these and other provisions of the new law are subject to substantial civil monetary penalties.
 
The requirements and changes imposed by the FDAAA may make it more difficult, and more costly, to obtain and maintain approval for new biologics, or to produce, market and distribute existing products.  In addition, the FDA’s regulations, policies and guidance are often revised or reinterpreted by the agency or the courts in ways that may significantly affect our business and our products.  It is impossible to predict whether additional legislative changes will be enacted, or FDA regulations, guidance or interpretations changed, or what the impact of such changes, if any, may be.
 
 
 
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Follow-on Biologics, or Biosimilars
 
In the past few years, there have been a number of legislative initiatives that intended to create a regulatory pathway for approval of follow-on biologics, or biosimilars.  The forms of the proposed legislation differed in several aspects, including the length and scope of intellectual property protection, and the clinical testing standards.  At this time it is not possible to predict whether any of the biosimilar proposals will be enacted and become law, and if so, which version of the proposals will be enacted.  However, if a regulatory pathway is established for biosimilars in the future pursuant to the enactment of biosimilar legislation, our business may be adversely affected, although the extent of the impact will depend on the details of the biosimilar law.
 
Expedited Development and Review Programs
 
A Fast Track product is defined as a new drug or biologic intended for the treatment of a serious or life-threatening condition that demonstrates the potential to address unmet medical needs for this condition.  Under the Fast Track program, the sponsor of a new drug or biologic may request the FDA to designate the drug or biologic as a Fast Track product at any time during the clinical development of the product.  This designation assures access to FDA personnel for consultation throughout the development process and provides an opportunity to request priority review of a marketing application providing a six-month review timeline for the designated product.  If a preliminary review of the clinical data suggests that a Fast Track product may be effective, the FDA may initiate review of sections of a marketing application for a Fast Track product before the sponsor completes the application.  This rolling review is available if the applicant provides a schedule for submission of remaining information and pays applicable user fees.  However, the time periods specified under PDUFA concerning goals to which the FDA has committed to reviewing an application do not begin until the sponsor submits the complete application.  Products that receive Fast Track designation may also be eligible for accelerated approval, or approval based on a clinical endpoint other than survival or irrevocable morbidity or on a surrogate endpoint that is reasonably likely to predict clinical benefit.
 
Orphan Drug Designations
 
The Orphan Drug Act provides incentives to manufacturers to develop and market drugs and biologics for rare diseases and conditions affecting fewer than 200,000 persons in the United States at the time of application for orphan drug designation, or more than 200,000 individuals in the United States and for which there is no reasonable expectation that the cost of developing and making a drug or biological product available in the United States for this type of disease or condition will be recovered from sales of the product.  Orphan product designation must be requested before submitting a new drug application, or NDA, or BLA.  After the FDA grants orphan product designation, the identity of the therapeutic agent and its potential orphan use are disclosed publicly by the FDA.  Orphan product designation does not convey any advantage in or shorten the duration of the regulatory review and approval process.  The first developer to receive FDA marketing approval for an orphan biologic is entitled to a seven year exclusive marketing period in the United States for that product as well as a waiver of the BLA user fee.  The exclusivity prevents FDA approval of another application for the same product for the same indication for a period of seven years, except in limited circumstances where there is a change in formulation in the original product and the second product has been proven to be clinically superior to the first.
 
Legislation similar to the Orphan Drug Act has been enacted in other jurisdictions, including the European Union.  The orphan legislation in the European Union is available for therapies addressing conditions that affect five or fewer out of 10,000 persons.  The marketing exclusivity period is for ten years, although that period can be reduced to six years if, at the end of the fifth year, available evidence establishes that the product is sufficiently profitable not to justify maintenance of market exclusivity.  We have received orphan drug designation for our Neo-Urinary Conduit for the treatment of bladder dysfunction requiring incontinent urinary diversion.
 
 
 
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Human Cellular and Tissue-Based Products
 
Human cells or tissue intended for implantation, transplantation, infusion, or transfer into a human recipient is regulated by the FDA as human cells, tissues, and cellular and tissue-based product, or HCT/Ps.  Certain types of HCT/Ps are regulated differently from drug or biologic products because they are minimally manipulated tissues intended for homologous use in the patient’s body, are not combined with a drug, device or biologic, and do not have systemic or metabolic effects on the body.  The FDA does not require pre-market approval for these types of HCT/Ps, however, it does require strict adherence to federally mandated current Good Tissue Practice, or cGTP, regulations for all HCT/Ps.  These regulations are analogous to the cGMP regulations described above in terms of manufacturing standards.  In addition, the FDA’s regulations include other requirements to prevent the introduction, transmission and spread of communicable disease.  These requirements apply to all HCT/Ps, including those regulated as drugs, biologics or devices.  Specifically, the FDA’s regulations require tissue establishments to register and list their HCT/Ps with the FDA and, when applicable, to evaluate donors through screening and testing.  We submit an annual registration and listing form to the FDA for our Winston-Salem facility as an HCT/Ps facility.
 
Privacy Law
 
Federal and state laws govern our ability to obtain and, in some cases, to use and disclose data we need to conduct research activities.  Through the Health Insurance Portability and Accountability Act of 1996, or HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (as incorporated in the American Recovery and Reinvestment Act of 2009) Congress required the Department of Health and Human Services to issue a series of regulations establishing standards for the electronic transmission of certain health information.  Among these regulations were standards for the privacy of individually identifiable health information.  Most health care providers were required to comply with the Privacy Rule as of April 14, 2003.
 
HIPAA does not preempt, or override, state privacy laws that provide even more protection for individuals’ health information.  These laws’ requirements could further complicate our ability to obtain necessary research data from our collaborators.  In addition, certain state privacy and genetic testing laws may directly regulate our research activities, affecting the manner in which we use and disclose individuals’ health information, potentially increasing our cost of doing business, and exposing us to liability claims.  In addition, patients and research collaborators may have contractual rights that further limit our ability to use and disclose individually identifiable health information.  Claims that we have violated individuals’ privacy rights or breached our contractual obligations, even if we are not found liable, could be expensive and time-consuming to defend and could result in adverse publicity that could harm our business.
 
Other Regulations
 
In addition to privacy law requirements and regulations enforced by the FDA, we also are subject to various local, state and federal laws and regulations relating to safe working conditions, laboratory and manufacturing practices, the experimental use of animals and the use and disposal of hazardous or potentially hazardous substances.  These laws include, but are not limited to, the Occupational Safety and Health Act, the Toxic Test Substances Control Act and the Resource Conservation and Recovery Act.
 
Foreign Regulation
 
We will most likely have to obtain approval for the manufacturing and marketing of each of our products from regulatory authorities in foreign countries prior to the commencement of marketing of the product in those countries.  The approval procedure varies among countries, may involve additional preclinical testing and clinical trials, and the time required may differ from that required for FDA approval or licensure.  Although there is now a centralized European Union approval mechanism in place, this applies only to certain specific medicinal product categories.  In respect of all other medicinal products each European country may impose certain of its own procedures and requirements in addition to those requirements set out in the appropriate legislation, many of which could be time-consuming and expensive.
 
 
 
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Employees
 
As of December 31, 2011, we had 34 employees, including 33 full-time employees, of which 26 employees were engaged in research, development, and facilities management, and 8 employees were engaged in administration and finance.  All of our employees have entered into non-disclosure agreements with us regarding our intellectual property, trade secrets and other confidential information.  None of our employees are represented by a labor union or covered under a collective bargaining agreement, nor have we experienced any work stoppages.
 
Corporate Website
 
Our Internet website address is http://www.tengion.com.  Our filings on Form 10-K, Form 10-Q, Form 3, Form 4, Form 5, Form 8-K and any and all amendments thereto are available free of charge through this internet website as soon as reasonably practicable after they are filed or furnished to the Securities and Exchange Commission, or the SEC.  They are also available through the SEC at http://www.sec.gov/edgar/searchedgar/companysearch.html.
 
 
 
 
 
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Item 1A.Risk Factors
 
Our business is subject to numerous risks.  We caution you that the following important factors, among others, could cause our actual results to differ materially from those expressed in forward-looking statements made by us in filings with the SEC, press releases, communications with investors and oral statements.  Any or all of our forward-looking statements in this Annual Report on Form 10-K and in any other public statements we make may turn out to be wrong.  They can be affected by inaccurate assumptions we might make or by known or unknown risks and uncertainties.  Many factors mentioned in the discussion below will be important in determining future results.  Consequently, forward-looking statements cannot be guaranteed.  Actual future results may differ materially from those anticipated in forward-looking statements.  We undertake no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.  You are advised, however, to consult any further disclosure we make in our reports filed with the SEC or in a press release.
 
Risks Related to Our Financial Position and Need for Additional Capital
 
In order to fund our operations, we will need to raise significant amounts of capital.  We may not be able to raise additional capital when necessary or on acceptable terms to us, if at all.  
 
Our future capital requirements will depend on many factors, including:
 
·  
the scope and results of our clinical trials, particularly regarding the number of patients required and the required duration of follow-up for our clinical trials in support of our product candidates;
 
·  
the scope and results of our research and preclinical development programs;
 
·  
the costs of operating our research and development facility to support our research and early clinical activities;
 
·  
the time, complexity and costs involved in obtaining marketing approvals for our product candidates, which could take longer and be more costly than obtaining approval for a new conventional drug candidate, given the FDA’s limited experience with clinical trials and marketing approval for products derived from a patient’s own cells;
 
·  
the costs of securing commercial manufacturing capacity to support later-stage clinical trials and subsequent commercialization activities, if any;
 
·  
the costs of maintaining, expanding, protecting and enforcing our intellectual property portfolio, including potential dispute and litigation costs and any associated liabilities and potentially challenging the intellectual property of others;
 
·  
the costs of entering new markets outside the United States; and
 
·  
the extent of our contractual obligations and amount of debt service payments we are obligated to make.
 
As a result of these factors, among others, we will need to seek additional funding prior to our being able to generate positive cash flow from operations.  We will need to raise additional funds through collaborative arrangements, public or private sales of debt, equity or equity-linked securities, commercial loan facilities, or some combination thereof.  Additional funding may not be available to us on acceptable terms, or at all.  If we obtain capital through collaborative arrangements, these arrangements could require us to relinquish some rights to our technologies or product candidates and we may become dependent on third parties.  If we raise capital through the sale of equity, or securities convertible into equity, dilution to our then-existing stockholders would result.  If we obtain funding through the incurrence of debt, we would likely become subject to covenants restricting our business activities, and holders of debt instruments would have rights and privileges senior to those of our equity investors.  In addition, servicing the interest and repayment obligations under our current and future borrowings would divert funds that would otherwise be available to support research and development, clinical or commercialization activities.
 
 
 
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If we are unable to obtain adequate financing on a timely basis, we may be required to delay, reduce the scope of or eliminate one or more of our development programs, and reduce our personnel, any of which could raise substantial doubt about our ability to continue as a going concern and have a material adverse effect on our business, financial condition and results of operations.
 
We have a substantial amount of debt and contractual obligations that expose us to risks that could adversely affect our business, operating results and financial condition.  
 
As of December 31, 2011, we had approximately $5.0 million of outstanding debt, which is secured by liens on substantially all of our assets.  We are obligated to make interest-only payments through January 2012, followed by 24 monthly payments of principal and interest at an interest rate of 11.75% per annum.  We expect that the annual principal and interest payments on our outstanding debt will be approximately $2.8 million, $2.8 million, and $0.2 million in 2012, 2013, and 2014, respectively.  The level and nature of our indebtedness could, among other things:
 
·  
make it difficult for us to obtain any necessary financing in the future;
 
·  
limit our flexibility in planning for or reacting to changes in our business;
 
·  
reduce funds available for use in our operations;
 
·  
impair our ability to incur additional debt because of financial and other restrictive covenants or the liens on our assets which secure our current debt;
 
·  
hinder our ability to raise equity capital because in the event of a liquidation of the business, debt holders receive a priority before equity holders;
 
·  
make us more vulnerable in the event of a downturn in our business; or
 
·  
place us at a possible competitive disadvantage relative to less leveraged competitors and competitors that have better access to capital resources.
 
The lease agreement for our Pennsylvania manufacturing facility requires us to provide security and restoration deposits totaling $2.2 million to the landlord.  In satisfaction of these security deposit obligations, we have deposited $1.0 million with the landlord and have secured a $1.2 million letter of credit from a bank in favor of the landlord.  The letter of credit is collateralized by an account held at the bank.  If the bank determines the collateral to be insufficient, the bank has the right to demand additional collateral.  If we fail to provide additional collateral, the bank has the right to withdraw the letter of credit.  In that event, the landlord would have the right to require us to deposit cash of up to $1.2 million in an account to satisfy our deposit obligation.

In November 2011, we made a business decision to restructure our corporate operations, consolidate our operations in our Winston-Salem research and development facility and seek to exit our commercial-scale manufacturing facility.  We currently have four years left under the lease agreement for our commercial-scale manufacturing facility and a net rental obligation of $3.6 million.  While we will seek to sublease or otherwise reduce the net rental obligation of this facility, there can be no assurance that we will be successful in doing so and we will remain contractually liable for the rental obligations under this lease.

Unless we raise substantial additional capital or generate substantial revenue from a licensing transaction or strategic partnership involving one of our product candidates, and there can be no assurance that we will be able to do so, we may not be able to:
 
·  
service or repay our debt when it becomes due, in which case our lenders could seek to accelerate payment of all unpaid principal and foreclose on our assets;
 
·  
meet our other contractual obligations, which includes the requirement for us to collateralize the $1.2 million letter of credit satisfying our restoration deposit obligation to our landlord; or
 
·  
continue to execute our current business and product development plans.
 
Any such event would raise substantial doubt about our ability to continue as a going concern and have a material adverse effect on our business, operating results and financial condition.
 
 
 
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We have a history of net losses and may not achieve or sustain profitability.  
 
Our recurring losses from operations and our need for significant additional capital to fund anticipated future losses from operations and debt repayment raise substantial doubt about our ability to continue as a going concern, and as a result, our independent registered public accounting firm included an explanatory paragraph in its report on our financial statements as of and for the year ended December 31, 2011 related to this uncertainty.  We have incurred losses in each year since our inception and expect to experience losses for the foreseeable future.  As of December 31, 2011, we had an accumulated deficit of $230.2 million.  We had net losses of $29.8 million, $25.6 million, and $19.1 million in the years ended December 31, 2009, 2010, and 2011, respectively.  These losses resulted principally from costs incurred in our clinical trials, research and development programs, construction of our research laboratories and commercial manufacturing facility, and from our general and administrative expenses.  These losses, among other things, have had and will continue to have an adverse effect on our stockholders’ equity, total assets and working capital.
 
We expect to continue to incur significant operating expenses and anticipate that our expenses and losses will increase in the foreseeable future as we seek to further develop our product candidates, technology and manufacturing capabilities.  Our expenses are expected to relate to the following:
 
·  
continuing research and development efforts, including relating to our Neo-Kidney Augment;
 
·  
conducting our Phase I clinical trial for our Neo-Urinary Conduit for patients with bladder cancer who require removal of their bladder;
 
·  
maintaining, expanding, protecting and enforcing our intellectual property portfolio and assets and potentially challenging the intellectual property of others;
 
·  
expanding our manufacturing capabilities to support commercialization of our current and future product candidates; and
 
·  
servicing and repaying indebtedness.
 
The extent of our future operating losses is highly uncertain, and we may never achieve or sustain profitability.  If we are unable to achieve and then maintain profitability, the market value of our common stock will decline.
 
If we do not successfully develop our product candidates and obtain the necessary marketing approvals to commercialize them, we will not generate sufficient revenues to continue our business operations.  
 
In order to obtain marketing approval of our product candidates so that we can generate revenues once they are commercialized, we must conduct extensive preclinical studies and clinical trials to demonstrate that our product candidates are safe and effective and obtain and maintain approval of our manufacturing facilities.  Our early stage product candidates, including our Neo-Urinary Conduit, for which we have commenced a Phase I clinical trial, may fail to perform as we expect.  Moreover, our Neo-Urinary Conduit and our other product candidates may ultimately fail to demonstrate the necessary safety and efficacy for marketing approval.  Even if results from preclinical studies and early phase clinical trials are positive, there can be no assurances that later stage studies or trials will be successful.  We will need to conduct additional research and development, and devote significant additional financial resources and personnel to develop commercially viable products and obtain the necessary marketing approvals, and if we fail to do so successfully, we may cease operations altogether.
 
Our short operating history may make it difficult for you to evaluate the success of our business to date and to assess our future viability.  
 
We are a development-stage company.  We commenced operations in July 2003.  Our operations to date have been limited to organizing and staffing our company, acquiring and developing our technology, and undertaking preclinical studies and clinical trials of our product candidates.  We have not demonstrated an ability to successfully complete large-scale clinical trials, obtain marketing approvals for product registration, manufacture a commercial-scale product or arrange for a third party to do so on our behalf, or conduct sales and marketing activities necessary for successful product commercialization.  As a result, we have a limited operating history.
 
 
 
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Even if we are successful in obtaining marketing approval for any of our product candidates, we will need to transition from a company with a research focus to a company capable of supporting commercial activities.  We may not be successful in such a transition.
 
Risks Related to the Development of Our Product Candidates
 
Our clinical trials may not be successful.  
 
We will only obtain marketing approval to commercialize a product candidate if we can demonstrate to the satisfaction of the FDA or the applicable non-United States regulatory authority, in clinical trials, that the product candidate is safe and effective, and otherwise meets the appropriate standards required for approval for a particular indication.  Clinical trials are lengthy, complex and extremely expensive processes with uncertain results.  A failure of one or more of our clinical trials may occur at any stage of testing.
 
We are currently conducting a Phase I open-label, single-arm study of our Neo-Urinary Conduit in patients who are undergoing bladder removal due to bladder cancer.  We have designed this trial to assess the safety and preliminary efficacy of the Neo-Urinary Conduit.  This trial is also intended to allow our clinical investigators to optimize and, as necessary, modify the surgical implantation technique and post-operative care based on the experience gained by prior patients enrolled.  As we have limited experience with this product candidate in humans, we may have difficulty optimizing the surgical implantation of the Neo-Urinary Conduit.  Four patients have been enrolled and implanted in this clinical trial.  Based upon the experience of the first three patients, clinical investigators have made surgical modifications in an effort to address stoma patency, conduit integrity and vascular supply.  We enrolled our fourth patient in this trial in the first quarter of 2012.  Assuming appropriate safety data, we anticipate that we will complete implantation of up to ten patients by the end of 2012.  There can be no assurance that, as part of our Phase I clinical trial, patients will not experience additional complications and/or serious adverse events related to our Neo-Urinary Conduit or experience serious adverse events that, although not related to our product candidate, could have a materially detrimental impact on our clinical trial.  Additionally, we may determine, based upon this trial, that our Neo-Urinary Conduit demonstrates limited safety and/or efficacy.
 
In April 2011, we terminated two Phase II clinical trials for our Neo-Bladder Augment, involving ten pediatric and six adult patients and subsequently withdrew the IND.  During these trials we have seen certain serious adverse events and limited efficacy data beyond the one-year primary endpoint.  As a result of these serious adverse events, the FDA placed our IND related to these clinical trials on hold.  We submitted a complete response in June 2009 and the FDA released the clinical hold in July 2009 with no recommended changes to our protocol, product candidate or implantation procedure.  In addition to these serious adverse events, we have seen limited efficacy of our Neo-Bladder Augment in patients.  As of the 36-month clinical follow-up of our pediatric patients, three of the ten patients continue to demonstrate sustained clinical benefit from our product candidate.  With respect to adult patients, as of the 24-month clinical follow-up, three of the six patients continue to demonstrate sustained clinical benefit from our product candidate.
 
We may find it difficult to enroll patients in our clinical trials.  
 
Our initial product candidates are designed to treat diseases that affect relatively few patients.  This could make it difficult for us to enroll the number of patients that may be required for the clinical trials we would be required to conduct in order to obtain marketing approval for our product candidates.
 
In addition, we may have difficulty finding eligible patients to participate in our clinical trials because our trials may include stringent enrollment criteria.  For example, a patient may require a concomitant surgical procedure that would prevent them from being enrolled in a clinical trial, may be using alternative therapies, or the extent of a patient’s overall medical condition may render such patient ineligible to participate in our trials.  Our Neo-Urinary Conduit has limited experience in humans and patients may not want to enroll in a trial where they are among the first group of patients to receive this product candidate.  Additionally, as we have been developing the surgical procedure in the first group of patients, each of the first three patients receiving our Neo-Urinary Conduit have experienced complications and serious adverse events which could have the effect of discouraging others from enrolling in this trial.  Our inability to enroll a sufficient number of patients for any of our current or future clinical trials would result in significant delays and could require us to abandon one or more clinical trials altogether.
 
 
 
 
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Our product development programs are based on novel technologies and are inherently risky.  
 
We are subject to the risks of failure inherent in the development of products based on new technologies.  The novel nature of our Organ Regeneration Platform creates significant challenges with respect to product development and optimization, manufacturing, government regulation and approval, third-party reimbursement and market acceptance.  For example, the FDA has relatively limited experience with the development and regulation of autologous neo-organs and, therefore, the pathway to marketing approval for our product candidates may accordingly be more complex, lengthy and uncertain than for a more conventional new drug candidate.  The FDA may not approve our product candidates or may approve them with certain restrictions that may limit our ability to market our product candidates, and our product candidates may not be successfully commercialized, if at all.
 
We have limited experience in conducting and managing the preclinical development activities and clinical trials necessary to obtain marketing approvals necessary for marketing our product candidates, including approval by the FDA.  
 
Our efforts to develop all of our product candidates are at an early stage.  We may be unable to progress our product candidates that are undergoing preclinical testing into clinical trials.  Success in preclinical testing and early clinical trials does not ensure that later clinical trials will be successful, and favorable initial results from a clinical trial do not necessarily predict outcomes in subsequent clinical trials.  The indications of use for which we are pursuing development may have clinical effectiveness endpoints that have not previously been reviewed or validated by the FDA, which may complicate or delay our effort to ultimately obtain FDA approval.  We cannot guarantee that our clinical trials will ultimately be successful.
 
We have not obtained marketing approval or commercialized any of our product candidates.  We may not successfully design or implement clinical trials required for marketing approval to market our product candidates.  We might not be able to demonstrate that our product candidates meet the appropriate standards for marketing approval, particularly as our technology may be the first of its kind to be reviewed by the FDA.  If we are not successful in conducting and managing our preclinical development activities or clinical trials or obtaining marketing approvals, we might not be able to commercialize our product candidates, or might be significantly delayed in doing so, which will materially harm our business.
 
If we are not able to retain qualified management and scientific personnel, we may fail to develop our technologies and product candidates.  
 
Our future success depends to a significant extent on the skills, experience and efforts of the principal members of our scientific and management personnel.  These members include John L. Miclot, our President and Chief Executive Officer, and Timothy Bertram, D.V.M., Ph.D., our President, Research and Development and Chief Scientific Officer.  The loss of either or both of these individuals could harm our business and might significantly delay or prevent the achievement of research, development or business objectives.  Competition for personnel is intense and our financial position may make it difficult to retain or attract management and scientific qualified personnel.  We may be unable to retain our current personnel or attract or integrate other qualified management and scientific personnel in the future.
 
We rely on third parties to conduct certain preclinical development activities and our clinical trials, and those third parties may not perform satisfactorily.  
 
We do not conduct in our facilities certain preclinical development activities of our product candidates, such as preclinical studies in animals, nor do we conduct clinical trials for our product candidates ourselves.  We rely on, or work in conjunction with, third parties, such as contract research organizations, medical institutions and clinical investigators, to perform these functions.  Our reliance on these third parties for preclinical and clinical development studies reduces our control over these activities.  We are responsible for ensuring that each of our preclinical development activities and our clinical trials is conducted in accordance with the applicable U.S. federal and state laws and foreign regulations, general investigational plans and protocols.  However, other than our contracts with these third parties, we have no direct control over these researchers or contractors, as they are not our employees.  Moreover, the FDA requires us to comply with standards, commonly referred to as Good Clinical Practices, or GCP, for conducting, recording and reporting the results of our clinical trials to assure that data and reported results are credible and accurate and that the rights, safety and confidentiality of trial participants are protected.  Our reliance on third parties that we do not control does not relieve us of these responsibilities and requirements.  Furthermore, these third parties also may have relationships with other entities, some of which may be our competitors.  If these third parties do not successfully carry out their contractual duties, meet expected deadlines or conduct our preclinical development activities or our clinical trials in accordance with regulatory requirements or our stated protocols, we will not be able to obtain, or may be delayed in obtaining, marketing approvals for our product candidates and will not be able to, or may be delayed in our efforts to, successfully commercialize our product candidates.  These third parties may be warned, suspended or otherwise sanctioned by the FDA or other government or regulatory authorities for failing to meet the applicable requirements imposed on such third parties.  As a result, the third parties may not be able to fulfill their contractual obligations, and the results obtained from the preclinical and clinical research using their services may not be accepted by the FDA to support the marketing approval of our product candidates.  If the third parties or their employees become debarred by the FDA, we cannot use the research data derived from their services to support the marketing approval of our product candidates.  Finally, these third parties may be bought by other entities, change their business plans or strategies or they may go out of business, thereby preventing them from meeting their contractual obligations to us.
 
 
 
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We may not be able to secure and maintain relationships with research institutions and clinical investigators that are capable of conducting and have access to necessary patient populations for the conduct our clinical trials.  
 
We rely on research institutions and clinical investigators to conduct our clinical trials.  Our reliance upon research institutions, including hospitals and clinics, provides us with less control over the timing and cost of clinical trials and the ability to recruit subjects.  If we are unable to reach agreement with suitable research institutions and clinical investigators on acceptable terms, or if any resulting agreement is terminated because, for example, the research institution and/or clinical investigators lose their licenses or permits necessary to conduct our clinical trials, we may be unable to quickly replace the research institution and/or clinical investigator with another qualified research institution and/or clinical investigator on acceptable terms.  We may not be able to secure and maintain agreement with suitable research institutions to conduct our clinical trials.
 
Compliance with governmental regulations regarding the treatment of animals used in research could increase our operating costs, which would adversely affect the commercialization of our technology.  
 
The Animal Welfare Act, or AWA, is the federal law that covers the treatment of certain animals used in research.  Currently, the AWA imposes a wide variety of specific regulations that govern the humane handling, care, treatment and transportation of certain animals by producers and users of research animals, most notably relating to personnel, facilities, sanitation, cage size, feeding, watering and shipping conditions.  Third parties with whom we contract are subject to registration, inspections and reporting requirements.  Furthermore, some states have their own regulations, including general anti-cruelty legislation, which establish certain standards in handling animals.  If we or any of our contractors fail to comply with regulations concerning the treatment of animals used in research, we may be subject to fines and penalties and adverse publicity, and our operations could be adversely affected.
 
Public perception of ethical and social issues may limit or discourage the type of research we conduct.  
 
Our clinical trials involve people, and we and third parties with whom we contract also do research involving animals.  Governmental authorities could, for public health or other purposes, limit the use of human or animal research or prohibit the practice of our technology.  Public attitudes may be influenced by claims that our technology or that regenerative medicine generally is unsafe for use in research or is unethical and akin to cloning.  In addition, animal rights activists could protest or make threats against our facilities, which may result in property damage and subsequently delay our research.  Ethical and other concerns about our methods, particularly our use of human subjects in clinical trials or the use of animal testing, could adversely affect our market acceptance.
 
 
 
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Risks Related to the Manufacturing of Our Product Candidates
 
We have only limited experience manufacturing our product candidates.  We may not be able to manufacture our product candidates in quantities sufficient for our clinical trials and/or any commercial launch of our product candidates.  
 
We may encounter difficulties in the production of our product candidates.  Construction of neo-organs from autologous live human cells involves strict adherence to complex manufacturing and storage protocols and procedures.  Early stage clinical manufacturing is conducted in our pilot facility and, while we have supported clinical manufacturing from this location, future difficulties may arise which limit our production capability and delay progress in our clinical trials.  Currently, we also occupy a commercial-scale manufacturing facility.  As a result of our November 2011 business decision to restructure our corporate operations, we have decided to consolidate our operations in our Winston-Salem research and development facility and to seek to exit our commercial-scale manufacturing facility.  As a result of this decision, as our product candidates advance into later-stage clinical trials toward commercialization, we will need to either develop our own internal manufacturing capability or contract with a third-party manufacturer to conduct this manufacturing on our behalf.  Obtaining our own commercial scale manufacturing capacity will be costly and time consuming.  Additionally, we may have difficulty finding suitable third parties with the manufacturing expertise that we need.  These occurrences could increase our costs or cause delays in the production of our product candidates necessary for any Phase III clinical trial and/or any anticipated commercial launch of our product candidates, any of which could damage our reputation and harm our business.
 
The current manufacture of our product candidates involves the use of regulated animal tissues, and future product candidates may also use animal-sourced materials.  
 
We currently utilize several bovine-derived products, such as growth media, in the manufacture of our Neo-Urinary Conduit.  Bovine-sourced materials are strictly regulated in the United States and other jurisdictions due to their capacity to transmit the prior disease Bovine Spongiform Encephalopathy, or BSE, which manifests itself in humans as Creutzfeldt-Jakob Disease.  Although we obtain our supply of bovine-based materials from closed herds in jurisdictions that are not currently known to carry BSE, there can be no assurance that these herds will remain BSE-free or that a future outbreak or presence of other unintended and potentially hazardous agents would not adversely affect our product candidates or patients that may receive them.  Further, our future product candidates may involve the use of bovine-sourced or other animal-based materials, which could increase the risk of transmission of other diseases carried by such animals.
 
If a natural or man-made disaster strikes our manufacturing facility, we would be unable to manufacture our product candidates for a substantial amount of time, which would harm our business.  
 
Our manufacturing facility and manufacturing equipment would be difficult to replace and could require substantial replacement lead-time and additional funds if we lost use of either the facility or equipment.  Our facility may be affected by natural disasters, such as floods.  We do not currently have back-up capacity, so in the event our facility or equipment was affected by man-made or natural disasters, we would be unable to manufacture any of our product candidates until such time as our facility could be repaired or rebuilt.  Although, currently we maintain global property insurance with property limits of $27.1 million and business interruption insurance coverage of $5.4 million for damage to our property and the disruption of our business from fire and other casualties, such insurance may not be sufficient to cover all of our potential losses and may not continue to be available to us on acceptable terms, or at all.
 
Our business involves the use of hazardous materials that could expose us to environmental and other liability.  
 
Our research and development processes and our operations involve the controlled storage, use and disposal of hazardous materials including, but not limited to, biological hazardous materials.  We are subject to federal, state and local regulations governing the use, manufacture, storage, handling and disposal of these materials and waste products.  Although we believe that our safety procedures for handling and disposing of these hazardous materials comply with the standards prescribed by law and regulation, the risk of accidental contamination or injury from hazardous materials cannot be completely eliminated.  In the event of an accident, we could be held liable for any damages that result, and any liability could exceed the limits or fall outside the coverage of our insurance.  Moreover, we may not be able to maintain insurance to cover these risks on acceptable terms, or at all.  We could also be required to incur significant costs to comply with current or future laws and regulations relating to hazardous materials.  We currently maintain insurance coverage that is consistent with similar companies in our stage of development.  In addition to global property insurance, we maintain general liability insurance coverage of $2.0 million with an excess liability insurance of $4.0 million, and workers’ compensation coverage of $0.5 million per incident.  Such insurance may not be sufficient to cover all of our potential losses and may not continue to be available to us on acceptable terms, or at all.
 
 
 
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Risks Related to Marketing Approval and Other Government Regulations
 
We cannot market and sell our product candidates in the United States or in other countries if we fail to obtain the necessary marketing approvals or licensure.  
 
We cannot sell our product candidates until regulatory agencies grant marketing approval, or licensure.  The process of obtaining such marketing approval is lengthy, expensive and uncertain.  It is likely to take many years to obtain the required marketing approvals for our product candidates or we may never gain the necessary approvals.  Any difficulties that we encounter in obtaining marketing approval may have a substantial adverse impact on our operations and cause our stock price to decline significantly.  Any adverse events in our clinical trials for one of our product candidates could negatively impact the clinical trials and approval process for our other product candidates.
 
To obtain marketing approvals in the United States for our product candidates, we must, among other requirements, complete carefully controlled and well-designed clinical trials sufficient to demonstrate to the FDA that the product candidate is safe and effective for each indication for which we seek approval.  Several factors could prevent completion or cause significant delay of these trials, including an inability to enroll the required number of patients or failure to obtain FDA approval to commence a clinical trial.  Negative or inconclusive results from, or adverse events during, a preclinical safety study or clinical trial could cause the preclinical study or clinical trial to be repeated or a program to be terminated, even if other studies or trials relating to the program are successful.  The FDA can place a clinical trial on hold if, among other reasons, it finds that patients enrolled in the trial are or would be exposed to an unreasonable and significant risk of illness or injury.  If safety concerns develop, we, an Institutional Review Board, or IRB, or the FDA could stop our trials before completion.  The populations for which we are developing our product candidates may have other medical complications that would affect their experience in our trials and would affect their experience with our product candidates, if approved.  A serious adverse event is an event that results in significant medical consequences, such as hospitalization or prolonged hospitalization, disability or death, and if unexpected must be reported to the FDA.  We cannot guarantee that other safety concerns regarding our product candidates will not develop.  For example, in February 2009, the FDA placed our IND for our Neo-Bladder Augment on clinical hold following certain serious adverse events that occurred with respect to patients in our Phase II clinical trials.  We submitted a complete response in June 2009 and the FDA released the clinical hold in July 2009, with no recommended changes to our protocol, product candidate or implantation procedure.
 
The pathway to marketing approval for our product candidates may be more complex and lengthy than for approval of a conventional new drug or biologic.  Similarly, to obtain approval to market our product candidates outside of the United States, we will need to submit clinical data concerning our product candidates and receive marketing approval from governmental agencies, which in certain countries includes approval of the price we intend to charge for our product.  We may encounter delays or rejections if changes occur in regulatory agency policies, or if reports from preclinical and clinical testing on similar technology or products raise safety and/or efficacy concerns, during the period in which we develop a product candidate or during the period required for review of any application for marketing approval.  If we are not able to obtain marketing approvals for use of our product candidates under development, we will not be able to commercialize such products and, therefore, may not be able to generate sufficient revenues to support our business.
 
 
 
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The FDA may impose requirements on our clinical trials that are difficult to comply with, which could harm our business.  
 
The requirements the FDA may impose on clinical trials for our product candidates are uncertain.  As a result, we cannot guarantee that we will be able to comply with such requirements.  For example, the FDA may require endpoints in our late-stage clinical trials that are different from or in addition to the endpoints in our early-stage clinical trials or the endpoints which we may propose.  The endpoints or other study elements, including sample size, the FDA requires may make it less likely that our Phase III clinical trials are successful or may delay completion of the trials.  If we are unable to comply with the FDA’s requirements, we will not be able to get approval for our product candidates and our business will suffer.
 
If we are not able to conduct our clinical trials properly and on schedule, marketing approval by the FDA and other regulatory authorities may be delayed or denied.  
 
Our clinical trials may be delayed or terminated for many reasons, including, but not limited to, if:
 
·  
the FDA does not grant permission to proceed or places the trial on clinical hold;
 
·  
subjects do not enroll or remain in our trials at the rate we expect;
 
·  
we fail to manufacture necessary amounts of product candidate;
 
·  
our pilot manufacturing facility is ordered by FDA or other government or regulatory authority to temporarily or permanently shut down due to violations of current Good Manufacturing Practice, or cGMP, or other applicable requirements, or infections or cross-contaminations of product candidates in the manufacturing process;
 
·  
subjects choose an alternative treatment for the indications for which we are developing our product candidates, or participate in competing clinical trials;
 
·  
subjects experience an unacceptable rate or severity of adverse side effects;
 
·  
reports from preclinical or clinical testing on similar technologies and products raise safety and/or efficacy concerns;
 
·  
third-party clinical investigators lose their license or permits necessary to perform our clinical trials, do not perform our clinical trials on our anticipated schedule or consistent with the clinical trial protocol, Good Clinical Practice and regulatory requirements, or other third parties do not perform data collection and analysis in a timely or accurate manner;
 
·  
inspections of clinical trial sites by the FDA or IRBs find regulatory violations that require us to undertake corrective action, suspend or terminate one or more sites, or prohibit us from using some or all of the data in support of our marketing applications;
 
·  
third-party contractors become debarred or suspended or otherwise penalized by FDA or other government or regulatory authorities for violations of regulatory requirements, in which case we may need to find a substitute contractor, and we may not be able to use some or any of the data produced by such contractors in support of our marketing applications; or
 
·  
one or more IRBs or our Data Safety Monitoring Board, or DSMB, refuses to approve, suspends or terminates the trial at an investigational site, precludes enrollment of additional subjects, or withdraws its approval of the trial.
 
If we are unable to conduct our clinical trials properly and on schedule, the FDA may delay or deny marketing approval.
 
 
 
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Final marketing approval of our product candidates by the FDA or other regulatory authorities for commercial use may be delayed, limited, or denied, any of which would adversely affect our ability to generate operating revenues.  
 
Any of the following factors, if one or more were to occur, could cause final marketing approval for our product candidates to be delayed, limited or denied:
 
·  
our product candidates could fail to demonstrate safety and efficacy in preclinical or clinical testing;
 
·  
the manufacturing processes for our product candidates could fail to consistently demonstrate their safety and purity;
 
·  
the FDA could disagree with the clinical endpoints we propose for our clinical trials and refuse to allow us to conduct clinical trials utilizing clinical endpoints we believe are appropriate;
 
·  
it could take many years to complete the testing of our product candidates, and failure can occur at any stage of the process;
 
·  
negative results or adverse side effects during a clinical trial could cause us to delay or terminate development efforts for a product candidate;
 
·  
the FDA could seek the advice of an Advisory Committee of physician and patient representatives that may view the risks of our product candidates as outweighing the benefits;
 
·  
the FDA could require us to expand the size and scope of the clinical trials; or
 
·  
the FDA could impose post-marketing restrictions.
 
Our development costs will increase if we have material delays in our clinical trials, or if we are required to modify, suspend, terminate or repeat a clinical trial.  If marketing approval for our product candidates is delayed, limited or denied, our ability to market products, and our ability to generate product sales, would be adversely affected.
 
Any product for which we obtain marketing approval could be subject to restrictions or withdrawal from the market and we may be subject to penalties if we fail to comply with regulatory requirements or if we experience unanticipated problems with our product candidates, when and if any of them are approved.  
 
Any product for which we obtain marketing approval, along with the manufacturing processes, post-approval clinical data, labeling, advertising and promotional activities for such product, will be subject to continual requirements of and review by the FDA and comparable regulatory authorities, including through periodic inspections.  These requirements include, but are not limited to, submissions of safety and other post-marketing information and reports, registration requirements, cGMP and Quality System Regulation, or QSR, requirements relating to quality control, quality assurance and corresponding maintenance of records and documents.  Even if marketing approval of a product is granted, the approval may be subject to limitations on the indicated uses for which the product may be marketed or to other conditions of approval, or may contain requirements for costly and time consuming post-marketing testing and surveillance to monitor the safety or efficacy of the product.  Discovery after approval of previously unknown problems with our product candidates or manufacturing processes, or failure to comply with regulatory requirements, may result in actions such as:
 
·  
restrictions on such products’ manufacturers or manufacturing processes;
 
·  
restrictions on the marketing or distribution of a product, including refusals to permit the import or export of products;
 
·  
warning letters or untitled letters;
 
·  
warning labels on the products;
 
·  
withdrawal of the products from the market;
 
 
 
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·  
refusal to approve pending applications or supplements to approved applications that we submit;
 
·  
suspension of any ongoing clinical trials;
 
·  
recall of products;
 
·  
fines, restitution or disgorgement of profits or revenue;
 
·  
suspension or withdrawal of marketing approvals;
 
·  
product seizure;
 
·  
injunctions; or
 
·  
imposition of civil or criminal penalties.
 
In addition, if any of our product candidates are approved, our product labeling, advertising and promotion would be subject to regulatory requirements and continuing regulatory review.  The FDA strictly regulates the promotional claims that may be made about prescription products.  In particular, a product may not be promoted for uses that are not approved by the FDA as reflected in the product’s approved labeling.  The FDA and other agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses, and a company that is found to have improperly promoted off-label uses may be subject to significant sanctions.
 
Current or future legislation may make it more difficult and costly for us to obtain marketing approval of our product candidates.  
 
In 2007, the Food and Drug Administration Amendments Act of 2007, or the FDAAA, became law.  This legislation grants significant new powers to the FDA, many of which are aimed at assuring the safety of drugs and biologics after approval.  For example, FDAAA granted the FDA new authority to impose post-approval clinical study requirements, require safety-related changes to product labeling and require the adoption of risk management plans, referred to as risk evaluation and mitigation strategies, or REMS.  The REMS may include requirements for special labeling or medication guides for patients, special communication plans to health care professionals, and restrictions on distribution and use.  Pursuant to FDAAA, if the FDA makes the requisite findings, it might require that a new product be used only by physicians with specified specialized training, only in specified designated health care settings, or only in conjunction with special patient testing and monitoring.  The legislation also included requirements for disclosing clinical study results to the public through a clinical study registry, and renewed requirements for conducting clinical studies to generate information on the use of products in pediatric patients.  Under the FDAAA, companies that violate the new law are subject to substantial civil monetary penalties.  The requirements and changes imposed by the FDAAA may make it more difficult, and more costly, to obtain and maintain approval of new biological products.
 
In addition, the FDA’s regulations, policies or guidance may change and new or additional statutes or government regulations may be enacted that could prevent or delay marketing approval of our product candidates or further restrict or regulate post-approval activities.  For example, proposals have been made to further expand post-approval requirements and restrict sales and promotional activities.  It is impossible to predict whether additional legislative changes will be enacted, or whether the FDA regulations, guidance or interpretations will be changed, or what the impact of such changes or the marketing approvals of our product candidates, if any, may be.
 
Risks Related to the Commercialization of Our Product Candidates
 
If we fail to educate and train physicians as to the distinctive characteristics, benefits, safety, clinical efficacy and cost-effectiveness of our product candidates, our sales will not grow.  
 
Acceptance of our product candidates depends, in large part, on our ability to train physicians in the proper implantation of our neo-organs, which will require significant expenditure of our resources.  Convincing physicians to dedicate the time and energy necessary to properly train to use new products and techniques is challenging, and we may not be successful in these efforts.  If physicians are not properly trained, they may ineffectively implant our product candidates.  Such misuse or ineffective implantation may result in unsatisfactory patient outcomes, patient injury, negative publicity or lawsuits against us.  Accordingly, even if our product candidates are superior to alternative treatments, our success will depend on our ability to gain and maintain market acceptance for our product candidates.  If we fail to do so, our sales will not grow and our business, financial condition and results of operations will be adversely affected.  We may not have adequate resources to effectively educate the medical community and/or our efforts may not be successful due to physician resistance or perceptions regarding our product candidates.
 
 
 
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We face uncertainty related to pricing, reimbursement and health care reform, which could reduce our revenue.  
 
Sales of our product candidates, if approved for commercialization, will depend in part on the availability of coverage and reimbursement from third-party payors such as government insurance programs, including Medicare and Medicaid, private health insurers, health maintenance organizations and other health care related organizations.  If our product candidates are approved for commercialization, pricing and reimbursement may be uncertain.  Both the federal and state governments in the United States and foreign governments continue to propose and pass new legislation affecting coverage and reimbursement policies, which are designed to contain or reduce the cost of health care.  Further federal and state proposals and health care reforms are likely which could limit the prices that can be charged for the product candidates that we develop and may further limit our commercial opportunity.  There may be future changes that result in reductions in current coverage and reimbursement levels for our products, if commercialized, and we cannot predict the scope of any future changes or the impact that those changes would have on our operations.
 
Adoption of our product candidates by the medical community may be limited if doctors and hospitals do not receive full reimbursement for our products, if commercialized.  Cost control initiatives may decrease coverage and payment levels for our product candidates and, in turn, the price that we will be able to charge for any product.  We are impacted by efforts by public and private third-party payors to control costs.  We are unable to predict all changes to the coverage or reimbursement methodologies that will be applied by private or government payors to our product candidates.  Any denial of private or government payor coverage or inadequate reimbursement for procedures performed using our products, if commercialized, could harm our business and reduce our revenue.
 
We could be adversely affected if healthcare reform measures substantially change the market for medical care or healthcare coverage in the United States.  
 
The U.S. Congress recently adopted legislation regarding health insurance, which has been signed into law.  As a result of this new legislation, substantial changes could be made to the current system for paying for healthcare in the United States, including changes made in order to extend medical benefits to those who currently lack insurance coverage.  Extending coverage to a large population could substantially change the structure of the health insurance system and the methodology for reimbursing medical services, drugs and devices.  These structural changes could entail modifications to the existing system of private payors and government programs, such as Medicare, Medicaid and State Children’s Health Insurance Program, creation of a government-sponsored healthcare insurance source, or some combination of both, as well as other changes.  Restructuring the coverage of medical care in the United States could impact the reimbursement for prescribed drugs, biopharmaceuticals, medical devices, or our product candidates.  If reimbursement for our approved product candidates, if any, is substantially less that we expect in the future, or rebate obligations associated with them are substantially increased, our business could be materially and adversely impacted.
 
Extending medical benefits to those who currently lack coverage will likely result in substantial cost to the U.S. federal government, which may force significant changes to the healthcare system in the United States.  Much of the funding for expanded healthcare coverage may be sought through cost savings.  While some of these savings may come from realizing greater efficiencies in delivering care, improving the effectiveness of preventive care and enhancing the overall quality of care, much of the cost savings may come from reducing the cost of care.  Cost of care could be reduced by decreasing the level of reimbursement for medical services or products, or by restricting coverage and, thereby, utilization of medical services or products.  In either case, a reduction in the utilization of, or reimbursement for, any product for which we receive marketing approval in the future could have a materially adverse impact on our financial performance.
 
 
 
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There is substantial uncertainty regarding the exact meaning and interpretation of the provisions of healthcare reform that have been enacted.  This uncertainty limits our ability to forecast changes that may occur in the future and to manage our business accordingly.
 
We may face competition from companies and institutions that may develop products that make ours less attractive or obsolete through both new technologies that may be similar to ours, or more traditional pharmaceutical or medical device treatments.  
 
Many of our competitors have greater resources or capabilities than we have, or may already have or succeed in developing better products or in developing products more quickly than we do, and we may not compete successfully with them.
 
The medical device, pharmaceutical and biotechnology industries are highly competitive.  We compete for funding.  If our product candidates become available for commercial sale, we will compete in the marketplace.  For funding, we compete primarily with other companies which, like us, are focused on discovering and developing novel products or therapies for the treatment of human disease based on regenerative medicine technologies or other novel scientific principles.  In the marketplace, we may eventually compete with other companies and organizations that are marketing or developing therapies for our targeted disease indications, based on traditional pharmaceutical, medical device or other, non-cellular therapies and technologies.
 
We also face competition in the cell therapy field from academic institutions and governmental agencies.  Many of our current and potential competitors have greater financial and human resources than we have, including more experience in research and development and more established sales, marketing and distribution capabilities.
 
We anticipate that competition in our industry will increase.  In addition, the health care industry is characterized by rapid technological change, resulting in new product introductions and other technological advancements.  Our competitors may develop and market products that render our current product or any future product non-competitive or otherwise obsolete.
 
The use of our product candidates in human subjects may expose us to product liability claims, and we may not be able to obtain adequate insurance.  
 
We face an inherent risk of product liability claims.  Our clinical-stage product candidates are in early development and have not been used over an extended period of time in a large number of patients and, therefore, our long-term safety and efficacy data are limited.  Patients have experienced in the past and may experience in the future serious adverse events.  Our current product liability coverage is $5.0 million per occurrence and in the aggregate.  We will need to increase our insurance coverage if and when we begin commercializing any of our product candidates.  We may not be able to obtain or maintain product liability insurance on acceptable terms with adequate coverage.  If claims against us substantially exceed our coverage, then our business could be adversely impacted.  Regardless of whether we are ultimately successful in any product liability litigation, such litigation could consume substantial amounts of our financial and managerial resources and could result in, among others:
 
·  
significant awards against us;
 
·  
substantial litigation costs;
 
·  
injury to our reputation and the reputation of our product candidates; and
 
·  
withdrawal of clinical trial participants; and adverse regulatory action.
 
Any of these results would substantially harm our business.
 
 
 
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We have never marketed a product before, and if we are unable to establish an effective focused sales force and marketing infrastructure, we will not be able to commercialize our product candidates successfully.  
 
We intend to explore building the necessary marketing and sales infrastructure to market and sell our current product candidates, if they receive marketing approval.  We currently do not have internal sales, distribution and marketing capabilities.  The development of a sales and marketing infrastructure for our domestic operations will require substantial resources, will be expensive and time consuming and could negatively impact our commercialization efforts, including delay of any product launch.  These costs may be incurred in advance of any approval of our product candidates.  In addition, we may not be able to hire a focused sales force in the United States that is sufficient in size or has adequate expertise in the medical markets that we intend to target, including surgery.  If we are unable to establish our focused sales force and marketing capability for our product candidates, we may not be able to generate any product revenue, may generate increased expenses and may never become profitable.
 
If we are unable to establish development or marketing collaborations with third parties, we may not be able to develop, commercialize or distribute our products successfully.  
 
We may need to establish development or marketing collaborations with third parties in order to complete development of our product candidates or for the commercialization or distribution of our product candidates.  We expect to face competition in our efforts to identify appropriate collaborators or partners to help develop or commercialize our product candidates in our target commercial areas.  If we are unable to establish adequate collaborations, our ability to develop or market our product candidates could be adversely affected.  Further, to the extent third parties with whom we collaborate fail to perform, our ability to achieve our development or marketing goals may be adversely affected, and our business could suffer.
 
Risks Related to Intellectual Property
 
If we are unable to obtain and maintain protection for our intellectual property, the value of our technology and products will be adversely affected.  
 
Our success will depend in large part on our ability to obtain and maintain protection in the United States and other countries for the intellectual property covering or incorporated into our technology and products.  The patent situation in the field of biotechnology and pharmaceuticals generally is highly uncertain and involves complex legal, technical, scientific and factual questions.  We may not be able to obtain additional issued patents relating to our technology or products.  Even if issued, patents issued to us or our licensors may be challenged, narrowed, invalidated, held to be unenforceable or circumvented, or determined not to cover our product candidates or our competitors’ products, which could limit our ability to stop competitors from marketing identical or similar products or reduce the term of patent protection we may have for our product candidates.  Changes in either patent laws or in interpretations of patent laws in the United States and other countries may diminish the value of our intellectual property or narrow the scope of our patent protection.  The degree of future protection for our proprietary rights is uncertain, and we cannot ensure that:
 
·  
we or our licensors were the first to make the inventions covered by each of our pending patent applications;
 
·  
we or our licensors were the first to file patent applications for these inventions;
 
·  
others will not independently develop similar or alternative technologies or duplicate any of our technologies;
 
·  
any patents issued to us or our licensors will provide a basis for commercially viable products, will provide us with any competitive advantages or will not be successfully challenged by third parties;
 
·  
we will continue developing additional proprietary technologies that are patentable;
 
·  
we will file patent applications for new proprietary technologies promptly or at all;
 
·  
our patents will not expire prior to or shortly after commencing commercialization of a product;
 
 
 
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·  
our licensors will enforce the rights of the patents we license; or
 
·  
the patents of others will not have a negative effect on our ability to do business.
 
In addition, we cannot guarantee that any of our pending patent applications will result in issued patents.  If patents are not issued in respect of our pending patent applications, we may not be able to stop competitors from marketing products similar to ours.
 
Our patents also may not afford us protection against competitors with identical or similar technology.  
 
Because patent applications in the United States and many other jurisdictions are typically not published until 18 months after filing, or in some cases not at all, and because publications of discoveries in the scientific literature often lag behind the actual discoveries, neither we nor our licensors can be certain that we or they were the first to make the inventions claimed in our or their issued patents or pending patent applications, or that we or they were the first to file for protection of the inventions set forth in these patent applications.  If a third party has also filed a United States patent application covering our product candidates or a similar invention, we may have to participate in an adversarial proceeding, known as an interference, declared by the United States Patent and Trademark Office to determine priority of invention in the United States.  The costs of these proceedings could be substantial and it is possible that our efforts could be unsuccessful, resulting in a loss of our United States patent position.  If a third party believes we or our licensor were not entitled to the grant of one or more patents, such third party may challenge such patents in an interference or re-examination proceeding in the United States, or opposition or similar proceeding in another country.
 
If we fail to comply with our obligations in our intellectual property licenses with third parties, we could lose license rights that are important to our business.  
 
We are a party to license agreements with Children’s Hospital Boston and Wake Forest University Health Sciences pursuant to which we license certain intellectual property relating to our product candidates.  We may enter into additional licenses in the future.  Our existing licenses impose, and we expect that future licenses will impose, various diligence, milestone payment, royalty, insurance and other obligations on us.  If we fail to comply with these obligations, the licensor may have the right to terminate the license, in which event we might not be able to market any product that is covered by the licensed patents.
 
If we are unable to protect the confidentiality of our proprietary information, trade secrets and know-how, the value of our technology and product candidates could be adversely affected.  
 
Our proprietary information, trade secrets and know-how are important components of our intellectual property, particularly in connection with the manufacturing of our product candidates.  We seek to protect our proprietary information, trade secrets, know-how and confidential information, in part, by confidentiality agreements with our employees, corporate partners, outside scientific collaborators, sponsored researchers, consultants and other advisors.  We also have confidentiality and invention or patent assignment agreements with our employees and our consultants.  If our employees or consultants breach these agreements, we may not have adequate remedies for any of these breaches.  In addition, our proprietary information, trade secrets and know-how may otherwise become known to or be independently developed by others.  Enforcing a claim that a party illegally obtained and is using our proprietary information, trade secrets and know-how is difficult, expensive and time consuming, and the outcome is unpredictable.  In addition, courts outside the United States may be less willing to protect trade secrets.  Costly and time consuming litigation could be necessary to seek to enforce and determine the scope of our proprietary information, trade secrets and know-how, and failure to obtain or maintain protection of proprietary information, trade secret and know-how could adversely affect our competitive business position.
 
If we infringe or are alleged to infringe the intellectual property rights of third parties, our business could suffer.  
 
Our research, development and commercialization activities, as well as any product candidates or products resulting from these activities, may infringe or be accused of infringing one or more claims of an issued patent or may fall within the scope of one or more claims in a published patent application that may subsequently issue and to which we do not hold a license or other rights.  Third parties may own or control these patents or patent applications in the United States and abroad.  These third parties could bring claims against us that would cause us to incur substantial expenses and, if successful against us, could cause us to pay substantial damages.  Further, if a patent infringement suit were brought against us, we could be forced to stop or delay research, development, manufacturing or sales of the product or product candidate that is the subject of the suit.  No assurance can be given that patents do not exist, have not been filed, or could not be filed or issued, which contain claims covering our product candidates, technology or methods.
 
 
 
36
 
 
 
 
In order to avoid or settle potential claims with respect to any of the patent rights described above or any other patent rights of third parties, we may choose or be required to seek a license from a third party and be required to pay license fees or royalties or both.  These licenses may not be available on acceptable terms, or at all.  Even if we or our future collaborators were able to obtain a license, the rights may be non-exclusive, which could result in our competitors gaining access to the same intellectual property.  Ultimately, we could be prevented from commercializing one or more product candidates, or be forced to cease some aspect of our business operations, if, as a result of actual or threatened patent infringement claims, we are unable to enter into licenses on acceptable terms.  This could harm our business significantly.
 
Others may sue us for infringing their patent or other intellectual property rights or file nullity, opposition, re-examination or interference proceedings against our patents, even if such claims or proceedings are without merit, which would similarly harm our business.  Furthermore, during the course of litigation, confidential information may be disclosed in the form of documents or testimony in connection with discovery requests, depositions or trial testimony.  Disclosure of our confidential information and our involvement in intellectual property litigation could materially adversely affect our business.
 
There has been substantial litigation and other proceedings regarding patent and other intellectual property rights in the pharmaceutical and biotechnology industries.  In addition to infringement claims against us, we may become a party to other patent litigation and other proceedings, including interference proceedings declared by the United States Patent and Trademark Office and opposition proceedings in the European Patent Office, regarding intellectual property rights with respect to our product candidates and technology.  Even if we prevail, the cost to us of any patent litigation or other proceeding could be substantial.
 
Some of our competitors may be able to sustain the costs of complex patent litigation more effectively than we can because they have substantially greater resources.  In addition, any uncertainties resulting from any litigation could significantly limit our ability to continue our operations.  Patent litigation and other proceedings may also absorb significant management time.  Many of our employees were previously employed at universities or other biotechnology or pharmaceutical companies, including our competitors or potential competitors.  We try to ensure that our employees do not use the proprietary information, trade secrets or know-how of others in their work for us.  However, we may be subject to claims that we or these employees have inadvertently or otherwise used or disclosed intellectual property, trade secrets, know-how or other proprietary information of any such employee’s former employer.  Litigation may be necessary to defend against these claims and, even if we are successful in defending ourselves, could result in substantial costs to us or be distracting to our management.  If we fail to defend any such claims, in addition to paying monetary damages, we may jeopardize valuable intellectual property rights, disclose confidential information or lose personnel.
 
Risks Related to our Common Stock
 
The trading price of the shares of our common stock could be highly volatile, and purchasers of our common stock could incur substantial losses.
 
The trading price of our common stock has fluctuated significantly since our IPO and our stock price is likely to continue to be volatile.  The stock market in general and the market for biotechnology companies in particular have experienced extreme volatility that has often been unrelated to the operating performance of particular companies.  The market price for our common stock may be influenced by many factors, including:
 
·  
setbacks or difficulties associated with our clinical trials;
 
 
 
 
37
 
 
 
 
 
·  
our ability to enroll patients in our clinical trials;
 
·  
results of clinical trials of our product candidates or those of our competitors;
 
·  
regulatory developments in the United States and foreign countries;
 
·  
variations in our financial results or those of companies that are perceived to be similar to us;
 
·  
changes in the structure of healthcare payment systems, especially in light of current reforms to the U.S. healthcare system;
 
·  
announcements by us of significant acquisitions, strategic partnerships, joint ventures or capital commitments;
 
·  
market conditions in the pharmaceutical and biotechnology sectors and issuance of securities analysts’ reports or recommendations;
 
·  
sales of substantial amounts of our stock by existing stockholders;
 
·  
sales of our stock by insiders and 5% stockholders;
 
·  
general economic, industry and market conditions;
 
·  
additions or departures of key personnel;
 
·  
intellectual property, product liability or other litigation against us;
 
·  
expiration or termination of our relationships with our collaborators; and
 
·  
the other factors described in this “Risk Factors” section.
 
In addition, in the past, stockholders have initiated class action lawsuits against biotechnology and pharmaceutical companies following periods of volatility in the market prices of these companies’ stock.  Such litigation, if instituted against us, could cause us to incur substantial costs and divert management’s attention and resources, which could have a material adverse effect on our business, financial condition and results of operations.
 
The future sale of our common stock could negatively affect our stock price.
 
Sales of substantial amounts of our common stock in the public market, or the perception that these sales could occur, could cause the market price of our common stock to decline. These sales could also make it more difficult for us to sell equity or equity-related securities in the future at times or prices that we deem appropriate.  As of March 26, 2012, we had 24,252,519 shares of common stock outstanding and warrants to purchase 10,645,888 shares of common stock at a weighted average exercise price of $3.11 per share.  The currently outstanding shares can be freely sold in the public market and the warrant shares, upon issuance, may also be freely sold in the public market, subject, in each case, to certain restrictions imposed by federal securities laws on our affiliates.
 
We also currently have under our stock option and equity incentive plans 2,878,116 shares reserved for issuance related to equity awards granted to our officers, directors and employees and an additional 856,413 shares reserved for issuance, all of which, when issued, may be freely sold in the public market, subject to certain restrictions imposed by federal securities laws on our affiliates.
 
Concentration of ownership of our common stock among our existing executive officers and directors may prevent new investors from influencing significant corporate decisions.
 
As of March 26, 2012, our executive officers, directors and their affiliates own, in the aggregate, approximately 31.4% of the 24,252,519 shares of our outstanding common stock.  Funds affiliated with directors own warrants to purchase an aggregate of 4,328,625 shares of common stock upon exercising their warrants at an exercise price of $2.88 per share.  In addition, our executive officers and directors hold options to purchase 1,573,915 shares of common stock upon exercising their options at a weighted-average exercise price of $0.87 per share.  These persons, if acting together, would be able to significantly influence all matters requiring stockholder approval, including the election and removal of directors and any merger or other significant corporate transactions.  The interests of this group of stockholders may not coincide with our interests or the interests of other stockholders.
 
 
 
38
 
 
 
We will need to raise additional capital to fund our operations, which may cause dilution to our existing stockholders, restrict our operations or require us to relinquish rights.  
 
We may seek additional capital through a combination of private and public equity offerings, debt financings and collaboration, strategic and licensing arrangements.  To the extent that we raise additional capital through the sale of equity or convertible debt securities, your ownership interest may be diluted, and the terms may include liquidation or other preferences that adversely affect your rights as a stockholder.  In addition, the warrants we issued in connection with our March 2011 private placement transaction provide that the exercise price of such warrants would be adjusted downward in the event we subsequently issue stock at a price per share less than the current exercise price per share of the warrants.  Debt financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions such as incurring debt, making capital expenditures or declaring dividends.  If we raise additional funds through collaboration, strategic alliance and licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies or product candidates or grant licenses on terms that are not favorable to us.
 
Certain provisions of the warrants issued in connection with our March 2011 private placement provide for preferential treatment to the holders of the warrant and could impede a sale of the Company.
 
In March 2011, we closed a private placement transaction pursuant to which we sold securities consisting of 11,079,250 shares of common stock and warrants to purchase 10,460,875 shares of common stock.  The warrant agreement gives each holder the option to receive a cash payment based on a Black-Scholes valuation of the warrant upon a change in control of the Company or upon the Company’s failure to be listed on any of the New York Stock Exchange, the NYSE Alternext (formerly the American Stock Exchange), the NASDAQ Global Select Market, the NASDAQ Global Market, the NASDAQ Capital Market or any other national securities exchange, which failure to be listed is not the result of a transaction approved by the Company’s stockholders (a Delisting).  The warrant agreement, which specifies the method of calculating the Black-Scholes value, includes the requirement to calculate the Black-Scholes value using a minimum volatility of 100%.  Holders of the Company’s common stock, or holders of other warrants, do not have the right to receive a cash payment upon a Delisting.  Further, other current warrant holders do not have the right to receive a cash payment in every change in control transaction.  The cash payment could be greater than the consideration that the Company’s other equity holders would receive in a change in control transaction.  This provision of the warrant agreement could make a change in control transaction more expensive for a potential acquirer and could negatively impact the Company’s ability to pursue and consummate such a transaction.
 
If our common stock were to be delisted, holders of the warrants issued in connection with our March 2011 private placement could require the Company to settle the warrants by making a cash payment, which would have a material adverse effect on our liquidity and ability to fund our operations.
 
The warrant agreement issued in our private placement gives each holder the option to receive a cash payment based on a Black-Scholes valuation of the warrant upon a change-in-control or upon a delisting, other than a stockholder-approved delisting, from the NASDAQ Global Market, where our common stock is currently traded, or from any other national securities exchange on which our common stock may be traded at the time.
 
On October 4, 2011, we received a non-compliance letter from NASDAQ stating that we had failed to maintain the minimum bid price requirement for continued listing on the NASDAQ Global market and providing us a six month period to regain compliance.  If we are unable to maintain the requisite continued listing standards as required by either the NASDAQ Global Market or the NASDAQ Capital Market and we cannot meet the listing requirements of any other national securities exchange, our common stock could cease to be listed on a national securities exchange, which would have a material adverse impact on our stockholders’ ability to buy or sell our common stock and would severely limit our ability to raise additional capital.  Additionally, in the event of such a delisting, the holders of the warrants issued in connection with our March 2011 private placement could demand that we make a cash payment to them reflecting the Black-Scholes valuation of the warrant at the time of the delisting.  Assuming announcement of a delisting, the net cash settlement value as of December 31, 2011 would have been approximately $3.6 million.  Both a delisting and the resulting cash payment to the holders of our warrants issued in connection with our March 2011 private placement would have a material adverse effect on our business, financial condition and results of operations.
 
 
 
39
 
 
 
Certain provisions of Delaware law and of our charter documents contain provisions that could delay and discourage takeover attempts and any attempts to replace our current management by stockholders.
 
Certain provisions of our certificate of incorporation and bylaws, and applicable provisions of Delaware corporate law, may make it more difficult for or prevent a third party from acquiring control of us or changing our board of directors and management.  These provisions include:
 
·  
the ability of our board of directors to issue preferred stock with voting or other rights or preferences;
 
·  
the inability of stockholders to act by written consent;
 
·  
a classified board of directors with staggered three-year terms;
 
·  
requirement that special meetings of our stockholders may only be called upon a resolution adopted by an affirmative vote of a majority of our board of directors; and
 
·  
requirements that our stockholders comply with advance notice procedures in order to nominate candidates for election to our board of directors or to place stockholders’ proposals on the agenda for consideration at meetings of stockholders.
 
We are afforded the protections of Section 203 of the Delaware General Corporation Law, which prevents us from engaging in a business combination with a person who acquires at least 15% of our common stock for a period of three years from the date such person acquired such common stock, unless prior board or stockholder approval was obtained.
 
Any delay or prevention of a change of control transaction or changes in our board of directors or management could deter potential acquirers or prevent the completion of a transaction in which our stockholders could receive a substantial premium over the then-current market price for their shares.
 
We do not expect to pay cash dividends on our common stock in the foreseeable future.
 
We do not anticipate paying cash dividends on our common stock in the foreseeable future.  Any payment of cash dividends will depend upon our financial condition, results of operations, capital requirements and other factors and will be at the discretion of our board of directors.  Accordingly, you will have to rely on capital appreciation, if any, to earn a return on your investment in our common stock.  Currently, we are subject to contractual restrictions on the payment of dividends under certain of our debt instruments.  Furthermore, we may become subject to additional contractual restrictions or prohibitions on the payment of dividends.

Item 1B.Unresolved Staff Comments

We have received no written comments regarding our periodic or current reports from the staff of the Securities and Exchange Commission that were issued 180 days or more preceding the end of our 2011 fiscal year and that remain unresolved.

Item 2.  Properties

Our corporate headquarters are located in Winston-Salem, North Carolina, where we occupy approximately 38,400 square feet of office, laboratory and manufacturing space.  In May 2011, the Company exercised the first five-year renewal option under its lease.  The amended lease extends the lease term to October 2016 and provides for payments of average annual base rent of approximately $0.2 million which commenced in October 2011.

We also currently lease a facility of 80,000 square feet in East Norriton, Pennsylvania.  This lease expires in February 2016.  We are currently subleasing 35,000 square feet, which is primarily warehouse space.  As a result of the restructuring announced in November 2011 to centralize our operations in our Winston-Salem facility, we are seeking to sublease or otherwise reduce the net rental obligation of the remaining 45,000 square feet of office and manufacturing space.
 
 
 
40
 
 
 
We believe our current leased facilities are adequate for our needs for the immediate future and that, should it be needed, additional space can be leased to accommodate any future growth.
 
Item 3.  Legal Proceedings
 
None
 
 
Item 4.  Mine Safety Disclosures
 
Not applicable
 
 
 
 
41
 
 
PART II
 
 
Item 5.  Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities
 
Market Information
 
Our common stock has traded on the NASDAQ Global Market since April 9, 2010, under the symbol “TNGN”.  On March 22, 2012, we submitted an application to NASDAQ to have our listing of common stock transferred to the NASDAQ Capital Market.  The following table sets forth, for the periods indicated, the high and low sales prices of our common stock on the NASDAQ Global Market.  These prices represent prices between dealers and do not include retail mark-ups, markdowns, or commissions and may not necessarily represent actual transactions.
 
 
High
Low
Year Ended December 31, 2011
    
First Quarter
$6.24
$2.36
Second Quarter
$2.82
$1.04
Third Quarter
$1.60
$0.53
Fourth Quarter
$0.63
$0.33
 
Year Ended December 31, 2010
    
First Quarter
—
—
Second Quarter (beginning April 9, 2010)
$5.24
$3.33
Third Quarter
$4.24
$2.75
Fourth Quarter
$3.32
$2.03

Holders of Record
 
At December 30, 2011, the closing price per share of our common stock was $0.47 as reported on the NASDAQ Global Market and there were approximately 68 holders of record.  Because many of such shares are held by brokers and other institutions on behalf of stockholders, we are unable to estimate the total number of stockholders represented by these record holders.
 
Dividends
 
We have never declared or paid any cash dividends on our common stock.
 
Securities Authorized for Issuance Under Equity Compensation Plans
 
The information under the heading "Equity Compensation Plan Information" in our definitive Proxy Statement for our 2012 Annual Meeting of Stockholders, to be filed with the SEC, is incorporated herein by reference.
 
Recent Sales of Unregistered Securities
 
All information under this Item regarding our March 2011 private placement of common stock and warrants to purchase common stock has been previously reported on our Current Report on Form 8-K, filed with the Securities and Exchange Commission (the “SEC”) on March 1, 2011.
 
Comparative Stock Performance Graph
 
The graph set forth below compares the cumulative total stockholder return on an initial investment of $100 in our common stock between April 9, 2010 (the date of our initial public offering) and December 31, 2011, with the comparative cumulative total return of such amount on (i) the NASDAQ Biotechnology Index and (ii) the NASDAQ Composite Index, over the same period.  We have not paid any cash dividends and, therefore, the cumulative total return calculation for us is based solely upon stock price appreciation and not upon reinvestment of cash dividends.  The graph assumes our closing sale price on April 9, 2010 of $5.02 per share as the initial value of our common stock.
 
 
 
42
 
 
 
The comparisons shown in the graph below are based upon historical data.  We caution that the stock price performance shown in the graph below is not necessarily indicative of, nor is it intended to forecast, the potential future performance of our common stock.  Information used in the graph was obtained from the NASDAQ Stock Market, Inc., a financial data provider and a source believed to be reliable.  The NASDAQ Stock Market, Inc. is not responsible for any errors or omissions in such information.
 
 
 
 
The information presented above in the stock performance graph shall not be deemed to be “soliciting material” or to be “filed” with the SEC or subject to Regulation 14A or 14C, except to the extent that we subsequently specifically request that such information be treated as soliciting material or specifically incorporate it by reference into a filing under the Securities Act of 1933, as amended, or a filing under the Securities Exchange Act of 1934, as amended.
 
 
 
 
43
 
 
 
Item 6.  Selected Financial Data
 
The following selected financial data should be read in conjunction with “Management's Discussion and Analysis of Financial Condition and Results of Operations” and our financial statements and the related notes appearing elsewhere in this Report.  The statements of operations data for the years ended December 31, 2009, 2010, and 2011, and the balance sheet data as of December 31, 2010 and 2011 have been derived from our audited financial statements and related notes, which are included elsewhere in this Report.  The statement of operations data for the year ended December 31, 2007 and 2008 and the balance sheet data as of December 31, 2007 and 2008 have been derived from audited financial statements which do not appear in this Report.  The historical results presented are not necessarily indicative of future results.

   
Years Ended December 31,
   
2007
  
2008
  
2009
  
2010
  
2011
   
(in thousands, except share and per share data)
Statement of Operations Data:
        
  
      
  
      
  
      
  
      
Operating expenses:
                                        
Research and development
  
$
22,335
    
$
27,947
    
$
17,948
    
$
12,855
    
$
13,293
  
General and administrative
    
5,290
      
7,467
      
5,527
      
6,032
      
7,191
  
Depreciation
    
3,678
      
4,716
      
4,937
      
4,862
      
3,141
  
Impairment of property and equipment
    
—
      
—
      
—
      
—
      
7,371
  
Other expense
    
—
      
—
      
—
      
—
      
1,705
  
Loss from operations
    
(31,303
) 
    
(40,130
) 
    
(28,412
) 
    
(23,749
) 
    
(32,701
) 
Interest income (expense), net
    
45
      
(2,206
) 
    
(3,257
) 
    
(2,043
) 
    
(796
) 
Change in fair value of warrant liability
    
270
      
 (57
)
    
1,824 
      
192
      
14,436
  
Net loss
    
(30,988
)
    
(42,393
)
    
(29,845
)
    
(25,600
)
    
(19,061
)
Accretion of redeemable convertible preferred stock to redemption value
    
(8,742
)
    
(11,754
)
    
(14,059
)
    
(3,993
)
    
—
  
Net loss applicable to common stockholders
  
$
(39,730
) 
  
$
(54,147
) 
  
$
(43,904
) 
  
$
(29,593
) 
  
$
(19,061
) 
Basic and diluted net loss per common share
  
$
(60.16
) 
  
$
(80.16
) 
  
$
(62.95
) 
  
$
(3.22
) 
  
$
(0.88
) 
Weighted-average common shares outstanding
    
660,423
      
675,461
  
    
697,448
      
9,196,920
      
21,628,902
  
                                         


   
As of December 31,
   
2007
  
2008
  
2009
  
2010
  
2011
   
(in thousands)
Balance Sheet Data:
        
  
      
  
      
  
      
  
      
Cash, cash equivalents, and short-term investments
  
$
66,554
  
  
$
50,601
  
  
$
19,303
  
  
$
11,972
  
  
$
15,310
  
Working capital
    
63,075
      
41,379
      
2,766
      
4,247
      
6,643
  
Total assets
    
91,313
  
    
72,276
  
    
37,238
  
    
24,144
  
    
17,817
  
Long-term debt
    
25,650
      
21,137
      
8,640
      
4,585
      
2,782
  
Redeemable convertible preferred stock
    
140,751
      
173,857
      
187,916
      
—
      
—
  
Total stockholders’ equity (deficit)
    
(82,277
) 
    
(135,079
) 
    
(178,074
) 
    
11,060
      
5,015
  

 
 
 
44
 
 
 
Item 7.  Management’s Discussion and Analysis of Financial Condition and Results of Operations.
 
Forward-Looking Statements
 
Any statements herein or otherwise made in writing or orally by us with regard to our expectations as to financial results and other aspects of our business may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.  These statements relate to our future plans, objectives, expectations and intentions and may be identified by words like “believe,” “expect,” “designed,” “may,” “will,” “should,” “seek,” or “anticipate,” and similar expressions.  These forward looking statements may include, but are not limited to, statements concerning: (i) our plans to develop and commercialize our product candidates; (ii) our ongoing and planned preclinical studies and clinical trials; (iii) the timing of and our ability to obtain and maintain marketing approvals for our product candidates; (iv) the rate and degree of market acceptance and clinical utility of our products; (v) our plans to leverage our Organ Regeneration Platform to discover and develop product candidates; (vi) our ability to identify and develop product candidates; (vii) our commercialization, marketing and manufacturing capabilities and strategy; (viii) our intellectual property position; (ix) our estimates regarding expenses, future revenues, capital requirements and needs for additional financing; and (x) other risks and uncertainties, including those under the heading “Risk Factors” in Item 1A of Part I of this Annual Report on Form 10-K, as well as in other documents filed by us with the SEC.
 
Although we believe that our expectations are based on reasonable assumptions within the bounds of our knowledge of our business and operations, the forward-looking statements contained in this document are neither promises nor guarantees.  Our business is subject to significant risks and uncertainties and there can be no assurance that our actual results will not differ materially from our expectations.  Factors which could cause actual results to differ materially from our expectations set forth in our forward-looking statements are set forth in the section entitled “Risk Factors” in Item 1A of Part I of this Annual Report on Form 10-K, as well as in other documents filed by us with the SEC and include, among others: (i) patients enrolled in our clinical trials may experience adverse events related to our product candidates, which could delay our clinical trials or cause us to terminate the development of a product candidate; (ii) we may have difficulty enrolling patients in our clinical trials, including our Phase I clinical trial for our Neo-Urinary Conduit; (iii) we may be unable to progress our product candidates that are undergoing preclinical testing into clinical trials; (iv) we will need to raise additional funds or enter into strategic collaborations necessary to execute our business plan beyond November 2012 and such financings or strategic collaborations may not be available to us or, if available, on terms acceptable to us and (v) we may not  be able to reduce the net rental obligation for our Pennsylvania facility prior to the expiration of the existing lease.
 
The forward-looking statements made in this document are made only as of the date hereof and we do not intend to update any of these factors or to publicly announce the results of any revisions to any of our forward-looking statements other than as required under the federal securities laws.
 
Overview
 
We believe we are the only regenerative medicine company focused on discovering, developing, manufacturing and commercializing a range of neo-organs, which we define as products composed of living cells, with or without synthetic or natural materials, implanted into the body to incorporate, replace or regenerate a damaged tissue or organ.  Our Organ Regeneration Platform enables us to create proprietary product candidates that are intended to harness the intrinsic regenerative pathways of the body to produce a range of native-like organs and tissues.  Our product candidates eliminate the need to utilize other tissues of the body for a purpose to which they are poorly suited, to procure donor organs or to administer anti-rejection medications.  We are developing neo-organs in our scalable manufacturing facilities using efficient and repeatable proprietary processes, and have implanted neo-organs in our clinical trials.  We intend to develop our technology to address unmet medical needs in urologic, renal, and other diseases and disorders.
 
To date, we have devoted substantially all of our resources to the development of our Organ Regeneration Platform and product candidates, as well as to our facilities that we employ to manufacture our neo-organs.  Since our inception in July 2003, we have had no revenue from product sales, and have funded our operations principally through the private and public sales of equity securities and debt financings.  We have never been profitable and, as of December 31, 2011, we had an accumulated deficit of $230.2 million, including $48.4 million of cumulative accretion on the Redeemable Convertible Preferred Stock through April 2010.  We expect to continue to incur significant operating losses for the foreseeable future as we advance our product candidates from discovery through preclinical studies and clinical trials and seek marketing approval and eventual commercialization.
 
 
 
45
 
 
 
Cash, cash equivalents and short-term investments at December 31, 2011 were $15.3 million, representing 86% of total assets.  Based upon our current expected level of operating expenditures and debt repayment, we expect to be able to fund our operations to September 2012.  We will need to raise more funds to complete the Phase I clinical trial for our Neo-Urinary Conduit and continue preclinical research and development activities for our Neo-Kidney Augment.  There is no assurance that such financing will be available or, if available, on terms acceptable to us.
 
Financial Operations Overview
 
Research and Development Expense
 
Our research and development expense consists of expenses incurred in developing and testing our product candidates and are expensed as incurred.  Research and development expense consists of:
 
·  
personnel-related expenses, including salaries, benefits, stock-based compensation, travel, and other related expenses;
 
·  
payments made to third-party contract research organizations for preclinical studies, investigative sites for clinical trials and consultants;
 
·  
costs associated with regulatory filings and the advancement of our product candidates through preclinical studies and clinical trials;
 
·  
laboratory and other supplies;
 
·  
manufacturing development costs; and
 
·  
facility maintenance.
 
Preclinical study and clinical trial costs for our product candidates are a significant component of our current research and development expenses.  We track and record information regarding external research and development expenses on a per study basis.  Preclinical studies are currently coordinated with third-party contract research organizations and expense is recognized based on the percentage completed by study at the end of each reporting period.  Clinical trials are currently coordinated through a number of contracted sites and expense is recognized based on a number of factors, including actual and estimated patient enrollment and visits, direct pass-through costs and other clinical site fees.  We utilize employees, resources and facilities across multiple product candidates.  We do not allocate internal research and development expenses among product candidates.
 
The following table summarizes our research and development expense for the years ended December 31, 2009, 2010, and 2011.
 
 
Year Ended December 31,
 
2009
  
2010
  
2011
 
(in thousands)
Third-party direct program expenses:
      
  
      
  
      
Urologic                                                                              
$
2,753
    
$
194
    
$
707
  
Renal                                                                              
  
1,000
      
1,813
      
2,314
  
Total third-party direct program expenses                                                                                    
  
3,753
      
2,007
      
3,021
  
Other research and development expense                                                                              
  
14,195
      
10,848
      
10,272
  
Total research and development expense                                                                                    
$
17,948
    
$
12,855
    
$
13,293
  
                       
 
 
 
 
46
 
 

 
From our inception in July 2003 through December 31, 2011, we have incurred research and development expense of $117.9 million.  We expect that a large percentage of our research and development expense in the future will be incurred in support of our current and future preclinical and clinical development programs.  These expenditures are subject to numerous uncertainties in timing and cost to completion.  We expect to continue to test our product candidates in preclinical studies for toxicology, safety and efficacy, and to conduct additional clinical trials for each product candidate.  If we are not able to engage a partner prior to the commencement of later stage clinical trials, we may fund these trials ourselves.  As we obtain results from clinical trials, we may elect to discontinue or delay clinical trials for certain product candidates or programs in order to focus our resources on more promising product candidates or programs.  Completion of clinical trials by us or our future collaborators may take several years or more, but the length of time generally varies according to the type, complexity, novelty and intended use of a product candidate.  The cost of clinical trials may vary significantly over the life of a project as a result of differences arising during clinical development, including, among others:
 
·  
the number of sites included in the trials;
 
·  
the length of time required to enroll suitable patients;
 
·  
the number of patients that participate in the trials;
 
·  
the duration of patient follow-up;
 
·  
the development stage of the product candidate; and
 
·  
the efficacy and safety profile of the product candidate.
 
None of our product candidates has received FDA or foreign regulatory marketing approval.  In order to grant marketing approval, the FDA or foreign regulatory agencies must conclude that clinical data establish the safety and efficacy of our product candidates.  Furthermore, our strategy includes entering into collaborations with third parties to participate in the development and commercialization of our product candidates.  In the event that third parties have control over the clinical trial process for a product candidate, the estimated completion date would largely be under control of that third party rather than under our control.  We cannot forecast with any degree of certainty which of our product candidates will be subject to future collaborations or how such arrangements would affect our development plan or capital requirements.
 
As a result of the uncertainties discussed above, we are unable to determine the duration and completion costs of our development projects or when and to what extent we will receive cash inflows from the commercialization and sale of an approved product candidate.
 
General and Administrative Expense
 
General and administrative expense consists primarily of salaries, benefits and other related costs, including stock-based compensation, for persons serving in our executive, finance, legal, marketing planning and human resource functions.  Our general and administrative expense includes facility-related costs not otherwise included in research and development expense, professional fees for legal services, including patent-related expense, tax and accounting services, and other consulting services and general corporate expenses applicable to public companies.  We expect that our general and administrative expenses will increase with the development and potential commercialization of our product candidates.
 
Depreciation Expense
 
Depreciation expense is the amortization of capitalized property and equipment that is recognized over the estimated useful lives of the assets using the straight-line method.  We use a life of three years for computer equipment; five years for laboratory, office and warehouse equipment; seven years for furniture and fixtures; and the lesser of the useful life of the asset or the remaining life of the underlying facility lease for leasehold improvements.  Expenditures for maintenance, repairs, and betterments that do not prolong the useful life of the asset are charged to expense as incurred.
 
 
 
47
 
 
 
Interest Income and Interest Expense  
 
Interest income consists of interest earned on our cash and cash equivalents and short-term investments.  Interest expense consists primarily of cash and non-cash interest costs related to our outstanding debt.
 
Change in Fair Value of Preferred Stock Warrants
 
The change in the fair value of our preferred stock warrants consists of non-cash interest for the warrants that were classified as a liability prior to the Company’s initial public offering in April 2010 and warrants issued in connection with a private placement transaction in March 2011and were revalued at each reporting date with changes in the fair value reported in the statements of operations.  The fair value of the warrants were subject to fluctuations based on changes in the Company’s preferred stock price, expected volatility, remaining contractual life, and the risk-free interest rate.
 
Net Operating Losses and Tax Loss Carryforwards
 
As of December 31, 2011, we had net operating loss carryforwards available to offset future federal and state taxable income of $138.6 million and $153.6 million, respectively, as well as $5.2 million of research and development tax credits.  The net operating loss carryforwards and credits expire at various dates through 2031.  The Tax Reform Act of 1986 (the Act) provides for a limitation on the annual use of net operating loss and research and development tax credit carryforwards following certain ownership changes (as defined by the Act) that could limit our ability to utilize these carryforwards.  We have not completed a study to assess whether an ownership change has occurred, or whether there have been multiple ownership changes since our formation, due to the significant costs and complexities associated with a study.  We may have experienced various ownership changes, as defined by the Act, as a result of past financings.  Accordingly, our ability to utilize the aforementioned carryforwards may be limited.  Additionally, U.S. tax laws limit the time during which these carryforwards may be applied against future taxes; therefore, we may not be able to take full advantage of these carryforwards for federal or state income tax purposes.
 
Critical Accounting Policies and Use of Estimates
 
The preparation of financial statements in conformity with accounting principles generally accepted in the United States requires management to make significant judgments and estimates that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period.  Management bases these significant judgments and estimates on historical experience and other assumptions it believes to be reasonable based upon information presently available.  Actual results could differ from those estimates under different assumptions, judgments or conditions.
 
All of our significant accounting policies are discussed in Note 3, Summary of Significant Accounting Policies, to our financial statements, included elsewhere in this Annual Report on Form 10-K.  We have identified the following as our critical accounting policies and estimates, which are defined as those that are reflective of significant judgments and uncertainties, are the most pervasive and important to the presentation of our financial condition and results of operations and could potentially result in materially different results under different assumptions, judgments or conditions.  Management has reviewed these critical accounting policies and estimates with the Audit Committee of our board of directors.
 
Impairment of Long-lived Assets
 
Long-lived assets, such as property and equipment, are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable.  Conditions that would necessitate an impairment assessment include a significant change in the planned use of the acquired asset, a decline in the observable market value of an asset, or a significant adverse change in the business such as the occurrence of a negative clinical regulatory matter that would prohibit us from obtaining the approval for commercializing a product candidate.  Upon identification of an indicator of impairment, recoverability of assets to be held and used is measured by a comparison of the carrying amount of an asset to the estimated undiscounted future cash flows expected to be generated by the asset.  If the carrying amount of an asset exceeds its estimated undiscounted future cash flows, then an impairment charge is recognized by the amount by which the carrying amount of the asset exceeds the estimated fair value of the asset.
 
 
 
48
 
 
 
The evaluation of the recoverability of long-lived assets, and the determination of their fair value should such fair values need to be estimated, requires us to make significant estimates and assumptions.  These estimates and assumptions include, but are not limited to, the estimation of future cash flows, discount rates and costs to sell.  Due to the inherent uncertainty involved in making these estimates, actual results could differ from those estimates.  Such a change in assumptions could have a significant impact on the conclusion that an asset’s carrying value is recoverable, or the determination of any impairment charge if it was determined that the asset values were indeed impaired.
 
During the year ended December 31, 2011, the Company recorded a non-cash property and equipment impairment charge of $7.4 million in connection with the restructuring plan announced in November 2011.  Under the restructuring plan, the Company eliminated plans to use its facility in East Norriton, Pennsylvania as a manufacturing center and centralized its research and development operations in its leased facility in Winston-Salem, North Carolina.
 
Preclinical and Clinical Trial Costs
 
A substantial portion of our ongoing research and development activities are performed under agreements we enter into with external service providers who conduct many of our research and development activities.  Estimates of incurred costs are made to determine the accrued balance in any accounting period.  The estimates incurred under the contracts are based on factors such as work performed, milestones achieved, patient enrollment and costs historically incurred for similar contracts.  As actual costs become known, we adjust our estimates.  To date, our estimates have been within management’s expectations, and no material adjustments to research and development expense have been recognized.  For the year ended December 31, 2011, a 10% increase or decrease in our estimate of research and development expense incurred under such contracts would result in an increase or decrease in research and development expense of approximately $11,000.  We may expand the level of research and development activity to be performed by external service providers in which case our estimates would be more material to our future operations.  Subsequent changes in estimates may result in a material change in our accruals, which could also materially affect our future results of operations
 
Warrant Liability
 
We account for stock warrants as either equity instruments or derivative liabilities depending on the specific terms of the warrant agreement.  Stock warrants that allow for cash settlement or provide for modification of the warrant exercise price are accounted for as derivative liabilities under Financial Accounting Standards Board (FASB) Accounting Standard Codification (ASC) 815, Derivatives and Hedging (ASC 815).  We classify derivative warrant liabilities on the balance sheet as a current liability, which is revalued at each balance sheet date subsequent to the initial issuance.

In March 2011, we issued warrants to purchase 10,460,875 shares of common stock in connection with a private placement transaction.  We valued the warrants as derivative financial instruments as of the date of issuance (March 4, 2011) and will continue to do so at each reporting date, with any changes in fair value being recorded on the Statements of Operations.  During the year ended December 31, 2011, we recorded non-operating income of $14.4 million due to decreases in the estimated fair value of the warrants.

The warrants contain provisions that require the modification of the exercise price and shares to be issued under certain circumstances, including in the event we complete subsequent equity financings at a price per share lower than the then-current warrant exercise price.  In addition, the warrants contain a net cash settlement provision under which the warrant holders may require us to purchase the warrants in exchange for a cash payment following the announcement of specified events defined as Fundamental Transactions involving the Company (e.g., merger, sale of all or substantially all assets, tender offer, or share exchange) or a Delisting, which is deemed to occur when the common stock is no longer listed on a national securities exchange.
 
 
 
49
 
 

 
The net cash settlement provision requires use of the Black-Scholes model in calculating the cash payment value in the event of a Fundamental Transaction or a Delisting.  The net cash settlement value at the time of any future Fundamental Transaction or Delisting will depend upon the value of the following inputs at that time: the price per share of our common stock, the volatility of our common stock, the expected term of the warrant, the risk-free interest rate based on U.S. Treasury security yields, and our dividend yield.  The warrant requires use of a volatility assumption equal to the greater of (i) 100%, (ii) the 30-day volatility determined as of the trading day immediately following announcement of a Fundamental Transaction or Delisting, or (iii) the arithmetic average of the 10, 30, and 50-day volatility determined as of the trading day immediately following announcement of a Fundamental Transaction or Delisting.

The fair value of the warrants is determined using a risk-neutral lattice methodology within a Monte Carlo analysis to model the impact of potential modifications to the warrant exercise price and to include the probability of a Fundamental Transaction or Delisting into the calculation of fair value.  The valuation of warrants is subjective and is affected by changes in inputs to the valuation model including the price per share of our common stock, assumptions regarding the expected amounts and dates of future equity financing activities, assumptions regarding the likelihood and timing of Fundamental Transactions or a Delisting, the historical volatility of the stock prices of our peer group, risk-free rates based on U.S. Treasury security yields, and our dividend yield.  Changes in these assumptions can materially affect the fair value estimate.  We could, at any point in time, ultimately incur amounts significantly different than the carrying value.  For example, as of December 31, 2011, the calculated cash settlement value of $3.6 million exceeded the fair value of $2.5 million.  We will continue to classify the fair value of the warrants as a liability until the warrants are exercised, expire, or are amended in a way that would no longer require these warrants to be classified as a liability.

The following table summarizes the calculated aggregate fair values and net cash settlement value as of the dates indicated along with the assumptions utilized in each calculation.
             
   
Fair value as of:
  
Net cash settlement
value as of
December 31, 2011
   
March 4, 2011
  
December  31, 2011
  
             
Calculated aggregate value                                                                 
  
$16,947
  
$2,511
  
$3,596 (1)
Exercise price per share of warrant                                                                 
  
$2.88
  
$2.88
  
$2.88
Closing price per share of common stock
  
$2.60
  
$0.47
  
$0.47
Volatility                                                                 
  
65.0%
  
93.8%
  
151.0% (2)
Probability of Fundamental Transaction or Delisting
  
48.9%
  
28.9%
  
Not applicable
Expected term (years)                                                                 
  
Not applicable
  
Not applicable
  
4.2
Risk-free interest rate                                                                 
  
2.2%
  
0.7%
  
0.6%
Dividend yield                                                                 
  
None
  
None
  
None
             

(1)
Represents the net cash settlement value of the warrant as of December 31, 2011, which value was calculated utilizing the Black-Scholes model specified in the warrant.
 
(2)
Represents the volatility assumption used to calculate the net cash settlement value as of December 31, 2011.

 
Stock-Based Compensation
 
Effective January 1, 2006, we adopted the revised accounting standards for stock-based compensation guidance which was adopted prospectively to new awards and to awards modified, repurchased, or canceled after December 31, 2005.  This current guidance requires companies to measure and recognize compensation expense for all employee stock-based payments at fair value, net of estimated forfeitures, over the vesting period of the underlying stock-based awards.  In addition, we account for stock-based compensation to nonemployees in accordance with the FASB accounting guidance for equity instruments that are issued to other than employees.
 
 
 
50
 
 
 
We use the Black-Scholes option-pricing model to value our stock option awards.  The Black-Scholes option-pricing model requires the input of subjective assumptions, including the expected life of the stock-based payment awards and stock price volatility.  Since we do not have sufficient historical volatility of our stock as a public company for the expected term of the options, we use comparable public companies as a basis for our expected volatility to calculate the fair value of option grants.  We intend to continue to consistently apply this process using comparable companies until a sufficient amount of historical information regarding the volatility of our own share price becomes available.  The expected term is based on the simplified method provided by SEC guidance.  The risk-free interest rate is based on the U.S. Treasury yield curve with a remaining term equal to the expected life assumed at grant.  The assumptions used in calculating the fair value of stock-based payment awards represent management’s best estimate and involve inherent uncertainties and the application of management’s judgment.  As a result, if factors change and management uses different assumptions, stock-based compensation expense could be materially different in the future.
 
The estimation of the number of stock awards that will ultimately vest requires judgment, and to the extent actual results or updated estimates differ from our current estimates, such amounts will be recorded as a cumulative adjustment in the period in which estimates are revised.  We consider many factors when estimating expected forfeitures, including types of awards, employee class and an analysis of our historical and known forfeitures on existing awards.  Under the true-up provisions of the FASB stock based compensation guidance, we record additional expense if the actual forfeiture rate is lower than estimated, and a recovery of expense if the actual forfeiture rate is higher than estimated, during the period in which the options vest.
 
Prior to the completion of our initial public offering in April 2010, the fair value of our common stock underlying stock options granted during 2009 was determined by our compensation committee pursuant to authority delegated by our board of directors.   The fair value of our common stock underlying stock options granted during 2010, subsequent to the completion of our IPO, was determined by the closing price of our stock on the day of grant.  In the absence of a public trading market for our common stock, our compensation committee was required to estimate the fair value of our common stock at each option grant date.  Our compensation committee, in making its independent determination, utilized the assistance of an independent valuation firm.  In each of the separate valuations performed by our compensation committee, our compensation committee’s determination of the fair market values was consistent with the results and conclusions of our independent third party valuation.  We used methodologies, approaches and assumptions consistent with the American Institute of Certified Public Accountants Practice Guide, or the AICPA Practice Guide, Valuation of Privately-Held-Company Equity Securities Issued as Compensation, considering numerous objective and subjective factors to determine common stock fair market value at each option grant date, including but not limited to the following factors:
 
·  
arm’s length private transactions involving our preferred stock, including the sale of our Series A preferred stock at $23.44 per share in 2004 and 2005, the sale of our Series B preferred stock at $26.39 per share in 2006 and the sale of our Series C preferred stock at $26.39 per share in 2007 and 2008, all of which had superior rights and preferences compared to our common stock.  All per share prices in this paragraph reflect the automatic conversion of all outstanding shares of preferred stock into 5,651,955 shares of common stock upon the completion of our initial public offering in April 2010;
 
·  
our financial and operating performance;
 
·  
the likelihood of achieving a liquidity event for the shares of our common stock and options, such as an initial public offering or sale of our company, given prevailing market conditions;
 
·  
the conditions of the equity markets in general and the biotechnology markets in particular;
 
·  
developmental milestones achieved;
 
·  
business risks; and
 
·  
management and board experience.
 
The following table represents a summary of the contemporaneous valuations performed by our compensation committee concurrently with the achievement or failure of significant milestones or with major financing events, where applicable.  Listed are the related stock option grants and exercise prices that utilized these valuations from October 15, 2008 through December 31, 2009.
 
 
 
51
 
 
 
Date of Valuation
  
Milestone / Financing Event
  
Number
of Shares
  
Exercise or
Purchase
Price per
Share
  
Per Share
Estimated Fair
Value of
Common
Stock
October 15, 2008
  
$21.5 million raised in Series C preferred stock financing extension on October 15, 2008
  
3,039
  
$
11.75
  
$
11.75
January 15, 2009
  
To support 2008 performance grants issued in February 2009
  
2,519
  
$
10.01
  
$
10.01
February 13, 2009
  
IND for Neo-Bladder Augment placed on clinical hold; revision of projections; delay in IPO event
  
276
  
$
2.03
  
$
2.03
July 31, 2009
  
Board approval of amended operating plan to focus on Neo-Urinary Conduit and further delay of IPO event
  
355,155
  
$
0.44
  
$
0.44
December 3, 2009
  
Board approval for the Company to pursue an IPO event
  
—
  
$
—
  
$
2.90


 
Results of Operations
 
Year Ended December 31, 2010 compared to Year Ended December 31, 2011
 
Research and Development Expense.  Research and development expense for the years ended December 31, 2010 and 2011 was comprised of the following:
 
   
Year Ended
December 31,
  
Increase
(Decrease)
   
2010
  
2011
  
$
    
%
   
(in thousands)
        
Compensation and related expense                                                                  
  
$
7,482
  
$
7,085
  
$
(397
)
  
 (5)
% 
External services – direct third parties                                                                  
    
2,007
  
  
3,021
  
  
1,014
    
51
% 
External services – other                                                                  
    
510
  
  
511
  
  
1
    
—
% 
Research materials and related expense                                                                  
    
975
  
  
948
  
  
(27
)
  
 (3)
% 
Facilities and related expense                                                                  
    
1,881
  
  
1,728
  
  
(153
)
  
 (8)
% 
       
  
    
  
            
Total research and development expense  
  
$
12,855
  
$
13,293
  
$
438
    
3
% 

Research and development expense increased primarily due to higher direct third-party expenses of $0.5 million for preclinical studies related to our Neo-Kidney Augment and $0.5 million for clinical studies. Research and development expense with respect to compensation and other related costs decreased $0.4 million due to reduced headcount in our Pennsylvania facility.  The decrease in headcount in our Pennsylvania facility resulted in a decrease in facility and related expenses of $0.2 million.
 

 

 
52
 
 

 
General and Administrative Expense. General and administrative expense for the years ended December 31, 2010 and 2011 was comprised of the following:
 
   
Year Ended
December 31,
  
Increase
(Decrease)
   
2010
  
2011
  
$
    
%
   
(in thousands)
        
Compensation and related expense                                                                  
  
$
3,328
  
$
4,367
  
$
1,039
    
31
% 
Professional fees                                                                  
    
1,642
  
  
1,888
  
  
246
    
15
% 
Facilities and related expense                                                                  
    
349
  
  
315
  
  
(34
)
  
(10)
% 
Insurance, travel, and other expenses                                                                  
    
713
  
  
621
  
  
(92
)
  
 (13)
% 
Total general and administrative expense   
  
$
6,032
  
$
7,191
  
$
1,159
    
19
% 

General and administrative expense increased primarily due to the recognition of one-time termination benefits incurred during the second and fourth quarters of 2011 totaling $1.6 million in connection with severance agreements.  The increase is partially offset by a reduction in compensation and related expenses resulting from fewer employees in 2011 as compared to 2010.
 
Depreciation Expense.  Depreciation expense decreased by $1.8 million, or 35%, from $4.9 million in 2010 to $3.1 million in 2011 due primarily to an impairment charge recorded in the fourth quarter of 2011, which reduce the carrying value of assets at our Pennsylvania facility.  The decrease is also due to a change in the estimated useful life of leasehold improvements associated with leased laboratory space in Winston-Salem, North Carolina upon the extension of that lease. In May 2011, the Company exercised the first five-year renewal option under its lease for the laboratory space.  The amended lease extended the lease term to October 2016.
 
Impairment of Property and Equipment.  During the year ended December 31, 2011, we recorded a non-cash property and equipment impairment charge of $7.4 million in connection with the restructuring plan announced in November 2011.  Under the restructuring plan, the Company eliminated plans to use its facility in East Norriton, Pennsylvania as a manufacturing center and centralized its research and development operations in its leased facility in Winston-Salem, North Carolina.
 
Other Expense. Other expense was $1.7 million in 2011.  During the first and fourth quarters of 2011, we recorded non-cash charges totaling $1.6 million in connection with the lease liabilities.  The first quarter charge of $0.9 million resulted from a lease that became effective in March 2011 for additional warehouse space that will not be utilized over the lease term.  The fourth quarter charge of $0.9 million resulted from a restructuring that changed the Company’s operating plan, such that office and manufacturing space will not be utilized for the Company’s original planned use during the remaining years of the current lease term.
 
Interest Income (Expense).   Interest income was $62,000 and $53,000 for 2010 and 2011, respectively.  The decrease was primarily due to decreased average cash balances.  Interest expense was $2.1 million and $0.8 million for 2010 and 2011, respectively.  The decrease was primarily due to lower average debt facility balances outstanding in 2011.
 
Change in Fair Value of Warrant Liability.  During 2011, we recorded a non-cash credit of $14.6 million on our statement of operations due to a decrease in the fair value of the warrant liability for warrants to purchase common stock that were issued in March 2011.  This decrease in fair value was primarily due to a decrease in the price per share of our common stock on the reporting date.  During 2010, we recorded a non-cash credit of $0.2 million on our statement of operations due to a decrease in the fair value of the warrant liability for warrants to purchase preferred stock that were liability-classified at that time.  The preferred stock warrants were reclassified from liability to stockholders’ equity upon the completion of our initial public offering in April 2010.
 
Year Ended December 31, 2009 compared to Year Ended December 31, 2010
 
Research and Development Expense.  Research and development expense for the years ended December 31, 2009 and 2010 was comprised of the following:
 
 
 
53
 
 
 
 
   
Year Ended
December 31,
  
Increase
(Decrease)
   
2009
  
2010
  
$
    
%
   
(in thousands)
        
Compensation and related expense                                                                    
  
$
9,134
  
$
7,482
  
$
(1,652
)
  
(18)
% 
External services – direct third parties                                                                    
    
3,753
  
  
2,007
  
  
(1,746
)
  
(47)
% 
External services – other                                                                    
    
1,048
  
  
510
  
  
(538
)
  
(51)
% 
Research materials and related expense                                                                    
    
1,771
  
  
975
  
  
(796
)
  
(45)
% 
Facilities and related expense                                                                    
    
2,242
  
  
1,881
  
  
(361
)
  
(16)
% 
Total research and development expense    
  
$
17,948
  
$
12,855
  
$
(5,093
)
  
(28)
% 

Research and development expense decreased primarily due to lower direct third-party expenses of $0.8 million for preclinical studies and $0.2 million for clinical studies, as well as the receipt of Qualifying Therapeutic Discovery Project Grants totaling $0.7 million, which was recorded as a credit to external services-direct third parties.  Research and development expense with respect to compensation and other related costs decreased $1.7 million due to a full year with reduced headcount in our Pennsylvania facility.  The decrease in external services activity and headcount resulted in a decrease of $1.7 million in the demand for lab supplies and other services related to our product candidates.
 
General and Administrative Expense.  General and administrative expense for the years ended December 31, 2009 and 2010 was comprised of the following:
 
   
Year Ended
December 31,
  
Increase
(Decrease)
   
2009
  
2010
  
$
    
%
   
(in thousands)
        
Compensation and related expense                                                                  
  
$
3,324
  
$
3,328
  
$
4
    
—
% 
Professional fees                                                                  
    
1,093
  
  
1,642
  
  
454
    
42
% 
Facilities and related expense                                                                  
    
481
  
  
349
  
  
(132
)
  
(28)
% 
Insurance, travel, and other expenses                                                                  
    
629
  
  
713
  
  
179
    
 28
% 
Total general and administrative expense  
  
$
5,527
  
$
6,032
  
$
505
    
9
% 

General and administrative expense increased primarily due to increased outside professional services, including legal expenses associated with operating as a public company.
 
Depreciation Expense.  Depreciation expense remained relatively unchanged for the year ended 2009 compared to the year ended 2010, as additions were not significant in either period.
 
Interest Income (Expense).   Interest income decreased $0.1 million, or 71%, from $0.2 million in 2009 to $0.1 million in 2010 due to lower investment balances and lower rates and returns on our investments.  Interest expense decreased $1.4 million, or 39%, from the year ended 2009 to the year ended 2010, due to lower average debt balances and the end of our interest-only payments in the third quarter of 2009.
 
Change in Fair Value of Warrant Liability.  Change in fair value of warrant liability increased due to a non-cash credit of $1.6 million related to the preferred stock warrants in the year ended 2009, as the estimated fair value of the Company’s preferred stock warrants decreased during that period.  The preferred stock warrants were reclassified from a liability to stockholders equity upon the completion of our initial public offering in April 2010.
 
 
 
54
 
 
 
Liquidity and Capital Resources
 
Sources of Liquidity
 
We have incurred losses since our incorporation in 2003 as a result of our significant research and development expenditures and the lack of any approved products to generate product sales.  We have a deficit accumulated during the development stage of $230.2 million as of December 31, 2011, including $48.4 million of cumulative accretion on Redeemable Convertible Preferred Stock through April 2010.  We anticipate that we will continue to incur additional losses until such time that we can generate significant sales of our product candidates currently in development or we enter into cash flow positive business transactions.  We have funded our operations principally with proceeds from equity offerings and long-term debt.  The following table summarizes our equity funding sources as of December 31, 2011:
 
Issue
  
Year
    
Number of Shares
    
Net Proceeds
(in thousands)(2)
Series A Redeemable Convertible Preferred Stock
  
2004, 2005
    
1,668,311
  (1)
$
38,910
Series B Redeemable Convertible Preferred Stock
  
2006
    
1,906,009
  (1)
  
50,040
Series C Redeemable Convertible Preferred Stock
  
2007, 2008
    
2,077,635
  (1)
  
54,571
Initial Public Offering
  
2010
    
6,000,000
    
25,721
Private Placement
  
2011
    
11,079,250
    
28,941
         
22,731,205
  
$
198,183

 
(1)
Number of shares represents the number of shares of common stock into which each series of preferred stock converted at the time of our initial public offering.
 
(2)
Net proceeds represent gross proceeds received net of transaction costs associated with each equity offering.
 
In March 2011, we closed a private placement transaction pursuant to which we sold securities consisting of 11,079,250 shares of common stock and warrants to purchase 10,460,875 shares of common stock.  The purchase price per security was $2.83.  The warrants have a term of five years and are immediately exercisable for $2.88 per share.  We received net proceeds of approximately $28.9 million.
 
We have also funded our operations through the use of proceeds received from our long-term debt totaling $39.5 million through December 31, 2011.  At December 31, 2011, we had a working capital note with an outstanding principal of $5.0 million, which borrowings have been used for our general working capital needs.  In addition, we have loans to fund equipment and other asset purchases with outstanding principal amounts of $0.1 million as of December 31, 2011.
 
Cash, cash equivalents and short-term investments at December 31, 2011 were $15.3 million, representing 86% of total assets.
 
Based upon our current expected level of operating expenditures and debt repayment, we expect to be able to fund our operations to September 2012.  This period could be shortened if there are any significant increases in planned spending on development programs than anticipated or other unforeseen events.  We will need to raise additional funds through collaborative arrangements, public or private sales of debt or equity securities, commercial loan facilities, or some combination thereof.  There is no assurance that other financing will be available when needed to allow us to continue our operations or if available, on terms acceptable to us.
 
Equity Financings
 
In March 2011, we closed a private placement transaction pursuant to which we sold securities consisting of 11,079,250 shares of common stock and warrants to purchase 10,460,875 shares of common stock.  The purchase price per security was $2.83.  The warrants have a term of five years and are immediately exercisable for $2.88 per share.  Net proceeds received after payment of placement agent fees and related expenses were approximately $28.9 million.
 
 
 
55
 
 
 
In April 2010, we completed an initial public offering, selling 6,000,000 shares of common stock at an initial public offering price of $5.00 per share resulting in gross proceeds of $30.0 million.  Net proceeds received after underwriting fees and offering expenses were approximately $25.7 million.
 
Cash Flows
 
The following table summarizes our cash flows from operating, investing and financing activities for each of the past three years ended:
 
   
Year Ended December 31,
  
   
2009
    
2010
    
2011
  
 
(in thousands)
  
Statement of Cash Flows Data:
                      
Total cash provided by (used in):
                      
Operating activities                                                                              
$
(26,021
)
  
$
(19,412
)
  
$
(21,888
)
Investing activities                                                                              
  
1,876
      
2,347
      
(6,147
)
Financing activities                                                                              
  
(4,995
)
    
12,232
      
25,307
  
                       
Decrease in cash and cash equivalents                                                                                   
$
(29,140
) 
  
$
(4,833
)
  
$
(2,728
)

Operating Activities
 
Cash used in operating activities increased $2.5 million for the year ended December 31, 2011, compared to the year ended December 31, 2010, primarily due to the payment of a $1.0 million security deposit in connection with the lease for our corporate headquarters and a decrease in our accrued expenses of $1.5 million.
 
Cash used in operating activities decreased $6.6 million for the year ended December 31, 2010, compared to the year ended December 31, 2009, primarily due to a decrease in our net loss.  Specifically, the decrease in our net loss relates primarily to a decrease in research and development expense of $5.0 million associated with our preclinical and clinical studies, and a decrease in cash interest expense of $1.3 million due to lower average debt balances and the end of interest-only payments in 2009.
 
Investing Activities
 
Cash used in investing activities increased $8.5 million for the year ended December 31, 2011, compared to the year ended December 31, 2010, primarily due to an decrease in net sales and redemptions (net of purchases) of short-term investments of $8.6 million, which was offset in part by a decrease of $0.1 million in cash paid for property and equipment.
 
Cash provided by investing activities increased $0.5 million for the year ended December 31, 2010, compared to the year ended December 31, 2009, primarily due to an increase in sales and redemptions (net of purchases) of short-term investments of $0.4 million and a decrease of $0.1 million in cash paid for property and equipment.
 
Financing Activities
 
Cash provided by financing activities increased $13.1 million for the year ended December 31, 2011, compared to the year ended December 31, 2010, primarily due to a decrease in payments of long-term debt of $4.9 million primarily resulting from the March 2011 refinancing of our working capital facility, and an increase of $4.9 million in proceeds from long-term debt due to new borrowings under our working capital facility in March 2011.  In addition, the 2011 period included net proceeds received from our March 2011 equity financing of $29.0 million as compared to $25.7 million received in the 2010 period consisting of net proceeds received from our initial public offering in April 2010.
 
Cash provided by financing activities increased $17.2 million for the year ended December 31, 2010, compared to the year ended December 31, 2009, due to net proceeds received from our initial public offering of $25.7 million, offset by an increase in payments of long-term debt of $7.6 million primarily resulting from the end of interest-only payments on our long-term debt in 2009, and a decrease of $0.8 million in proceeds from long-term debt.
 
 
 
56
 
 
 
Potential Future Milestone Payments
 
In 2003, we executed a license agreement with Children’s Medical Center Corporation (CMCC), whereby CMCC granted to us the utilization of certain patent rights.  We are obligated to make payments to CMCC upon the occurrence of various clinical milestones.  During the fourth quarter of 2006, we achieved two of our clinical milestones for the first licensed product launched, as defined in the agreement, and paid $350,000, which was recorded as research and development expense for the year ended December 31, 2006.  No further milestones payments have been made since 2006.  Upon the successful completion of certain milestones, we will be obligated, under our current agreement, to make future milestone payments for the first licensed product.  As of December 31, 2010, we had no payment obligations to CMCC under this agreement.  In addition, upon commercialization of the licensed product, we will pay CMCC royalties based on net sales of products covered by the license by us, our affiliates and our sublicensees in all countries, except for those for which there is no valid patent claim, until the later of the expiration, on a country-by-country basis, of the last patent right and October 2018.
 
Off-Balance Sheet Arrangements
 
We do not have any off-balance sheet arrangements or relationships with unconsolidated entities or financial partnerships, such as entities often referred to as structured finance or special purpose entities.
 
Contractual Obligations
 
The following table summarizes our contractual obligations as of December 31, 2011 (in thousands):
 
   
Payments due by period
Contractual Obligations (1)(2)
  
Total
  
2012
  
2013 and
2014
  
2015 and
2016
  
2017 and
thereafter
         
  
      
  
      
  
      
  
      
Debt obligations
  
$
5,127
  
  
$
2,274
  
  
$
2,853
  
  
$
—
  
  
$
—
  
Interest payments on debt
    
687
      
488
      
199
      
—
      
—
  
Operating lease obligations
    
4,387
  
    
992
  
    
2,055
  
    
1,340
  
    
—
  
Other
    
—
      
—
      
—
      
—
      
—
  
Total
  
$
10,201
    
$
3,754
    
$
5,107
    
$
1,340
    
$
—
  
                                         
(1)
This table does not include any milestone payments which may become payable to third parties under license agreements, including milestones that may be payable to CMCC, as the timing and likelihood of such payments are not known.  We will be required to pay CMCC development milestones aggregating approximately $6.9 million, which includes $350,000 we have paid to date, if we develop and obtain regulatory approval of a licensed product in each of the four subfields covered by our license agreement.  Also, if cumulative net sales of all licensed products reach a certain level, we will be required to make a one-time sales milestone payment of $2.0 million.  A portion of milestone payments we make will be credited against our future royalty payments.
 
(2)
This table does not include any license maintenance fees which may become payable to Wake Forest University Health Sciences (WFUHS), as the timing and likelihood of such payments are not known.  We will be required to pay certain license maintenance fees with respect to each product covered by new development patents under our license with WFUHS, commencing two years after we initiate the first animal study conducted under cGLP, with respect to such product.  These license maintenance fees, which are in the low six figure range with respect to each product, will be creditable against royalties we are obligated to pay to WFUHS for such product.
 
 
 
57
 
 
 
Working Capital Note
 
In March 2011, we refinanced the outstanding debt owed to one of our lenders.  Pursuant to the terms of the refinancing, we simultaneously borrowed $5.0 million from the lender and repaid the then outstanding principal amount of $4.5 million.  As of December 31, 2011, the outstanding balance of this loan was $5.0 million.  We are obligated to make interest-only payments through January 2012, followed by 24 monthly payments of principal and interest at an interest rate of 11.75% per annum.  In October 2008, we refinanced the terms of the working capital note with a then principal amount of $20 million, which was previously refinanced in 2006 and 2007.  Under the 2008 refinancing, the repayment terms of $14.2 million principal amount of the working capital note were extended to add an additional six-month period of interest-only payments through July 2009 followed by 24 monthly payments of principal and accrued interest at an annual interest rate of 12.26%.  The repayment of $5.8 million of the working capital note were extended to add a 14-month period of interest-only payments through January 2010 followed by 20 monthly payments of principal and accrued interest at an annual interest rate of 12.26%.
 
Borrowings under the Working Capital Note are secured by all of our assets, except for intellectual property and permitted liens that have priority, including liens on certain equipment acquired to secure the purchase price or lease obligation, as defined in the loan agreement.
 
Equipment and Supplemental Working Capital Note
 
We have an additional loan with another lender to fund equipment and other asset purchases.  As of December 31, 2011, the outstanding balance of this loan was $0.1 million, which is scheduled to be repaid during 2012.  The original amount borrowed of $9.8 million consisted of a $7.4 million note to purchase equipment, or the equipment note, and a $2.4 million note for other soft costs, or supplemental working capital note, for purchases from July 2005 through December 2009.  In October 2007, we refinanced the equipment and supplemental working capital notes with a then carrying amount of $4.6 million.  Under the terms of the refinanced equipment and supplemental working capital notes, we had a 12-month period of interest-only payments through October 2008 followed by 24 monthly payments of principal and accrued interest at an annual interest rate of 10.44%.  During 2008, we executed an additional loan in the amount of $1.1 million on the equipment and supplemental working capital notes.  During 2009, we executed an additional loan in the amount of $0.5 million on the equipment and supplemental working capital notes.  The equipment note bears interest at an average rate of 11.69% and matures over 36 to 48 months.  The supplemental working capital note bears interest at an average rate of 11.67% and matures over 36 months.  The equipment note and the supplemental working capital note are secured by a first priority lien on equipment and assets purchased with the proceeds from the notes.
 
Machinery and Equipment Loan
 
In December 2007, we executed a $1.65 million agreement with the Commonwealth of Pennsylvania to fund machinery and equipment and other asset purchases through December 31, 2009.  As of December 31, 2011, this loan was paid in full.   On December 31, 2007 we borrowed $1.3 million under the loan to fund equipment purchases.  In March 2009, we borrowed an additional $0.3 million under the loan to fund equipment purchases.  Under the terms of the loan, we have a four year period of payments of principal and accrued interest at an annual interest rate of 5% until September 2011 and 5.25% from September 2011 through maturity of the loan.  The loan is secured by a first priority lien on equipment and assets purchased with the proceeds from the loan.
 
Operating Leases
 
In 2006, we entered into a ten-year, non-cancelable lease agreement for space for our corporate offices and full-scale manufacturing facility located in East Norriton, Pennsylvania.  Under the lease agreement, we began leasing additional space in the same building in March 2011.  We are currently subleasing this additional warehouse space to a third party.  The lease will expire by its terms in February 2016.  Effective March 2011, the lease agreement for our corporate headquarters required us to provide security and restoration deposits totaling $2.2 million to the landlord, an increase from the prior amount of $1.7 million. Until January 2011, we obtained letters of credit from a bank in favor of the landlord to satisfy the obligation of $1.7 million.  In January 2011, we deposited $1.0 million with the landlord.  As of March 2011, an outstanding letter of credit is satisfying the remaining obligation of $1.2 million.  The letter of credit is collateralized by an account held at the bank.  If the bank determines the collateral to be insufficient, the bank has the right to demand additional collateral.  If we fail to provide additional collateral, the bank has the right to withdraw the letter of credit.  In that event, the landlord would have the right to require us to deposit cash of up to $1.2 million in an account to satisfy our deposit obligation.
 
 
 
58
 
 
 
In June 2005, we entered into a six-year, non-cancelable lease agreement for laboratory space for our research and development projects in Winston-Salem, North Carolina.  The lease agreement includes the right to lease additional contiguous space, which we executed in February 2007.  The initial term for the lease for this facility expired in September 2011.  In May 2011, we exercised the first five-year renewal option under the lease.  The amended lease extends the lease term to October 2016 and provides for payments of average annual base rent of approximately $0.2 million commencing in October 2011.
 
Other Contractual Obligations
 
In January 2006, we entered into a research agreement with WFUHS, which was amended in September 2006 and extended in September 2010 for an additional three-year period.  Under the research agreement, WFUHS agreed to perform sponsored research in return for quarterly payments.  Under the extended agreement, we made payments of $800,000 for 2011 research activities of WFUHS.  We terminated the research agreement with WFUHS effective as of December 31, 2011.
 
We have entered into agreements with consultants and clinical research organizations which are partially responsible for conducting and monitoring our clinical trials for our product candidates.  We have also entered into agreements with consultants and clinical research organizations that are responsible for work in our preclinical studies, public relations and other areas in the ordinary course of our business.  These contractual obligations have been excluded from the contractual obligations table elsewhere in this section, because we may terminate these at any time without penalty.
 
 
Item 7A.Quantitative and Qualitative Disclosures about Market Risk
 
The primary objective of our investment activities is to preserve our capital to fund operations.  We also seek to maximize income from our investments without assuming significant risk.  To achieve our objectives, we maintain a portfolio of cash equivalents and investments in a variety of securities of high credit quality.  Due to the nature of these investments, we believe that we are not subject to any material market risk exposure.  As of December 31, 2011, we had cash and cash equivalents of $15.3 million.
 
 
Item 8.  Financial Statements and Supplementary Data
 
This information required by this Item is included in our Financial Statements and Supplementary Data listed in Item 15 (a) (1) of Part IV of this Annual Report on Form 10-K.
 
 
Item 9.  Changes in and Disagreements with Accountants on Accounting and Financial Disclosure
 
None.
 
 
Item 9A.Controls and Procedures
 
Evaluation of Disclosure Controls and Procedures and Changes in Internal Control over Financial Reporting
 
Our management, with the participation of our Chief Executive Officer and Chief Financial Officer, evaluated the effectiveness of our disclosure controls and procedures (as defined in Rule 13a-15(e) of the Securities Exchange Act of 1934, as amended (the Exchange Act)) as of the end of the period covered by this report.  Based on that evaluation, our Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures as of the end of the period covered by this report were effective in ensuring that information required to be disclosed by us in reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the Securities and Exchange Commission’s rules and forms.  We believe that a control system, no matter how well designed and operated, cannot provide absolute assurance that the objectives of the control system are met, and no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within a company have been detected.
 
 
 
59
 
 
 
There was no change in our internal control over financial reporting (as defined in Rule 13a-15(f) of the Exchange Act) that occurred during the period covered by this report that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
 
Management’s Annual Report on Internal Control over Financial Reporting and Attestation Report of the Registered Accounting Firm
 
 
Our management is responsible for establishing and maintaining adequate internal control over financial reporting. Our internal control over financial reporting is designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of consolidated financial statements for external purposes in accordance with accounting principles generally accepted in the United States.
 
Our internal control over financial reporting includes those policies and procedures that:
 
·  
pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect our transactions and dispositions of our assets;
 
·  
provide reasonable assurance that our transactions are recorded as necessary to permit preparation of our consolidated financial statements in accordance with accounting principles generally accepted in the United States and that our receipts and expenditures are being made only in accordance with authorization of our management and our directors; and
 
·  
provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of our assets that could have a material effect on the consolidated financial statements.
 
Because of its inherent limitations, internal control over financial reporting can provide only reasonable assurance and may not prevent or detect misstatements. Also, projections of any evaluation of the effectiveness of such controls in future periods are subject to the risk that the controls may become inadequate because of changes in conditions or that the degree of compliance with the policies and procedures may deteriorate.
 
Our management conducted an assessment of the effectiveness of internal control over financial reporting based on the framework in Internal Control—Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission. Based on this assessment, our management concluded that, as of December 31, 2011, our internal control over financial reporting was effective to provide reasonable assurance regarding the reliability of financial reporting and the preparation of consolidated financial statements for external purposes in accordance with accounting principles generally accepted in the United States.
 
 
This Annual Report on Form 10-K does not include an attestation report of our registered public accounting firm regarding internal control over financial reporting as required by Section 404(c) of the Sarbanes Oxley Act of 2002. Management’s report was not subject to attestation by our registered public accounting firm pursuant to Section 989G(a) of the Dodd-Frank Wall Street Reform and Consumer Protection Act, which permits us to provide only management’s report in this Annual Report on Form 10-K.
 
Item 9B.Other Information
 
None
 
 
 
 
60
 
 
PART III 
 
 
Item 10.  Directors, Executive Officers and Corporate Governance
 
The information required under this item is incorporated herein by reference to the Company’s definitive proxy statement pursuant to Regulation 14A, which proxy statement will be filed with the Securities and Exchange Commission not later than 120 days after the close of the Company’s fiscal year ended December 31, 2011.
 
 
Item 11.  Executive Compensation
 
The information required under this item is incorporated herein by reference to the Company’s definitive proxy statement pursuant to Regulation 14A, which proxy statement will be filed with the Securities and Exchange Commission not later than 120 days after the close of the Company’s fiscal year ended December 31, 2011.
 
 
Item 12.  Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
 
The information required under this item is incorporated herein by reference to the Company’s definitive proxy statement pursuant to Regulation 14A, which proxy statement will be filed with the Securities and Exchange Commission not later than 120 days after the close of the Company’s fiscal year ended December 31, 2011.
 
 
Item 13.  Certain Relationships and Related Party Transactions, and Director Independence
 
The information required under this item is incorporated herein by reference to the Company’s definitive proxy statement pursuant to Regulation 14A, which proxy statement will be filed with the Securities and Exchange Commission not later than 120 days after the close of the Company’s fiscal year ended December 31, 2011.
 
 
Item 14.  Principal Accounting Fees and Services
 
The information required under this item is incorporated herein by reference to the Company’s definitive proxy statement pursuant to Regulation 14A, which proxy statement will be filed with the Securities and Exchange Commission not later than 120 days after the close of the Company’s fiscal year ended December 31, 2011.
 
 
 
61
 
 
 
PART IV 
 
 
Item 15.  Exhibits and Financial Statement Schedules
 
(a)  
The following documents are filed as part of this Annual Report on Form 10-K:
 
(1)  
Financial Statements
 
See index to financial statements on page F-1
 
(2)  
Financial Statement Schedules
 
All schedules to the financial statements are omitted as the required information is either inapplicable or presented in the financial statements or notes thereto.
 
(3)  
Exhibits
 
The information required by this Item is set forth in the Exhibit Index hereto which is incorporated herein by reference.
 
(b)  
Exhibits
 
The information required by this Item is set forth in the Exhibit Index hereto which is incorporated herein by reference.
 
 
 
 
62
 
 
 
SIGNATURES
 
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
 
 
  TENGION, INC.
   
   
Date: March 28, 2012   By:  /s/    John L. Miclot
 
John L. Miclot
President and Chief Executive Officer
 


                                                                
 

 
POWER OF ATTORNEY
 
We, the undersigned officers and directors of Tengion, Inc., hereby severally constitute and appoint John L. Miclot and A. Brian Davis, and each of them singly (with full power to each of them to act alone), our true and lawful attorneys-in-fact and agents, with full power of substitution and resubstitution in each of them for him and in his name, place and stead, and in any and all capacities, to sign for us and in our names in the capacities indicated below any and all amendments to this report, and to file the same, with all exhibits thereto and other documents in connection therewith, with the Securities and Exchange Commission, granting unto said attorneys-in-fact and agents, and each of them, full power and authority to do and perform each and every act and thing requisite or necessary to be done in and about the premises, as full to all intents and purposes as he might or could do in person, hereby ratifying and confirming all that said attorneys-in-fact and agents or any of them, or their or his substitute or substitutes, may lawfully do or cause to be done by virtue hereof.
 
Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the registrant and in the capacities, and on the dates indicated below.
 
Signature
Title
Date
/s/ John L. Miclot
John L. Miclot
President and Chief Executive Officer, Director (Principal Executive Officer)
 
March 28, 2012
     
/s/ A. Brian Davis
A. Brian Davis
Chief Financial Officer and Vice President of Finance (Principal Financial and Accounting Officer)
 
March 28, 2012
     
/s/ David I. Scheer
David I. Scheer
Chairman of the Board of Directors
March 28, 2012
     
/s/ Carl-Johan Dalsgaard
Carl-Johan Dalsgaard, M.D., Ph.D.
Director
March 28, 2012
     
/s/ Scott D. Flora
Scott D. Flora
Director
March 28, 2012
     
/s/ Diane K. Jorkasky
Diane K. Jorkasky, M.D.
Director
March 28, 2012
     
/s/ Richard E. Kuntz
Richard E. Kuntz, M.D., M.Sc.
Director
March 28, 2012
     
/s/ Lorin J. Randall
Lorin J. Randall
Director
March 28, 2012

 
 
 
 
63
 
 
 

TENGION, INC.
 
INDEX TO FINANCIAL STATEMENTS
 
 
 
 
Page
   
Report of Ernst & Young LLP, Independent Registered Public Accounting Firm
   
Report of KPMG LLP, Independent Registered Public Accounting Firm
   
Balance Sheets
   
Statements of Operations
   
Statements of Redeemable Convertible Preferred Stock and Stockholders’ Equity (Deficit)
   
Statements of Cash Flows
   
Notes to the Financial Statements
 
 
 
 
 
 
 
 
 
 
F-1
 
 
 
 
 
Report of Independent Registered Public Accounting Firm
 
Board of Directors
Tengion, Inc.

We have audited the accompanying balance sheets of Tengion, Inc. (the Company) (a development stage company), as of December 31, 2011 and 2010, and the related statements of operations, redeemable convertible preferred stock and stockholders’ equity (deficit), and cash flows for each of the three years in the period ended December 31, 2011, and for the period from July 10, 2003 (inception) through December 31, 2011.  These financial statements are the responsibility of the Company’s management.  Our responsibility is to express an opinion on these financial statements based on our audits.  The financial statements for the period from July 10, 2003 (inception) through December 31, 2008 were audited by other auditors whose report dated May 29, 2009 expressed an unqualified opinion on those statements.  The financial statements for the period July 10, 2003 (inception) through December 31, 2008 include a net loss of $107.4 million.  Our opinion on the statements of operations, redeemable convertible preferred stock and stockholders’ equity (deficit) and cash flows for the period July 10, 2003 (inception) through December 31, 2011, insofar as it relates to amounts for prior periods through December 31, 2008, is based solely on the report of other auditors.
 
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.  We were not engaged to perform an audit of the Company’s internal control over financial reporting.  Our audits included consideration of internal control over financial reporting as a basis for designing audit procedures that are 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, and evaluating the overall financial statement presentation.  We believe that our audits provide a reasonable basis for our opinion.
 
In our opinion, based on our audits and the report of other auditors, the financial statements referred to above present fairly, in all material respects, the financial position of the Company at December 31, 2011 and 2010, and the results of its operations and its cash flows for each of the three years in the period ended December 31, 2011 and the period from July 10, 2003 (inception) through December 31, 2011, in conformity with accounting principles generally accepted in the United States.
 
The accompanying financial statements have been prepared assuming the Company will continue as a going concern. As more fully described in Note 2 to the financial statements, the Company has recurring losses from operations and will require additional capital to support operations. These conditions raise substantial doubt about the Company's ability to continue as a going concern. Management's plans in regard to these matters are also described in Note 2. The December 31, 2011 financial statements do not include any adjustments that may result from the outcome of this uncertainty.
 

 
/s/ ERNST & YOUNG LLP
 
Philadelphia, Pennsylvania
March 28, 2012
 
 
 
 
 
 
 
F-2
 
 
 
 
Report of Independent Registered Public Accounting Firm
 
The Board of Directors and Stockholders
Tengion, Inc.:
 
We have audited the accompanying statements of operations, redeemable convertible preferred stock and stockholders’ deficit, and cash flows of Tengion, Inc. (a development-stage company) (the Company) for the period from July 10, 2003 (inception) through December 31, 2008. These financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on these 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. An audit includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements. An audit also includes assessing the accounting principles used and significant estimates made by management, as well as evaluating the overall financial statement presentation. We believe that our audits provide a reasonable basis for our opinion.
 
In our opinion, the financial statements referred to above present fairly, in all material respects, the results of operations and the cash flows of Tengion, Inc. for the period from July 10, 2003 (inception) through December 31, 2008, in conformity with U.S. generally accepted accounting principles.
 
/s/ KPMG LLP
 
Philadelphia, Pennsylvania
May 29, 2009, except as to
Note 3(l), which is as of March 24, 2010

 
 
 
 
F-3
 
 
 
 
TENGION, INC.
(A Development-Stage Company)

Balance Sheets
(in thousands, except per share data)

   
December 31,
   
2010
  
2011
             
ASSETS
Current assets:
  
              
Cash and cash equivalents, including $1,661 and $1,194 of cash as of December 31, 2010 and 2011, respectively, collateralizing letters of credit (Note 16)
  
$
11,972
  
  
$
9,244
  
Short-term investments                                                                                       
    
              —
      
6,066
  
Deferred equity offering costs                                                                                       
  
  
41
  
  
  
                —
  
Prepaid expenses and other                                                                                       
  
  
492
  
  
  
408
  
Total current assets                                                                                
  
  
12,505
  
  
  
15,718
  
Property and equipment, net of accumulated depreciation of $19,830 and $12,622 as of December 31, 2010 and 2011, respectively
  
  
11,492
  
  
  
1,021
  
Other assets                                                                                           
  
  
147
  
  
  
1,078
  
Total assets                                                                                           
  
$
24,144
  
  
$
17,817
  
 
  
              
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
  
              
Current portion of long-term debt                                                                                       
  
$
4,016
  
  
$
2,205
  
Current portion of lease liability                                                                                       
  
  
                —
  
  
  
739
  
Accounts payable                                                                                       
  
  
1,194
  
  
  
829
  
Accrued compensation and benefits                                                                                       
    
1,291
      
2,354
  
Accrued expenses                                                                                       
    
1,552
      
437
  
Warrant liability                                                                                       
    
—
      
2,511
  
Other current liabilities                                                                                       
  
  
205
  
  
  
—
  
Total current liabilities                                                                                
  
  
8,258
  
  
  
9,075
  
Long-term debt                                                                                           
  
  
4,585
  
  
  
2,782
  
Lease liability                                                                                           
  
  
          —
  
  
  
943
  
Other liabilities                                                                                           
  
  
241
  
  
  
2
  
Total liabilities                                                                                
  
  
13,084
  
  
  
12,802
  
                 
Commitments and contingencies (Note 16)                                                                                           
  
  
            —
  
  
  
—
  
 
  
              
Stockholders’ equity:
  
              
Preferred stock, $0.001 par value; 10,000 shares authorized; zero shares issued or outstanding at December 31, 2010 and 2011, respectively
    
            —
  
  
  
—
  
Common stock, $0.001 par value; 90,000 shares authorized; 12,386 and 23,814 shares issued and outstanding at December 31, 2010 and  2011, respectively
  
  
12
  
  
  
24
  
Additional paid-in capital                                                                                       
  
  
222,231
      
235,235
  
Deficit accumulated during the development stage                                                                                       
  
  
(211,183
)
    
(230,244
)
Total stockholders’ equity                                                                                
  
  
11,060
  
  
  
5,015
  
Total liabilities and stockholders’ equity                                                                                           
  
$
24,144
    
$
17,817
  
                 

The accompanying notes are an integral part of these financial statements.
 
 
 
F-4
 
 
 
TENGION, INC.
(A Development-Stage Company)

Statements of Operations
(in thousands, except per share data)
 
    Year Ended December 31,     Period from
July 10, 2003
(inception)
through
December 31,
    Period from
July 10, 2003
(inception)
through
December 31,
 
    2009     2010     2011     2008     2011  
Operating expenses:
                              
Research and development                                                 
   $ 17,948     $ 12,855     $ 13,293     $ 73,761     $ 117,857  
General and administrative                                                 
     5,527       6,032       7,191       23,143       41,893  
Depreciation                                                 
     4,937       4,862       3,141       10,212       23,152  
Impairment of property and equipment
     —       —       7,371       —       7,371  
Other expense                                                 
     —       —       1,705       —       1,705  
                                         
Total operating expenses                                                      
     (28,412 )      (23,749 )      (32,701 )      (107,116 )      (191,978 ) 
Interest income                                                      
     211       62       53       8,185       8,511  
Interest expense                                                      
     (3,468 )     (2,105 )     (849 )     (8,467 )     (14,889 )
Change in fair value of warrant liability
     1,824       192       14,436       47       16,499  
                                         
Net loss                                                      
     (29,845 )      (25,600 )      (19,061 )    $ (107,351 )   $ (181,857 )
                                         
Accretion of redeemable convertible preferred stock to redemption value
     (14,059 )      (3,993 )      —                  
                                         
Net loss attributable to common stockholders
   $ (43,904 )   $ (29,593 )   $ (19,061 )                
                                         
Basic and diluted net loss attributable to common stockholders per share
   $ (62.95 )   $ (3.22 )   $ (0.88 )                
                                         
Weighted-average common stock outstanding – basic and diluted
     697       9,197       21,629                  

 
The accompanying notes are an integral part of these financial statements.
 


 
F-5
 


TENGION, INC.
(A Development-Stage Company)

Statements of Redeemable Convertible Preferred Stock and Stockholders’ Equity (Deficit)
(in thousands, except per share data)
                                                               
               
Stockholders’ equity (deficit)
                                                 
Deficit accumulated during the development stage
        
 
Redeemable convertible
preferred stock
    
Common stock
  
Additional paid-in capital
  
Deferred compensation
          
 
Shares
  
Amount
    
Shares
  
Amount
        
Total
                                                               
Balance, July 10, 2003
—
    
$
—
        
—
  
  
$
—
  
  
$
—
  
  
$
—
  
  
$
—
  
  
$
—
  
Issuance of common stock to initial stockholder
—
      
—
        
2,000
  
    
2
  
    
(2
) 
    
—
  
    
—
  
    
—
  
Effect of reverse stock split (see Note 3)
—
      
—
        
(1,862
) 
    
(2
) 
    
2
  
    
—
  
    
—
  
    
—
  
Net loss
—
      
—
        
—
  
    
—
  
    
—
  
    
—
  
    
(1,032
) 
    
(1,032
) 
Balance, December 31, 2003
—
      
—
        
138
  
    
—
  
    
—
      
—
  
    
(1,032
) 
    
(1,032
) 
Issuance of Series A Redeemable Convertible Preferred stock at $1.62 per share, net of expenses
18,741
      
30,126
        
—
  
    
—
  
    
—
  
    
—
  
    
—
  
    
—
  
Conversion of notes payable, including interest
2,203
      
3,562
        
—
  
    
—
  
    
—
  
    
—
  
    
—
  
    
—
  
Issuance of restricted common stock to employees and nonemployees
—
      
—
        
240
  
    
1
  
    
336
  
    
(336
) 
    
—
  
    
1
  
Issuance of common stock to consultants
—
      
—
        
140
  
    
—
  
    
21
  
    
—
  
    
—
  
    
21
  
Issuance of common stock to convertible noteholders
—
      
—
        
93
  
    
—
  
    
67
  
    
—
  
    
—
  
    
67
  
Issuance of options to purchase common stock to consultants for services rendered
—
      
—
        
—
  
    
—
  
    
14
  
    
(14
) 
    
—
  
    
—
  
Amortization of deferred compensation
—
      
—
        
—
  
    
—
  
    
—  
  
    
23
  
    
—
  
    
23
  
Change in value of restricted common stock subject to vesting
—
      
—
        
—
  
    
—
  
    
11
  
    
(11
) 
    
—
  
    
—
  
Accretion of redeemable convertible preferred stock to redemption value
—
      
1,035
        
—
  
    
—
  
    
—
  
    
—
  
    
(1,035
) 
    
(1,035
) 
Net loss
—
      
—
        
—
  
    
—
  
    
—
  
    
—
  
    
(2,438
) 
    
(2,438
) 
Balance, December 31, 2004
20,944
      
34,723
        
611
  
    
1
  
    
449
  
    
(338
) 
    
(4,505
) 
    
(4,393
) 
Issuance of Series A Redeemable Convertible Preferred stock at $1.62 per share, net of expenses
3,247
      
5,223
        
—
  
    
—
  
    
—
  
    
—
  
    
—
  
    
—
  
Issuance of restricted common stock to employees and nonemployees at $2.32 per share
—
      
—
        
60
  
    
—
  
    
140
  
    
(139
) 
    
—
  
    
1
  
Issuance of warrants to purchase preferred stock to noteholders
—
      
—
        
—
  
    
—
  
    
681
  
    
—
  
    
—
  
    
681
  
Issuance of options to purchase common stock to consultants for services rendered
—
      
—
        
—
  
    
—
  
    
7
  
    
(7
) 
    
—
  
    
—
  
Amortization of deferred compensation
—
      
—
        
—
  
    
—
  
    
—
  
    
111
  
    
—
  
    
111
  
Accretion of redeemable convertible preferred stock to redemption value
—
      
3,164
        
—
  
    
—
  
    
—
  
    
—
  
    
(3,164
) 
    
(3,164
) 
Net loss
—
      
—
        
—
  
    
—
  
    
—
  
    
—
  
    
(9,627
) 
    
(9,627
) 
Balance, December 31, 2005
24,191
      
43,110
        
671
  
    
1
  
    
1,277
  
    
(373
) 
    
(17,296
) 
    
(16,391
) 
Issuance of Series B Redeemable Convertible Preferred stock at $1.82 per share, net of expenses
27,637
      
50,040
        
—
  
    
—
  
    
—
  
    
—
  
    
—
  
    
—
  
Issuance of restricted common stock to employees
—
      
—
        
3
  
    
—
  
    
—
  
    
—
      
—
  
    
—
  
Issuance of common stock upon exercise of options
—
      
—
        
4
  
    
—
  
    
9
  
    
—
  
    
—
  
    
9
  
Repurchased nonvested restricted stock
—
      
—
        
(14
) 
    
—
  
    
—
  
    
—
      
—
  
    
—
  
Reclassification of deferred compensation
—
      
—
        
—
  
    
—
  
    
(373
)
    
373
  
    
—
  
    
—
  
Reclassification of warrants to purchase preferred stock
—
      
—
        
—
  
    
—
  
    
(681
)
    
—
  
    
—
  
    
(681
) 
Stock-based compensation expense
—
      
—
        
—
  
    
—
  
    
400
      
—
  
    
—
  
    
400
  
Accretion of redeemable convertible preferred stock to redemption value
—
      
5,640
        
—
  
    
—
  
    
—
  
    
—
  
    
(5,640
) 
    
(5,640
) 
Net loss
—
      
—
        
—
  
    
—
  
    
—
  
    
—
  
    
(20,873
) 
    
(20,873
) 
Balance, December 31, 2006
51,828
      
98,790
        
664
  
    
1
  
    
632
  
    
—
      
(43,809
) 
    
(43,176
) 
Issuance of Series C Redeemable Convertible Preferred stock at $1.82 per share, net of expenses
18,333
      
33,219
        
—
  
    
—
  
    
—
  
    
—
  
    
—
  
    
—
  
Issuance of common stock upon exercise of options
—
      
—
        
16
  
    
—
  
    
60
  
    
—
  
    
—
  
    
60
  
Repurchased vested restricted stock
—
      
—
        
(5
) 
    
—
  
    
(94
)
    
—
      
—
  
    
(94
)
Stock-based compensation expense
—
      
—
        
—
  
    
—
  
    
664
      
—
  
    
—
  
    
664
  
Accretion of redeemable convertible preferred stock to redemption value
—
      
8,742
        
—
  
    
—
  
    
—
  
    
—
  
    
(8,742
) 
    
(8,742
) 
Net loss
—
      
—
        
—
  
    
—
  
    
—
  
    
—
  
    
(30,988
) 
    
(30,988
) 
Balance, December 31, 2007
70,161
    
$
140,751
        
675
  
  
$ 
1
  
  
$
1,262
  
  
$
—
    
$
(83,539
) 
  
$
(82,276
) 

The accompanying notes are an integral part of these financial statements.
 
F-6
 



TENGION, INC.
(A Development-Stage Company)

Statements of Redeemable Convertible Preferred Stock and Stockholders’ Equity (Deficit) – (continued)
(in thousands, except per share data)
 

                                                               
               
Stockholders’ equity (deficit)
                                                 
Deficit accumulated during the development stage
        
 
Redeemable convertible
preferred stock
    
Common stock
  
Additional paid-in capital
  
Deferred compensation
          
 
Shares
  
Amount
    
Shares
  
Amount
        
Total
                                                               
Balance, December 31, 2007
70,161
    
$
140,751
        
675
  
  
 $
1
  
  
$
1,262
  
  
 $
—
    
$
(83,539
) 
  
$
(82,276
) 
Issuance of Series C Redeemable Convertible Preferred stock at $1.82 per share, net of expenses
11,793
      
21,352
        
—
  
    
—
  
    
—
  
    
—
  
    
—
  
    
—
  
Issuance of common stock upon exercise of options
—
      
—
        
8
  
    
—
  
    
28
  
    
—
  
    
—
  
    
28
  
Repurchased vested restricted stock
—
      
—
        
(1
) 
    
—
  
    
—
      
—
      
—
  
    
—
  
Stock-based compensation expense
—
      
—
        
—
  
    
—
  
    
1,317
      
—
  
    
—
  
    
1,317
  
Accretion of redeemable convertible preferred stock to redemption value
—
      
11,754
        
—
  
    
—
  
    
—
  
    
—
  
    
(11,754
) 
    
(11,754
) 
Net loss
—
      
—
        
—
  
    
—
  
    
—
  
    
—
  
    
(42,393
) 
    
(42,393
) 
Balance, December 31, 2008
81,954
      
173,857
        
682
  
    
1
  
    
2,607
  
    
—
      
(137,686
) 
    
(135,078
) 
Issuance of common stock upon exercise of options
—
      
—
        
20
  
    
—
  
    
54
  
    
—
  
    
—
  
    
54
  
Stock-based compensation expense
—
      
—
        
—
  
    
—
  
    
855
      
—
  
    
—
  
    
855
  
Accretion of redeemable convertible preferred stock to redemption value
—
      
14,059
        
—
  
    
—
  
    
—
  
    
—
  
    
(14,059
) 
    
(14,059
) 
Net loss
—
      
—
        
—
  
    
—
  
    
—
  
    
—
  
    
(29,845
) 
    
(29,845
) 
Balance, December 31, 2009
81,954
      
187,916
        
702
  
    
1
  
    
3,516
  
    
—
      
(181,590
) 
    
(178,073
) 
Issuance of common stock upon exercise of options
—
      
—
        
32
  
    
—
  
    
14
  
    
—
  
    
—
  
    
14
  
Accretion of redeemable convertible preferred stock to redemption value
—
      
3,993
        
—
  
    
—
  
    
—
  
    
—
  
    
(3,993
) 
    
(3,993
) 
Conversion of preferred stock to common stock
(81,954
)
    
(191,909
)
      
5,652
  
    
5
  
    
191,904
      
—
  
    
—
  
    
191,909
  
Conversion of preferred stock warrants to common stock warrants
—
      
—
        
—
  
    
—
  
    
123
      
—
  
    
—
  
    
123
  
Proceeds from initial public offering, net of expenses
—
      
—
        
6,000
  
    
6
  
    
25,721
      
—
  
    
—
  
    
25,727
  
Stock-based compensation expense
—
      
—
        
—
  
    
—
  
    
953
      
—
  
    
—
  
    
953
  
Net loss
—
      
—
        
—
  
    
—
  
    
—
  
    
—
  
    
(25,600
) 
    
(25,600
) 
Balance, December 31, 2010
—
      
—
        
12,386
  
    
12
  
    
222,231
  
    
—
      
(211,183
) 
    
11,060
  
Proceeds from equity financing, net of expenses
—
      
—
        
11,079
  
    
11
  
    
28,930
      
—
  
    
—
  
    
28,941
  
Issuance of warrants to purchase common stock issued in connection with equity financing
—
      
—
        
—
  
    
—
  
    
(16,947
)
    
—
  
    
—
  
    
(16,947
)
Issuance of common stock upon exercise of options
—
      
—
        
187
      
1
  
    
82
  
    
—
  
    
—
  
    
83
  
Issuance of restricted stock to employees
—
      
—
        
311
      
—
      
—
      
—
      
—
      
—
  
Cancellation of non-vested restricted stock
—
      
—
        
(149
)
    
—
      
—
      
—
      
—
      
—
  
Issuance of warrants to purchase common stock in connection with debt financing
—
      
—
        
—
  
    
—
  
    
105
  
    
—
  
    
—
  
    
105
  
Stock-based compensation expense
—
      
—
        
—
  
    
—
  
    
834
      
—
  
    
—
  
    
834
  
Net loss
—
      
—
        
—
  
    
—
  
    
—
  
    
—
  
    
(19,061
) 
    
(19,061
) 
Balance, December 31, 2011
—
    
$
—
        
23,814
  
  
$
24
  
  
$
235,235
  
  
$
—
    
$
(230,244
) 
  
$
5,015
  
                                                               

 

 
The accompanying notes are an integral part of these financial statements.
 


 
F-7
 

TENGION, INC.
(A Development-Stage Company)

Statements of Cash Flows
(in thousands)
           
Period from
July 10, 2003
(inception)
through
    
Period from
July 10, 2003
(inception)
through
  
   
Year Ended December 31,
     December 31,
2008
    December 31,  
   
2009
    
2010
    
2011
  
2011
  
Cash flows from operating activities:
                            
Net loss 
   $ (29,845 )   $ (25,600 )   $ (19,061 )   $ (107,351 ) $ (181,857 )
Adjustments to reconcile net loss to net cash used in operating activities:
                                      
Depreciation   
     4,937       4,862       3,141       10,212     23,152  
Change in fair value of warrant liability
     (1,824 )      (192 )      (14,436 )     (47 )    (16,499 ) 
Charge related to lease liability  
     —       —       1,705       —     1,705  
Loss on disposition of property and equipment
     101       2       —       16     119  
Impairment of property and equipment
     —       —       7,371       —     7,371  
Amortization of net discount on short-term investments
     —       —       —       (149 )    (149 ) 
Noncash interest expense 
     460       325       162       1,601     2,548  
Noncash rent expense (income)
     19       4       (24 )     218     217  
Stock-based compensation expense
     855       954       834       2,536     5,179  
Changes in operating assets and liabilities:
                                      
Prepaid expenses and other assets
     71       (137 )      (802 )     (760 )    (1,628 ) 
Accounts payable    
     969       (631 )      (283 )     815     870  
Accrued expenses and other 
     (1,764 )      1,000       (495 )      4,021     2,763  
Net cash used in operating activities 
     (26,021 )      (19,411 )      (21,888 )      (88,888 )    (156,208 ) 
                                       
Cash flows from investing activities:
                                      
Purchases of short-term investments   
     (17,432 )     (33,445 )      (13,066 )     (260,565 )    (324,508 ) 
Sales and redemptions of short-term investments
     19,590       35,944       7,000       256,057     318,591  
Cash paid for property and equipment
     (289 )     (152 )      (81 )     (31,152 )    (31,674 ) 
Proceeds from the sale of property and equipment
     7       —       —       4     11  
Net cash provided by (used in) investing activities
     1,876       2,347       (6,147 )      (35,656 )    (37,580 ) 
                                       
Cash flows from financing activities:
                                      
Proceeds from sale of redeemable convertible preferred stock, net
     —       —       —       139,960     139,960  
Proceeds from sales of common stock and warrants, net
     47       25,748       29,023       99     54,917  
Repurchases of common stock 
     —       —       —       (94 )    (94 ) 
Proceeds from long-term debt, net of issuance costs
     841       —       4,908       33,768     39,517  
Payments on long-term debt 
     (5,883 )      (13,516 )      (8,624 )      (3,245 )    (31,268 ) 
Net cash (used in) provided by financing activities
     (4,955 )      12,232       25,307       170,488     203,032  
                                       
Net (decrease) increase in cash and cash equivalents
     (29,140 )      (4,832 )      (2,728 )     45,944     9,244  
Cash and cash equivalents, beginning of period
     45,944       16,804       11,972       —     —  
Cash and cash equivalents, end of period
   $ 16,804     $ 11,972     $ 9,244     $ 45,944   $ 9,244  
                                       

The accompanying notes are an integral part of these financial statements.
 
 
 
 
F-8
 
 

TENGION, INC.
(A Development-Stage Company)
 
Notes to Financial Statements
 
(1)           Organization and Nature of Operations
 
Tengion, Inc. (the Company) was incorporated in Delaware on July 10, 2003.  The Company is focused on discovering, developing, manufacturing and commercializing replacement human neo-organs derived from a patient’s own cells, or autologous cells.  Building on clinical and preclinical experience, the Company is leveraging its platform to develop its Neo-Urinary Conduit for bladder cancer patients and its Neo-Kidney Augment for patients with advanced chronic kidney disease.  The Company operates as a single business segment.
 
Operations of the Company are subject to certain risks and uncertainties, including, among others, uncertainty of product candidate development; technological uncertainty; dependence on collaborative partners; uncertainty regarding patents and proprietary rights; comprehensive government regulations; having no commercial manufacturing experience, marketing or sales capability or experience; and dependence on key personnel.
 
(2)           Management’s Plans to Continue as a Going Concern
 
The accompanying financial statements have been prepared on a going-concern basis, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business.  The Company has incurred losses since inception and has a deficit accumulated during the development stage of $230.2 million as of December 31, 2011, including $48.4 million of cumulative accretion on redeemable convertible preferred stock through April 2010.  The Company anticipates incurring additional losses until such time, if ever, that it can generate significant sales of its therapeutic product candidates currently in development or enters into cash flow positive business development transactions.
 
Based upon its current expected level of operating expenditures and debt repayment, and assuming it is not required to settle any outstanding warrants in cash, the Company expects to be able to fund its operations to September 2012.  The Company intends to pursue additional sources of capital to continue its business operations as currently conducted and fund deficits in operating cash flows.  There is no assurance that such financing will be available when needed or, if available, on terms acceptable to the Company.
 
In November 2011, the Company’s Board of Directors approved a restructuring plan designed to fund the Company’s lead development programs through key milestones in 2012, eliminate plans to use its facility in East Norriton, Pennsylvania as a manufacturing center, and centralize its research and development operations in its leased facility in Winston-Salem, North Carolina.  The Company has retained a few administrative employees in its facility in East Norriton, Pennsylvania, and is exploring options to significantly reduce the amount of space it currently rents.
 
In the event financing is not obtained, the Company could pursue additional headcount reductions and other cost cutting measures to preserve cash as well as explore the sale of selected assets to generate additional funds.If the Company is required to significantly reduce operating expenses and delay, reduce the scope of, or eliminate one or more of its development programs, these events could have a material adverse effect on the Company's business, results of operations and financial condition.
 
These factors could significantly limit the Company's ability to continue as a going concern. The financial statements do not include any adjustments relating to recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might be necessary should the Company be unable to continue in existence.
 
 
 
 
F-9
 
 
 
(3)           Summary of Significant Accounting Policies
 
(a)Use of Estimates
 
The preparation of financial statements, in accordance 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 and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period.  Actual results could differ from those estimates.
 
(b)Fair Value of Financial Instruments
 
As of December 31, 2010 and 2011, the carrying amounts of financial instruments held by the Company, which include cash equivalents, short-term investments, prepaid expenses and other current assets, accounts payable, and accrued expenses, approximate fair value due to the short-term nature of those instruments.  In addition, the carrying value of the Company’s debt instruments, which do not have readily ascertainable market values, approximate fair value, given that the interest rates on outstanding borrowings approximate market rates.
 
(c)Cash and Cash Equivalents
 
The Company considers all highly liquid investments purchased with an original maturity of three months or less to be cash equivalents.  As of December 31, 2010 and 2011, cash and cash equivalents included government-backed money market funds, commercial paper, and various bank deposit accounts.  As of December 31, 2011, $1.2 million of the Company’s cash is held in a separate account collateralizing letters of credit issued by a bank in favor of the landlord of our leased facility in East Norriton, Pennsylvania.  See Note 16 for more details.
 
(d)Short-term Investments
 
The Company classifies investments as held-to-maturity at the time of purchase and reevaluates such designation as of each balance sheet date.  Securities are classified as held-to-maturity when the Company has the positive intent and the ability to hold the securities until maturity.  Held-to-maturity investments are recorded at amortized cost, adjusted for the accretion of discounts or premiums.  Discounts or premiums are accreted into interest income over the life of the related investment using the straight-line method, which approximates the effective- yield method.  Dividend and interest income are recognized when earned.
 
(e)Property and Equipment
 
Property and equipment are stated at cost.  Depreciation is provided over the estimated useful lives of the assets using the straight-line method.  The Company uses a life of three years for computer equipment, five years for laboratory and office and warehouse equipment, seven years for furniture and fixtures, and the lesser of the useful life of the asset or the remaining life of the underlying facility lease for leasehold improvements.  Expenditures for maintenance, repairs, and betterments that do not prolong the useful life of the asset are charged to expense as incurred.  The Company capitalizes interest in connection with the construction of property and equipment.
 
(f)Impairment of Long-Lived Assets
 
Long-lived assets, such as property and equipment, are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable.  Recoverability of assets to be held and used is measured by a comparison of the carrying amount of an asset to estimated undiscounted future cash flows expected to be generated by the asset.  If the carrying amount of an asset exceeds its estimated future cash flows, then an impairment charge is recognized by the amount by which the carrying amount of the asset exceeds the fair value of the asset.  During the year ended December 31, 2011, the Company recorded a charge for impairment of property and equipment.  See Note 6 for additional information.
 
 
 
 
F-10
 
 
 
(g)Research and Development
 
Research and development costs are charged to expense as incurred.  Research and development costs consist of personnel related expenses, including salaries, benefits, travel, and other related expenses, including stock-based compensation; payments made to third party contract research organizations for preclinical studies, investigative sites for clinical trials, and consultants; costs associated with regulatory filings and the advancement of the Company’s product candidates through preclinical studies and clinical trials; laboratory and other supplies; manufacturing development costs; and related facility maintenance.
 
(h)Income Taxes
 
Income taxes are accounted for under the asset-and-liability method.  Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases and operating loss and tax credit carryforwards.  Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled.  The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date.
 
(i)Stock-Based Compensation
 
The Company measures and recognizes compensation expense for all employee stock-based payments at fair value, net of estimated forfeitures, over the vesting period of the underlying stock-based awards.  In addition, the Company accounts for stock-based compensation to nonemployees in accordance with the accounting guidance for equity instruments that are issued to other than employees.
 
Determining the appropriate fair value of stock-based payment awards require the input of subjective assumptions, including the expected life of the stock-based payment awards and stock price volatility.  The Company uses the Black-Scholes option-pricing model to value its stock option awards.  The assumptions used in calculating the fair value of stock-based payment awards represent management’s best estimates and involve inherent uncertainties and the application of management’s judgment.  As a result, if factors change and management uses different assumptions, stock-based compensation expense could be materially different in the future.  Since the Company does not have sufficient historical volatility of its stock for the expected term of its options, it uses comparable public companies as a basis for its expected volatility to calculate the fair value of option grants.
 
The estimation of the number of stock awards that will ultimately vest requires judgment, and to the extent actual results or updated estimates differ from the Company’s current estimates, such amounts will be recorded as an adjustment in the period in which estimates are revised.  The Company considers many factors when estimating expected forfeitures for stock awards granted to employees, consultants and directors, including types of awards, employee class, and an analysis of the Company’s historical and known forfeitures on existing awards.  Under the true-up provisions of the stock based compensation guidance, the Company records additional expense if the actual forfeiture rate is lower than estimated, and a recovery of expense if the actual forfeiture rate is higher than estimated, during the period in which the options vest.
 
(j)Net Loss Per Share
 
Basic and diluted net loss per common share is determined by dividing net loss attributable to common stockholders by the weighted-average common shares outstanding less the weighted-average shares subject to repurchase during the period.  For all periods presented, the outstanding Series A, Series B, and Series C, common stock options and preferred and common stock warrants have been excluded from the calculation because their effect would be anti-dilutive.  Therefore, the weighted-average shares used to calculate both basic and diluted loss per share are the same.
 
 
 
 
F-11
 
 
 
The following potentially dilutive securities have been excluded from the computations of diluted weighted-average shares outstanding as of December 31, 2009, 2010, and 2011, as they would be anti-dilutive:

                         
   
Year Ended December 31,
   
2009
  
2010
  
2011
Shares underlying warrants outstanding
    
1,605,439
      
114,342
      
10,645,888
  
Shares underlying options outstanding
    
712,379
      
1,377,710
      
1,746,970
  
Unvested restricted stock
    
432
      
—
      
139,779
  
Shares of redeemable convertible preferred stock
    
81,954,127
      
—
      
—
  

 (k)Deferred Equity Offering Costs
 
Deferred equity offering costs include costs directly attributable to the Company’s offering of its equity securities.  In accordance with FASB ASC 340-10, Other Assets and Deferred Costs, these costs are deferred and capitalized as part of other assets.  Costs attributable to the equity offerings will be charged against the proceeds of the offering once completed.
 
(l)Reverse Stock Split
 
On February 18, 2010, the board of directors of the Company, subject to stockholder approval, approved a reverse stock split of the Company’s common stock at a ratio of one share for every 14.5 shares previously held.  The reverse stock split was effective on March 24, 2010.  All common stock share and per-share data included in these financial statements reflect such reverse stock split.
 
(m)Reclassification
 
Certain prior period amounts in the financial statements and notes thereto have been reclassified to conform to the current period presentation.
 
 
 
 
 
 
 
 
 
F-12
 
 
 
 
(4)  
Supplemental Cash Flow Information
 
The following table contains additional cash flow information for the periods reported (in thousands).
                   
   
Year Ended December 31,
    
Period from
July 10, 2003
(inception)
through
December 31,
    
Period from
July 10, 2003
(inception)
through
December 31,
  
    2009     2010     2011     2008     2011  
Supplemental cash flow disclosures:
                              
Noncash investing and financing activities:
                              
Conversion of note principal to redeemable convertible preferred stock
   $ —     $ —     $ —     $ 3,562     $ 3,562  
Convertible note issued to initial stockholder for consulting expense
     —       —       —       210       210  
Fair value of warrants issued with issuance of long-term debt
     9       —       105       2,176       2,290  
Fair value of warrants issued with sale of common stock
     —       —       16,947       —       16,947  
Conversion of redeemable convertible preferred stock into 5,652 shares of common stock
     —       191,909       —       —       191,909  
Conversion of warrant liability
     —       123       —       —       123  
Noncash property and equipment additions
     80       41       —       52       —  
Cash paid for interest, net of amounts capitalized
     3,008       1,695       722       6,853       12,278  

(5)  
Short-term Investments and Financial Instruments
 
As of December 31, 2010 and 2011, the carrying amounts of financial instruments held by the Company, which include cash equivalents, prepaid expenses and other current assets, accounts payable, and accrued expenses, approximate fair value due to the short-term nature of those instruments.  In addition, the carrying value of the Company’s debt instruments, which do not have readily ascertainable market values, approximate fair value, given that the interest rates on outstanding borrowings approximate market rates.  See below and Note 13 for a discussion of fair value of the warrants.
 
As of December 31, 2011, short-term investments consisted of investments in commercial paper and U.S. government agency and corporate securities of $6.1 million.  As of December 31, 2010, the Company had no short-term investments.  The Company had the ability and intent to hold these investments until maturity and therefore has classified the investments as held-to-maturity.  Due to the short-term nature of these investments, unrealized gains and losses have been deemed temporary and therefore not recognized in the accompanying financial statements.  Income generated from short-term investments is recorded to interest income.
 
The fair value guidance requires fair value measurements be classified and disclosed in one of the following three categories:
 
·  
Level 1: Unadjusted quoted prices in active markets that are accessible at the measurement date for identical, unrestricted assets or liabilities;
 
·  
Level 2: Quoted prices in markets that are not active, or inputs which are observable, either directly or indirectly, for substantially the full term of the asset or liability;
 
·  
Level 3: Prices or valuation techniques that require inputs that are both significant to the fair value measurement and unobservable (i.e., supported by little or no market activity).
 
 
 
 
F-13
 
 
 
The following fair value hierarchy table presents information about each major category of the Company’s financial assets and liability measured at fair value on a recurring basis as of December 31, 2010 and 2011 (in thousands).

   
Fair value measurement at reporting date using:
        
   
Quoted prices in active markets for identical assets (Level 1)
    
Significant other observable inputs
(Level 2)
    
Significant unobservable inputs
(Level 3)
    
Total
  
At December 31, 2010
                        
Assets:
                        
Cash and cash equivalents
   $ 11,972     $ —     $ —     $ 11,972  
                                 
At December 31, 2011
                                
Assets:
                                
Cash and cash equivalents
   $ 9,244     $ —     $ —     $ 9,244  
Short-term investments
                                
    U.S. government agency funds
     4,021       —       —       4,021  
    Corporate securities
     2,045       —       —       2,045  
Short-term investments
     6,066       —       —       6,066  
    $ 15,310     $ —     $ —     $ 15,310  
                                 
Liabilities:
                                
Warrant liability
   $ —     $ —     $ 2,511     $ 2,511  

The reconciliation of warrant liability measured at fair value on a recurring basis using unobservable inputs (Level 3) is as follows (in thousands):

         
Balance at January 1, 2010
  
$
314
  
Issuance of additional warrants    
    
—
  
Change in fair value of warrant liability           
    
(191
)
Reclassification of warrant liability to stockholders’ equity                    
    
(123
)
Balance at December 31, 2010
  
$
—
  
Issuance of additional warrants     
    
16,947
  
Change in fair value of warrant liability                    
    
(14,436
)
Balance at December 31, 2011
  
$
2,511
  
         

The fair value of the warrant liability is based on Level 3 inputs.  For this liability, the Company developed its own assumptions that do not have observable inputs or available market data to support the fair value.  See Note 13 for further discussion of the warrant liability.
 
Certain assets and liabilities, including property and equipment, severance benefits and the lease liability, are measured at fair value on a nonrecurring basis.  These assets and liabilities are recognized at fair value when they are deemed to be impaired or in the period in which the liability is incurred.  The Company recorded an impairment charge of $7.4 million in the year ended December 31, 2011, to fully write off certain property and equipment as discussed in Note 6.  The Company recorded another charge of $1.8 million in the year ended December 31, 2011 related to the fair value of the liability incurred at the cease-use date related to certain operating leases as discussed in Note 10.  The Company also recorded $1.7 million charge in the year ended December 31, 2011 related to termination benefits as discussed in Note 9.
 

 
 
F-14
 

 

 
(6)  
Property and Equipment
 
Property and equipment consisted of the following (in thousands):
 
   
December 31,
   
2010
  
2011
Office and warehouse equipment
  
$
356
  
  
$
323
  
Computer equipment
    
1,246
      
985
  
Furniture and fixtures
    
524
      
524
  
Laboratory equipment
    
7,762
      
4,913
  
Leasehold improvements
  
  
21,434
  
  
  
6,898
  
 
  
  
31,322
  
  
  
13,643
  
Less accumulated depreciation
  
  
(19,830
)
  
  
(12,622
)
 
  
$
11,492
  
  
$
1,021
  

During the year ended December 31, 2011, the Company recorded a non-cash property and equipment impairment charge of $7.4 million in connection with the restructuring plan described in Note 9.  Under the restructuring plan, the Company eliminated plans to use its facility in East Norriton, Pennsylvania as a manufacturing center and centralized its research and development operations in its leased facility in Winston-Salem, North Carolina.  The aggregate acquisition value of the impaired assets, most of which were leasehold improvements, was reduced by $17.6 million and the related accumulated depreciation was reduced by $10.2 million as there was no future realizable value related to these assets.

(7)  
Accrued compensation and benefits
 
Accrued compensation and benefits expenses consist of the following (in thousands):
 
   
December 31,
   
2010
  
2011
Accrued severance benefits
  
$
-
  
  
$
1,774
  
Other accrued compensation and benefits
  
  
1,291
  
  
  
580
  
 
  
$
1,291
  
  
$
2,354
  

As of December 31, 2011 accrued severance benefits included $1.5 million related to the restructuring in November 2011 (See Note 9 below for more details).  The Company expects to complete payment of these severance benefits by September 2012.

As of December 31, 2011 accrued severance benefits also included $0.2 million related to the severance agreement the Company entered into with its former president and chief executive officer in June 2011.  The severance agreement provided for the employee to receive 12 monthly severance payments equal to his current monthly salary and a one-time cash payment equal to his target bonus amount for 2011.  During the year ended December 31, 2011, the Company recorded compensation expense within general and administrative expense and a corresponding liability of $0.7 million for the estimated value of the Company’s obligations under the severance agreement.  As of December 31, 2011, the Company paid $0.5 million and anticipates making payments of the remaining $0.2 million through June 30, 2012 in connection with the severance agreement.

 
Other accrued compensation and benefits for the year ended December 31, 2010 and 2011 consisted primarily of accrued bonus of $1.1 million and $0.4 million, respectively.
 

 
F-15
 
 

 
(8)  
Accrued Expenses
 
Accrued expenses consist of the following (in thousands):
 
    December 31,  
   
2010
    
2011
  
Accrued consulting and professional fees
  
$
730
  
  
$
119
  
Accrued research and development
    
679
      
235
  
Other
  
  
143
  
  
  
83
  
 
  
$
1,552
  
  
$
437
  
 
  
              

(9)  
Restructuring Expenses
 
In November 2011, the Company’s Board of Directors approved a restructuring plan designed to fund the Company’s lead development programs through key milestones in 2012, eliminate plans to use its facility in East Norriton, Pennsylvania as a manufacturing center, and centralize its research and development operations in its leased facility in Winston-Salem, North Carolina.   The Company has retained a few administrative employees in its facility in East Norriton, Pennsylvania, and is exploring options to significantly reduce the amount of space it currently rents.  In connection with the restructuring, the Company recorded a non-cash property and equipment impairment charge (see Note 6 for further information) and a non-cash charge related to its lease obligations (see Note 10 for further information).

The Company offered severance benefits to the terminated employees, and estimates a total charge for personnel-related termination costs of approximately $2.0 million. The Company recorded $1.7 million of the total charge in the fourth quarter of 2011, of which $0.8 million is included in research and development expense and $0.9 million is included in general and administrative expense in the accompanying statements of operations.  The Company expects to complete payment of these severance benefits by September 2012.  The following table summarizes the activity related to accrued severance benefits for the year ended December 31, 2011 (in thousands).

   
2011 charges to operations
  
2011 charges
paid
  
Accrual balance as of December 31, 2011
Restructuring Expenses:
                        
Severance benefits
  
$
1,716
    
$
172
    
$
1,544
  
                         

In 2009, the Company implemented a restructuring plan, which reduced headcount by 34 employees.  Expenses incurred related to the 2009 restructuring consisted of termination benefits of $0.9 million in the year ended December 31, 2009, of which $0.6 million is included in research and development expense and $0.3 million is included in general and administrative expense in the accompanying statements of operations.  As of December 31, 2010 all cost associated with the 2009 restructuring plan were incurred and paid.
 
(10)  
Lease Liability
 
The Company entered into an agreement in February 2006 to lease warehouse space effective March 1, 2011, at which time the Company determined it was not likely to utilize the space during the five-year lease term.  Therefore, the Company recorded a liability as of March 1, 2011, the cease-use date, for the fair value of its obligations under the lease.  The most significant assumptions used in determining the amount of the estimated lease liability are the potential sublease revenues and the credit-adjusted risk-free rate utilized to discount the estimated future cash flows.  During 2011, the Company recorded a liability and corresponding expense, which is included in other expense on the statement of operations, of $0.9 million, based on the Company’s estimate of the fair value of its obligations.
 
In connection with the restructuring described in Note 9, the Company determined it was not likely to utilize substantially all of the leased office and manufacturing space in its East Norriton, Pennsylvania facility during the remainder of the lease term.  Therefore, the Company recorded a liability as November 30, 2011, the cease-use date, for the fair value of its obligations under the lease.  During 2011, the Company recorded a liability and corresponding expense, which is included in other expense on the statement of operations, of $0.9 million, based on the Company’s estimate of the fair value of its obligations.
 
 
 
 
F-16
 
 
 
The following table summarizes the activity related to the lease liability for the year ended December 31, 2011 (in thousands).
 
   
Warehouse
space
  
Office and manufacturing
space
  
Total
Balance at January 1, 2011
  
$
—
    
$
—
    
$
—
  
Initial fair value
    
933
      
891
      
1,824
  
Charges utilized
    
(193
)
    
(45
)
    
(238
)
Additional charges to operations
    
88
      
8
      
96
  
Balance at December 31, 2011
    
828
      
854
      
1,682
  
Less current portion
    
(225
)
    
(514
)
    
(739
)
   
$
603
    
$
340
    
$
943
  

(11)  
Debt
 
Total debt outstanding consists of the following (in thousands):

   
December 31,
   
2010
  
2011
Working Capital Note  
  
$
7,257
  
  
$
5,000
  
Equipment and Supplemental Working Capital Notes
  
  
1,015
  
  
  
126
  
Machinery and Equipment Loan    
  
  
477
  
  
  
-
  
Unamortized debt discount    
  
  
(148
)
  
  
(139
)
 
  
  
8,601
  
  
  
4,987
  
Less current portion    
  
  
(4,016
)
  
  
(2,205
)
 
  
$
4,585
  
  
$
2,782
  
 
  
              

Principal payments due as of December 31, 2011 are as follows (in thousands):

         
2012  
  
$
2,274
  
2013  
    
2,620
  
2014  
    
232
  
     
5,126
  
Less unamortized debt discount
    
(139
)
   
$
4,987
  
 
Working Capital Note
        
 
The Company has an outstanding working capital loan (the Working Capital Note) that was utilized to fund working capital needs of the Company.  In March 2011, the Company refinanced the outstanding debt owed to its lender of the Working Capital Note.  Pursuant to the terms of the refinancing, the Company simultaneously borrowed $5 million and repaid the then outstanding principal amount of $4.5 million. The Company modified the classification of long-term debt on its balance sheet as of December 31, 2010 to reflect the revised payment terms included in the new loan agreement.
 
Borrowings under the Working Capital Note are secured by all assets of the Company, except for Intellectual Property and permitted liens that have priority, including liens on equipment subsequently acquired to secure the purchase price or lease obligation, as defined in the loan agreement.  The Company is obligated to make interest-only payments through January 2012, followed by 24 monthly payments of principal and interest at an interest rate of 11.75% per annum.  In connection with the refinancing, the Company granted a warrant to the lender to purchase 70,671 shares of common stock.  The fair value of the warrant issued in connection with the refinancing was $0.1 million, using the Black-Scholes model.  See Note 13 for further discussion on warrants.
 
 
 
 
F-17
 
 
 
In addition, the lender also holds warrants exercisable into 100,874 shares of common stock as of December 31, 2011.  The estimated fair value of all of the warrants issued to the lender has been recorded against the carrying value of the Working Capital Note as an original issue discount (OID), which is being amortized to interest expense over the term of the Working Capital Note.  During the years ended December 31, 2009, 2010 and 2011, the Company recognized a noncash charge to interest expense of $0.4 million, $0.3 million, and $0.1 million, respectively, for the amortization of OID.
 
The Company recorded interest expense of $2.4 million, $1.5 million, and $0.6 million related to the Working Capital Note for the years ended December 31, 2009, 2010 and 2011, respectively.
 
Equipment and Supplemental Working Capital Note
 
In 2005, the Company executed a loan facility with another lender to fund equipment (the Equipment Note) and other asset purchases (the Supplemental Working Capital Note) from July 2005 through December 2010. Borrowings under the Equipment and Supplemental Working Capital Note are secured by equipment, as defined in the loan agreements.  As of December 31, 2011, the Equipment Note and the Supplemental Working Capital Note bear interest at an average rate of 11.49% and 13.52%, respectively.  The Company will make its final monthly principal and interest payment in April 2012 for each of the Equipment Note and the Supplemental Working Capital Note.  The Company recorded interest expense of $0.6 million, $0.3 million, and $0.1 million related to the Equipment and Supplemental Working Capital Notes for the years ended December 31, 2009, 2010 and 2011, respectively.
 
The lender holds warrants exercisable into 9,578 shares of common stock as of December 31, 2011.  The estimated fair value of the warrants issued to this lender has been recorded against the carrying value as OID, which is being amortized as interest expense over the term of the Equipment and Supplemental Working Capital Notes.  During the years ended December 31, 2009, 2010 and 2011, the Company recognized a noncash charge to interest expense of $44,000, $31,000, and $9,000, respectively, for the amortization of OID.
 
Machinery and Equipment Loan
 
In December 2007, the Company executed an agreement with the Commonwealth of Pennsylvania to fund machinery and equipment and other asset purchases (MELF Loan) through December 31, 2010.  Borrowings under the MELF Loan are secured by equipment, as defined in the loan agreement.  Under the terms of the MELF Loan, the Company has a four year period of payments of principal and accrued interest at an annual interest rate of 5% until September 2011 and 5.25% from September 2011 through maturity of the loan. The Company made its final monthly principal and interest payment in December 2011.  The Company recorded interest expense of $54,000, $36,000 and $13,000 related to the MELF Loan for the years ended December 31, 2009, 2010 and 2011, respectively.
 
In connection with the Working Capital Note, Equipment Note, Supplemental Working Capital Note, and the MELF Loan, the Company incurred financing costs of $0.3 million, recorded as other assets on the accompanying balance sheets, which are being amortized on a straight-line basis until maturity of the related notes. The Company recorded amortization of deferred financing costs of  $44,000, $44,000, and $47,000 during the years ended December 31, 2009, 2010 and 2011, respectively, which was included in interest expense on the accompanying statements of operations.
 
Borrowings under the Working Capital Note are secured by all assets of the Company, except for Intellectual Property and permitted liens that have priority, including liens on equipment subsequently acquired to secure the purchase price or lease obligation, as defined in the loan agreement.  Borrowings under the Equipment Note, Supplemental Working Capital Note and the MELF Loan are secured by equipment, as defined in the loan agreements.
 
 
 
 
F-18
 
 
 
(12)  
Capital Structure
 
Common Stock
 
Since inception, the Company has sold common stock to certain officers, directors, employees, consultants, and Scientific Advisory Board members.  As of December 31, 2011, the Company was authorized to issue 90,000,000 shares of common stock.  Each holder of common stock is entitled to one vote for each share held.  The Company will, at all times, reserve and keep available out of its authorized but unissued shares of common stock sufficient shares to effect the exercise of outstanding stock options and warrants.
 
March 2011 Equity Financing
 
In March 2011, the Company closed a private placement transaction pursuant to which the Company sold securities consisting of 11,079,250 shares of common stock and warrants to purchase 10,460,875 shares of common stock.  The purchase price per security was $2.83.  The Company received net proceeds of $28.9 million.

In connection with the March 2011 equity financing, the Company filed a registration statement with the SEC for the registration of the total number of shares sold to the investors and shares issuable upon exercise of the warrants and the registration statement was declared effective by the SEC on May 16, 2011.  The Company is required to use commercially reasonable efforts to cause the registration statement to remain continuously effective until such time when all of the registered shares are sold or such shares may be sold by non-affiliates without volume or manner-of-sale restrictions pursuant to Rule 144 of the Securities Act and without the requirement for the Company to be in compliance with the current public information requirement under Rule 144.  In the event the Company fails to meet certain legal requirements in regards to the registration statement, it will be obligated to pay the investors, as partial liquidated damages and not as a penalty, an amount in cash equal to 1.5% of the aggregate purchase price paid by investors for each monthly period that the registration statement is not effective, up to a maximum aggregate payment of 6% of the purchase price paid by investors, except that if the Company fails to satisfy the current public information requirement pursuant to Rule 144(c)(1), the maximum aggregate payment would be 12% of the purchase price paid by investors.  If the Company determines a registration payment arrangement in connection with the securities issued in March 2011 is probable and can be reasonably estimated, a liability will be recorded. As of December 31, 2011, we concluded the likelihood of having to make any payments under the arrangements was remote, and therefore did not record any related liability.
 
Initial Public Offering
 
In April 2010, the Company completed its initial public offering, selling 6,000,000 shares of common stock at an initial public offering price of $5.00 per share resulting in gross proceeds of $30.0 million.  Net proceeds received after underwriting fees and offering expenses were $25.7 million.  In connection with the closing of the initial public offering, all outstanding shares of the Company’s redeemable convertible preferred stock were converted into an aggregate of 5,651,955 shares of common stock, and all outstanding warrants to purchase preferred stock were converted into warrants to purchase 110,452 shares of common stock.

Preferred Stock
 
As of December 31, 2011, the Company was authorized to issue 10,000,000 shares of preferred stock in one or more series and to fix the rights, preferences, privileges, and restrictions thereof.  These rights, preferences and privileges could include dividend rights, conversion rights, voting rights, terms of redemption, liquidation preferences, sinking fund terms and the number of shares constituting any series or the designation of such series, any or all of which may be greater than the rights of common stock.  The issuance of our preferred stock could adversely affect the voting power of holders of common stock and the likelihood that such holders will receive dividend payments and payments upon liquidation.  In addition, the issuance of preferred stock could have the effect of delaying, deferring or preventing a change of control of our company or other corporate action.  There are no shares issued or outstanding as of December 31, 2011.
 
 
 
 
F-19
 
 
 
 
In August 2004 and March 2005, the Company issued 20,943,577 and 3,247,095 shares, respectively, of Series A-1 at $1.61683 per share.  The shares issued in August 2004 resulted in cash proceeds of approximately $30.1 million, net of transaction costs, and the conversion of principal and interest on the convertible notes in the aggregate amount of approximately $3.6 million.  The shares issued in March 2005 resulted in cash proceeds of approximately $5.2 million, net of transaction costs.  In June 2006, the Company converted each share of Series A-1 into one share of Series A.  All terms of the Series A remained the same as the Series A-1.  In June 2006, the Company issued 27,637,363 shares of Series B at $1.82 per share.  The shares issued resulted in cash proceeds of approximately $50.0 million, net of transaction costs.  In September 2007 and October 2008, the Company issued 18,332,965 and 11,793,127 shares of Series C, respectively, at $1.82 per share.  The shares issued resulted in cash proceeds of approximately $33.2 million and $21.4 million, net of transaction costs, in 2007 and 2008, respectively.  The Company incurred aggregate costs of $0.2 million for Series A, $0.3 million for Series B, and $0.3 million for Series C, respectively, in connection with the sale of the Series A, Series B, and Series C, which reduced the initial carrying value of each Series of redeemable convertible preferred stock.
 
The Series A, Series B, and Series C were convertible into common stock at the option of the holder on a share-for-share basis, subject to certain customary anti-dilution adjustments contained in the Company’s certificate of incorporation, which were triggered, with respect to each series of preferred stock, upon the closing of the Company’s IPO in April 2010.  In addition, the Series A, Series B and Series C were entitled to vote together with the common stockholders as one class and were entitled to separate votes on certain matters.  The Series A, Series B, and Series C stockholders were entitled to receive an annual 8% dividend, when and if declared by the board of directors.  No dividends were declared through the conversion date in April 2010.
 
(13)  
Warrants
 
We account for stock warrants as either equity instruments or derivative liabilities depending on the specific terms of the warrant agreement.  Stock warrants are accounted for as derivative liabilities under FASB ASC 815, Derivatives and Hedging (ASC 815) if the stock warrants allow for cash settlement or provide for modification of the warrant exercise price in the event subsequent sales of common stock are at a lower price per share than the then-current warrant exercise price.  We classify derivative warrant liabilities on the balance sheet as a current liability, which is revalued at each balance sheet date subsequent to the initial issuance of the stock warrant. 

The following table summarizes outstanding warrants to purchase common stock as of December 31, 2011:
             
 
Number of shares
  
Exercise price
  
Expiration
Equity–classified warrants
            
Issued to vendors
3,890
  
$
2.32
  
September 2015 through December 2016
Issued pursuant to March 2011 refinancing of Working Capital Note
70,671
  
$
2.88
  
March 2016
Issued to lenders
64,409
  
$
23.44
  
August 2013 through December 2016
Issued to lenders
46,043
  
$
26.39
  
October 2015 through September 2019
 
185,013
          
Liability–classified warrants
            
Issued pursuant to March 2011 equity financing
10,460,875
  
$
2.88
  
March 2016
 
10,645,888
          
             
Equity-classified Warrants
 
In March 2011, the Company granted a warrant to a lender to purchase 70,671 shares of common stock in connection with the refinancing of the Company’s Working Capital Note.  See Note 10 for a discussion of the refinancing.  The Company determined the fair value of the warrant as of the date of grant was $1.49 per share by utilizing the Black-Scholes model.  In estimating the fair value of the warrant, the Company utilized the following inputs: closing price per share of common stock of $2.74, volatility of 64.96%, expected term of 5 years, risk-free interest rate of 2.0% and dividend yield of zero.
 
 
 
 
F-20
 
 
 
In conjunction with the Working Capital Note, Equipment Note, and the Supplemental Working Capital Note, the Company issued warrants to purchase shares of Series A, B, and C Preferred Stock.  Upon the close of the Company’s initial public offering, the preferred stock warrants automatically converted into warrants to purchase 110,452 shares of common stock.  Warrants related to the Working Capital Note expire ten years from the date of issuance. Warrants related to the Equipment and Supplemental Working Capital Notes expire the earlier of eight years from the date of issuance or upon acquisition of the Company as defined in the warrant agreement.
 
Prior to the Company’s initial public offering, the warrants were classified as a warrant liability on the balance sheet because the warrants entitled the holder to purchase shares of preferred stock, which the holder could have caused the Company to redeem at the option of the holder.  Subsequent to the closing of the initial public offering, these warrants no longer are exercisable for a redeemable security, and therefore such warrants are now classified within stockholders’ equity.
 
The aggregate fair value of these warrants as of the initial public offering date was lower than the aggregate fair value as of December 31, 2009, resulting in a noncash credit to change in fair value of common stock warrants of $0.2 million during the year ended December 31, 2010.
 
Liability-classified Warrants
 
In March 2011, the Company issued warrants to purchase 10,460,875 shares of common stock in connection with a private placement transaction.  Each warrant is exercisable in whole or in part at any time until March 4, 2016 at a per share exercise price of $2.88, subject to certain adjustments as specified in the warrant agreement.  The Company valued the warrants as derivative financial instruments as of the date of issuance (March 4, 2011) and will continue to do so at each reporting date, with any changes in fair value being recorded on the Statement of Operations.  During the year ended December 31, 2011, the Company recorded non-operating income of $14.4 million due to a decrease in the estimated fair value of these warrants. 

The warrants contain provisions that require the modification of the exercise price and shares to be issued under certain circumstances, including in the event the Company completes subsequent equity financings at a price per share lower than the then-current warrant exercise price.  In addition, the warrants contain a net cash settlement provision under which the warrant holders may require the Company to purchase the warrants in exchange for a cash payment following the announcement of specified events defined as Fundamental Transactions involving the Company (e.g., merger, sale of all or substantially all assets, tender offer, or share exchange) or a Delisting, which is deemed to occur when the common stock is no longer listed on a national securities exchange.  The net cash settlement provision requires use of the Black-Scholes model in calculating the cash payment value in the event of a Fundamental Transaction or a Delisting.

The net cash settlement value at the time of any future Fundamental Transaction or Delisting will depend upon the value of the following inputs at that time: the price per share of the Company’s common stock, the volatility of the Company’s common stock, the expected term of the warrant, the risk-free interest rate based on U.S. Treasury security yields, and the Company’s dividend yield.  The warrant requires use of a volatility assumption equal to the greater of (i) 100%, (ii) the 30-day volatility determined as of the trading day immediately following announcement of a Fundamental Transaction or Delisting, or (iii) the arithmetic average of the 10, 30, and 50-day volatility determined as of the trading day immediately following announcement of a Fundamental Transaction or Delisting.

The fair value of the warrants is determined using a risk-neutral lattice methodology within a Monte Carlo analysis to model the impact of potential modifications to the warrant exercise price and to include the probability of a Fundamental Transaction or Delisting into the calculation of fair value.  The valuation of warrants is subjective and is affected by changes in inputs to the valuation model including the price per share of the Company’s common stock, assumptions regarding the expected amounts and dates of future equity financing activities, assumptions regarding the likelihood and timing of Fundamental Transactions or a Delisting, the historical volatility of the stock prices of the Company’s peer group, risk-free rates based on U.S. Treasury security yields, and the Company’s dividend yield.  Changes in these assumptions can materially affect the fair value estimate.  We could, at any point in time, ultimately incur amounts significantly different than the carrying value.  For example, as of December 31, 2011, the calculated cash settlement value of $3.6 million exceeded the fair value of $2.5 million.  The Company will continue to classify the fair value of the warrants as a liability until the warrants are exercised, expire, or are amended in a way that would no longer require these warrants to be classified as a liability.
 
 
 
 
 
F-21
 
 

 
The following table summarizes the calculated aggregate fair values and net cash settlement value as of the dates indicated along with the assumptions utilized in each calculation.

                   
   
Fair value as of:
    
Net cash settlement value
as of
December 31,
2011
  
   
March 4,
2011
    
December 31,
2011
  
                   
Calculated aggregate value
   $ 16,947     $ 2,511     $ 3,596 (1)
Exercise price per share of warrant
   $ 2.88     $ 2.88     $ 2.88  
Closing price per share of common stock
   $ 2.60     $ 0.47     $ 0.47  
Volatility
     65.0 %     93.8 %     151.0 % (2)
Probability of Fundamental Transaction or Delisting
     48.9 %     28.9 %  
Not applicable
  
Expected term (years)
  
Not applicable
    
Not applicable
       4.2  
Risk-free interest rate
     2.2 %     0.7 %     0.6 %
Dividend yield
  
None
    
None
    
None
  
                         

(1)
Represents the net cash settlement value of the warrant as of December 31, 2011, which value was calculated utilizing the Black-Scholes model specified in the warrant.
 
(2)
Represents the volatility assumption used to calculate the net cash settlement value as of December 31, 2011.
 
(14)  
Stock-based Compensation
 
The Company currently maintains two stock-based compensation plans.  Under the 2004 Stock Option Plan (the 2004 Plan), stock awards were granted to employees, directors, and consultants of the Company, in the form of restricted stock and stock options. The amounts and terms of options granted were determined by the Company’s compensation committee. The equity awards granted under the Plan generally vest over four years and have terms of up to ten years after the date of grant, and options are exercisable in cash or as otherwise determined by the board of directors. There are no shares available for future grants under the 2004 Plan, as grants from the 2004 Plan ceased upon the Company’s initial public offering in April 2010.
 
The 2010 Stock Incentive and Option Plan (2010 Plan) became effective upon the closing of the Company’s initial public offering.  Under the 2010 Plan, stock awards may be granted to employees, directors, and consultants of the Company, in the form of restricted or unrestricted stock, stock appreciation rights, cash-based or performance share awards and stock options. The amounts and terms of options granted are determined by the Company’s compensation committee. The equity awards granted under the Plan generally vest over four years and have terms of up to ten years after the date of grant, and options are exercisable in cash or as otherwise determined by the board of directors.  The 2010 Plan allows for the transfer of forfeited shares from the 2004 Plan.  As of December 31, 2011, 727,488 shares of common stock were available for future grants under the Plan.
 
 
 
 
 
F-22
 
 

 
Stock Options
 
The following table summarizes stock option activity under the Plans:
 
   
Number of shares
    
Weighted-average exercise price
    
Weighted-average remaining contractual term (in years)
    
Aggregate intrinsic value (in thousands)
  
Outstanding at December 31, 2008
     518,977     $ 3.63              
Granted
     358,640     $ 0.44              
Exercised
     (20,005 )   $ 2.71              
Forfeited
     (145,233 )   $ 13.54              
Outstanding at December 31, 2009
     712,379     $ 1.00              
Granted
     790,812     $ 3.65              
Exercised
     (32,255 )   $ 0.44              
Forfeited
     (93,226 )   $ 1.73              
Outstanding at December 31, 2010
     1,377,710     $ 2.49              
Granted
     1,305,675     $ 1.14              
Exercised
     (187,158 )   $ 0.44              
Forfeited
     (749,257 )   $ 2.54              
Outstanding at December 31, 2011
     1,746,970     $ 1.68       8.9     $ 63  
                                 
Vested and expected to vest at December 31, 2011
     1,618,332     $ 1.71       8.9     $ 57  
                                 
Exercisable at December 31, 2011
     457,300     $ 2.74       7.3     $ 6  
                                 
During 2009, 2010 and 2011, the Company issued options to purchase 358,640, 758,812, and 1,295,675 shares of common stock, respectively, to employees and non-employee directors under the Plans.  The per-share weighted-average fair value of the options granted to employees during 2009, 2010 and 2011 was estimated at $0.44, $3.65, and $0.61, respectively, on the date of grant using the Black-Scholes option-pricing model with the following weighted-average assumptions:
 
   
Year ended December 31,
   
2009
  
2010
  
2011
             
Volatility      
  
66.2%
  
69.4%
  
78.79%
Expected term      
  
6 years
  
6 years
  
5.5 years
Risk-free interest rate     
  
2.7%
  
2.0%
  
1.37%
Dividend yield
  
None
  
None
  
None
             

Total stock-based compensation expense recognized for stock options to employees and non-employee directors for the years ended December 31, 2009, 2010, and 2011 was $0.9 million, $0.9 million, and $0.7 million, respectively.  As of December 31, 2011, there was $0.9 million of unrecognized compensation expense, net of forfeitures, related to non-vested employee stock options and remaining incremental expense associated with the modification of stock options and $26,000 of unrecognized compensation expense related to non-vested non-employee director stock options, which are expected to be recognized over a weighted- average period of approximately 3.5 years.
 
During 2010 and 2011, the Company issued options to purchase 32,000 and 10,000 shares of common stock, respectively, to non-employee consultants under the Plan.  No options were granted to non-employees during the year ended December 31, 2009.  The per-share weighted-average fair value of the options granted to non-employees during 2010 and 2011 was estimated at $1.21 and $0.29, respectively, on the date of grant using the Black-Scholes option-pricing model with the following weighted-average assumptions:
 
 
 
 
F-23
 
 
 
   
Year ended December 31,
   
2009
  
2010
  
2011
             
Volatility   
  
Not applicable
  
69.35%
  
88.47%
Expected term  
  
Not applicable
  
6 years
  
5 years
Risk-free interest rate   
  
Not applicable
  
2.0%
  
0.83%
Dividend yield      
  
Not applicable
  
None
  
None
             
Total stock-based compensation expense recognized for stock options to nonemployees for the years ended December 31, 2010 and 2011 was $14,000 and $9,000, respectively.  For the year ended December 31, 2009, the Company recognized a credit of $66,000 due to the decline in the per-share fair value of the outstanding options granted to non-employees.  As of December 31, 2011, there was approximately $5,000 of unrecognized compensation expense related to non-vested non-employee stock options, which is expected to be recognized over a weighted- average period of less than 1 year.
 
Restricted Stock
 
The Company has issued restricted stock as compensation for the services of certain employees and other third parties.  The grant date fair value of restricted stock was based on the fair value of the common stock on the date of grant, and compensation expense is recognized based on the period in which the restrictions lapse.
 
The following table summarizes restricted stock activity under the Plans:
   
Number of shares
    
Weighted-average grant date fair value
  
Nonvested at December 31, 2008 
     3,191     $ —  
Granted 
     —     $ —  
Vested   
     (2,759 )   $ 3.51  
Forfeited     
     —     $ —  
Nonvested at December 31, 2009   
     432     $ 5.80  
Granted     
     —     $ —  
Vested      
     (432 )   $ 5.80  
Forfeited   
     —     $ —  
Nonvested at December 31, 2010   
     —     $ —  
Granted   
     310,783     $ 2.42  
Vested           
     (21,667 )   $ 2.42  
Forfeited    
     (149,337 )   $ 2.42  
Nonvested at December 31, 2011    
     139,779     $ 2.42  

Total stock-based compensation expense for restricted stock was $10,000, $1,000, and $0.1 million for the years ended December 31, 2009, 2010, and 2011, respectively.  As of December 31, 2011, there was $0.2 million of unrecognized compensation expense related to restricted stock awards, which is expected to be recognized over a weighted- average period of 3.1 years.
 
(15)  
Employee Benefit Plan
 
The Company maintains a defined contribution 401(k) plan (the 401(k) Plan) for the benefit of its employees.  Employee contributions are voluntary and are determined on an individual basis, limited by the maximum amounts allowable under federal tax regulations.  As of December 31, 2011, the Company has not elected to match any of the employee’s contributions to the 401(k) Plan.
 
 
 
 
 
F-24
 
 
 
 
(16)  
Commitments and Contingencies
 
(a)Leases and Letters of Credit
 
The Company leases office space and office equipment under operating leases, which expire at various times through February 2016.  Rent expense under these operating leases was $0.7 million for each of the years ended December 31, 2009, 2010, 2011, and $4.6 million for the period from July 10, 2003 (inception) through December 31, 2011.
 
 
The following table summarizes future minimum lease payments as of December 31, 2011 (in thousands):
 

         
2012                                                   
  
$
992
  
2013                      
    
1,016
  
2014        
    
1,040
  
2015       
    
1,063
  
2016             
    
276
  
Total minimum lease payments (1)    
  
$
4,387
  
         
(1)
 The future minimum lease payments above do not include the impact of any potential sublease income discussed in Note 9 related to the Company’s lease liability.

Effective March 2011, the lease agreement for the Company’s facility in East Norriton, Pennsylvania required the Company to provide security and restoration deposits totaling $2.2 million to the landlord, an increase from the prior amount of $1.7 million. Until January 2011, the Company obtained letters of credit from a bank in favor of the landlord to satisfy the obligations.  In January 2011, the Company deposited $1.0 million with the landlord as a security deposit, which amount is recorded as a non-current other asset on the Company’s balance sheet as of December 31, 2011.  As of December 31, 2011, an outstanding letter of credit is satisfying the remaining o restoration deposit obligation of $1.2 million.  At the end of the lease term, the landlord has the right to require the Company to utilize the funds collateralizing this letter of credit to restore the facility to its original condition.  The letter of credit is collateralized by an account held at the bank.  If the bank determines the collateral to be insufficient, the bank has the right to demand additional collateral.  If the Company fails to provide additional collateral, the bank has the right to withdraw the letter of credit.  In that event, the landlord would have the right to require the Company to deposit cash of up to $1.2 million in an account to satisfy its deposit obligation.

In May 2011, the Company exercised the first five-year renewal option under its lease for laboratory space in Winston-Salem, North Carolina.  The amended lease extends the lease term to October 2016 and provides for payments of average annual base rent of approximately $0.2 million commencing in October 2011.

(b)  
License and Research Agreements
 
In 2003, a license agreement was executed with Children’s Medical Center Corporation (CMCC), whereby CMCC granted the Company a license to utilize certain patent rights.  In accordance with the license agreement, the Company paid an initial license fee of $0.2 million, which was recorded as research and development expense.  Additionally, the license agreement requires the Company to reimburse CMCC for patent costs related to the underlying licensed rights.  In 2009, 2010, 2011, and for the period from July 10, 2003 (inception) through December 31, 2011, the Company recorded $0.2 million, $0.2 million, $0.2 million, and $2.3 million, respectively, related to the reimbursement of such patent costs as general and administrative expenses in the accompanying statements of operations.
 
The Company is obligated to make payments to CMCC upon the occurrence of various development and sales milestones.  During the fourth quarter of 2006, the Company achieved two of its development milestones for the first licensed product launched, as defined in the agreement, and paid $0.4 million, which was recorded as research and development expense for the year ended December 31, 2006.  No further milestones payments have been made.  If the Company develops and obtains regulatory approval of a licensed product in each of the four subfields covered under the license, it will be required to pay CMCC milestones aggregating approximately $6.9 million, which includes $0.4 million paid to date.  Also, if cumulative net sales of all licensed products reach a certain level, the Company will be required to make a one-time sales milestone payment of $2.0 million.  The timing and likelihood of such milestone payments are not currently known to the Company.  A portion of the milestone payments the Company makes will be credited against its future royalty payments.  The Company must pay CMCC royalties in the mid-single digit range based on net sales of licensed products as defined in the agreement by the Company, its affiliates and its sublicensees, which royalties will be reduced for certain amounts the Company is required to pay to license patents or intellectual property from third parties and under certain circumstances if there is a competing product.  No royalties will be payable with respect to sales of licensed products in countries where there is no valid patent claim, unless the Company advised CMCC not to file for patent protection in that country and later chose to market and sell licensed products in such country.  The license agreement, and the Company’s obligation to pay royalties, terminates on the later of the expiration, on a country-by-country basis, of the last patent right and October 2018.
 
 
 
 
F-25
 
 
 
In January 2006 the Company entered into a license agreement with Wake Forest University Health Sciences, or WFUHS, which was amended in May 2007, for the license of certain of WFUHS’s intellectual property rights.  Under the license agreement, the Company issued WFUHS a warrant to purchase 3,200 shares of the Company’s common stock through January 1, 2016 at an exercise of $2.32 per share and is required to pay WFUHS a percentage of certain consideration received from a sublicensee.  The Company is not required to make any milestone payments to WFUHS related to the development or commercialization of the licensed products, but the Company is required to pay certain license maintenance fees with respect to each product covered by new development patents, commencing two years after the Company initiates the first animal study conducted under cGLP, with respect to such product.  These license maintenance fees, which are in the low six figure range with respect to each product, will be creditable against royalties the Company is obligated to pay to WFUHS for such product.  In addition, the Company is required to pay WFUHS royalties in the low- to mid-single digit range based on net sales of licensed products in all countries.  With respect to any product covered by an improvement patent, the Company’s obligation to pay royalties to WFUHS terminates upon the later of the expiration, on a product-by-product basis, of the last to expire patent covering such product and the date that is 15 years from the first commercial sale of such product, provided that no such royalty is payable more than seven years after expiration of the last-to-expire patent covering such product.
 
In January 2006, the Company entered into a research agreement with WFUHS, which was amended in September 2006 and extended in September 2010 for an additional three-year period.  Under the research agreement, WFUHS agreed to perform sponsored research in return for quarterly payments.  As of December 31, 2010, the Company was obligated to make payments of $800,000 with respect to the 2011 research activities of WFUHS under the extended agreement.  The Company terminated the research agreement with WFUHS effective December 31, 2011 and has no further financial or other obligations under this agreement.
 
(17)  
Income Taxes
 
A reconciliation of the statutory U.S. federal rate to the Company’s effective tax rate is as follows:
 
   
Year Ended December 31,
   
2009
  
2010
  
2011
Percent of pre-tax income:
                        
U.S. federal statutory income tax rate
    
(34.0
)
    
(34.0
) 
    
(34.0
)
State taxes, net of federal benefit
    
(6.7
)
    
(7.1
) 
    
(7.2
)
Interest expense –revaluation of warrants
    
—
      
—
      
(25.5
)
Other
    
(1.1
)
    
(0.5
) 
    
0.8
  
Valuation allowance
    
41.8
      
41.6
      
65.9
  
Effective income tax expense rate
    
—
      
—
      
—
  
                         
 
 
 
 
F-26
 
 

 
The tax effects of temporary differences that gave rise to significant portions of the deferred tax assets were as follows (in thousands):

   
December 31,
   
2010
  
2011
Net operating loss carryforwards 
  
$
44,765
  
  
$
56,702
  
Research and development credits 
  
  
4,697
  
  
  
5,241
  
Depreciation and amortization    
  
  
8,148
  
  
  
5,198
  
Capitalized start-up costs    
  
  
12,162
  
  
  
14,703
  
Other temporary differences  
  
  
1,134
  
  
  
2,384
  
Gross deferred tax asset   
  
  
70,906
  
  
  
84,228
  
Deferred tax assets valuation allowance  
  
  
(70,906
)
  
  
(84,228
)
 
  
$
—
  
  
$
—
  

In assessing the realizability of deferred tax assets, the Company considers whether it is more likely than not that some portion or all of the deferred tax assets will not be realized.  The ultimate realization of deferred tax assets is dependent upon the generation of future taxable income during the periods in which the temporary differences representing net future deductible amounts become deductible.  Due to the Company’s history of losses, the deferred tax assets are fully offset by a valuation allowance at December 31, 2010 and 2011.  The valuation allowance in 2010 increased by $12.5 million over 2009 and the valuation allowance in 2011 increased by $13.3 million over 2010, related primarily to additional net operating losses incurred by the Company and additional capitalized start-up expenses.
 
The Company has moved its corporate headquarters to its leased facility in Winston-Salem, North Carolina during the first quarter of 2012.   As a result of differences in effective tax rates in North Carolina versus Pennsylvania, the deferred effective state tax rate is anticipated to be reduced.  As the Company has a full valuation allowance on its deferred taxes, there is no impact related to the change in the effective state tax rate on the balance sheet and statement of operations.   The Company is updating its forecasted effective state tax rate to consider this impact on its deferred taxes and will continue to monitor and update the rate as necessary.  Additionally, the Company has approximately a $8.3 million deferred tax asset related to Pennsylvania net operating loss carryforwards.  The ultimate use of this deferred tax asset may be impacted by the size of operations remaining in Pennsylvania in the future.  This deferred tax asset is currently offset by a full valuation allowance.
 
As of December 31, 2010, and 2011, approximately $29.6 million and $35.7 million, respectively, of the Company’s expenses had been capitalized for tax purposes as start-up costs.  For tax purposes, capitalized start-up costs will be amortized over fifteen years beginning when the Company commences operations, as defined under the Internal Revenue Code.
 
The following table summarizes carryforwards of net operating losses and tax credits as of December 31, 2011 (in thousands).
 
   
Amount
  
Expiration
Federal net operating losses
   $ 138,631  
2023 to 2031
State net operating losses
     153,557  
2019 to 2031
Research and development credits
     5,241  
2024 to 2031

The Tax Reform Act of 1986 (the Act) provides for a limitation on the annual use of net operating loss and research and development tax credit carryforwards following certain ownership changes (as defined by the Act) that could limit the Company’s ability to utilize these carryforwards.  The Company has not completed a study to assess whether an ownership change has occurred, or whether there have been multiple ownership changes since its formation, due to the significant costs and complexities associated with such a study.  The Company may have experienced various ownership changes, as defined by the Act, as a result of past financings.  Accordingly, the Company’s ability to utilize the aforementioned carryforwards may be limited.  Additionally, U.S. tax laws limit the time during which these carryforwards may be applied against future taxes; therefore, the Company may not be able to take full advantage of these carryforwards for federal or state income tax purposes.
 
 
 
 
F-27
 
 
 
 
(18)  
Quarterly Financial Data (Unaudited)
 

   
Quarter Ended
  
   
March 31
    
June 30
    
September 30
    
December 31
  
   
(in thousands, except per share data)
  
YEAR 2011
                        
Research and development expense
   $ 3,345     $ 3,397     $ 2,837     $ 3,714  
Net (loss) income  
     (7,029 )     2,898       (960 )     (13,970 )
Per common share information:
                                
Basic and diluted net (loss) income per share
   $ (0.45 )   $ 0.12     $ (0.04 )   $ (0.59 )
                                 
YEAR 2010
                                
Research and development expense
   $ 3,316     $ 3,253     $ 3,543     $ 2,743  
Net loss  
     (6,435 )     (6,505 )     (6,715 )     (5,945 )
Per common share information:
                                
Basic and diluted net loss per share
   $ (14.33 )   $ (0.61 )   $ (0.54 )   $ (0.48 )
                                 

 

 
 
 
 
 
F-28
 
 
 
 
 
 
 
Exhibit Index

Exhibit No.
Description
   
3.1
Fourth Amended and Restated Certificate of Incorporation of Tengion, Inc. (Incorporated by reference to Exhibit 3.1 to Amendment No. 3 to our Registration Statement on Form S-1 filed on March 17, 2010 (Registration No. 333-164011)).
   
3.2
Amended and Restated Bylaws of Tengion, Inc. (Incorporated by reference to Exhibit 3.2 to Amendment No. 3 to our Registration Statement on Form S-1 filed on March 17, 2010 (Registration No. 333-164011)).
   
4.1
Form of Tengion, Inc.’s Common Stock Certificate.  (Incorporated by reference to Exhibit 4.1 to Amendment No. 3 to our Registration Statement on Form S-1 filed on March 17, 2010 (Registration No. 333-164011)).
   
4.2
Second Amended and Restated Investor Rights Agreement by and among the investors listed therein and Tengion, Inc., dated as of September 24, 2007.  (Incorporated by reference to Exhibit 4.2 to our Registration Statement on Form S-1 filed on December 23, 2009 (Registration No. 333-164011)).
   
4.3
Amendment No. 1 to Second Amended and Restated Investor Rights Agreement by and among the investors listed therein and Tengion, Inc., dated as of October 15, 2008.  (Incorporated by reference to Exhibit 4.3 to our Registration Statement on Form S-1 filed on December 23, 2009 (Registration No. 333-164011)).
   
4.4
Registration Rights Agreement by and among the investors party thereto and Tengion, Inc., dated as of March 4, 2011.  (Incorporated by reference to Exhibit 10.2 to our Current Report on Form 8-K, filed on March 16, 2011).
   
4.5
Form of Preferred Stock Warrant by and between Oxford Finance Corporation and the Company.  (Incorporated by reference to Exhibit 4.4 to our Registration Statement on Form S-1 filed on December 23, 2009 (Registration No. 333-164011)).
   
4.6
Form of Preferred Stock Warrant by and between Horizon Funding Company II LLC and the Company.  (Incorporated by reference to Exhibit 4.5 to our Registration Statement on Form S-1 filed on December 23, 2009 (Registration No. 333-164011)).
   
4.7
Stock Subscription Warrant issued to APCO Worldwide Inc., dated September 1, 2005.  (Incorporated by reference to Exhibit 4.6 to Amendment No. 2 to our Registration Statement on Form S-1 filed on January 29, 2010 (Registration No. 333-164011)).
   
4.8
Form of Warrant to Purchase Common Stock, dated as of March 4, 2011.  (Incorporated by reference to Exhibit 4.1 to our Current Report on Form 8-K filed on March 1, 2011).
   
4.9
Warrant to Purchase Common Stock issued to Horizon Technology Finance Corporation, dated March 14, 2011.  (Incorporated by reference to Exhibit 4.1 to our Current Report on Form 8-K filed on March 16, 2011).
   
10.1
Lease Agreement by and between 3929 Westpoint Industrial, LLC and Tengion, Inc., dated as of June 8, 2005.  (Incorporated by reference to Exhibit 10.1 to Amendment No. 2 to our Registration Statement on Form S-1 filed on January 29, 2010 (Registration No. 333-164011)).
   
10.2
First Amendment to Lease by and among Fawn Industrial LLC and 1881 Industrial LLC, successors in interest to 3929 Westpoint Industrial, LLC and together as Landlord, and Tengion, Inc., dated as of March 15, 2007.  (Incorporated by reference to Exhibit 10.2 to our Registration Statement on Form S-1 filed on December 23, 2009 (Registration No. 333-164011)).
   
 
 
 
E-1
 
 
 
10.3
Lease Agreement by and between Norriton Business Campus, L.P. and Tengion, Inc., dated as of February 1, 2006, as amended.  (Incorporated by reference to Exhibit 10.4 to our Registration Statement on Form S-1 filed on December 23, 2009 (Registration No. 333-164011)).
   
10.4
Amended and Restated Tengion, Inc. 2004 Stock Incentive Plan, Form Notice of Stock Option Grant and Stock Option Agreement.  (Incorporated by reference to Exhibit 10.5 to Amendment No. 2 to our Registration Statement on Form S-1 filed on February 23, 2010 (Registration No. 333-164011)).#
   
10.5
2010 Stock Option and Incentive Plan, Form of Incentive Stock Option Agreement, Form of Non-Qualified Stock Option Agreement and Form of Restricted Stock Award Agreement.  (Incorporated by reference to Exhibit 10.34 to Amendment No. 2 to our Registration Statement on Form S-1 filed on February 23, 2010 (Registration No. 333-164011)).#
   
10.6
Exclusive License Agreement by and between Children’s Medical Center Corporation and Tengion, Inc., dated as of October 10, 2003.  (Incorporated by reference to Exhibit 10.6 to Amendment No. 1 to our Registration Statement on Form S-1 filed on January 29, 2010 (Registration No. 333-164011)).*
   
10.7
Tengion, Inc. Non-Employee Director Compensation Policy.  (Incorporated by reference to Exhibit 10.36 to Amendment No. 3 to our Registration Statement on Form S-1 filed on March 17, 2010 (Registration No. 333-164011)).#
   
10.8
License Agreement by and between the Company and Wake Forest University Health Sciences, effective as of January 1, 2006.  (Incorporated by reference to Exhibit 10.7 to Amendment No. 1 to our Registration Statement on Form S-1 filed on January 29, 2010 (Registration No. 333-164011)).*
   
10.9
License Agreement Amendment No. 1 by and between the Company and Wake Forest University Health Sciences, dated as of May 3, 2007.  (Incorporated by reference to Exhibit 10.8 to Amendment No. 1 to our Registration Statement on Form S-1 filed on January 29, 2010 (Registration No. 333-164011)).*
   
10.10
Right of First Refusal and Right of First Negotiation Agreement by and between Medtronic, Inc. and Tengion, Inc., dated as of March 1, 2011.  (Incorporated by reference to Exhibit 10.3 to our Current Report on Form 8-K, filed on March 1, 2011).
   
10.11
Venture Loan and Security Agreement by and between Horizon Technology Finance Corporation and Tengion, Inc., dated as of March 14, 2011.  (Incorporated by reference to Exhibit 10.1 to our Current Report on Form 8-K, filed on March 16, 2011).
   
10.12
Master Security Agreement No. 5081099 by and between Oxford Finance Corporation and Tengion, Inc., dated as of July 20, 2005.  (Incorporated by reference to Exhibit 10.14 to Amendment No. 1 to our Registration Statement on Form S-1 filed on January 29, 2010 (Registration No. 333-164011)).
   
10.13
Amendment Agreement by and between Oxford Finance Corporation and Tengion, Inc., dated as of April 3, 2006.  (Incorporated by reference to Exhibit 10.15 to Amendment No. 1 to our Registration Statement on Form S-1 filed on January 29, 2010 (Registration No. 333-164011)).
   
10.14
Amendment Agreement by and between Oxford Finance Corporation and Tengion, Inc., dated as of December 28, 2006.  (Incorporated by reference to Exhibit 10.16 to Amendment No. 1 to our Registration Statement on Form S-1 filed on January 29, 2010 (Registration No. 333-164011)).
   
 
 
 
 
E-2
 
 
 
10.15
Offer Letter by and between Tim Bertram and Tengion, Inc., dated July 28, 2004.  (Incorporated by reference to Exhibit 10.24 to Amendment No. 1 to our Registration Statement on Form S-1 filed on January 29, 2010 (Registration No. 333-164011)).#
   
10.16
Offer Letter Amendment by and between Tim Bertram and the Company, dated as of December 22, 2008.  (Incorporated by reference to Exhibit 10.26 to Amendment No. 1 to our Registration Statement on Form S-1 filed on January 29, 2010 (Registration No. 333-164011)).#
   
10.17
Restricted Stock Purchase Agreement by and between the Company and Tim Bertram, dated as of August 16, 2004.  (Incorporated by reference to Exhibit 10.27 to Amendment No. 1 to our Registration Statement on Form S-1 filed on January 29, 2010 (Registration No. 333-164011)).
   
10.18
Restricted Stock Purchase Agreement by and between the Company and Tim Bertram, dated as of July 28, 2004.  (Incorporated by reference to Exhibit 10.28 to Amendment No. 1 to our Registration Statement on Form S-1 filed on January 29, 2010 (Registration No. 333-164011)).
   
10.19
Offer Letter by and between A. Brian Davis and the Company, dated as of July 29, 2010.  (Incorporated by reference to Exhibit 10.1 to our Quarterly Report on Form 10-Q for the quarter ended June 30, 2010).#
   
10.20
Form of Indemnification Agreement.  (Incorporated by reference to Exhibit 10.33 to Amendment No. 3 to our Registration Statement on Form S-1 filed on March 17, 2010 (Registration No. 333-164011)).
   
10.21
Third Amendment to Master Security Agreement No. 5081099 dated as of June 23, 2010 by and between the Company and Oxford Finance Corporation. (Incorporated by reference to Exhibit 10.2 to our Quarterly Report on Form 10-Q for the quarter ended June 30, 2010).
   
10.22
Right of First Refusal and Right of First Negotiation between the Company and Medtronic, Inc., dated March 1, 2011 (Incorporated by reference to Exhibit 10.3 to our Current Report on Form 8-K filed on March 1, 2011).
   
10.23
Loan Agreement by and between the Company and Horizon Technology Finance Corporation, dated as of March 14, 2011 (Incorporated by reference to Exhibit 10.1 to our Current Report on Form 8-K filed on March 16, 2011).
   
10.24
Secured Promissory Note in favor of Horizon Technology Finance Corporation, dated as of March 14, 2011 (Incorporated by reference to Exhibit 10.2 to our Current Report on Form 8-K filed on March 16, 2011).
   
10.25
Change in Control Payment Plan (Incorporated by reference to Exhibit 10.6 to our Quarterly Report on Form 10-Q for the quarter ended March 31, 2011).#
   
10.26
Management Severance Pay Plan (Incorporated by reference to Exhibit 10.1 to our Current Report on Form 8-K filed on March 20, 2012).#
   
10.27
Second Amendment to Lease, dated May 23, 2011, by and between Fawn Industrial, LLC, 1881 Industrial LLC and Tengion, Inc. (Incorporated by reference to Exhibit 10.1 to our Current Report on Form 8-K filed on May 25, 2011).
   
10.28
Severance Agreement and General Release of Claims by and between the Company and Steven A. Nichtberger, MD, dated June 29, 2011 (Incorporated by reference to Exhibit 10.1 to our Current Report on Form 8-K filed on June 30, 2011).#
   
 
 
 
 
E-3
 
 
 
10.29
Form of Severance Agreement and Release of Claims by and between the Company and each of Mark Stejbach and Sunita Sheth, MD (Incorporated by reference to Exhibit 10.1 to our Current Report on Form 8-K filed on November 23, 2011).#
   
10.30
Amended Employment Agreement by and between the Company and John L. Miclot, dated January 20, 2012 (Incorporated by reference to Exhibit 10.1 to our Current Report on Form 8-K filed on January 20, 2012).#
   
   
   
24.1
Power of Attorney (included on signature page).  (Filed herewith).
   
   
   
   
 
 
101 The following materials from the Registrant’s Annual Report on Form 10-K for the annual report ended December 31, 2011, formatted in XBRL (eXtensible Business Reporting Language): (i) the Condensed Balance Sheets, (ii) Condensed Statements of Redeemable Convertible Preferred Stock and Stockholders’ Equity (Deficit), (iii) the Condensed Statements of Operations, (iv) the Condensed Statements of Cash Flows, and (v) Notes to Condensed Financial Statements. **

#  -           Indicates a management contract or any compensatory plan, contract or arrangement.

*  -           Confidential status has been granted for certain portions thereof pursuant to a Commission Order granted April 9, 2010.  Such provisions have been filed separately with the Commission.

 **  -Pursuant to Rule 406T of Regulation S-T, the Interactive Data Files on Exhibit
 101 hereto are deemed not filed as part of a registration statement or prospectus for purposes of Sections 11 or 12 of the Securities Act of 1933, as amended, are deemed not filed for purposes of Section 18 of the Securities and Exchange Act of 1934, as amended, and otherwise are not subject to liability under those sections.
 
 
 
 E-4
EX-23.1 2 ex23-1.htm EXHIBIT 23.1 ex23-1.htm
 
 
 

 
Exhibit 23.1
 
 
Consent of Independent Registered Public Accounting Firm
 
 
 
 
We consent to the incorporation by reference in the Registration Statements (Form S-8 No. 333-166996) pertaining to the Tengion, Inc. Amended and Restated 2004 Stock Incentive Plan, (Form S-8 Nos. 333-166996, 333-173573, and 333-178864) pertaining to the  Tengion, Inc. 2010 Stock Option and Incentive Plan, (Form S-3 No. 333-173574) pertaining to registration of its common stock, and (Form S-3 No. 333-179293) pertaining to registration of its common stock preferred stock, debt securities, warrants, rights and units our report dated March 28, 2012, with respect to the financial statements of Tengion, Inc. included in its Annual Report (Form 10-K) for the year ended December 31, 2011, filed with the Securities and Exchange Commission.

/s/ Ernst & Young LLP
 
Philadelphia, Pennsylvania
March 28, 2012
 

 
 
 
 
EX-23.2 3 ex23-2.htm EXHIBIT 23.2 Unassociated Document
 
 
 

 
Exhibit 23.2
 
 
Consent of Independent Registered Public Accounting Firm
 
The Board of Directors
Tengion, Inc.:
 
We consent to the incorporation by reference in the registration statements (Nos. 333-166996, 333-173573 and 333-178864) on Form S-8 and (Nos. 333-173574 and 333-179293) on Form S-3 of Tengion, Inc. of our report dated May 29, 2009, with respect to the statements of operations, redeemable convertible preferred stock and stockholders’ deficit, and cash flows of Tengion, Inc. for the period from July 10, 2003 (inception) through December 31, 2008, which  report appears in the December 31, 2011 annual report on Form 10-K of Tengion, Inc.
 
/s/ KPMG LLP
 
Philadelphia, Pennsylvania
March 28, 2012
 

 
 
 
EX-31.1 4 ex31-1.htm EXHIBIT 31.1 Unassociated Document
 
 
 
Exhibit 31.1
 
CERTIFICATION PURSUANT TO
SECTION 302 OF
THE SARBANES-OXLEY ACT OF 2002
 
I, John L. Miclot, certify that:
 
1.
I have reviewed this Annual Report of Tengion, Inc.;
 
2.
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
 
3.
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
 
4.
The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
 
 
(a)
designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
 
 
(b)
designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervisions, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
 
 
(c)
evaluated the effectiveness of the registrant's disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
 
 
(d)
disclosed in this report any change in the registrant's internal control over financial reporting that occurred during the registrant's most recent fiscal quarter (the registrant's fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant's internal control over financial reporting; and
 
5.
The registrant’s other certifying officers and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent function):
 
 
(a)
all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
 
 
(b)
any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
 
 
 
Date: March 28, 2012
  
 
/s / John L. Miclot
 
John L. Miclot
 
President and Chief Executive Officer
 
 
 
 
 
 
EX-31.2 5 ex31-2.htm EXHIBIT 31.2 ex31-2.htm
 
 
 
Exhibit 31.2
 
CERTIFICATION PURSUANT TO
SECTION 302 OF
THE SARBANES-OXLEY ACT OF 2002
 
I, A. Brian Davis, certify that:
 
1.
I have reviewed this Annual Report of Tengion, Inc.;
 
2.
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
 
3.
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
 
4.
The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
 
 
(a)
designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
 
 
(b)
designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervisions, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
 
 
(c)
evaluated the effectiveness of the registrant's disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
 
 
(d)
disclosed in this report any change in the registrant's internal control over financial reporting that occurred during the registrant's most recent fiscal quarter (the registrant's fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant's internal control over financial reporting; and
 
5.
The registrant’s other certifying officers and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent function):
 
 
(a)
all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
 
 
(b)
any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
 
 
Date: March 28, 2012
  
 
/s/ A. Brian Davis
 
A. Brian Davis
 
Chief Financial Officer
 
(Principal Financial and Accounting Officer)
 
 
 
 
 
 
 
EX-32.1 6 ex32-1.htm EXHIBIT 32.1 ex32-1.htm
 
 
Exhibit 32.1
 
CERTIFICATION PURSUANT TO
18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
 

 
In connection with the Annual Report of Tengion, Inc. (the “Company”) on Form 10-K for the year ended December 31, 2011, as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, John L. Miclot, President and Chief Executive Officer of the Company, certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that to his knowledge:
 
 
(1)
The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
 
 
(2)
The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
 
Date: March 28, 2012
  
 
/s/ John L. Miclot
 
John L. Miclot
 
President and Chief Executive Officer
 
 
 
 
 
 
 
EX-32.2 7 ex32-2.htm EXHIBIT 32.2 ex32-2.htm
 
 
 
Exhibit 32.2
 
CERTIFICATION PURSUANT TO
18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
 

 
In connection with the Annual Report of Tengion, Inc. (the “Company”) on Form 10-K for the year ended December 31, 2011, as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, A. Brian Davis, Chief Financial Officer of the Company, certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that to his knowledge:
 
 
(1)
The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
 
 
(2)
The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
 
Date: March 28, 2012
  
 
 
 
/s/A. Brian Davis
 
Chief Financial Officer
 
(Principal Financial and Accounting Officer)

 
 
 
 
 
 
 
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display: block; margin-left: 0pt; margin-right: 0pt;"><font style="display: inline; font-family: times new roman; font-size: 10pt;">Unamortized debt discount&#160;&#160;&#160;&#160;</font></div></td><td valign="bottom" width="1%" style="padding-bottom: 2px;"><div align="justify" style="text-indent: 0pt; display: block; margin-left: 0pt; margin-right: 0pt;"><font style="display: inline; font-family: times new roman; font-size: 10pt;">&#160;&#160;</font></div></td><td valign="bottom" width="1%" style="border-bottom: black 2px solid;"><font style="display: inline; font-family: times new roman; font-size: 10pt;">&#160; </font></td><td align="right" valign="bottom" width="9%" style="border-bottom: black 2px solid;"><div align="right" style="text-indent: 0pt; display: block; margin-left: 0pt; margin-right: 0pt;"><font style="display: inline; font-family: times new roman; font-size: 10pt;">(148</font></div></td><td valign="bottom" width="1%" style="padding-bottom: 2px;"><div align="justify" style="text-indent: 0pt; display: block; margin-left: 0pt; margin-right: 0pt;"><font style="display: inline; font-family: times new roman; font-size: 10pt;">)</font></div></td><td valign="bottom" width="1%" style="padding-bottom: 2px;"><div align="justify" style="text-indent: 0pt; display: block; margin-left: 0pt; margin-right: 0pt;"><font style="display: inline; font-family: times new roman; font-size: 10pt;">&#160;&#160;</font></div></td><td valign="bottom" width="1%" style="border-bottom: black 2px solid;"><font style="display: inline; font-family: times new roman; font-size: 10pt;">&#160; </font></td><td align="right" valign="bottom" width="9%" style="border-bottom: black 2px solid;"><div align="right" style="text-indent: 0pt; display: block; margin-left: 0pt; margin-right: 0pt;"><font style="display: inline; font-family: times new roman; font-size: 10pt;">(139</font></div></td><td valign="bottom" width="1%" style="padding-bottom: 2px;"><div align="justify" style="text-indent: 0pt; display: block; margin-left: 0pt; 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display: block; margin-left: 0pt; margin-right: 0pt;"><font style="display: inline; font-family: times new roman; font-size: 10pt;">&#160;&#160;</font></div></td><td valign="bottom" width="1%"><font style="display: inline; font-family: times new roman; font-size: 10pt;">&#160; </font></td><td align="right" valign="bottom" width="9%"><div align="right" style="text-indent: 0pt; display: block; margin-left: 0pt; margin-right: 0pt;"><font style="display: inline; font-family: times new roman; font-size: 10pt;">4,987</font></div></td><td valign="bottom" width="1%"><font style="display: inline; font-family: times new roman; font-size: 10pt;">&#160; </font></td></tr><tr><td valign="bottom" width="76%" style="padding-bottom: 2px;"><div align="justify" style="text-indent: 0pt; display: block; margin-left: 0pt; margin-right: 0pt;"><font style="display: inline; font-family: times new roman; font-size: 10pt;">Less current portion&#160;&#160;&#160;&#160;</font></div></td><td valign="bottom" width="1%" style="padding-bottom: 2px;"><div align="justify" style="text-indent: 0pt; display: block; margin-left: 0pt; margin-right: 0pt;"><font style="display: inline; font-family: times new roman; font-size: 10pt;">&#160;&#160;</font></div></td><td valign="bottom" width="1%" style="border-bottom: black 2px solid;"><font style="display: inline; font-family: times new roman; font-size: 10pt;">&#160; </font></td><td align="right" valign="bottom" width="9%" style="border-bottom: black 2px solid;"><div align="right" style="text-indent: 0pt; display: block; margin-left: 18pt; margin-right: 0pt;"><font style="display: inline; font-family: times new roman; font-size: 10pt;">(4,016</font></div></td><td valign="bottom" width="1%" style="padding-bottom: 2px;"><div align="justify" style="text-indent: 0pt; display: block; margin-left: 0pt; margin-right: 0pt;"><font style="display: inline; font-family: times new roman; font-size: 10pt;">)</font></div></td><td valign="bottom" width="1%" style="padding-bottom: 2px;"><div align="justify" style="text-indent: 0pt; display: block; margin-left: 0pt; 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display: block; margin-left: 0pt; margin-right: 0pt;"><font style="display: inline; font-family: times new roman; font-size: 10pt;">&#160;&#160;</font></div></td><td valign="bottom" width="1%" style="border-bottom: black 4px double;"><div align="justify" style="text-indent: 0pt; display: block; margin-left: 0pt; margin-right: 0pt;"><font style="display: inline; font-family: times new roman; font-size: 10pt;">$</font></div></td><td align="right" valign="bottom" width="9%" style="border-bottom: black 4px double;"><div align="right" style="text-indent: 0pt; display: block; margin-left: 18pt; margin-right: 0pt;"><font style="display: inline; font-family: times new roman; font-size: 10pt;">4,585</font></div></td><td valign="bottom" width="1%" style="padding-bottom: 4px;"><font style="display: inline; font-family: times new roman; font-size: 10pt;">&#160; </font></td><td valign="bottom" width="1%" style="padding-bottom: 4px;"><div align="justify" style="text-indent: 0pt; display: block; margin-left: 0pt; 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display: block; margin-left: 0pt; margin-right: 0pt;"><font style="display: inline; font-family: times new roman; font-size: 10pt;">&#160;&#160;</font></div></td><td valign="bottom" width="1%"><font style="display: inline; font-family: times new roman; font-size: 10pt;">&#160; </font></td><td align="right" valign="bottom" width="9%"><div align="right" style="text-indent: 0pt; display: block; margin-left: 0pt; margin-right: 0pt;"><font style="display: inline; font-family: times new roman; font-size: 10pt;">5,241</font></div></td><td valign="bottom" width="1%"><font style="display: inline; font-family: times new roman; font-size: 10pt;">&#160; </font></td></tr><tr><td valign="bottom" width="76%"><div align="justify" style="text-indent: 0pt; display: block; margin-left: 0pt; margin-right: 0pt;"><font style="display: inline; font-family: times new roman; font-size: 10pt;">Depreciation and amortization&#160;&#160;&#160;&#160;</font></div></td><td valign="bottom" width="1%"><div align="justify" style="text-indent: 0pt; 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font-family: times new roman; font-size: 10pt;">&#160;</font></td><td valign="bottom" style="text-align: left;"><font style="display: inline; font-family: times new roman; font-size: 10pt;">&#160;</font></td><td valign="bottom" style="text-align: right;"><font style="display: inline; font-family: times new roman; font-size: 10pt;">712,379</font></td><td nowrap="nowrap" valign="bottom" style="text-align: left;"><font style="display: inline; font-family: times new roman; font-size: 10pt;">&#160;</font></td><td align="right" valign="bottom"><font style="display: inline; font-family: times new roman; font-size: 10pt;">&#160;</font></td><td valign="bottom" style="text-align: left;"><font style="display: inline; font-family: times new roman; font-size: 10pt;">$</font></td><td valign="bottom" style="text-align: right;"><font style="display: inline; font-family: times new roman; font-size: 10pt;">1.00</font></td><td nowrap="nowrap" valign="bottom" style="text-align: left;"><font style="display: inline; font-family: times new roman; font-size: 10pt;">&#160;</font></td><td valign="bottom"><font style="display: inline; font-family: times new roman; font-size: 10pt;">&#160;</font></td><td colspan="2" valign="bottom"><font style="display: inline; font-family: times new roman; font-size: 10pt;">&#160;</font></td><td nowrap="nowrap" valign="bottom" style="text-align: left;"><font style="display: inline; font-family: times new roman; font-size: 10pt;">&#160;</font></td><td valign="bottom"><font style="display: inline; font-family: times new roman; font-size: 10pt;">&#160;</font></td><td colspan="2" valign="bottom"><font style="display: inline; font-family: times new roman; font-size: 10pt;">&#160;</font></td><td nowrap="nowrap" valign="bottom" style="text-align: left;"><font style="display: inline; font-family: times new roman; font-size: 10pt;">&#160;</font></td></tr><tr><td valign="bottom"><div align="justify" style="text-indent: 0pt; display: block; margin-left: 0pt; margin-right: 0pt;"><font style="display: inline; 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font-size: 10pt;">&#160;</font></td><td nowrap="nowrap" valign="bottom" style="text-align: left;"><font style="display: inline; font-family: times new roman; font-size: 10pt;">&#160;</font></td><td valign="bottom"><font style="display: inline; font-family: times new roman; font-size: 10pt;">&#160;</font></td><td colspan="2" valign="bottom"><font style="display: inline; font-family: times new roman; font-size: 10pt;">&#160;</font></td><td nowrap="nowrap" valign="bottom" style="text-align: left;"><font style="display: inline; font-family: times new roman; font-size: 10pt;">&#160;</font></td></tr><tr><td valign="bottom"><div align="justify" style="text-indent: 0pt; display: block; margin-left: 0pt; margin-right: 0pt;"><font style="display: inline; font-family: times new roman; font-size: 10pt;">Granted</font></div></td><td align="right" valign="bottom"><font style="display: inline; font-family: times new roman; font-size: 10pt;">&#160;</font></td><td valign="bottom" style="text-align: left;"><font style="display: inline; 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font-size: 10pt;">&#160;</font></td><td colspan="2" valign="bottom"><font style="display: inline; font-family: times new roman; font-size: 10pt;">&#160;</font></td><td nowrap="nowrap" valign="bottom" style="text-align: left;"><font style="display: inline; font-family: times new roman; font-size: 10pt;">&#160;</font></td><td valign="bottom"><font style="display: inline; font-family: times new roman; font-size: 10pt;">&#160;</font></td><td colspan="2" valign="bottom"><font style="display: inline; font-family: times new roman; font-size: 10pt;">&#160;</font></td><td nowrap="nowrap" valign="bottom" style="text-align: left;"><font style="display: inline; font-family: times new roman; font-size: 10pt;">&#160;</font></td></tr><tr><td valign="bottom"><div align="justify" style="text-indent: 0pt; display: block; margin-left: 0pt; margin-right: 0pt;"><font style="display: inline; font-family: times new roman; font-size: 10pt;">Exercised</font></div></td><td align="right" valign="bottom"><font style="display: inline; 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font-family: times new roman; font-size: 10pt;">&#160;</font></td><td valign="bottom"><font style="display: inline; font-family: times new roman; font-size: 10pt;">&#160;</font></td><td colspan="2" valign="bottom"><font style="display: inline; font-family: times new roman; font-size: 10pt;">&#160;</font></td><td nowrap="nowrap" valign="bottom" style="text-align: left;"><font style="display: inline; font-family: times new roman; font-size: 10pt;">&#160;</font></td><td valign="bottom"><font style="display: inline; font-family: times new roman; font-size: 10pt;">&#160;</font></td><td colspan="2" valign="bottom"><font style="display: inline; font-family: times new roman; font-size: 10pt;">&#160;</font></td><td nowrap="nowrap" valign="bottom" style="text-align: left;"><font style="display: inline; font-family: times new roman; font-size: 10pt;">&#160;</font></td></tr><tr><td valign="bottom" style="padding-bottom: 2px;"><div align="justify" style="text-indent: 0pt; display: block; margin-left: 0pt; 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font-family: times new roman; font-size: 10pt;">&#160;</font></td><td valign="bottom" width="9%" style="text-align: right;"><font style="display: inline; font-family: times new roman; font-size: 10pt;">&#160;</font></td><td nowrap="nowrap" valign="bottom" width="1%" style="text-align: left;"><font style="display: inline; font-family: times new roman; font-size: 10pt;">&#160;</font></td><td valign="bottom" width="1%"><font style="display: inline; font-family: times new roman; font-size: 10pt;">&#160;</font></td><td valign="bottom" width="1%" style="text-align: left;"><font style="display: inline; font-family: times new roman; font-size: 10pt;">&#160;</font></td><td valign="bottom" width="9%" style="text-align: right;"><font style="display: inline; font-family: times new roman; font-size: 10pt;">&#160;</font></td><td nowrap="nowrap" valign="bottom" width="1%" style="text-align: left;"><font style="display: inline; font-family: times new roman; font-size: 10pt;">&#160;</font></td><td valign="bottom" width="1%"><font style="display: inline; font-family: times new roman; font-size: 10pt;">&#160;</font></td><td valign="bottom" width="1%" style="text-align: left;"><font style="display: inline; font-family: times new roman; font-size: 10pt;">&#160;</font></td><td valign="bottom" width="9%" style="text-align: right;"><font style="display: inline; font-family: times new roman; font-size: 10pt;">&#160;</font></td><td nowrap="nowrap" valign="bottom" width="1%" style="text-align: left;"><font style="display: inline; font-family: times new roman; font-size: 10pt;">&#160;</font></td></tr><tr><td align="left" valign="bottom" width="52%"><div align="left" style="text-indent: 0pt; display: block; margin-left: 0pt; margin-right: 0pt;"><font style="display: inline; font-family: times new roman; font-size: 10pt; font-weight: bold;">At December 31, 2011</font></div></td><td valign="bottom" width="1%"><font style="display: inline; font-family: times new roman; font-size: 10pt;">&#160;</font></td><td valign="bottom" width="1%" style="text-align: left;"><font style="display: inline; font-family: times new roman; font-size: 10pt;">&#160;</font></td><td valign="bottom" width="9%" style="text-align: right;"><font style="display: inline; font-family: times new roman; font-size: 10pt;">&#160;</font></td><td nowrap="nowrap" valign="bottom" width="1%" style="text-align: left;"><font style="display: inline; font-family: times new roman; font-size: 10pt;">&#160;</font></td><td valign="bottom" width="1%"><font style="display: inline; font-family: times new roman; font-size: 10pt;">&#160;</font></td><td valign="bottom" width="1%" style="text-align: left;"><font style="display: inline; font-family: times new roman; font-size: 10pt;">&#160;</font></td><td valign="bottom" width="9%" style="text-align: right;"><font style="display: inline; font-family: times new roman; font-size: 10pt;">&#160;</font></td><td nowrap="nowrap" valign="bottom" width="1%" style="text-align: left;"><font style="display: inline; font-family: times new roman; font-size: 10pt;">&#160;</font></td><td valign="bottom" width="1%"><font style="display: inline; font-family: times new roman; font-size: 10pt;">&#160;</font></td><td valign="bottom" width="1%" style="text-align: left;"><font style="display: inline; font-family: times new roman; font-size: 10pt;">&#160;</font></td><td valign="bottom" width="9%" style="text-align: right;"><font style="display: inline; font-family: times new roman; font-size: 10pt;">&#160;</font></td><td nowrap="nowrap" valign="bottom" width="1%" style="text-align: left;"><font style="display: inline; font-family: times new roman; font-size: 10pt;">&#160;</font></td><td valign="bottom" width="1%"><font style="display: inline; font-family: times new roman; font-size: 10pt;">&#160;</font></td><td valign="bottom" width="1%" style="text-align: left;"><font style="display: inline; font-family: times new roman; font-size: 10pt;">&#160;</font></td><td valign="bottom" width="9%" style="text-align: right;"><font style="display: inline; font-family: times new roman; font-size: 10pt;">&#160;</font></td><td nowrap="nowrap" valign="bottom" width="1%" style="text-align: left;"><font style="display: inline; 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font-family: times new roman; font-size: 10pt;">&#160;</font></td><td valign="bottom" width="1%" style="text-align: left;"><font style="display: inline; font-family: times new roman; font-size: 10pt;">&#160;</font></td><td valign="bottom" width="9%" style="text-align: right;"><font style="display: inline; font-family: times new roman; font-size: 10pt;">&#160;</font></td><td nowrap="nowrap" valign="bottom" width="1%" style="text-align: left;"><font style="display: inline; font-family: times new roman; font-size: 10pt;">&#160;</font></td><td valign="bottom" width="1%"><font style="display: inline; font-family: times new roman; font-size: 10pt;">&#160;</font></td><td valign="bottom" width="1%" style="text-align: left;"><font style="display: inline; font-family: times new roman; font-size: 10pt;">&#160;</font></td><td valign="bottom" width="9%" style="text-align: right;"><font style="display: inline; font-family: times new roman; font-size: 10pt;">&#160;</font></td><td nowrap="nowrap" valign="bottom" width="1%" style="text-align: left;"><font style="display: inline; 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font-family: times new roman; font-size: 10pt;">&#160;</font></td><td valign="bottom" width="1%" style="text-align: left;"><font style="display: inline; font-family: times new roman; font-size: 10pt;">$</font></td><td valign="bottom" width="9%" style="text-align: right;"><font style="display: inline; font-family: times new roman; font-size: 10pt;">9,244</font></td><td nowrap="nowrap" valign="bottom" width="1%" style="text-align: left;"><font style="display: inline; font-family: times new roman; font-size: 10pt;">&#160;</font></td><td align="right" valign="bottom" width="1%"><font style="display: inline; font-family: times new roman; font-size: 10pt;">&#160;</font></td><td valign="bottom" width="1%" style="text-align: left;"><font style="display: inline; font-family: times new roman; font-size: 10pt;">$</font></td><td valign="bottom" width="9%" style="text-align: right;"><font style="display: inline; font-family: times new roman; font-size: 10pt;">-</font></td><td nowrap="nowrap" valign="bottom" width="1%" style="text-align: left;"><font style="display: inline; 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font-family: times new roman; font-size: 10pt;">&#160;</font></td><td valign="bottom" width="1%"><font style="display: inline; font-family: times new roman; font-size: 10pt;">&#160;</font></td><td valign="bottom" width="1%" style="text-align: left;"><font style="display: inline; font-family: times new roman; font-size: 10pt;">&#160;</font></td><td valign="bottom" width="9%" style="text-align: right;"><font style="display: inline; font-family: times new roman; font-size: 10pt;">&#160;</font></td><td nowrap="nowrap" valign="bottom" width="1%" style="text-align: left;"><font style="display: inline; font-family: times new roman; font-size: 10pt;">&#160;</font></td><td valign="bottom" width="1%"><font style="display: inline; font-family: times new roman; font-size: 10pt;">&#160;</font></td><td valign="bottom" width="1%" style="text-align: left;"><font style="display: inline; font-family: times new roman; font-size: 10pt;">&#160;</font></td><td valign="bottom" width="9%" style="text-align: right;"><font style="display: inline; 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font-family: times new roman; font-size: 10pt;">&#160;</font></td><td nowrap="nowrap" valign="bottom" width="1%" style="text-align: left;"><font style="display: inline; font-family: times new roman; font-size: 10pt;">&#160;</font></td><td valign="bottom" width="1%"><font style="display: inline; font-family: times new roman; font-size: 10pt;">&#160;</font></td><td valign="bottom" width="1%" style="text-align: left;"><font style="display: inline; font-family: times new roman; font-size: 10pt;">&#160;</font></td><td valign="bottom" width="9%" style="text-align: right;"><font style="display: inline; font-family: times new roman; font-size: 10pt;">&#160;</font></td><td nowrap="nowrap" valign="bottom" width="1%" style="text-align: left;"><font style="display: inline; font-family: times new roman; font-size: 10pt;">&#160;</font></td><td valign="bottom" width="1%"><font style="display: inline; font-family: times new roman; font-size: 10pt;">&#160;</font></td><td valign="bottom" width="1%" style="text-align: left;"><font style="display: inline; 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Quarterly Financial Data (Unaudited)
 12 Months Ended
Dec. 31, 2011
Quarterly Financial Data (Unaudited) [Abstract]  
Quarterly Financial Data (Unaudited)
(18)  
Quarterly Financial Data (Unaudited)
 

   
Quarter Ended
 
   
March 31
  
June 30
  
September 30
  
December 31
 
   
(in thousands, except per share data)
 
YEAR 2011
            
Research and development expense
 $3,345  $3,397  $2,837  $3,714 
Net (loss) income  
  (7,029 )  2,898   (960 )  (13,970 )
Per common share information:
                
Basic and diluted net (loss) income per share
 $(0.45) $0.12  $(0.04) $(0.59)
                  
YEAR 2010
                
Research and development expense
 $3,316  $3,253  $3,543  $2,743 
Net loss  
  (6,435 )  (6,505 )  (6,715 )  (5,945 )
Per common share information:
                
Basic and diluted net loss per share
 $(14.33) $(0.61) $(0.54) $(0.48)
                  
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Management's Plans to Continue as a Going Concern
 12 Months Ended
Dec. 31, 2011
Management's Plans To Continue As A Going Concern [Abstract]  
Management's Plans to Continue as a Going Concern
(2)           Management's Plans to Continue as a Going Concern
 
The accompanying financial statements have been prepared on a going-concern basis, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business.  The Company has incurred losses since inception and has a deficit accumulated during the development stage of $230.2 million as of December 31, 2011, including $48.4 million of cumulative accretion on redeemable convertible preferred stock through April 2010.  The Company anticipates incurring additional losses until such time, if ever, that it can generate significant sales of its therapeutic product candidates currently in development or enters into cash flow positive business development transactions.
 
Based upon its current expected level of operating expenditures and debt repayment, and assuming it is not required to settle any outstanding warrants in cash, the Company expects to be able to fund its operations to September 2012.  The Company intends to pursue additional sources of capital to continue its business operations as currently conducted and fund deficits in operating cash flows.  There is no assurance that such financing will be available when needed or, if available, on terms acceptable to the Company.
 
In November 2011, the Company's Board of Directors approved a restructuring plan designed to fund the Company's lead development programs through key milestones in 2012, eliminate plans to use its facility in East Norriton, Pennsylvania as a manufacturing center, and centralize its research and development operations in its leased facility in Winston-Salem, North Carolina.  The Company has retained a few administrative employees in its facility in East Norriton, Pennsylvania, and is exploring options to significantly reduce the amount of space it currently rents.
 
In the event financing is not obtained, the Company could pursue additional headcount reductions and other cost cutting measures to preserve cash as well as explore the sale of selected assets to generate additional funds.If the Company is required to significantly reduce operating expenses and delay, reduce the scope of, or eliminate one or more of its development programs, these events could have a material adverse effect on the Company's business, results of operations and financial condition.
 
These factors could significantly limit the Company's ability to continue as a going concern. The financial statements do not include any adjustments relating to recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might be necessary should the Company be unable to continue in existence.
 
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Organization and Nature of Operations
 12 Months Ended
Dec. 31, 2011
Organization and Nature of Operations [Abstract]  
Organization and Nature of Operations
(1)           Organization and Nature of Operations
 
Tengion, Inc. (the Company) was incorporated in Delaware on July 10, 2003.  The Company is focused on discovering, developing, manufacturing and commercializing replacement human neo-organs derived from a patient's own cells, or autologous cells.  Building on clinical and preclinical experience, the Company is leveraging its platform to develop its Neo-Urinary Conduit for bladder cancer patients and its Neo-Kidney Augment for patients with advanced chronic kidney disease.  The Company operates as a single business segment.
 
Operations of the Company are subject to certain risks and uncertainties, including, among others, uncertainty of product candidate development; technological uncertainty; dependence on collaborative partners; uncertainty regarding patents and proprietary rights; comprehensive government regulations; having no commercial manufacturing experience, marketing or sales capability or experience; and dependence on key personnel.
 

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Balance Sheets (USD $)
In Thousands, unless otherwise specified
Dec. 31, 2011
Dec. 31, 2010
Current assets:    
Cash and cash equivalents, including $1,661 and $1,194 of cash as of December 31, 2010 and 2011, respectively, collateralizing letters of credit (Note 16) $ 9,244 $ 11,972
Short-term investments 6,066 0
Deferred equity offering costs 0 41
Prepaid expenses and other 408 492
Total current assets 15,718 12,505
Property and equipment, net of accumulated depreciation of $19,830 and $12,622 as of December 31, 2010 and 2011, respectively 1,021 11,492
Other assets 1,078 147
Total assets 17,817 24,144
Current liabilities:    
Current portion of long-term debt 2,205 4,016
Current portion of lease liability 739 0
Accounts payable 829 1,194
Accrued compensation and benefits 2,354 1,291
Accrued expenses 437 1,552
Warrant liability 2,511 0
Other current liabilities 0 205
Total current liabilities 9,075 8,258
Long-term debt 2,782 4,585
Lease liability 943 0
Other liabilities 2 241
Total liabilities 12,802 13,084
Commitments and contingencies (Note 16)      
Stockholders' equity:    
Preferred stock, $0.001 par value; 10,000 shares authorized; zero shares issued or outstanding at December 31, 2010 and 2011, respectively 0 0
Common stock, $0.001 par value; 90,000 shares authorized; 12,386 and 23,814 shares issued and outstanding at December 31, 2010 and 2011, respectively 24 12
Additional paid-in capital 235,235 222,231
Deficit accumulated during the development stage (230,244) (211,183)
Total stockholders' equity 5,015 11,060
Total liabilities and stockholders' equity $ 17,817 $ 24,144
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Statements of Redeemable Convertible Preferred Stock and Stockholders' Equity (Deficit) (Parenthetical) (USD $)
Dec. 31, 2008
Dec. 31, 2007
Dec. 31, 2006
Dec. 31, 2005
Dec. 31, 2004
Condensed Statements of Redeemable Convertible Preferred Stock and Stockholders' Equity (Deficit) (unaudited) [Abstract]          
Series A Redeemable Convertible Preferred stock, value per share (in dollars per share)       $ 1.62 $ 1.62
Restricted common stock issued to employees and nonemployees, value per share (in dollars per share)       $ 2.32  
Series B Redeemable Convertible Preferred stock, value per share (in dollars per share)     $ 1.82    
Series C Redeemable Convertible Preferred stock, value per share (in dollars per share) $ 1.82 $ 1.82      
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Employee Benefit Plan
 12 Months Ended
Dec. 31, 2011
Employee Benefit Plan [Abstract]  
Employee Benefit Plan
 
(15)  
Employee Benefit Plan
 
The Company maintains a defined contribution 401(k) plan (the 401(k) Plan) for the benefit of its employees.  Employee contributions are voluntary and are determined on an individual basis, limited by the maximum amounts allowable under federal tax regulations.  As of December 31, 2011, the Company has not elected to match any of the employee's contributions to the 401(k) Plan.
 
 
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Income Taxes
 12 Months Ended
Dec. 31, 2011
Income Taxes [Abstract]  
Income Taxes
(17)  
Income Taxes
 
A reconciliation of the statutory U.S. federal rate to the Company's effective tax rate is as follows:
 
   
Year Ended December 31,
   
2009
 
2010
 
2011
Percent of pre-tax income:
                       
U.S. federal statutory income tax rate
   
(34.0
)
   
(34.0
) 
   
(34.0
)
State taxes, net of federal benefit
   
(6.7
)
   
(7.1
) 
   
(7.2
)
Interest expense –revaluation of warrants
   
-
     
-
     
(25.5
)
Other
   
(1.1
)
   
(0.5
) 
   
0.8
 
Valuation allowance
   
41.8
     
41.6
     
65.9
 
Effective income tax expense rate
   
-
     
-
     
-
 
                         

 
The tax effects of temporary differences that gave rise to significant portions of the deferred tax assets were as follows (in thousands):

   
December 31,
   
2010
 
2011
Net operating loss carryforwards 
  
$
44,765
 
  
$
56,702
 
Research and development credits 
  
 
4,697
 
  
 
5,241
 
Depreciation and amortization    
  
 
8,148
 
  
 
5,198
 
Capitalized start-up costs    
  
 
12,162
 
  
 
14,703
 
Other temporary differences  
  
 
1,134
 
  
 
2,384
 
Gross deferred tax asset   
  
 
70,906
 
  
 
84,228
 
Deferred tax assets valuation allowance  
  
 
(70,906
)
  
 
(84,228
)
 
  
$
-
 
  
$
-
 

In assessing the realizability of deferred tax assets, the Company considers whether it is more likely than not that some portion or all of the deferred tax assets will not be realized.  The ultimate realization of deferred tax assets is dependent upon the generation of future taxable income during the periods in which the temporary differences representing net future deductible amounts become deductible.  Due to the Company's history of losses, the deferred tax assets are fully offset by a valuation allowance at December 31, 2010 and 2011.  The valuation allowance in 2010 increased by $12.5 million over 2009 and the valuation allowance in 2011 increased by $13.3 million over 2010, related primarily to additional net operating losses incurred by the Company and additional capitalized start-up expenses.
 
The Company has moved its corporate headquarters to its leased facility in Winston-Salem, North Carolina during the first quarter of 2012.   As a result of differences in effective tax rates in North Carolina versus Pennsylvania, the deferred effective state tax rate is anticipated to be reduced.  As the Company has a full valuation allowance on its deferred taxes, there is no impact related to the change in the effective state tax rate on the balance sheet and statement of operations.   The Company is updating its forecasted effective state tax rate to consider this impact on its deferred taxes and will continue to monitor and update the rate as necessary.  Additionally, the Company has approximately a $8.3 million deferred tax asset related to Pennsylvania net operating loss carryforwards.  The ultimate use of this deferred tax asset may be impacted by the size of operations remaining in Pennsylvania in the future.  This deferred tax asset is currently offset by a full valuation allowance.
 
As of December 31, 2010, and 2011, approximately $29.6 million and $35.7 million, respectively, of the Company's expenses had been capitalized for tax purposes as start-up costs.  For tax purposes, capitalized start-up costs will be amortized over fifteen years beginning when the Company commences operations, as defined under the Internal Revenue Code.
 
The following table summarizes carryforwards of net operating losses and tax credits as of December 31, 2011 (in thousands).
 
   
Amount
 
Expiration
Federal net operating losses
 $138,631 
2023 to 2031
State net operating losses
  153,557 
2019 to 2031
Research and development credits
  5,241 
2024 to 2031

The Tax Reform Act of 1986 (the Act) provides for a limitation on the annual use of net operating loss and research and development tax credit carryforwards following certain ownership changes (as defined by the Act) that could limit the Company's ability to utilize these carryforwards.  The Company has not completed a study to assess whether an ownership change has occurred, or whether there have been multiple ownership changes since its formation, due to the significant costs and complexities associated with such a study.  The Company may have experienced various ownership changes, as defined by the Act, as a result of past financings.  Accordingly, the Company's ability to utilize the aforementioned carryforwards may be limited.  Additionally, U.S. tax laws limit the time during which these carryforwards may be applied against future taxes; therefore, the Company may not be able to take full advantage of these carryforwards for federal or state income tax purposes.
 
 
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Statements of Cash Flows (USD $)
In Thousands, unless otherwise specified
 12 Months Ended 66 Months Ended 102 Months Ended
Dec. 31, 2011
Dec. 31, 2010
Dec. 31, 2009
Dec. 31, 2008
Dec. 31, 2011
Cash flows from operating activities:          
Net loss $ (19,061) $ (25,600) $ (29,845) $ (107,351) $ (181,857)
Adjustments to reconcile net loss to net cash used in operating activities:          
Depreciation 3,141 4,862 4,937 10,212 23,152
Change in fair value of warrant liability (14,436) (192) (1,824) (47) (16,499)
Charge related to lease liability 1,705 0 0 0 1,705
Loss on disposition of property and equipment 0 2 101 16 119
Impairment of property and equipment 7,371 0 0 0 7,371
Amortization of net discount on short-term investments 0 0 0 (149) (149)
Noncash interest expense 162 325 460 1,601 2,548
Noncash rent expense (income) (24) 4 19 218 217
Stock-based compensation expense 834 954 855 2,536 5,179
Changes in operating assets and liabilities:          
Prepaid expenses and other assets (802) (137) 71 (760) (1,628)
Accounts payable (283) (631) 969 815 870
Accrued expenses and other (495) 1,000 (1,764) 4,021 2,763
Net cash used in operating activities (21,888) (19,411) (26,021) (88,888) (156,208)
Cash flows from investing activities:          
Purchases of short-term investments (13,066) (33,445) (17,432) (260,565) (324,508)
Sales and redemptions of short-term investments 7,000 35,944 19,590 256,057 318,591
Cash paid for property and equipment (81) (152) (289) (31,152) (31,674)
Proceeds from the sale of property and equipment 0 0 7 4 11
Net cash provided by (used in) investing activities (6,147) 2,347 1,876 (35,656) (37,580)
Cash flows from financing activities:          
Proceeds from sale of redeemable convertible preferred stock, net 0 0 0 139,960 139,960
Proceeds from sales of common stock and warrants, net 29,023 25,748 47 99 54,917
Repurchases of common stock 0 0 0 (94) (94)
Proceeds from long-term debt, net of issuance costs 4,908 0 841 33,768 39,517
Payments on long-term debt (8,624) (13,516) (5,883) (3,245) (31,268)
Net cash (used in) provided by financing activities 25,307 12,232 (4,955) 170,488 203,032
Net (decrease) increase in cash and cash equivalents (2,728) (4,832) (29,140) 45,944 9,244
Cash and cash equivalents, beginning of period 11,972 16,804 45,944 0 0
Cash and cash equivalents, end of period $ 9,244 $ 11,972 $ 16,804 $ 45,944 $ 9,244
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Balance Sheets (Parenthetical) (USD $)
In Thousands, except Per Share data, unless otherwise specified
Dec. 31, 2011
Dec. 31, 2010
Current assets:    
Collateralizing letters of credit $ 1,194 $ 1,661
Accumulated depreciation, Property and equipment $ 12,622 $ 19,830
Stockholders equity:    
Preferred stock, par value ( in dollars per share) $ 0.001 $ 0.001
Preferred stock, shares authorized (in shares) 10,000 10,000
Preferred stock, shares issued (in shares) 0 0
Preferred stock, shares outstanding (in shares) 0 0
Common stock, par value (in dollars per share) $ 0.001 $ 0.001
Common stock, shares authorized (in shares) 90,000 90,000
Common stock, shares issued (in shares) 23,814 12,386
Common stock, shares outstanding (in shares) 23,814 12,386
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Lease Liability
 12 Months Ended
Dec. 31, 2011
Lease Liability [Abstract]  
Lease Liability
(10)  
Lease Liability
 
The Company entered into an agreement in February 2006 to lease warehouse space effective March 1, 2011, at which time the Company determined it was not likely to utilize the space during the five-year lease term.  Therefore, the Company recorded a liability as of March 1, 2011, the cease-use date, for the fair value of its obligations under the lease.  The most significant assumptions used in determining the amount of the estimated lease liability are the potential sublease revenues and the credit-adjusted risk-free rate utilized to discount the estimated future cash flows.  During 2011, the Company recorded a liability and corresponding expense, which is included in other expense on the statement of operations, of $0.9 million, based on the Company's estimate of the fair value of its obligations.
 
In connection with the restructuring described in Note 9, the Company determined it was not likely to utilize substantially all of the leased office and manufacturing space in its East Norriton, Pennsylvania facility during the remainder of the lease term.  Therefore, the Company recorded a liability as November 30, 2011, the cease-use date, for the fair value of its obligations under the lease.  During 2011, the Company recorded a liability and corresponding expense, which is included in other expense on the statement of operations, of $0.9 million, based on the Company's estimate of the fair value of its obligations.
 
The following table summarizes the activity related to the lease liability for the year ended December 31, 2011 (in thousands).
 
   
Warehouse
space
 
Office and manufacturing
space
 
Total
Balance at January 1, 2011
 
$
-
   
$
-
   
$
-
 
Initial fair value
   
933
     
891
     
1,824
 
Charges utilized
   
(193
)
   
(45
)
   
(238
)
Additional charges to operations
   
88
     
8
     
96
 
Balance at December 31, 2011
   
828
     
854
     
1,682
 
Less current portion
   
(225
)
   
(514
)
   
(739
)
   
$
603
   
$
340
   
$
943
 

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Document And Entity Information (USD $)
 12 Months Ended
Dec. 31, 2011
Mar. 26, 2012
Jun. 30, 2011
Entity Registrant Name TENGION INC    
Entity Central Index Key 0001296391    
Current Fiscal Year End Date --12-31    
Entity Well-known Seasoned Issuer No    
Entity Voluntary Filers No    
Entity Current Reporting Status Yes    
Entity Filer Category Smaller Reporting Company    
Entity Public Float     $ 19,786,913
Entity Common Stock, Shares Outstanding   24,252,219  
Document Fiscal Year Focus 2011    
Document Fiscal Period Focus FY    
Document Type 10-K    
Amendment Flag false    
Document Period End Date Dec. 31, 2011    
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Debt
 12 Months Ended
Dec. 31, 2011
Debt [Abstract]  
Debt
(11)  
Debt
 
Total debt outstanding consists of the following (in thousands):

   
December 31,
   
2010
 
2011
Working Capital Note  
  
$
7,257
 
  
$
5,000
 
Equipment and Supplemental Working Capital Notes
  
 
1,015
 
  
 
126
 
Machinery and Equipment Loan    
  
 
477
 
  
 
-
 
Unamortized debt discount    
  
 
(148
)
  
 
(139
)
 
  
 
8,601
 
  
 
4,987
 
Less current portion    
  
 
(4,016
)
  
 
(2,205
)
 
  
$
4,585
 
  
$
2,782
 
 
  
             

Principal payments due as of December 31, 2011 are as follows (in thousands):

         
2012  
 
$
2,274
 
2013  
   
2,620
 
2014  
   
232
 
     
5,126
 
Less unamortized debt discount
   
(139
)
   
$
4,987
 
 
Working Capital Note
       
 
The Company has an outstanding working capital loan (the Working Capital Note) that was utilized to fund working capital needs of the Company.  In March 2011, the Company refinanced the outstanding debt owed to its lender of the Working Capital Note.  Pursuant to the terms of the refinancing, the Company simultaneously borrowed $5 million and repaid the then outstanding principal amount of $4.5 million. The Company modified the classification of long-term debt on its balance sheet as of December 31, 2010 to reflect the revised payment terms included in the new loan agreement.
 
Borrowings under the Working Capital Note are secured by all assets of the Company, except for Intellectual Property and permitted liens that have priority, including liens on equipment subsequently acquired to secure the purchase price or lease obligation, as defined in the loan agreement.  The Company is obligated to make interest-only payments through January 2012, followed by 24 monthly payments of principal and interest at an interest rate of 11.75% per annum.  In connection with the refinancing, the Company granted a warrant to the lender to purchase 70,671 shares of common stock.  The fair value of the warrant issued in connection with the refinancing was $0.1 million, using the Black-Scholes model.  See Note 13 for further discussion on warrants.
 
 
In addition, the lender also holds warrants exercisable into 100,874 shares of common stock as of December 31, 2011.  The estimated fair value of all of the warrants issued to the lender has been recorded against the carrying value of the Working Capital Note as an original issue discount (OID), which is being amortized to interest expense over the term of the Working Capital Note.  During the years ended December 31, 2009, 2010 and 2011, the Company recognized a noncash charge to interest expense of $0.4 million, $0.3 million, and $0.1 million, respectively, for the amortization of OID.
 
The Company recorded interest expense of $2.4 million, $1.5 million, and $0.6 million related to the Working Capital Note for the years ended December 31, 2009, 2010 and 2011, respectively.
 
Equipment and Supplemental Working Capital Note
 
In 2005, the Company executed a loan facility with another lender to fund equipment (the Equipment Note) and other asset purchases (the Supplemental Working Capital Note) from July 2005 through December 2010. Borrowings under the Equipment and Supplemental Working Capital Note are secured by equipment, as defined in the loan agreements.  As of December 31, 2011, the Equipment Note and the Supplemental Working Capital Note bear interest at an average rate of 11.49% and 13.52%, respectively.  The Company will make its final monthly principal and interest payment in April 2012 for each of the Equipment Note and the Supplemental Working Capital Note.  The Company recorded interest expense of $0.6 million, $0.3 million, and $0.1 million related to the Equipment and Supplemental Working Capital Notes for the years ended December 31, 2009, 2010 and 2011, respectively.
 
The lender holds warrants exercisable into 9,578 shares of common stock as of December 31, 2011.  The estimated fair value of the warrants issued to this lender has been recorded against the carrying value as OID, which is being amortized as interest expense over the term of the Equipment and Supplemental Working Capital Notes.  During the years ended December 31, 2009, 2010 and 2011, the Company recognized a noncash charge to interest expense of $44,000, $31,000, and $9,000, respectively, for the amortization of OID.
 
Machinery and Equipment Loan
 
In December 2007, the Company executed an agreement with the Commonwealth of Pennsylvania to fund machinery and equipment and other asset purchases (MELF Loan) through December 31, 2010.  Borrowings under the MELF Loan are secured by equipment, as defined in the loan agreement.  Under the terms of the MELF Loan, the Company has a four year period of payments of principal and accrued interest at an annual interest rate of 5% until September 2011 and 5.25% from September 2011 through maturity of the loan. The Company made its final monthly principal and interest payment in December 2011.  The Company recorded interest expense of $54,000, $36,000 and $13,000 related to the MELF Loan for the years ended December 31, 2009, 2010 and 2011, respectively.
 
In connection with the Working Capital Note, Equipment Note, Supplemental Working Capital Note, and the MELF Loan, the Company incurred financing costs of $0.3 million, recorded as other assets on the accompanying balance sheets, which are being amortized on a straight-line basis until maturity of the related notes. The Company recorded amortization of deferred financing costs of  $44,000, $44,000, and $47,000 during the years ended December 31, 2009, 2010 and 2011, respectively, which was included in interest expense on the accompanying statements of operations.
 
Borrowings under the Working Capital Note are secured by all assets of the Company, except for Intellectual Property and permitted liens that have priority, including liens on equipment subsequently acquired to secure the purchase price or lease obligation, as defined in the loan agreement.  Borrowings under the Equipment Note, Supplemental Working Capital Note and the MELF Loan are secured by equipment, as defined in the loan agreements.
 
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Statements of Operations (USD $)
In Thousands, except Per Share data, unless otherwise specified
 12 Months Ended 66 Months Ended 102 Months Ended
Dec. 31, 2011
Dec. 31, 2010
Dec. 31, 2009
Dec. 31, 2008
Dec. 31, 2011
Operating expenses:          
Research and development $ 13,293 $ 12,855 $ 17,948 $ 73,761 $ 117,857
General and administrative 7,191 6,032 5,527 23,143 41,893
Depreciation 3,141 4,862 4,937 10,212 23,152
Impairment of property and equipment 7,371 0 0 0 7,371
Other expense 1,705 0 0 0 1,705
Total operating expenses (32,701) (23,749) (28,412) (107,116) (191,978)
Interest income 53 62 211 8,185 8,511
Interest expense (849) (2,105) (3,468) (8,467) (14,889)
Change in fair value of warrant liability 14,436 192 1,824 47 16,499
Net loss (19,061) (25,600) (29,845) (107,351) (181,857)
Accretion of redeemable convertible preferred stock to redemption value 0 (3,993) (14,059)    
Net loss attributable to common stockholders $ (19,061) $ (29,593) $ (43,904)    
Basic and diluted net loss attributable to common stockholders per share (in dollars per share) $ (0.88) $ (3.22) $ (62.95)    
Weighted-average common stock outstanding - basic and diluted (in shares) 21,629 9,197 697   21,629
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Short-term Investments and Financial Instruments
 12 Months Ended
Dec. 31, 2011
Short-term Investments and Financial Instruments [Abstract]  
Short-term Investments and Financial Instruments
(5)  
Short-term Investments and Financial Instruments
 
As of December 31, 2010 and 2011, the carrying amounts of financial instruments held by the Company, which include cash equivalents, prepaid expenses and other current assets, accounts payable, and accrued expenses, approximate fair value due to the short-term nature of those instruments.  In addition, the carrying value of the Company's debt instruments, which do not have readily ascertainable market values, approximate fair value, given that the interest rates on outstanding borrowings approximate market rates.  See below and Note 13 for a discussion of fair value of the warrants.
 
As of December 31, 2011, short-term investments consisted of investments in commercial paper and U.S. government agency and corporate securities of $6.1 million.  As of December 31, 2010, the Company had no short-term investments.  The Company had the ability and intent to hold these investments until maturity and therefore has classified the investments as held-to-maturity.  Due to the short-term nature of these investments, unrealized gains and losses have been deemed temporary and therefore not recognized in the accompanying financial statements.  Income generated from short-term investments is recorded to interest income.
 
The fair value guidance requires fair value measurements be classified and disclosed in one of the following three categories:
 
·  
Level 1: Unadjusted quoted prices in active markets that are accessible at the measurement date for identical, unrestricted assets or liabilities;
 
·  
Level 2: Quoted prices in markets that are not active, or inputs which are observable, either directly or indirectly, for substantially the full term of the asset or liability;
 
·  
Level 3: Prices or valuation techniques that require inputs that are both significant to the fair value measurement and unobservable (i.e., supported by little or no market activity).
 
 
The following fair value hierarchy table presents information about each major category of the Company's financial assets and liability measured at fair value on a recurring basis as of December 31, 2010 and 2011 (in thousands).

   
Fair value measurement at reporting date using:
    
   
Quoted prices in active markets for identical assets (Level 1)
  
Significant other observable inputs
(Level 2)
  
Significant unobservable inputs
(Level 3)
  
Total
 
At December 31, 2010
            
Assets:
            
Cash and cash equivalents
 $11,972  $-  $-  $11,972 
                  
At December 31, 2011
                
Assets:
                
Cash and cash equivalents
 $9,244  $-  $-  $9,244 
Short-term investments
                
    U.S. government agency funds
  4,021   -   -   4,021 
    Corporate securities
  2,045   -   -   2,045 
Short-term investments
  6,066   -   -   6,066 
   $15,310  $-  $-  $15,310 
                  
Liabilities:
                
Warrant liability
 $-  $-  $2,511  $2,511 

The reconciliation of warrant liability measured at fair value on a recurring basis using unobservable inputs (Level 3) is as follows (in thousands):

         
Balance at January 1, 2010
 
$
314
 
Issuance of additional warrants    
   
-
 
Change in fair value of warrant liability           
   
(191
)
Reclassification of warrant liability to stockholders' equity                    
   
(123
)
Balance at December 31, 2010
 
$
-
 
Issuance of additional warrants     
   
16,947
 
Change in fair value of warrant liability                    
   
(14,436
)
Balance at December 31, 2011
 
$
2,511
 
         

The fair value of the warrant liability is based on Level 3 inputs.  For this liability, the Company developed its own assumptions that do not have observable inputs or available market data to support the fair value.  See Note 13 for further discussion of the warrant liability.
 
Certain assets and liabilities, including property and equipment, severance benefits and the lease liability, are measured at fair value on a nonrecurring basis.  These assets and liabilities are recognized at fair value when they are deemed to be impaired or in the period in which the liability is incurred.  The Company recorded an impairment charge of $7.4 million in the year ended December 31, 2011, to fully write off certain property and equipment as discussed in Note 6.  The Company recorded another charge of $1.8 million in the year ended December 31, 2011 related to the fair value of the liability incurred at the cease-use date related to certain operating leases as discussed in Note 10.  The Company also recorded $1.7 million charge in the year ended December 31, 2011 related to termination benefits as discussed in Note 9.
 
XML 35 R11.htm IDEA: XBRL DOCUMENT v2.4.0.6
Supplemental Cash Flow Information
 12 Months Ended
Dec. 31, 2011
Supplemental Cash Flow Information [Abstract]  
Supplemental Cash Flow Information
(4)  
Supplemental Cash Flow Information
 
The following table contains additional cash flow information for the periods reported (in thousands).
           
   
Year Ended December 31,
  
Period from
July 10, 2003
(inception)
through
December 31,
  
Period from
July 10, 2003
(inception)
through
December 31,
 
  2009  2010  2011  2008  2011 
Supplemental cash flow disclosures:
               
Noncash investing and financing activities:
               
Conversion of note principal to redeemable convertible preferred stock
 $-  $-  $-  $3,562  $3,562 
Convertible note issued to initial stockholder for consulting expense
  -   -   -   210   210 
Fair value of warrants issued with issuance of long-term debt
  9   -   105   2,176   2,290 
Fair value of warrants issued with sale of common stock
  -   -   16,947   -   16,947 
Conversion of redeemable convertible preferred stock into 5,652 shares of common stock
  -   191,909   -   -   191,909 
Conversion of warrant liability
  -   123   -   -   123 
Noncash property and equipment additions
  80   41   -   52   - 
Cash paid for interest, net of amounts capitalized
  3,008   1,695   722   6,853   12,278 
XML 36 R23.htm IDEA: XBRL DOCUMENT v2.4.0.6
Commitments and Contingencies
 12 Months Ended
Dec. 31, 2011
Commitments and Contingencies [Abstract]  
Commitments and Contingencies
(16)  
Commitments and Contingencies
 
(a)Leases and Letters of Credit
 
The Company leases office space and office equipment under operating leases, which expire at various times through February 2016.  Rent expense under these operating leases was $0.7 million for each of the years ended December 31, 2009, 2010, 2011, and $4.6 million for the period from July 10, 2003 (inception) through December 31, 2011.
 
 
The following table summarizes future minimum lease payments as of December 31, 2011 (in thousands):
 

         
2012                                                   
 
$
992
 
2013                      
   
1,016
 
2014        
   
1,040
 
2015       
   
1,063
 
2016             
   
276
 
Total minimum lease payments (1)    
  
$
4,387
 
         
(1)
 The future minimum lease payments above do not include the impact of any potential sublease income discussed in Note 9 related to the Company's lease liability.

Effective March 2011, the lease agreement for the Company's facility in East Norriton, Pennsylvania required the Company to provide security and restoration deposits totaling $2.2 million to the landlord, an increase from the prior amount of $1.7 million. Until January 2011, the Company obtained letters of credit from a bank in favor of the landlord to satisfy the obligations.  In January 2011, the Company deposited $1.0 million with the landlord as a security deposit, which amount is recorded as a non-current other asset on the Company's balance sheet as of December 31, 2011.  As of December 31, 2011, an outstanding letter of credit is satisfying the remaining o restoration deposit obligation of $1.2 million.  At the end of the lease term, the landlord has the right to require the Company to utilize the funds collateralizing this letter of credit to restore the facility to its original condition.  The letter of credit is collateralized by an account held at the bank.  If the bank determines the collateral to be insufficient, the bank has the right to demand additional collateral.  If the Company fails to provide additional collateral, the bank has the right to withdraw the letter of credit.  In that event, the landlord would have the right to require the Company to deposit cash of up to $1.2 million in an account to satisfy its deposit obligation.

In May 2011, the Company exercised the first five-year renewal option under its lease for laboratory space in Winston-Salem, North Carolina.  The amended lease extends the lease term to October 2016 and provides for payments of average annual base rent of approximately $0.2 million commencing in October 2011.

(b)  
License and Research Agreements
 
In 2003, a license agreement was executed with Children's Medical Center Corporation (CMCC), whereby CMCC granted the Company a license to utilize certain patent rights.  In accordance with the license agreement, the Company paid an initial license fee of $0.2 million, which was recorded as research and development expense.  Additionally, the license agreement requires the Company to reimburse CMCC for patent costs related to the underlying licensed rights.  In 2009, 2010, 2011, and for the period from July 10, 2003 (inception) through December 31, 2011, the Company recorded $0.2 million, $0.2 million, $0.2 million, and $2.3 million, respectively, related to the reimbursement of such patent costs as general and administrative expenses in the accompanying statements of operations.
 
The Company is obligated to make payments to CMCC upon the occurrence of various development and sales milestones.  During the fourth quarter of 2006, the Company achieved two of its development milestones for the first licensed product launched, as defined in the agreement, and paid $0.4 million, which was recorded as research and development expense for the year ended December 31, 2006.  No further milestones payments have been made.  If the Company develops and obtains regulatory approval of a licensed product in each of the four subfields covered under the license, it will be required to pay CMCC milestones aggregating approximately $6.9 million, which includes $0.4 million paid to date.  Also, if cumulative net sales of all licensed products reach a certain level, the Company will be required to make a one-time sales milestone payment of $2.0 million.  The timing and likelihood of such milestone payments are not currently known to the Company.  A portion of the milestone payments the Company makes will be credited against its future royalty payments.  The Company must pay CMCC royalties in the mid-single digit range based on net sales of licensed products as defined in the agreement by the Company, its affiliates and its sublicensees, which royalties will be reduced for certain amounts the Company is required to pay to license patents or intellectual property from third parties and under certain circumstances if there is a competing product.  No royalties will be payable with respect to sales of licensed products in countries where there is no valid patent claim, unless the Company advised CMCC not to file for patent protection in that country and later chose to market and sell licensed products in such country.  The license agreement, and the Company's obligation to pay royalties, terminates on the later of the expiration, on a country-by-country basis, of the last patent right and October 2018.
 
In January 2006 the Company entered into a license agreement with Wake Forest University Health Sciences, or WFUHS, which was amended in May 2007, for the license of certain of WFUHS's intellectual property rights.  Under the license agreement, the Company issued WFUHS a warrant to purchase 3,200 shares of the Company's common stock through January 1, 2016 at an exercise of $2.32 per share and is required to pay WFUHS a percentage of certain consideration received from a sublicensee.  The Company is not required to make any milestone payments to WFUHS related to the development or commercialization of the licensed products, but the Company is required to pay certain license maintenance fees with respect to each product covered by new development patents, commencing two years after the Company initiates the first animal study conducted under cGLP, with respect to such product.  These license maintenance fees, which are in the low six figure range with respect to each product, will be creditable against royalties the Company is obligated to pay to WFUHS for such product.  In addition, the Company is required to pay WFUHS royalties in the low- to mid-single digit range based on net sales of licensed products in all countries.  With respect to any product covered by an improvement patent, the Company's obligation to pay royalties to WFUHS terminates upon the later of the expiration, on a product-by-product basis, of the last to expire patent covering such product and the date that is 15 years from the first commercial sale of such product, provided that no such royalty is payable more than seven years after expiration of the last-to-expire patent covering such product.
 
In January 2006, the Company entered into a research agreement with WFUHS, which was amended in September 2006 and extended in September 2010 for an additional three-year period.  Under the research agreement, WFUHS agreed to perform sponsored research in return for quarterly payments.  As of December 31, 2010, the Company was obligated to make payments of $800,000 with respect to the 2011 research activities of WFUHS under the extended agreement.  The Company terminated the research agreement with WFUHS effective December 31, 2011 and has no further financial or other obligations under this agreement.
 
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Capital Structure
 12 Months Ended
Dec. 31, 2011
Capital Structure [Abstract]  
Capital Structure
(12)  
Capital Structure
 
Common Stock
 
Since inception, the Company has sold common stock to certain officers, directors, employees, consultants, and Scientific Advisory Board members.  As of December 31, 2011, the Company was authorized to issue 90,000,000 shares of common stock.  Each holder of common stock is entitled to one vote for each share held.  The Company will, at all times, reserve and keep available out of its authorized but unissued shares of common stock sufficient shares to effect the exercise of outstanding stock options and warrants.
 
March 2011 Equity Financing
 
In March 2011, the Company closed a private placement transaction pursuant to which the Company sold securities consisting of 11,079,250 shares of common stock and warrants to purchase 10,460,875 shares of common stock.  The purchase price per security was $2.83.  The Company received net proceeds of $28.9 million.

In connection with the March 2011 equity financing, the Company filed a registration statement with the SEC for the registration of the total number of shares sold to the investors and shares issuable upon exercise of the warrants and the registration statement was declared effective by the SEC on May 16, 2011.  The Company is required to use commercially reasonable efforts to cause the registration statement to remain continuously effective until such time when all of the registered shares are sold or such shares may be sold by non-affiliates without volume or manner-of-sale restrictions pursuant to Rule 144 of the Securities Act and without the requirement for the Company to be in compliance with the current public information requirement under Rule 144.  In the event the Company fails to meet certain legal requirements in regards to the registration statement, it will be obligated to pay the investors, as partial liquidated damages and not as a penalty, an amount in cash equal to 1.5% of the aggregate purchase price paid by investors for each monthly period that the registration statement is not effective, up to a maximum aggregate payment of 6% of the purchase price paid by investors, except that if the Company fails to satisfy the current public information requirement pursuant to Rule 144(c)(1), the maximum aggregate payment would be 12% of the purchase price paid by investors.  If the Company determines a registration payment arrangement in connection with the securities issued in March 2011 is probable and can be reasonably estimated, a liability will be recorded. As of December 31, 2011, we concluded the likelihood of having to make any payments under the arrangements was remote, and therefore did not record any related liability.
 
Initial Public Offering
 
In April 2010, the Company completed its initial public offering, selling 6,000,000 shares of common stock at an initial public offering price of $5.00 per share resulting in gross proceeds of $30.0 million.  Net proceeds received after underwriting fees and offering expenses were $25.7 million.  In connection with the closing of the initial public offering, all outstanding shares of the Company's redeemable convertible preferred stock were converted into an aggregate of 5,651,955 shares of common stock, and all outstanding warrants to purchase preferred stock were converted into warrants to purchase 110,452 shares of common stock.

Preferred Stock
 
As of December 31, 2011, the Company was authorized to issue 10,000,000 shares of preferred stock in one or more series and to fix the rights, preferences, privileges, and restrictions thereof.  These rights, preferences and privileges could include dividend rights, conversion rights, voting rights, terms of redemption, liquidation preferences, sinking fund terms and the number of shares constituting any series or the designation of such series, any or all of which may be greater than the rights of common stock.  The issuance of our preferred stock could adversely affect the voting power of holders of common stock and the likelihood that such holders will receive dividend payments and payments upon liquidation.  In addition, the issuance of preferred stock could have the effect of delaying, deferring or preventing a change of control of our company or other corporate action.  There are no shares issued or outstanding as of December 31, 2011.
 
In August 2004 and March 2005, the Company issued 20,943,577 and 3,247,095 shares, respectively, of Series A-1 at $1.61683 per share.  The shares issued in August 2004 resulted in cash proceeds of approximately $30.1 million, net of transaction costs, and the conversion of principal and interest on the convertible notes in the aggregate amount of approximately $3.6 million.  The shares issued in March 2005 resulted in cash proceeds of approximately $5.2 million, net of transaction costs.  In June 2006, the Company converted each share of Series A-1 into one share of Series A.  All terms of the Series A remained the same as the Series A-1.  In June 2006, the Company issued 27,637,363 shares of Series B at $1.82 per share.  The shares issued resulted in cash proceeds of approximately $50.0 million, net of transaction costs.  In September 2007 and October 2008, the Company issued 18,332,965 and 11,793,127 shares of Series C, respectively, at $1.82 per share.  The shares issued resulted in cash proceeds of approximately $33.2 million and $21.4 million, net of transaction costs, in 2007 and 2008, respectively.  The Company incurred aggregate costs of $0.2 million for Series A, $0.3 million for Series B, and $0.3 million for Series C, respectively, in connection with the sale of the Series A, Series B, and Series C, which reduced the initial carrying value of each Series of redeemable convertible preferred stock.
 
The Series A, Series B, and Series C were convertible into common stock at the option of the holder on a share-for-share basis, subject to certain customary anti-dilution adjustments contained in the Company's certificate of incorporation, which were triggered, with respect to each series of preferred stock, upon the closing of the Company's IPO in April 2010.  In addition, the Series A, Series B and Series C were entitled to vote together with the common stockholders as one class and were entitled to separate votes on certain matters.  The Series A, Series B, and Series C stockholders were entitled to receive an annual 8% dividend, when and if declared by the board of directors.  No dividends were declared through the conversion date in April 2010.
 
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Accrued Expenses
 12 Months Ended
Dec. 31, 2011
Accrued Expenses [Abstract]  
Accrued Expenses
 
(8)  
Accrued Expenses
 
Accrued expenses consist of the following (in thousands):
 
  December 31, 
  
2010
  
2011
 
Accrued consulting and professional fees
  
$
730
 
  
$
119
 
Accrued research and development
   
679
     
235
 
Other
  
 
143
 
  
 
83
 
 
  
$
1,552
 
  
$
437
 
 
  
             

XML 39 R13.htm IDEA: XBRL DOCUMENT v2.4.0.6
Property and Equipment
 12 Months Ended
Dec. 31, 2011
Property and Equipment [Abstract]  
Property and Equipment
 
(6)  
Property and Equipment
 
Property and equipment consisted of the following (in thousands):
 
   
December 31,
   
2010
 
2011
Office and warehouse equipment
  
$
356
 
  
$
323
 
Computer equipment
   
1,246
     
985
 
Furniture and fixtures
   
524
     
524
 
Laboratory equipment
   
7,762
     
4,913
 
Leasehold improvements
  
 
21,434
 
  
 
6,898
 
 
  
 
31,322
 
  
 
13,643
 
Less accumulated depreciation
  
 
(19,830
)
  
 
(12,622
)
 
  
$
11,492
 
  
$
1,021
 

During the year ended December 31, 2011, the Company recorded a non-cash property and equipment impairment charge of $7.4 million in connection with the restructuring plan described in Note 9.  Under the restructuring plan, the Company eliminated plans to use its facility in East Norriton, Pennsylvania as a manufacturing center and centralized its research and development operations in its leased facility in Winston-Salem, North Carolina.  The aggregate acquisition value of the impaired assets, most of which were leasehold improvements, was reduced by $17.6 million and the related accumulated depreciation was reduced by $10.2 million as there was no future realizable value related to these assets.
XML 40 R14.htm IDEA: XBRL DOCUMENT v2.4.0.6
Accrued compensation and benefits
 12 Months Ended
Dec. 31, 2011
Accrued compensation and benefits [Abstract]  
Accrued compensation and benefits
(7)  
Accrued compensation and benefits
 
Accrued compensation and benefits expenses consist of the following (in thousands):
 
   
December 31,
   
2010
 
2011
Accrued severance benefits
  
$
-
 
  
$
1,774
 
Other accrued compensation and benefits
  
 
1,291
 
  
 
580
 
 
  
$
1,291
 
  
$
2,354
 

As of December 31, 2011 accrued severance benefits included $1.5 million related to the restructuring in November 2011 (See Note 9 below for more details).  The Company expects to complete payment of these severance benefits by September 2012.

As of December 31, 2011 accrued severance benefits also included $0.2 million related to the severance agreement the Company entered into with its former president and chief executive officer in June 2011.  The severance agreement provided for the employee to receive 12 monthly severance payments equal to his current monthly salary and a one-time cash payment equal to his target bonus amount for 2011.  During the year ended December 31, 2011, the Company recorded compensation expense within general and administrative expense and a corresponding liability of $0.7 million for the estimated value of the Company's obligations under the severance agreement.  As of December 31, 2011, the Company paid $0.5 million and anticipates making payments of the remaining $0.2 million through June 30, 2012 in connection with the severance agreement.

 
Other accrued compensation and benefits for the year ended December 31, 2010 and 2011 consisted primarily of accrued bonus of $1.1 million and $0.4 million, respectively.
 
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Restructuring Expenses
 12 Months Ended
Dec. 31, 2011
Restructuring Expenses [Abstract]  
Restructuring Expenses
(9)  
Restructuring Expenses
 
In November 2011, the Company's Board of Directors approved a restructuring plan designed to fund the Company's lead development programs through key milestones in 2012, eliminate plans to use its facility in East Norriton, Pennsylvania as a manufacturing center, and centralize its research and development operations in its leased facility in Winston-Salem, North Carolina.   The Company has retained a few administrative employees in its facility in East Norriton, Pennsylvania, and is exploring options to significantly reduce the amount of space it currently rents.  In connection with the restructuring, the Company recorded a non-cash property and equipment impairment charge (see Note 6 for further information) and a non-cash charge related to its lease obligations (see Note 10 for further information).

The Company offered severance benefits to the terminated employees, and estimates a total charge for personnel-related termination costs of approximately $2.0 million. The Company recorded $1.7 million of the total charge in the fourth quarter of 2011, of which $0.8 million is included in research and development expense and $0.9 million is included in general and administrative expense in the accompanying statements of operations.  The Company expects to complete payment of these severance benefits by September 2012.  The following table summarizes the activity related to accrued severance benefits for the year ended December 31, 2011 (in thousands).

   
2011 charges to operations
 
2011 charges
paid
 
Accrual balance as of December 31, 2011
Restructuring Expenses:
                       
Severance benefits
 
$
1,716
   
$
172
   
$
1,544
 
                         

In 2009, the Company implemented a restructuring plan, which reduced headcount by 34 employees.  Expenses incurred related to the 2009 restructuring consisted of termination benefits of $0.9 million in the year ended December 31, 2009, of which $0.6 million is included in research and development expense and $0.3 million is included in general and
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Stock-based Compensation
 12 Months Ended
Dec. 31, 2011
Stock-based Compensation [Abstract]  
Stock-based Compensation
(14)  
Stock-based Compensation
 
The Company currently maintains two stock-based compensation plans.  Under the 2004 Stock Option Plan (the 2004 Plan), stock awards were granted to employees, directors, and consultants of the Company, in the form of restricted stock and stock options. The amounts and terms of options granted were determined by the Company's compensation committee. The equity awards granted under the Plan generally vest over four years and have terms of up to ten years after the date of grant, and options are exercisable in cash or as otherwise determined by the board of directors. There are no shares available for future grants under the 2004 Plan, as grants from the 2004 Plan ceased upon the Company's initial public offering in April 2010.
 
The 2010 Stock Incentive and Option Plan (2010 Plan) became effective upon the closing of the Company's initial public offering.  Under the 2010 Plan, stock awards may be granted to employees, directors, and consultants of the Company, in the form of restricted or unrestricted stock, stock appreciation rights, cash-based or performance share awards and stock options. The amounts and terms of options granted are determined by the Company's compensation committee. The equity awards granted under the Plan generally vest over four years and have terms of up to ten years after the date of grant, and options are exercisable in cash or as otherwise determined by the board of directors.  The 2010 Plan allows for the transfer of forfeited shares from the 2004 Plan.  As of December 31, 2011, 727,488 shares of common stock were available for future grants under the Plan.

 
Stock Options
 
The following table summarizes stock option activity under the Plans:
 
   
Number of shares
  
Weighted-average exercise price
  
Weighted-average remaining contractual term (in years)
  
Aggregate intrinsic value (in thousands)
 
Outstanding at December 31, 2008
  518,977  $3.63       
Granted
  358,640  $0.44       
Exercised
  (20,005 ) $2.71       
Forfeited
  (145,233 ) $13.54       
Outstanding at December 31, 2009
  712,379  $1.00       
Granted
  790,812  $3.65       
Exercised
  (32,255 ) $0.44       
Forfeited
  (93,226 ) $1.73       
Outstanding at December 31, 2010
  1,377,710  $2.49       
Granted
  1,305,675  $1.14       
Exercised
  (187,158 ) $0.44       
Forfeited
  (749,257 ) $2.54       
Outstanding at December 31, 2011
  1,746,970  $1.68   8.9  $63 
                  
Vested and expected to vest at December 31, 2011
  1,618,332  $1.71   8.9  $57 
                  
Exercisable at December 31, 2011
  457,300  $2.74   7.3  $6 
                  
During 2009, 2010 and 2011, the Company issued options to purchase 358,640, 758,812, and 1,295,675 shares of common stock, respectively, to employees and non-employee directors under the Plans.  The per-share weighted-average fair value of the options granted to employees during 2009, 2010 and 2011 was estimated at $0.44, $3.65, and $0.61, respectively, on the date of grant using the Black-Scholes option-pricing model with the following weighted-average assumptions:
 
   
Year ended December 31,
   
2009
 
2010
 
2011
             
Volatility      
 
66.2%
 
69.4%
 
78.79%
Expected term      
 
6 years
 
6 years
 
5.5 years
Risk-free interest rate     
 
2.7%
 
2.0%
 
1.37%
Dividend yield
 
None
 
None
 
None
             

Total stock-based compensation expense recognized for stock options to employees and non-employee directors for the years ended December 31, 2009, 2010, and 2011 was $0.9 million, $0.9 million, and $0.7 million, respectively.  As of December 31, 2011, there was $0.9 million of unrecognized compensation expense, net of forfeitures, related to non-vested employee stock options and remaining incremental expense associated with the modification of stock options and $26,000 of unrecognized compensation expense related to non-vested non-employee director stock options, which are expected to be recognized over a weighted- average period of approximately 3.5 years.
 
During 2010 and 2011, the Company issued options to purchase 32,000 and 10,000 shares of common stock, respectively, to non-employee consultants under the Plan.  No options were granted to non-employees during the year ended December 31, 2009.  The per-share weighted-average fair value of the options granted to non-employees during 2010 and 2011 was estimated at $1.21 and $0.29, respectively, on the date of grant using the Black-Scholes option-pricing model with the following weighted-average assumptions:
 
 
   
Year ended December 31,
   
2009
 
2010
 
2011
             
Volatility   
 
Not applicable
 
69.35%
 
88.47%
Expected term  
 
Not applicable
 
6 years
 
5 years
Risk-free interest rate   
 
Not applicable
 
2.0%
 
0.83%
Dividend yield      
 
Not applicable
 
None
 
None
             
Total stock-based compensation expense recognized for stock options to nonemployees for the years ended December 31, 2010 and 2011 was $14,000 and $9,000, respectively.  For the year ended December 31, 2009, the Company recognized a credit of $66,000 due to the decline in the per-share fair value of the outstanding options granted to non-employees.  As of December 31, 2011, there was approximately $5,000 of unrecognized compensation expense related to non-vested non-employee stock options, which is expected to be recognized over a weighted- average period of less than 1 year.
 
Restricted Stock
 
The Company has issued restricted stock as compensation for the services of certain employees and other third parties.  The grant date fair value of restricted stock was based on the fair value of the common stock on the date of grant, and compensation expense is recognized based on the period in which the restrictions lapse.
 
The following table summarizes restricted stock activity under the Plans:
   
Number of shares
  
Weighted-average grant date fair value
 
Nonvested at December 31, 2008 
  3,191  $- 
Granted 
  -  $- 
Vested   
  (2,759 ) $3.51 
Forfeited     
  -  $- 
Nonvested at December 31, 2009   
  432  $5.80 
Granted     
  -  $- 
Vested      
  (432 ) $5.80 
Forfeited   
  -  $- 
Nonvested at December 31, 2010   
  -  $- 
Granted   
  310,783  $2.42 
Vested           
  (21,667 ) $2.42 
Forfeited    
  (149,337 ) $2.42 
Nonvested at December 31, 2011    
  139,779  $2.42 

Total stock-based compensation expense for restricted stock was $10,000, $1,000, and $0.1 million for the years ended December 31, 2009, 2010, and 2011, respectively.  As of December 31, 2011, there was $0.2 million of unrecognized compensation expense related to restricted stock awards, which is expected to be recognized over a weighted- average period of 3.1 years.
 
XML 43 R5.htm IDEA: XBRL DOCUMENT v2.4.0.6
Statements of Redeemable Convertible Preferred Stock and Stockholders' Equity (Deficit) (USD $)
In Thousands, unless otherwise specified
Redeemable Convertible Preferred Stock [Member]
Common Stock [Member]
Additional Paid-in Capital [Member]
Deferred Compensation [Member]
Accumulated deficit during the development stage [Member]
Total
Balance at Jul. 10, 2003 $ 0 $ 0 $ 0 $ 0 $ 0 $ 0
Balance (in shares) at Jul. 10, 2003           0
Increase (Decrease) in Stockholders' Equity [Roll Forward]            
Issuance of common stock to initial stockholder 0 2 (2) 0 0 0
Issuance of common stock to initial stockholder (in shares)   2,000        
Effect of reverse stock split (see Note 3) 0 (2) 2 0 0 0
Effect of reverse stock split (see Note 3) (in shares)   (1,862)        
Net loss 0 0 0 0 (1,032) (1,032)
Balance at Dec. 31, 2003 0 0 0 0 (1,032) (1,032)
Balance (in shares) at Dec. 31, 2003   138        
Increase (Decrease) in Stockholders' Equity [Roll Forward]            
Net loss 0 0 0 0 (2,438) (2,438)
Issuance of Series A Redeemable Convertible Preferred stock, net of expenses 30,126 0 0 0 0 0
Issuance of Series A Redeemable Convertible Preferred stock, net of expenses (in shares) 18,741          
Conversion of notes payable, including interest 3,562 0 0 0 0 0
Conversion of notes payable, including interest (in shares) 2,203          
Issuance of restricted common stock to employees and nonemployees 0 1 336 (336) 0 1
Issuance of restricted common stock to employees and nonemployees (in shares)   240        
Issuance of common stock to consultants 0 0 21 0 0 21
Issuance of common stock to consultants (in shares)   140        
Issuance of common stock to convertible noteholders 0 0 67 0 0 67
Issuance of common stock to convertible noteholders (in shares)   93        
Issuance of options to purchase common stock to consultants for services rendered 0 0 14 (14) 0 0
Amortization of deferred compensation 0 0 0 23 0 23
Change in value of restricted common stock subject to vesting 0 0 11 (11) 0 0
Accretion of redeemable convertible preferred stock to redemption value 1,035 0 0 0 (1,035) (1,035)
Balance at Dec. 31, 2004 34,723 1 449 (338) (4,505) (4,393)
Balance (in shares) at Dec. 31, 2004 20,944 611        
Increase (Decrease) in Stockholders' Equity [Roll Forward]            
Net loss 0 0 0 0 (9,627) (9,627)
Issuance of Series A Redeemable Convertible Preferred stock, net of expenses 5,223 0 0 0 0 0
Issuance of Series A Redeemable Convertible Preferred stock, net of expenses (in shares) 3,247          
Issuance of restricted common stock to employees and nonemployees 0 0 140 (139) 0 1
Issuance of restricted common stock to employees and nonemployees (in shares)   60        
Issuance of warrants to purchase preferred stock to noteholders 0 0 681 0 0 681
Issuance of options to purchase common stock to consultants for services rendered 0 0 7 (7) 0 0
Amortization of deferred compensation 0 0 0 111 0 111
Accretion of redeemable convertible preferred stock to redemption value 3,164 0 0 0 (3,164) (3,164)
Balance at Dec. 31, 2005 43,110 1 1,277 (373) (17,296) (16,391)
Balance (in shares) at Dec. 31, 2005 24,191 671        
Increase (Decrease) in Stockholders' Equity [Roll Forward]            
Net loss 0 0 0 0 (20,873) (20,873)
Issuance of Series B Redeemable Convertible Preferred stock, net of expenses 50,040 0 0 0 0 0
Issuance of Series B Redeemable Convertible Preferred stock, net of expenses (in shares) 27,637          
Issuance of restricted common stock to employees 0 0 0 0 0 0
Issuance of restricted common stock to employees (in shares)   3        
Issuance of common stock upon exercise of options 0 0 9 0 0 9
Issuance of common stock upon exercise of options (in shares)   4        
Repurchased nonvested restricted stock 0 0 0 0 0 0
Repurchased nonvested restricted stock (in shares)   (14)        
Reclassification of deferred compensation 0 0 (373) 373 0 0
Reclassification of warrants to purchase preferred stock 0 0 (681) 0 0 (681)
Stock-based compensation expense 0 0 400 0 0 400
Accretion of redeemable convertible preferred stock to redemption value 5,640 0 0 0 (5,640) (5,640)
Balance at Dec. 31, 2006 98,790 1 632 0 (43,809) (43,176)
Balance (in shares) at Dec. 31, 2006 51,828 664        
Increase (Decrease) in Stockholders' Equity [Roll Forward]            
Net loss 0 0 0 0 (30,988) (30,988)
Issuance of Series C Redeemable Convertible Preferred stock, net of expenses 33,219 0 0 0 0 0
Issuance of Series C Redeemable Convertible Preferred stock, net of expenses (in shares) 18,333          
Issuance of common stock upon exercise of options 0 0 60 0 0 60
Issuance of common stock upon exercise of options (in shares)   16        
Repurchased vested restricted stock 0 0 (94) 0 0 (94)
Repurchased vested restricted stock (in shares)   (5)        
Stock-based compensation expense 0 0 664 0 0 664
Accretion of redeemable convertible preferred stock to redemption value 8,742 0 0 0 (8,742) (8,742)
Balance at Dec. 31, 2007 140,751 1 1,262 0 (83,539) (82,276)
Balance (in shares) at Dec. 31, 2007 70,161 675        
Increase (Decrease) in Stockholders' Equity [Roll Forward]            
Net loss 0 0 0 0 (42,393) (42,393)
Issuance of Series C Redeemable Convertible Preferred stock, net of expenses 21,352 0 0 0 0 0
Issuance of Series C Redeemable Convertible Preferred stock, net of expenses (in shares) 11,793          
Issuance of common stock upon exercise of options 0 0 28 0 0 28
Issuance of common stock upon exercise of options (in shares)   8        
Repurchased vested restricted stock 0 0 0 0 0 0
Repurchased vested restricted stock (in shares)   (1)        
Stock-based compensation expense 0 0 1,317 0 0 1,317
Accretion of redeemable convertible preferred stock to redemption value 11,754 0 0 0 (11,754) (11,754)
Balance at Dec. 31, 2008 173,857 1 2,607 0 (137,686) (135,078)
Balance (in shares) at Dec. 31, 2008 81,954 682        
Increase (Decrease) in Stockholders' Equity [Roll Forward]            
Net loss 0 0 0 0 (29,845) (29,845)
Issuance of common stock upon exercise of options 0 0 54 0 0 54
Issuance of common stock upon exercise of options (in shares)   20        
Stock-based compensation expense 0 0 855 0 0 855
Accretion of redeemable convertible preferred stock to redemption value 14,059 0 0 0 (14,059) (14,059)
Balance at Dec. 31, 2009 187,916 1 3,516 0 (181,590) (178,073)
Balance (in shares) at Dec. 31, 2009 81,954 702        
Increase (Decrease) in Stockholders' Equity [Roll Forward]            
Net loss 0 0 0 0 (25,600) (25,600)
Issuance of common stock upon exercise of options 0 0 14 0 0 14
Issuance of common stock upon exercise of options (in shares)   32        
Stock-based compensation expense 0 0 953 0 0 953
Accretion of redeemable convertible preferred stock to redemption value 3,993 0 0 0 (3,993) (3,993)
Conversion of preferred stock to common stock (191,909) 5 191,904 0 0 191,909
Conversion of preferred stock to common stock (in shares) (81,954) 5,652        
Conversion of preferred stock warrants to common stock warrants 0 0 123 0 0 123
Proceeds from initial public offering, net of expenses 0 6 25,721 0 0 25,727
Proceeds from initial public offering, net of expenses (in shares)   6,000        
Balance at Dec. 31, 2010 0 12 222,231 0 (211,183) 11,060
Balance (in shares) at Dec. 31, 2010   12,386        
Increase (Decrease) in Stockholders' Equity [Roll Forward]            
Net loss 0 0 0 0 (19,061) (19,061)
Proceeds from equity financing, net of expenses 0 11 28,930 0 0 28,941
Proceeds from equity financing, net of expenses (in shares)   11,079        
Issuance of warrants to purchase common stock issued in connection with equity financing 0 0 (16,947) 0 0 (16,947)
Issuance of common stock upon exercise of options 0 1 82 0 0 83
Issuance of common stock upon exercise of options (in shares)   187        
Issuance of restricted stock to employees 0 0 0 0 0 0
Issuance of restricted stock to employees (in shares)   311        
Cancellation of non-vested restricted stock 0 0 0 0 0 0
Cancellation of non-vested restricted stock (in shares)   (149)        
Issuance of warrants to purchase common stock in connection with debt financing 0 0 105 0 0 105
Stock-based compensation expense 0 0 834 0 0 834
Balance at Dec. 31, 2011 $ 0 $ 24 $ 235,235 $ 0 $ (230,244) $ 5,015
Balance (in shares) at Dec. 31, 2011   23,814        
XML 44 R10.htm IDEA: XBRL DOCUMENT v2.4.0.6
Summary of Significant Accounting Policies
 12 Months Ended
Dec. 31, 2011
Summary of Significant Accounting Policies [Abstract]  
Summary of Significant Accounting Policies
3)           Summary of Significant Accounting Policies
 
(a)Use of Estimates
 
The preparation of financial statements, in accordance 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 and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period.  Actual results could differ from those estimates.
 
(b)Fair Value of Financial Instruments
 
As of December 31, 2010 and 2011, the carrying amounts of financial instruments held by the Company, which include cash equivalents, short-term investments, prepaid expenses and other current assets, accounts payable, and accrued expenses, approximate fair value due to the short-term nature of those instruments.  In addition, the carrying value of the Company's debt instruments, which do not have readily ascertainable market values, approximate fair value, given that the interest rates on outstanding borrowings approximate market rates.
 
(c)Cash and Cash Equivalents
 
The Company considers all highly liquid investments purchased with an original maturity of three months or less to be cash equivalents.  As of December 31, 2010 and 2011, cash and cash equivalents included government-backed money market funds, commercial paper, and various bank deposit accounts.  As of December 31, 2011, $1.2 million of the Company's cash is held in a separate account collateralizing letters of credit issued by a bank in favor of the landlord of our leased facility in East Norriton, Pennsylvania.  See Note 16 for more details.
 
(d)Short-term Investments
 
The Company classifies investments as held-to-maturity at the time of purchase and reevaluates such designation as of each balance sheet date.  Securities are classified as held-to-maturity when the Company has the positive intent and the ability to hold the securities until maturity.  Held-to-maturity investments are recorded at amortized cost, adjusted for the accretion of discounts or premiums.  Discounts or premiums are accreted into interest income over the life of the related investment using the straight-line method, which approximates the effective- yield method.  Dividend and interest income are recognized when earned.
 
(e)Property and Equipment
 
Property and equipment are stated at cost.  Depreciation is provided over the estimated useful lives of the assets using the straight-line method.  The Company uses a life of three years for computer equipment, five years for laboratory and office and warehouse equipment, seven years for furniture and fixtures, and the lesser of the useful life of the asset or the remaining life of the underlying facility lease for leasehold improvements.  Expenditures for maintenance, repairs, and betterments that do not prolong the useful life of the asset are charged to expense as incurred.  The Company capitalizes interest in connection with the construction of property and equipment.
 
(f)Impairment of Long-Lived Assets
 
Long-lived assets, such as property and equipment, are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable.  Recoverability of assets to be held and used is measured by a comparison of the carrying amount of an asset to estimated undiscounted future cash flows expected to be generated by the asset.  If the carrying amount of an asset exceeds its estimated future cash flows, then an impairment charge is recognized by the amount by which the carrying amount of the asset exceeds the fair value of the asset.  During the year ended December 31, 2011, the Company recorded a charge for impairment of property and equipment.  See Note 6 for additional information.
 
 
(g)Research and Development
 
Research and development costs are charged to expense as incurred.  Research and development costs consist of personnel related expenses, including salaries, benefits, travel, and other related expenses, including stock-based compensation; payments made to third party contract research organizations for preclinical studies, investigative sites for clinical trials, and consultants; costs associated with regulatory filings and the advancement of the Company's product candidates through preclinical studies and clinical trials; laboratory and other supplies; manufacturing development costs; and related facility maintenance.
 
(h)Income Taxes
 
Income taxes are accounted for under the asset-and-liability method.  Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases and operating loss and tax credit carryforwards.  Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled.  The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date.
 
(i)Stock-Based Compensation
 
The Company measures and recognizes compensation expense for all employee stock-based payments at fair value, net of estimated forfeitures, over the vesting period of the underlying stock-based awards.  In addition, the Company accounts for stock-based compensation to nonemployees in accordance with the accounting guidance for equity instruments that are issued to other than employees.
 
Determining the appropriate fair value of stock-based payment awards require the input of subjective assumptions, including the expected life of the stock-based payment awards and stock price volatility.  The Company uses the Black-Scholes option-pricing model to value its stock option awards.  The assumptions used in calculating the fair value of stock-based payment awards represent management's best estimates and involve inherent uncertainties and the application of management's judgment.  As a result, if factors change and management uses different assumptions, stock-based compensation expense could be materially different in the future.  Since the Company does not have sufficient historical volatility of its stock for the expected term of its options, it uses comparable public companies as a basis for its expected volatility to calculate the fair value of option grants.
 
The estimation of the number of stock awards that will ultimately vest requires judgment, and to the extent actual results or updated estimates differ from the Company's current estimates, such amounts will be recorded as an adjustment in the period in which estimates are revised.  The Company considers many factors when estimating expected forfeitures for stock awards granted to employees, consultants and directors, including types of awards, employee class, and an analysis of the Company's historical and known forfeitures on existing awards.  Under the true-up provisions of the stock based compensation guidance, the Company records additional expense if the actual forfeiture rate is lower than estimated, and a recovery of expense if the actual forfeiture rate is higher than estimated, during the period in which the options vest.
 
(j)Net Loss Per Share
 
Basic and diluted net loss per common share is determined by dividing net loss attributable to common stockholders by the weighted-average common shares outstanding less the weighted-average shares subject to repurchase during the period.  For all periods presented, the outstanding Series A, Series B, and Series C, common stock options and preferred and common stock warrants have been excluded from the calculation because their effect would be anti-dilutive.  Therefore, the weighted-average shares used to calculate both basic and diluted loss per share are the same.
 
 
The following potentially dilutive securities have been excluded from the computations of diluted weighted-average shares outstanding as of December 31, 2009, 2010, and 2011, as they would be anti-dilutive:

                         
   
Year Ended December 31,
   
2009
 
2010
 
2011
Shares underlying warrants outstanding
   
1,605,439
     
114,342
     
10,645,888
 
Shares underlying options outstanding
   
712,379
     
1,377,710
     
1,746,970
 
Unvested restricted stock
   
432
     
-
     
139,779
 
Shares of redeemable convertible preferred stock
   
81,954,127
     
-
     
-
 

 (k)Deferred Equity Offering Costs
 
Deferred equity offering costs include costs directly attributable to the Company's offering of its equity securities.  In accordance with FASB ASC 340-10, Other Assets and Deferred Costs, these costs are deferred and capitalized as part of other assets.  Costs attributable to the equity offerings will be charged against the proceeds of the offering once completed.
 
(l)Reverse Stock Split
 
On February 18, 2010, the board of directors of the Company, subject to stockholder approval, approved a reverse stock split of the Company's common stock at a ratio of one share for every 14.5 shares previously held.  The reverse stock split was effective on March 24, 2010.  All common stock share and per-share data included in these financial statements reflect such reverse stock split.
 
(m)Reclassification
 
Certain prior period amounts in the financial statements and notes thereto have been reclassified to conform to the current period presentation.
 
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Warrants
 12 Months Ended
Dec. 31, 2011
Warrants [Abstract]  
Warrants
(13)  
Warrants
 
We account for stock warrants as either equity instruments or derivative liabilities depending on the specific terms of the warrant agreement.  Stock warrants are accounted for as derivative liabilities under FASB ASC 815, Derivatives and Hedging (ASC 815) if the stock warrants allow for cash settlement or provide for modification of the warrant exercise price in the event subsequent sales of common stock are at a lower price per share than the then-current warrant exercise price.  We classify derivative warrant liabilities on the balance sheet as a current liability, which is revalued at each balance sheet date subsequent to the initial issuance of the stock warrant. 

The following table summarizes outstanding warrants to purchase common stock as of December 31, 2011:
             
 
Number of shares
 
Exercise price
 
Expiration
Equity–classified warrants
           
Issued to vendors
3,890
 
$
2.32
 
September 2015 through December 2016
Issued pursuant to March 2011 refinancing of Working Capital Note
70,671
 
$
2.88
 
March 2016
Issued to lenders
64,409
 
$
23.44
 
August 2013 through December 2016
Issued to lenders
46,043
 
$
26.39
 
October 2015 through September 2019
 
185,013
         
Liability–classified warrants
           
Issued pursuant to March 2011 equity financing
10,460,875
 
$
2.88
 
March 2016
 
10,645,888
         
             
Equity-classified Warrants
 
In March 2011, the Company granted a warrant to a lender to purchase 70,671 shares of common stock in connection with the refinancing of the Company's Working Capital Note.  See Note 10 for a discussion of the refinancing.  The Company determined the fair value of the warrant as of the date of grant was $1.49 per share by utilizing the Black-Scholes model.  In estimating the fair value of the warrant, the Company utilized the following inputs: closing price per share of common stock of $2.74, volatility of 64.96%, expected term of 5 years, risk-free interest rate of 2.0% and dividend yield of zero.
 
In conjunction with the Working Capital Note, Equipment Note, and the Supplemental Working Capital Note, the Company issued warrants to purchase shares of Series A, B, and C Preferred Stock.  Upon the close of the Company's initial public offering, the preferred stock warrants automatically converted into warrants to purchase 110,452 shares of common stock.  Warrants related to the Working Capital Note expire ten years from the date of issuance. Warrants related to the Equipment and Supplemental Working Capital Notes expire the earlier of eight years from the date of issuance or upon acquisition of the Company as defined in the warrant agreement.
 
Prior to the Company's initial public offering, the warrants were classified as a warrant liability on the balance sheet because the warrants entitled the holder to purchase shares of preferred stock, which the holder could have caused the Company to redeem at the option of the holder.  Subsequent to the closing of the initial public offering, these warrants no longer are exercisable for a redeemable security, and therefore such warrants are now classified within stockholders' equity.
 
The aggregate fair value of these warrants as of the initial public offering date was lower than the aggregate fair value as of December 31, 2009, resulting in a noncash credit to change in fair value of common stock warrants of $0.2 million during the year ended December 31, 2010.
 
Liability-classified Warrants
 
In March 2011, the Company issued warrants to purchase 10,460,875 shares of common stock in connection with a private placement transaction.  Each warrant is exercisable in whole or in part at any time until March 4, 2016 at a per share exercise price of $2.88, subject to certain adjustments as specified in the warrant agreement.  The Company valued the warrants as derivative financial instruments as of the date of issuance (March 4, 2011) and will continue to do so at each reporting date, with any changes in fair value being recorded on the Statement of Operations.  During the year ended December 31, 2011, the Company recorded non-operating income of $14.4 million due to a decrease in the estimated fair value of these warrants. 

The warrants contain provisions that require the modification of the exercise price and shares to be issued under certain circumstances, including in the event the Company completes subsequent equity financings at a price per share lower than the then-current warrant exercise price.  In addition, the warrants contain a net cash settlement provision under which the warrant holders may require the Company to purchase the warrants in exchange for a cash payment following the announcement of specified events defined as Fundamental Transactions involving the Company (e.g., merger, sale of all or substantially all assets, tender offer, or share exchange) or a Delisting, which is deemed to occur when the common stock is no longer listed on a national securities exchange.  The net cash settlement provision requires use of the Black-Scholes model in calculating the cash payment value in the event of a Fundamental Transaction or a Delisting.

The net cash settlement value at the time of any future Fundamental Transaction or Delisting will depend upon the value of the following inputs at that time: the price per share of the Company's common stock, the volatility of the Company's common stock, the expected term of the warrant, the risk-free interest rate based on U.S. Treasury security yields, and the Company's dividend yield.  The warrant requires use of a volatility assumption equal to the greater of (i) 100%, (ii) the 30-day volatility determined as of the trading day immediately following announcement of a Fundamental Transaction or Delisting, or (iii) the arithmetic average of the 10, 30, and 50-day volatility determined as of the trading day immediately following announcement of a Fundamental Transaction or Delisting.

The fair value of the warrants is determined using a risk-neutral lattice methodology within a Monte Carlo analysis to model the impact of potential modifications to the warrant exercise price and to include the probability of a Fundamental Transaction or Delisting into the calculation of fair value.  The valuation of warrants is subjective and is affected by changes in inputs to the valuation model including the price per share of the Company's common stock, assumptions regarding the expected amounts and dates of future equity financing activities, assumptions regarding the likelihood and timing of Fundamental Transactions or a Delisting, the historical volatility of the stock prices of the Company's peer group, risk-free rates based on U.S. Treasury security yields, and the Company's dividend yield.  Changes in these assumptions can materially affect the fair value estimate.  We could, at any point in time, ultimately incur amounts significantly different than the carrying value.  For example, as of December 31, 2011, the calculated cash settlement value of $3.6 million exceeded the fair value of $2.5 million.  The Company will continue to classify the fair value of the warrants as a liability until the warrants are exercised, expire, or are amended in a way that would no longer require these warrants to be classified as a liability.

 
The following table summarizes the calculated aggregate fair values and net cash settlement value as of the dates indicated along with the assumptions utilized in each calculation.

           
   
Fair value as of:
  
Net cash settlement value
as of
December 31,
2011
 
   
March 4,
2011
  
December 31,
2011
 
           
Calculated aggregate value
 $16,947  $2,511  $3,596(1)
Exercise price per share of warrant
 $2.88  $2.88  $2.88 
Closing price per share of common stock
 $2.60  $0.47  $0.47 
Volatility
  65.0%  93.8%  151.0% (2)
Probability of Fundamental Transaction or Delisting
  48.9%  28.9% 
Not applicable
 
Expected term (years)
 
Not applicable
  
Not applicable
   4.2 
Risk-free interest rate
  2.2%  0.7%  0.6%
Dividend yield
 
None
  
None
  
None
 
              

(1)
Represents the net cash settlement value of the warrant as of December 31, 2011, which value was calculated utilizing the Black-Scholes model specified in the warrant.
 
(2)
Represents the volatility assumption used to calculate the net cash settlement value as of December 31, 2011.