0000950159-14-000151.txt : 20140327 0000950159-14-000151.hdr.sgml : 20140327 20140327171750 ACCESSION NUMBER: 0000950159-14-000151 CONFORMED SUBMISSION TYPE: 424B3 PUBLIC DOCUMENT COUNT: 4 FILED AS OF DATE: 20140327 DATE AS OF CHANGE: 20140327 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 FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 424B3 SEC ACT: 1933 Act SEC FILE NUMBER: 333-186687 FILM NUMBER: 14722524 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 424B3 1 tengion424b3.htm TENGION, INC. FORM 424(B)(3) 333-186687 tengion424b3.htm
 
 
Filed Pursuant to Rule 424(b)(3)
Registration No. 333-186687
 
PROSPECTUS SUPPLEMENT NO. 20
(To Prospectus dated March 28, 2013)
 
27,891,407 Shares
 


Tengion, Inc.
 
This Prospectus Supplement No. 20 supplements the prospectus dated March 28, 2013 (as supplemented to date, the “Prospectus”), which forms a part of our Registration Statement on Form S-1 (Registration Statement No. 333-186687). The Prospectus and this prospectus supplement relate to the disposition from time to time of up to 27,891,407 shares of our common stock, which are held or may be held by the stockholders named in the Prospectus.
 
This prospectus supplement should be read in conjunction with the Prospectus, which is to be delivered with this prospectus supplement. This prospectus supplement updates, amends and supplements the information included or incorporated by reference in the Prospectus. If there is any inconsistency between the information in the Prospectus and this prospectus supplement, you should rely on the information in this prospectus supplement.
 
This prospectus supplement is not complete without, and may not be delivered or utilized except in connection with, the Prospectus, including any amendments or supplements to it.
 
Current Report on Form 8-K
 
On March 27, 2014, we filed a Current Report on Form 8-K with the Securities and Exchange Commission. The text of such Form 8-K is attached hereto.
 
 
Investing in our common stock involves a high degree of risk. Please see the section entitled “Risk Factors” beginning on page 13 of the Prospectus.
 
Neither the Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities, or determined if this prospectus is truthful or complete. Any representation to the contrary is a criminal offense.
 
The date of this prospectus supplement is March 27, 2014.

 
 
 
 
 
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

Form 8-K

Current Report

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported):  March 24, 2014


Tengion, Inc.
(Exact name of registrant as specified in its charter)

001-34688
(Commission File Number)
 
Delaware
20-0214813
(State or other jurisdiction of
(I.R.S. Employer Identification No.)
incorporation)
  
 
3929 Westpoint Blvd., Suite G
Winston-Salem, NC 27103
(Address of principal executive offices, with zip code)

(336) 722-5855
(Registrant’s telephone number, including area code)

Not Applicable
(Former name or former address, if changed since last report)


Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
 
o
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
 
 
 
 
 
 
 
 
Item 2.02 Results of Operations and Financial Condition.

On March 26, 2014, Tengion, Inc. (the “Company”) issued a press release providing financial results for the fourth quarter and twelve months ended December 31, 2013. A copy of the press release is furnished herewith as Exhibit 99.1.
 
The information contained in this Item, including Exhibit 99.1 attached hereto, is being furnished and shall not be deemed “filed” for any purpose, and shall not be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, regardless of any general incorporation language in any such filing.

Item 8.01 Other Events.
 
Annual Meeting Date Set
 
The Board of Directors of the Company has approved May 2, 2014 as the date for the Company’s 2014 annual meeting of stockholders (the “Annual Meeting”). The Board of Directors also approved the record date for stockholders entitled to notice of and to vote at the Annual Meeting, which is fixed as the close of business on March 24, 2014. Stockholders wishing to nominate a director or propose matters to be considered at the Annual Meeting in the manner contemplated by the Company’s Second Amended and Restated Bylaws (the “Bylaws”) must submit timely notice thereof to the Company in order for such matters to be considered at the Annual Meeting.  Because the date of the Annual Meeting has been changed to a date that is more than 30 days before the anniversary date of the Company’s 2013 annual meeting, in accordance with Section 2.1(d) of the Bylaws, to be timely, such notice must be delivered to the Secretary of the Company at the Company’s principal executive offices by April 11, 2014.  Such proposals must also comply with all other requirements set forth in the Bylaws and other applicable laws.
 
The address of the Company’s principal executive offices is 3929 Westpoint Boulevard, Suite G, Winston-Salem, NC 27103.

 
Item 9.01 Financial Statements and Exhibits

(d) Exhibits.


 
 
 
 
 
 

 
SIGNATURES


Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.


 
TENGION, INC.
   
   
   
Date:  March 27, 2014
By: /s/ A. Brian Davis
 
A. Brian Davis
 
Chief Financial Officer and Senior Vice President, Finance

 
 
 
 
 
 
 
 
Exhibit Index
                      

 
 
 

 EX-99.1 2 ex99-1.htm EXHIBIT 99.1 ex99-1.htm
 
 

 
 
Investor and Media Contact:
 
A. Brian Davis
 
brian.davis@tengion.com
 
336.201.0155


Tengion Reports Fourth Quarter and Full Year 2013 Financial Results

WINSTON-SALEM, NC, March 26, 2014 -- Tengion, Inc. (OTCQB: TNGN), a leader in regenerative medicine, today reported its financial results for the fourth quarter and full year ended December 31, 2013 and provided a business update.

“We made important progress on our two lead clinical programs over the last year. We now have two Phase 1 clinical trials ongoing for the Neo-Kidney Augment, one in Sweden and the other recently initiated in the U.S. to implant up to 12 patients. We have already successfully implanted five patients in the Sweden trial, and recently received regulatory approval to enroll 10 additional patients in that trial. We believe that the momentum in clinical development of the Neo-Kidney Augment is a testament to the tremendous need for this product candidate for patients suffering from chronic kidney disease,” commented John L. Miclot, President and Chief Executive Officer of Tengion. “We are also pleased to announce the completion of enrollment in the ongoing Phase 1 clinical trial for the Neo-Urinary Conduit. We believe that the Neo-Urinary Conduit offers significant improvements over the current standard of care for bladder cancer patients undergoing cystectomy, and we look forward to engaging key opinion leaders and the FDA for guidance on our plans for further development of this product candidate during this year.”

Neo-Kidney Augment™ Program Update

Tengion is currently conducting Phase 1 clinical trials for the Neo-Kidney Augment in Sweden and the U.S. The Neo-Kidney Augment is being developed to prevent or delay the need for dialysis by increasing renal function in patients with advanced chronic kidney disease (CKD). The Neo-Kidney Augment is based on the Company’s proprietary technology, which uses tubular epithelial cells procured by a cortical biopsy of the patient’s kidney, to create an injectable product candidate that can catalyze the regeneration of functional kidney tissue.

Both trials are designed to evaluate the safety and implantation of the Neo-Kidney Augment and involve delivery of an active regenerative dose of Neo-Kidney Augment in patients with CKD who will be followed for up to two years.

 
·
The Phase 1 clinical trial at the Karolinska Institute in Stockholm, Sweden commenced in May 2013, and five patients with CKD were implanted in 2013. To date, the Neo-Kidney Augment has been safe and well tolerated in these five patients. In March 2014, the Company received regulatory approval from the Medical Products Agency (MPA) to expand enrollment in this trial to a total of 15 patients.

 
·
In January 2014, Tengion announced the initiation of a Phase 1 clinical trial in the U.S. The Company expects to enroll up to 12 patients and anticipates that it will complete patient enrollment during 2014.

 
 
 
1
 

 
Neo-Urinary Conduit™ Clinical Program Update

In January 2014, Tengion completed enrollment in its ongoing Phase 1 clinical trial for the Neo-Urinary Conduit. Bladder cancer patients have been enrolled in the trial 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. Although the Company was permitted to enroll up to ten patients in this clinical trial, Tengion decided to limit the enrollment to eight patients, the last of which was implanted in December 2013. The Company and its clinical investigators believe that the surgical technique used in animal models has been successfully translated to humans, with evidence of tissue regeneration. During 2014, the Company expects to engage key opinion leaders and the U.S. Food and Drug Administration (FDA) for guidance on future trials.

Fourth Quarter and Year End 2013 Financial Results

For the year ended December 31, 2013, Tengion reported an adjusted net loss of $23.6 million, or $5.87 per basic and diluted common share, compared with an adjusted net loss of $19.0 million, or $8.00 per basic and diluted common share, for the same period in 2012. The increased adjusted net loss for the 2013 period was primarily due to increases in interest expense of $4.7 million and in general and administrative expense of $0.8 million, offset in part by a decrease in research and development expense of $0.6 million and depreciation expense of $0.2 million.

The increase in interest expense was primarily due to non-cash interest expense associated with the 2012 Convertible Notes issued in the fourth quarter of 2012 and the 2013 Convertible Notes issued in the second quarter of 2013. The increase in general and administrative expense for the year ended December 31, 2013 was primarily due to an increase in legal fees resulting from a change in corporate counsel as well as significant registration statement activity during 2013 related to securities issued in the Company’s 2011, 2012 and 2013 financings which were not capitalized as deferred financing costs. The decrease in research and development expense for the year ended December 31, 2013 was primarily due to a reduction in compensation and related expenses resulting from fewer employees as compared to the same period in 2012, as well as a reduction in external preclinical services associated with the Neo-Kidney Augment submission of a Pre-Investigational New Drug (IND) application filing with the FDA. The decrease in depreciation expense is due to an increased number of fully depreciated assets in 2013.

For the fourth quarter ended December 31, 2013, the Company reported an adjusted net loss of $6.3 million, or $1.10 per basic and diluted common share, compared with an adjusted net loss of $5.9 million, or $2.49 per basic and diluted common share, for the same period in 2012. The increased adjusted net loss for the 2013 period was primarily due to an increase in research and development expense of $0.5 million related to the Phase 1 clinical trial of the Company’s Neo-Kidney Augment initiated in May 2013 at the Karolinska Institute in Stockholm, Sweden.
 
 
 
 
2
 

 
As of December 31, 2013, the Company held $21.5 million in cash and cash equivalents. Based upon the Company’s current expected level of operating expenditures and debt repayment, and assuming it is not required to settle any outstanding warrants in cash or redeem, or pay cash interest on, any of its convertible notes, the Company expects to be able to fund its operations through December 31, 2014.

About the Neo-Kidney Augment™

The Neo-Kidney Augment is being developed to prevent or delay the need for dialysis by increasing renal function in patients with advanced chronic kidney disease (CKD). The Neo-Kidney Augment is based on the Company’s proprietary technology, which uses tubular epithelial cells procured by a cortical biopsy of the patient’s kidney, to create an injectable product candidate that can catalyze the regeneration of functional kidney tissue. According to the United States Renal Data System, there are approximately 26 million adults in the U.S. who have CKD and 100,000 new patients who start on dialysis each year, and CKD affects more than 10% of the world’s population. Additionally, $39 billion in direct U.S. costs each year are attributable to patients with end-stage renal disease, which is associated with an approximate 20% mortality rate per year and an average life expectancy of a patient initiating dialysis of approximately four years.  

About the Neo-Urinary Conduit™

The Neo-Urinary Conduit is designed to replace the standard of care for bladder cancer patients undergoing cystectomy (removal of bladder). There are over 25,000 cystectomies performed annually in bladder cancer patients in the U.S. and Europe. The Neo-Urinary Conduit is an implant made from a patient's own cells and is intended to catalyze regeneration of native-like urinary tissue, thereby eliminating the need to use bowel tissue in the current standard of care surgery. The Neo-Urinary Conduit is expected to eliminate the short-term and long-term complications associated with use of bowel tissue, such as electrolyte and metabolic disorders, nutritional and therapeutic-agent absorption anomalies, kidney and urinary tract infections, and stone formation. In addition, the Neo-Urinary Conduit is anticipated to improve recovery times, which results in faster hospital discharges compared to the current standard of care.

About Tengion

Tengion, a clinical-stage regenerative medicine company, is focused on developing its Organ Regeneration Platform™ to harness the intrinsic regenerative pathways of the body to regenerate a range of native-like organs and tissues with the goal of delaying or eliminating the need for chronic disease therapies, organ transplantation, and the administration of anti-rejection medications. The Company is currently conducting Phase 1 clinical trials in Sweden and the U.S. for its Neo-Kidney Augment, which is intended to prevent or delay dialysis and transplantation by increasing renal function in patients with advanced chronic kidney disease. A Phase 1 trial for the Company's Neo-Urinary Conduit, an autologous implant that is intended to catalyze regeneration of native-like urinary tissue for bladder cancer patients requiring a urinary diversion following bladder removal, has completed enrollment.
 
 
 
 
3
 

 
Forward-Looking Statements
 
Except for the historical information contained herein, the matters set forth in this press release, including statements regarding Tengion's plans, potential opportunities, or other expectations, projections, goals, objectives, strategies, timelines, clinical studies, product development and the potential benefits of its products under development are forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially, including the risks and uncertainties associated with Tengion's operating performance and financial position, research, development and commercialization of products, the risks and uncertainties associated with meeting the objectives of its clinical studies, including, but not limited to, risks related to availability of continued funding, delays or failures resulting from slower than expected enrollment in clinical trials or clinical holds, and the occurrence of adverse safety events, obtaining regulatory approvals, and other risks detailed from time to time in the Company's most recent Annual Report on Form 10-K and other documents subsequently filed with or furnished to the Securities and Exchange Commission. These forward-looking statements are based on current information that may change and you are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement, and the Company undertakes no obligation to revise or update any forward-looking statement to reflect events or circumstances after the issuance of this press release.
 
 
 
 
4
 
 

TENGION, INC.
(A Development-Stage Company)

CONDENSED STATEMENTS OF OPERATIONS
(in thousands, except per share data)
(unaudited)
 

 

   
Three Months Ended
December 31,
  
Twelve Months Ended
December 31,
  
Period from
July 10, 2003 (inception)
through
December 31,2013
   
2012
  
2013
  
2012
  
2013
  
Revenue
  
$
—
    
$
—
    
$
—
    
$
—
    
$
—
  
                                         
Operating expenses:
                    
 
                  
Research and development
  
$
2,182
    
$
2,651
    
$
10,103
    
$
9,480
    
$
137,440
  
General and administrative
    
1,479
      
1,480
      
5,496
      
6,295
      
53,684
  
Depreciation
    
99
      
63
      
456
      
267
      
23,875
  
Impairment of property and equipment
    
—
      
—
      
—
      
—
      
7,371
  
Other expense, net
    
35
      
278
      
165
      
555
      
2,425
  
                                         
Total operating expenses
    
(3,795
)
    
(4,472
)
    
(16,220
)
    
(16,597
)
    
(224,795
)
                                         
Loss from operations
    
(3,795
)
    
(4,472
)
    
(16,220
)
    
(16,597
)
    
(224,795
)
                                         
Interest income
    
15
      
21
      
27
      
47
      
8,586
  
Interest expense
    
(2,163
)
    
(2,119
)
    
(2,957
)
    
(7,622
)
    
(25,468
)
Change in fair value of derivative liability
    
944
      
1,297
      
944
      
(3,088
)
    
(2,144
)
Change in fair value of warrant liability
    
910
      
11,312
      
1,277
      
8,333
      
26,108
  
                                         
Net (loss) income
  
$
(4,089
)
  
$
6,039
    
$
(16,929
)
  
$
(18,927
)
  
$
(217,713
)
                                         
Basic and diluted net (loss) income per share
  
$
(1.72
)
  
$
1.06
    
$
(7.13
)
  
$
(4.70
)
        
                                         
Weighted-average common stock outstanding :
                                        
      Basic and diluted
    
2,374
      
5,722
      
2,374
      
4,024
          


 
 
 

 
 
5
 

 
TENGION, INC.
(A Development-Stage Company)

BALANCE SHEET DATA
(in thousands)
(unaudited)
 

   
December 31,
2012
  
December 31,
 2013
Cash and cash equivalents
  
$
7,536
  
  
$
21,510
  
Total assets
  
  
12,435
  
  
  
25,724
  
Derivative liability
  
  
2,449
      
—
  
Warrant liability
  
  
6,178
  
  
  
11,425
  
Total debt and embedded derivative, net of debt discount
  
  
11,269
  
  
  
26,952
  
Total liabilities
  
  
23,778
  
  
  
42,580
  
Total stockholders’ deficit
  
  
(11,343
)
  
  
(16,856
)
                 

 
 
 

 
 
6
 


TENGION, INC.
(A Development-Stage Company)

RECONCILIATION OF NON-GAAP FINANCIAL MEASURES
(in thousands, except per share data)
(unaudited)

In accordance with Regulation G of the Securities and Exchange Commission, the table set forth below reconciles certain financial measures used in this press release that were not calculated in accordance with generally accepted accounting principles, or GAAP, with the most directly comparable financial measure calculated in accordance with GAAP.
 
 
   
Three Months Ended
December 31,
  
Twelve Months Ended
December 31,
   
2012
  
2013
  
2012
  
2013
Net (loss) income– GAAP
  
$
(4,089
)
  
$
6,039
    
$
(16,929
)
  
$
(18,927
)
Change in fair value of derivative liability
    
(944
)
    
(1,297
)
    
(944
)
    
3,088
  
Change in fair value of warrant liability
    
(910
)
  
  
(11,312
)
    
(1,277
)
    
(8,333
)
Other expense, net
    
35
  
  
  
278
      
165
      
555
  
Adjusted net (loss) income
  
$
(5,908
)
  
$
(6,292
)
  
$
(18,985
)
  
$
(23,617
)
                                 
Shares used in computing basic and diluted net loss attributable to common stockholders:
                                
     Basic and diluted
    
2,374
      
5,722
      
2,374
      
4,024
  
                                 
Basic and diluted net (loss) income per share-GAAP
  
 $
(1.72
)
  
 $
1.06
    
 $
(7.13
)
  
 $
(4.70
)
Adjustment per share
  
$
(0.77
)
  
$
(2.16
)
  
$
(0.87
)
  
$
(1.17
)
Basic and diluted net (loss) per share - adjusted
  
$
(2.49
)
  
$
(1.10
)
  
$
(8.00
)
  
$
(5.87
)
                                 

 
 
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