-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, Il/bRyDf7wGizbsJ0CWVZpW1R8bUywq3F48jKOvJNRMqZoTkoFWeZkxn8/zXs5FK UHV5ZrxwaUqTMV26fFvZ6Q== 0000950152-08-003663.txt : 20080508 0000950152-08-003663.hdr.sgml : 20080508 20080508160023 ACCESSION NUMBER: 0000950152-08-003663 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20080508 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20080508 DATE AS OF CHANGE: 20080508 FILER: COMPANY DATA: COMPANY CONFORMED NAME: ATHERSYS, INC / NEW CENTRAL INDEX KEY: 0001368148 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 204864095 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-33876 FILM NUMBER: 08813977 BUSINESS ADDRESS: STREET 1: 3201 CARNEGIE AVENUE CITY: CLEVELAND STATE: OH ZIP: 44115-2634 BUSINESS PHONE: 216-431-9900 MAIL ADDRESS: STREET 1: 3201 CARNEGIE AVENUE CITY: CLEVELAND STATE: OH ZIP: 44115-2634 FORMER COMPANY: FORMER CONFORMED NAME: BTHC VI Inc DATE OF NAME CHANGE: 20060629 8-K 1 l31080ae8vk.htm ATHERSYS, INC. 8-K Athersys, Inc. 8-K
 

 
 
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 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): May 8, 2008
Athersys, Inc.
(Exact Name of Registrant as Specified in Charter)
         
Delaware   0-52108   20-4864095
         
(State or Other
Jurisdiction
of Incorporation)
  (Commission File
Number)
  (I.R.S. Employer
Identification No.)
     
3201 Carnegie Avenue, Cleveland, Ohio   44115-2634
 
(Address of Principal Executive Offices)   (Zip Code)
Registrant’s telephone number, including area code: (216) 431-9900
(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:
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 May 8, 2008, Athersys, Inc. issued a press release announcing financial results for its first quarter ended March 31, 2008. A copy of this press release is attached hereto as Exhibit 99.1.
     The information contained in Item 2.02 of this Current Report on Form 8-K, including Exhibit 99.1 attached hereto, is being furnished to the Securities and Exchange Commission and shall not be deemed to be “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934 or otherwise subject to the liabilities of that Section. Furthermore, the information contained in Item 2.02 of this Current Report on Form 8-K shall not be deemed to be incorporated by reference into any registration statement or other document filed pursuant to the Securities Act of 1933.
Item 9.01   Financial Statements and Exhibits.
  (d)   Exhibits.
                 
    Exhibit No.   Exhibit Description
 
               
 
  99.1       Press Release dated May 8, 2008    

2


 

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.
Date: May 8, 2008
         
 
ATHERSYS, INC.
 
 
  By:   /s/ Laura K. Campbell    
    Name:   Laura K. Campbell   
    Title:   Vice President, Finance   
 

 


 

EXHIBIT INDEX
         
Exhibit No.   Exhibit Description
 
       
99.1
  Press Release dated May 8, 2008    

 

EX-99.1 2 l31080aexv99w1.htm EX-99.1 EX-99.1
 

Exhibit 99.1
Contacts:
     
William (B.J.) Lehmann, J.D.
  Lisa M. Wilson
President and Chief Operating Officer
  In-Site Communications
Tel: (216) 431-9900
  Tel: (917) 543-9932
bjlehmann@athersys.com
  lwilson@insitecony.com
ATHERSYS REPORTS 2008 FIRST QUARTER RESULTS
Obesity and Stem Cell Programs Continue to Progress
Cleveland, OHIO, (May 8, 2008) – Athersys, Inc. (NASDAQ: ATHX) today announced its financial results for the quarter ended March 31, 2008.
First Quarter Highlights Include:
    Revenues of $0.8 million and a net loss of $4.7 million were recorded for the quarter ended March 31, 2008;
 
    A Phase I clinical trial of ATHX-105, a highly selective 5HT2c agonist being developed as an obesity therapy, was completed with favorable results;
 
    Clinical trial preparations and supporting operations for initial Phase I studies for MultiStem® for acute myocardial infarction (AMI) and Graft-versus-Host Disease (GvHD) are underway;
 
    Preparations for an ATHX-105 Phase II clinical trial to be initiated in the United States in the second half of 2008 are being conducted;
 
    The quarter was completed with a favorable capital position of $44.8 million in cash, cash equivalents and available-for-sale securities.
“We continue to advance our lead development candidates, namely ATHX-105 for obesity, and MultiStem for the treatment of cardiovascular disease and for the treatment of complications associated with hematopoietic stem cell transplantation associated with treating certain types of cancers. We are working to achieve meaningful clinical development activity through the remainder of the year,” said Gil Van Bokkelen, Ph.D., Chairman and Chief Executive Officer. “In addition, we continue to make progress with our earlier stage programs. Our cash position is strong and will support our operations through important development milestones for our lead programs.”
First Quarter Results
     Revenues for the three months ended March 31, 2008 decreased to $0.8 million from $0.9 million for the comparable period in 2007, due principally to a decrease in grant revenues during the period. Research and development expenses increased to $4.3 million for the three months ended March 31, 2008 from $2.4 million for the comparable period in 2007, reflecting, among other things, an increase in clinical and preclinical development costs associated with ATHX-105, the Company’s lead obesity product candidate, and the MultiStem® programs for AMI and GvHD. General and administrative expenses increased to $1.5 million for the three months ended March 31, 2008 from $608,000 for the comparable period in 2007, due principally to increases in stock compensation expense, legal and professional fees incurred in connection

 


 

with the annual audit and annual report, Sarbanes-Oxley compliance, board of directors fees and other expenses associated with the Company’s public company status. Interest income increased to $0.5 million during the three months ended March 31, 2008 from $0.05 million for the comparable period in 2007 due to the increase in the Company’s average cash and investment balances. Interest expense decreased to $0.1 million for the three months ended March 31, 2008 from $0.3 million for the comparable period in 2007 due principally to the conversion of the Company’s promissory notes in connection with its June 2007 equity offering.
As of March 31, 2008, cash, cash equivalents and available-for-sale securities totaled $44.8 million.
Conference Call
As previously announced, the Company will host a conference call today at 4:30 p.m. (Eastern Daylight Savings Time) to review the results. Gil Van Bokkelen, Chairman and Chief Executive Officer, and William (B.J.) Lehmann, President and Chief Operating Officer, will host the call. Investors and other interested parties are invited to listen to the conference call by dialing 800-273-1254 in the U.S. and Canada, 706-679-8592 from abroad, or via a live Internet broadcast on the Company’s website at www.athersys.com under the Investor Relations section.
A replay will be available for on-demand listening shortly after the completion of the call until 11:59 PM (Eastern Standard Time) on May 22, 2008 at the aforementioned URL, or by dialing 800-642-1687 in the U.S. and Canada, or 706-645-9291 from abroad, and entering access code 43257503.
About Athersys, Inc.
Athersys is a biopharmaceutical company engaged in the discovery and development of therapeutic product candidates designed to extend and enhance the quality of human life. In addition to its lead product candidate, ATHX-105, the Company is developing other orally active pharmaceutical product candidates for the treatment of metabolic and central nervous system disorders, utilizing proprietary technologies, including Random Activation of Gene Expression (RAGE). Athersys is developing MultiStem®, a patented, adult-derived “off-the-shelf” stem cell product platform for multiple disease indications, including damage caused by myocardial infarction, bone marrow transplantation/oncology support, ischemic stroke and other indications
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties. These forward-looking statements relate to, among other things, the expected timetable for development of our product candidates, our growth strategy, and our future financial performance, including our operations, economic performance, financial condition, prospects, and other future events. We have attempted to identify forward-looking statements by using such words as “anticipates,” “believes,” “can,” “continue,” “could,” “estimates,” “expects,” “intends,” “may,” “plans,” “potential,” “should,” “will,” or other similar expressions. These forward-looking statements are only predictions and are largely based on our current expectations. A number of known and unknown risks, uncertainties, and other factors could affect the accuracy of these statements. Some of the more significant known risks that we face that could cause actual results to differ materially from those implied by forward-looking statements are the risks and uncertainties

 


 

inherent in the process of discovering, developing, and commercializing products that are safe and effective for use as human therapeutics, including the uncertainty regarding market acceptance of our product candidates and our ability to generate revenues. These risks may cause our actual results, levels of activity, performance, or achievements to differ materially from any future results, levels of activity, performance, or achievements expressed or implied by these forward-looking statements. Other important factors to consider in evaluating our forward-looking statements include: the possibility of delays in, adverse results of, and excessive costs of the development process; changes in external market factors; changes in our industry’s overall performance; changes in our business strategy; our ability to protect our intellectual property portfolio; our possible inability to realize commercially valuable discoveries in our collaborations with pharmaceutical and other biotechnology companies; our possible inability to execute our strategy due to changes in our industry or the economy generally; changes in productivity and reliability of suppliers; and the success of our competitors and the emergence of new competitors. You should not place undue reliance on forward-looking statements contained in this press release, and we undertake no obligation to publicly update forward-looking statements, whether as a result of new information, future events or otherwise.
(Tables Follow)

 


 

Athersys, Inc.
Condensed Consolidated Balance Sheets

(In Thousands)
                 
    March 31,     December 31,  
    2008     2007  
    (Unaudited)     (Note)  
Assets
               
Cash, cash equivalents and available-for-sale securities
  $ 44,797     $ 49,575  
Other current assets
    1,652       1,718  
Equipment, net
    402       387  
Other long-term assets
    537       545  
     
Total assets
  $ 47,388     $ 52,225  
     
 
               
Liabilities and stockholders’ equity
               
Accounts payable and accrued expenses
  $ 2,882     $ 2,810  
Debt, current and long-term
    1,013       1,784  
Total stockholders’ equity
    43,493       47,631  
     
Total liabilities and stockholders’ equity
  $ 47,388     $ 52,225  
     
Note: The Condensed Consolidated Balance Sheet Data at December 31, 2007 has been derived from the audited financial statements as of that date.

 


 

Athersys, Inc.
Condensed Consolidated Statements of Operations

(In Thousands, Except Per Share Amounts)
                 
    Three Month ended March 31,  
    2008     2007  
    (Unaudited)  
Revenues
               
License fees
  $ 390     $ 310  
Grant revenue
    402       569  
     
Total revenues
    792       879  
 
               
Costs and Expenses
               
Research and development
    4,315       2,365  
General and administrative
    1,481       608  
Depreciation
    57       80  
     
Total costs and expenses
    5,853       3,053  
     
Loss from operations
    (5,061 )     (2,174 )
 
               
Interest income and other
    459       47  
Interest expense
    (62 )     (333 )
Accretion of premium on convertible debt
          (260 )
Net loss
  $ (4,664 )   $ (2,720 )
     
Preferred stock dividends
          (375 )
     
Net loss attributable to common stockholders
  $ (4,664 )   $ (3,095 )
     
 
Basic and diluted net loss per common share attributable to common stockholders
  $ (0.25 )   $ (10.54 )
 
               
Weighted average shares outstanding, basic and diluted
    18,927,988       293,770  

 

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