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8-K - FORM 8-K - Fortress Biotech, Inc.d534098d8k.htm

Exhibit 99.1

 

LOGO

CORONADO BIOSCIENCES REPORTS FINANCIAL RESULTS FOR THE FIRST QUARTER ENDED MARCH 31, 2013

Burlington, MA – May 8, 2013 – Coronado Biosciences, Inc. (NASDAQ: CNDO), a biopharmaceutical company focused on the development of novel immunotherapy biologic agents for the treatment of autoimmune diseases and cancer, announced today its financial results for the first quarter ended March 31, 2013.

“During the first quarter of 2013, Coronado remained focused on driving our clinical programs forward,” said Dr. Harlan F. Weisman, Coronado’s Chairman and CEO. “We expect to report data from two large Phase 2 trials evaluating TSO in Crohn’s disease during the second half of 2013: Top-line results from Coronado’s TRUST-I trial in the U.S. and a second interim analysis from our development partner Dr. Falk Pharma’s TRUST-II trial in Europe. Additionally, we have commenced several investigator-initiated studies. Data from the first studies in autism and psoriasis could also be available before the end of the year.”

“We have also strengthened our financial position during this quarter,” continued Dr. Weisman. “From January 1, 2013 through May 7, 2013, we sold an aggregate of approximately 3.4 million shares of our common stock under our at-the-market sales facilities for net proceeds of approximately $29.9 million.”

Financial Highlights:

 

   

Coronado reported a net loss of $8.9 million, or $0.35 per share, for the first quarter of 2013 compared to a net loss of $6.6 million, or $0.35 per share, for the first quarter of 2012.

 

   

Research and development expenses were $ 6.0 million for the three months ended March 31, 2013 compared to $4.6 million for the three months ended March 31, 2012.

 

   

General and administrative expenses totaled $ 2.5 million for the three months ended March 31, 2013 compared to $2.0 million for the three months ended March 31, 2012.

 

   

At March 31, 2013, Coronado’s cash and cash equivalents totaled $44.1 million. To date, the company has sold approximately 3.4 million shares under its at-the-market sales facilities for net proceeds of approximately $29.9 million.

Recent Corporate and Scientific Highlights:

 

   

Signed Research Collaboration and License Agreement with Freie Universität Berlin for secretory products of Trichuris suis

 

   

Commenced an investigator-initiated study at The Mount Sinai School of Medicine evaluating TSO in psoriasis

 

   

Hosted analyst event in New York City

 

   

Appointed Dr. Thomas Schaible as Project Leader, Inflammatory Bowel Disease

Upcoming Events:

 

   

Bank of America Merrill Lynch 2013 Health Care Conference, May 14, 2013

 

   

UBS Global Healthcare Conference, May 20, 2013


Conference Call and Webcast Information

Coronado management will review its first quarter financial results and development programs via conference call and webcast today at 8:30 AM ET. To participate in the conference call, please dial (877) 312-5413 (toll free from the US and Canada), or (253) 237-1511 (for international callers). Investors may also access a live audio webcast of the call at www.coronadobiosciences.com on the Events & Webcasts page.

A replay of the webcast will be available shortly after the conclusion of the call. The webcast archive will remain available for one year. An audio replay will also be available shortly after the conclusion of the call and will be made available until May 15, 2013. The audio replay can be accessed by dialing (855) 859-2056 (toll free from the US and Canada), or (404) 537-3406 (for international callers) and entering Event ID 54197810.

About Coronado Biosciences

Coronado Biosciences is engaged in the development of novel immunotherapy biologic agents. The company’s two principal pharmaceutical product candidates in clinical development are: TSO (Trichuris suis ova or CNDO-201), a biologic for the treatment of autoimmune diseases, such as Crohn’s disease, ulcerative colitis and multiple sclerosis; and CNDO-109, a biologic that activates natural killer (NK) cells, for the treatment of acute myeloid leukemia (AML), multiple myeloma and solid tumors. For more information, please visit www.coronadobiosciences.com.

Forward-Looking Statements

This press release may contain “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements include, but are not limited to, any statements relating to the company’s product development programs and any other statements that are not historical facts. Forward-looking statements are based on management’s current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from those currently anticipated are: risks relating to the results of research and development activities; uncertainties relating to preclinical and clinical testing; our ability to attract, integrate and retain key personnel; our ability to obtain, perform under and maintain financing and strategic agreements and relationships; the early stage of products under development; our need for substantial additional funds; government regulation; patent and intellectual property matters; our dependence on third party suppliers; and competition; as well as other risks described in our SEC filings. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law.

Contact:

Lucy Lu, MD, Executive Vice President & Chief Financial Officer

Coronado Biosciences, Inc.

781-652-4525; ir@coronadobio.com

Marcy Nanus, Vice President

The Trout Group, LLC.

646-378-2927; mnanus@troutgroup.com


Susan Forman

Dian Griesel Inc.

212-825-3210; susan@dgicomm.com


CORONADO BIOSCIENCES, INC. AND SUBSIDIARY

(A development stage enterprise)

Consolidated Balance Sheets

($ in thousands)

(Unaudited)

 

     March 31,
2013
     December 31,
2012
 

ASSETS

     

Cash and cash equivalents

   $ 44,052       $ 40,199   

Prepaid and other current assets

     1,010         393   
  

 

 

    

 

 

 

Total current assets

     45,062         40,592   

Property and equipment net

     50         51   

Other

     344         349   
  

 

 

    

 

 

 

Total Assets

   $ 45,456       $ 40,992   
  

 

 

    

 

 

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

     

Current liabilities

   $ 6,168       $ 5,132   

Note payable, non-current

     11,086         12,386   

Other long-term liabilities

     1,474         1,441   
  

 

 

    

 

 

 

Total Liabilities

     18,728         18,959   

Stockholders’ Equity

     26,728         22,033   
  

 

 

    

 

 

 

Total Liabilities and Stockholders’ Equity

   $ 45,456       $ 40,992   
  

 

 

    

 

 

 


CORONADO BIOSCIENCES, INC. AND SUBSIDIARY

(A development stage enterprise)

Consolidated Statements of Operations

($ in thousands except for share amounts)

(Unaudited)

 

     For the three months ended
March 31,
 
     2013     2012  

Operating expenses:

    

Research and development

   $ 5,974      $ 4,581   

General and administrative

     2,484        2,000   
  

 

 

   

 

 

 

Loss from operations

     (8,458     (6,581

Interest income

     76        44   

Interest expense

     (476     (19
  

 

 

   

 

 

 

Net loss

   ($ 8,858   ($ 6,556
  

 

 

   

 

 

 

Basic and diluted net loss per common share

   ($ 0.35   ($ 0.35
  

 

 

   

 

 

 

Weighted average common shares outstanding—basic and diluted

     25,182,369        18,604,245