Avenue Therapeutics Reports Second Quarter 2017 Financial Results and Recent Corporate Highlights

NEW YORK, Aug. 11, 2017 (GLOBE NEWSWIRE) -- Avenue Therapeutics, Inc. (NASDAQ:ATXI) (“Avenue”), a Fortress Biotech (NASDAQ:FBIO) Company, today announced financial results and recent corporate highlights for the second quarter ended June 30, 2017.

“We are thrilled to have completed our initial public offering. The initiation of the Phase 3 bunionectomy trial is planned for the third quarter of 2017, and we anticipate announcing topline data from the study as early as the second quarter of 2018,” said Lucy Lu, MD, Avenue’s Chief Executive Officer.  Dr. Lu continued, “I am also excited to take on an official leadership role at Avenue, and look forward to delivering value for our shareholders.” 

Financial Results:

  • As of June 30, 2017, Avenue’s cash totaled $34.7 million compared to $0.2 million at December 31, 2016, an increase of $34.5 million year-to-date.
  • Research and development expenses were $0.4 million for the second quarter of 2017, compared to $0.4 million for the second quarter of 2016.
  • General and administrative expenses were $1.3 million for the second quarter of 2017, compared to $0.2 million for the second quarter of 2016.
  • Net loss attributable to common stockholders was $2.4 million, or $0.70 per share, for the second quarter of 2017. This compares to a net loss attributable to common stockholders of $0.8 million, or $0.28 per share, for the second quarter of 2016. 

Recent Corporate Highlights:

  • In May 2017, Avenue received a Notice of Allowance from the U.S. Patent and Trademark Office for a new patent application (U.S. Application No. 15/163,111) titled "Intravenous Administration of Tramadol.” The patent application describes and claims a dosing regimen of IV 50 mg tramadol that provides certain pharmacokinetic parameters that are similar to those of 100 mg tramadol HCl administered orally every six hours at a steady state.  Issuance of the patent (U.S. Patent No. 9,693,949) occurred in July 2017. This patent application falls under Avenue’s licensing agreement with Revogenex Ireland Ltd.
  • On June 30, 2017, Avenue completed its initial public offering of 6,325,000 shares of common stock, at a public offering price of $6.00 per share, resulting in gross proceeds of approximately $38 million. Avenue’s common stock began trading on The NASDAQ Capital Market under the ticker symbol “ATXI”.
  • Also in June 2017, Dr. Lu was named President and Chief Executive Officer of Avenue, a position she held on an interim basis since the company’s inception.

About Avenue Therapeutics 
Avenue Therapeutics, Inc., a Fortress Biotech Company, is a specialty pharmaceutical company focused on the development and commercialization of an intravenous formulation of tramadol HCl (“IV tramadol”) for the management of postoperative pain. Avenue is headquartered in New York City. For more information, visit www.avenuetx.com.   

About Fortress Biotech
Fortress Biotech, Inc. (“Fortress”) is a biopharmaceutical company dedicated to acquiring, developing and commercializing novel pharmaceutical and biotechnology products. Fortress develops and commercializes products both within Fortress and through certain of its subsidiary companies, also known as Fortress Companies. In addition to its internal development programs, Fortress leverages its biopharmaceutical business expertise and drug development capabilities and provides funding and management services to help the Fortress Companies achieve their goals. Fortress and the Fortress Companies may seek licensings, acquisitions, partnerships, joint ventures and/or public and private financings to accelerate and provide additional funding to support their research and development programs. For more information, visit www.fortressbiotech.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, each as amended. Such statements include, but are not limited to, any statements relating to our growth strategy and 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 value. Factors that could cause actual results to differ materially from those currently anticipated include: risks relating to our growth strategy; risks relating to the results of research and development activities; risks relating to the timing of starting and completing clinical trials; our ability to obtain, perform under and maintain financing and strategic agreements and relationships; uncertainties relating to preclinical and clinical testing; our dependence on third-party suppliers; our ability to attract, integrate and retain key personnel; the early stage of products under development; our need for substantial additional funds; government regulation; patent and intellectual property matters; 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.

($ in thousands, except for share and per share amounts)
    June 30,   December 31,  
      2017       2016    
  Current Assets:        
  Cash $ 34,683     $ 197    
  Prepaid expenses   22       -    
  Total Assets $    34,705     $    197    
  Current Liabilities:        
  Accounts payable and accrued expenses $ 826     $ 506    
  Accrued expenses - related party   167       1,348    
  Interest payable   56       57    
  Accrued interest - related party   120       346    
  Notes payable - related party   3,486       2,848    
  NSC notes payable, short-term   2,500       1,000    
  Derivative warrant liability   -       314    
  Total current liabilities   7,155       6,419    
  Convertible notes payable, at fair value   -       200    
  NSC notes payable, long-term (net of debt discount of $106 and $174, respectively)   394       1,826    
  Total Liabilities   7,549       8,445    
  Commitments and Contingencies        
  Stockholders' Deficit        
  Preferred Stock ($0.0001 par value), 2,000,000 shares authorized        
  Class A Preferred Stock, 83,333 shares issued and outstanding as of June 30, 2017 and December 31, 2016   -       -    
  Common Stock ($0.0001 par value), 50,000,000 shares authorized        
  Common shares; 10,041,008 and 3,257,936 shares issued and outstanding as of June 30, 2017 and December 31, 2016, respectively   1       1    
  Common stock issuable, 0 and 83,532 shares as of June 30, 2017 and December 31, 2016, respectively   -       49    
  Additional paid-in capital   38,625       105    
  Accumulated deficit   (11,470 )     (8,403 )  
  Total Stockholders' Deficit   27,156       (8,248 )  
  Total Liabilities and Stockholders' Deficit $    34,705     $    197    


 ($ in thousands, except for share and per share amounts)
    For the Three Months Ended   For the Six Months Ended  
    June 30, 2017   June 30, 2016   June 30, 2017   June 30, 2016  
  Operating expenses:                
  Research and development $ 447     $ 421     $ 580     $ 985    
  General and administration   1,297       217       1,668       493    
  Loss from operations   (1,744 )     (638 )     (2,248 )     (1,478 )  
  Interest expense   93       87       188       172    
  Interest expense - related party   20       46       81       79    
  Change in fair value of convertible notes payable   95       -       99       -    
  Change in fair value of warrant liabilities   454       -       451       89    
  Net Loss $    (2,406 )   $    (771 )   $    (3,067 )   $    (1,818 )  
  Net loss per common share outstanding, basic and diluted $ (0.70 )   $ (0.28 )   $ (0.95 )   $ (0.66 )  
  Weighted average number of common shares outstanding, basic and diluted   3,459,942       2,785,865       3,242,602       2,761,367    


Joseph Vazzano, VP, Finance and Corporate Controller
Avenue Therapeutics, Inc.
(781) 652‐4500

Media Relations
Sarah Hall
Phase IV Communications
(215) 313-5638

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Source: Avenue Therapeutics