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8-K - 8-K - Pulmatrix, Inc.d228664d8k.htm

Exhibit 99.1

 

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Pulmatrix Reports Q2 2016 Financial Results

LEXINGTON, Mass., August 4, 2016 /PRNewswire/ — Pulmatrix, Inc. (NASDAQ:PULM) today reports its second quarter financial results and provides an update on the progress of its drug development pipeline.

“In the first half of the year, we continued to build awareness around our proprietary iSPERSETM inhaled drug delivery platform and communicate how we believe this technology offers advantages over other pulmonary delivery systems,” said Robert Clarke, PhD, Chief Executive Officer of Pulmatrix. “We are pleased that, under our collaboration agreement with Mylan, we completed the pilot study of PUR0200 for patients with chronic obstructive pulmonary disease (COPD) and announced positive pharmacokinetic bioavailability data that informs our continued development of PUR0200 for European Registration.”

Financials

Revenues for the second quarter of 2016 were $0.3 million, compared to $0.2 million for the second quarter of 2015. The increase was the result of revenue recognized under our collaboration agreement with Mylan to develop PUR0200 for COPD.

Research and development expenses for the second quarter of 2016 were $2.4 million, compared to $1.6 million for the same period last year. The increase was primarily due to increases in clinical development costs and external service costs on the PUR1900 project. General and administrative expenses for the second quarter of 2016 were $2.2 million, compared to $9.9 million for the same period in 2015. The decrease was primarily due to the non-recurring Merger related expenses that were incurred during the second quarter of 2015.

In the second quarter of 2016, Pulmatrix wrote off the in-process research and development (IPR&D) and the related deferred tax liability acquired as part of Pulmatrix’s merger with Ruthigen. As the acquired IPR&D consisted of a preclinical therapeutic for sterile surgical site infections (RUT58-60), it fell outside Pulmatrix’s core focus on differentiated inhaled therapies for pulmonary disease and was never part of the continuing strategy for the company. Pulmatrix’s rights to RUT58-60 lapsed and reverted back to the licensor. The noted write-off resulted in a one-time non-cash charge of $4.6 million.

Net loss for the second quarter of 2016 was $9.2 million compared to a net loss of $14.9 million in the same period last year. The decrease in net loss is attributable to the noted operating expense decreases and the non-recurring warrant and derivative liability fair value adjustments that were recorded in the first quarter of 2015, partially offset by the IPR&D write-off.

As of June 30, 2016, Pulmatrix had $10.8 million in cash and cash equivalents, compared to $18.9 million as of December 31, 2015.

“While working with our collaboration partner on the PUR0200 bioequivalence study for COPD patients, we continued to maintain financial discipline and believe that we have sufficient capital to fund our pipeline and business activities into mid-2017” said William Duke, Jr., chief financial officer of Pulmatrix.

About COPD

COPD is a long term, progressively destructive and life-threatening disease of the lungs. Cigarette smoking is the most common cause of COPD. Performance of everyday activities may be severely curtailed and overall quality of life significantly impaired. The most common symptoms of COPD are breathlessness, production of abnormal mucus in the airway, and a chronic cough. COPD is not curable, but treatment ameliorates symptoms and may slow the progress of the disease. According to the World Health Organization, approximately 65 million people worldwide had COPD in 2004 and it is predicted to become the third leading cause of death by 2020.


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About Pulmatrix

Pulmatrix is a clinical stage biopharmaceutical company developing innovative inhaled therapies to address serious pulmonary disease using its patented iSPERSE™ technology. The company’s proprietary product pipeline is focused on advancing treatments for lung diseases, including opportunities in major pulmonary diseases through collaborations, like PUR0200, a bronchodilator in clinical development for chronic obstructive pulmonary disease (COPD) and PUR1900, an inhaled antifungal that could benefit severe asthmatics and patients with rare disease like cystic fibrosis. Pulmatrix’s product candidates are based on iSPERSE™, its proprietary dry powder delivery platform, which seeks to improve therapeutic delivery to the lungs by maximizing local concentrations and reducing systemic side effects to improve patient outcomes.

FORWARD-LOOKING STATEMENTS

Certain statements in this press release that are forward-looking and not statements of historical fact are forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The Company cautions that such statements involve risks and uncertainties that may materially affect the Company’s results of operations. Such forward-looking statements are based on the beliefs of management as well as assumptions made by and information currently available to management. Actual results could differ materially from those contemplated by the forward-looking statements as a result of certain factors, including but not limited to the ability to establish that potential products are efficacious or safe in preclinical or clinical trials; the ability to establish or maintain collaborations on the development of therapeutic candidates; the ability to obtain appropriate or necessary governmental approvals to market potential products; the ability to obtain future funding for developmental products and working capital and to obtain such funding on commercially reasonable terms; the Company’s ability to manufacture product candidates on a commercial scale or in collaborations with third parties; changes in the size and nature of competitors; the ability to retain key executives and scientists; and the ability to secure and enforce legal rights related to the Company’s products, including patent protection. A discussion of these and other factors, including risks and uncertainties with respect to the Company, is set forth in the Company’s annual report on Form 10-K filed by the Company with the Securities and Exchange Commission on March 10, 2016. The Company disclaims any intention or obligation to revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

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Financial Tables to Follow


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CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands, except share and per share data)

 

     At June 30,
2016
    At December 31,
2015
 
     (unaudited)        

Assets

    

Current assets:

    

Cash and cash equivalents

   $ 10,788      $ 18,902   

Prepaid expenses and other current assets

     1,010        1,560   
  

 

 

   

 

 

 

Total current assets

     11,798        20,462   

Property and equipment, net

     875        685   

Long-term restricted cash

     204        250   

Intangible assets

     —          7,534   

Goodwill

     15,942        15,942   
  

 

 

   

 

 

 

Total assets

   $ 28,819      $ 44,873   
  

 

 

   

 

 

 

Liabilities and stockholders’ equity

    

Current liabilities:

    

Loan payable, net of debt discount

   $ 2,233      $ 1,029   

Accounts payable

     664        1,090   

Accrued expenses

     1,212        1,486   
  

 

 

   

 

 

 

Total current liabilities

     4,109        3,605   

Loan payable, net of current portion, debt discount and issuance costs

     4,548        5,692   

Derivative liability

     11        11   

Deferred tax liability

     —          2,959   
  

 

 

   

 

 

 

Total liabilities

     8,668        12,267   
  

 

 

   

 

 

 

Stockholders’ Equity (Deficit):

    

Preferred stock, $0.0001 par value — 500,000 authorized and 0 issued and outstanding at June 30, 2016 and December 31, 2015

     —         —    

Common stock, $0.0001 par value — 100,000,000 shares authorized; 14,850,526 shares and 14,745,754 shares issued and outstanding, including vested restricted stock units of 198,617 and 229,744, at June 30, 2016 and December 31, 2015, respectively

     1        1   

Additional paid-in capital

     163,110        160,708   

Accumulated deficit

     (142,960     (128,103
  

 

 

   

 

 

 

Total stockholders’ equity (deficit)

     20,151        32,606   
  

 

 

   

 

 

 

Total liabilities, redeemable convertible preferred stock and stockholders’ equity

   $ 28,819      $ 44,873   
  

 

 

   

 

 

 


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CONDENSED CONSOLIDATED RESULTS OF OPERATIONS

(unaudited)

(in thousands, except share and per share data)

 

     For the Three Months Ended
June 30,
 
     2016     2015  

Revenues

   $ 260      $ 170   

Operating expenses

    

Research and development

     2,441        1,610   

General and administrative

     2,214        9,879   

Write-off of intangibles, net of tax provision

     4,575        —     
  

 

 

   

 

 

 

Total operating expenses

     9,230        11,489   
  

 

 

   

 

 

 

Loss from operations

     (8,970     (11,319

Interest expense

     (224     (327

Loss on the conversion of convertible notes

     —          (1,170

Fair value adjustment of preferred stock warrant liability

     —          582   

Fair value adjustment of derivative liability

     —          (2,692

Other income, net

     7        29   
  

 

 

   

 

 

 

Net loss

   $ (9,187   $ (14,897
  

 

 

   

 

 

 

Net loss attributable to common stockholders

   $ (9,187   $ (14,897
  

 

 

   

 

 

 

Net loss per share attributable to common stockholders, basic and diluted

   $ (0.62   $ (5.77
  

 

 

   

 

 

 

Weighted average shares used to compute basic and diluted net loss per share attributable to common stockholders

     14,804,606        2,580,144   
  

 

 

   

 

 

 

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Investor Contact   

Robert Clarke, CEO

(781) 357-2333

rclarke@pulmatrix.com

  

William Duke, CFO

(781) 357-2333

wduke@pulmatrix.com

Chris Brinzey, Westwicke Partners

(339) 970-2843

IR@pulmatrix.com