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8-K - FORM 8-K - Pulmatrix, Inc.d124697d8k.htm

Exhibit 99.1

 

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May 5, 2016

Pulmatrix Reports Q1 2016 Financial Results

LEXINGTON, MA — Pulmatrix, Inc. (NASDAQ: PULM) today reports its first quarter financial results and provides an update on the progress of its drug development pipeline.

“During the first quarter, we continued to make progress across our development pipeline of inhaled therapeutics,” said Robert W. Clarke, Ph.D., chief executive officer of Pulmatrix. “In the second quarter, we expect to report data from the European bioequivalence study for our COPD program, PUR0200.”

Financials

Revenues for the first quarter of 2016 were $0.4 million, compared to $0.1 million for the first quarter of 2015. The increase was the result of revenue recognized under our collaboration agreement to develop PUR0200 for COPD.

Research and development expenses for the first quarter of 2016 were $3.4 million, compared to $0.9 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 and PUR0200 projects. General and administrative expenses for the first quarter of 2016 were $2.4 million, compared to $1.9 million for the same period in 2015. The increase was primarily due to an increase in stock-based compensation expense.

Net loss for the first quarter of 2016 was $5.7 million compared to a net loss of $1.8 million in the same period last year. The increase in net loss is attributable to the noted operating expense increases and the non-recurring impact of the fair value adjustments of our preferred stock warrant liability and derivative liability that were recorded in the first quarter of 2015.

As of March 31, 2016, Pulmatrix had $14.8 million in cash and cash equivalents, compared to $18.9 million as of December 31, 2015.

“Through continued financial discipline, we ended the first quarter in a strong financial position with sufficient capital to invest in the development of our current pipeline and operations into mid-2017 based on current expectations,” said William Duke, Jr., chief financial officer of Pulmatrix. “We believe that this will fund our business beyond multiple data readouts from ongoing and planned clinical studies, as well as other corporate milestones.”

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 rare diseases, including PUR1900, an inhaled anti-fungal for lung disease patients. In addition, Pulmatrix is pursuing opportunities in major pulmonary diseases through collaborations, including PUR0200, a branded generic in clinical development for chronic obstructive pulmonary disease (COPD). Pulmatrix’s


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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 March 31,
2016
    At December 31,
2015
 
     (unaudited)        

Assets

    

Current assets:

    

Cash and cash equivalents

   $ 14,753      $ 18,902   

Prepaid expenses and other current assets

     1,011        1,560   
  

 

 

   

 

 

 

Total current assets

     15,764        20,462   

Property and equipment, net

     783        685   

Long-term restricted cash

     200        250   

Intangible assets

     7,534        7,534   

Goodwill

     15,942        15,942   
  

 

 

   

 

 

 

Total assets

   $ 40,223      $ 44,873   
  

 

 

   

 

 

 

Liabilities and stockholders’ equity

    

Current liabilities:

    

Loan payable, net of debt discount

   $ 1,682      $ 1,029   

Accounts payable

     1,272        1,090   

Accrued expenses

     1,060        1,486   
  

 

 

   

 

 

 

Total current liabilities

     4,014        3,605   

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

     5,069        5,692   

Derivative liability

     11        11   

Deferred tax liability

     2,959        2,959   
  

 

 

   

 

 

 

Total liabilities

     12,053        12,267   
  

 

 

   

 

 

 

Stockholders’ Equity (Deficit):

    

Common stock, $0.0001 par value — 100,000,000 shares and 233,500,000 shares authorized at March 31, 2016 and December 31, 2015; 14,795,408 shares and 14,745,754 shares issued and outstanding, including vested restricted stock units of 279,398 and 229,744, at March 31, 2016 and December 31, 2015, respectively

     1        1   

Additional paid-in capital

     161,941        160,708   

Accumulated deficit

     (133,772     (128,103
  

 

 

   

 

 

 

Total stockholders’ equity (deficit)

     28,170        32,606   
  

 

 

   

 

 

 

Total liabilities, redeemable convertible preferred stock and stockholders’ equity

   $ 40,223      $ 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
March 31,
 
     2016     2015  

Revenues

   $ 396      $ 105   

Operating expenses

    

Research and development

     3,430        918   

General and administrative

     2,409        1,934   
  

 

 

   

 

 

 

Total operating expenses

     5,839        2,852   
  

 

 

   

 

 

 

Loss from operations

     (5,443     (2,747

Interest expense

     (223     (184

Fair value adjustment of preferred stock warrant liability

     —          727   

Fair value adjustment of derivative liability

     —          401   

Other expense, net

     (3     —     
  

 

 

   

 

 

 

Net loss

   $ (5,669   $ (1,803
  

 

 

   

 

 

 

Net loss attributable to common stockholders

   $ (5,669   $ (1,803
  

 

 

   

 

 

 

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

   $ (0.38   $ (9.55
  

 

 

   

 

 

 

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

     14,754,484        188,742   
  

 

 

   

 

 

 

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Investor Contact   
Robert Clarke, CEO    William Duke, CFO
(781) 357-2333    (781) 357-2333
rclarke@pulmatrix.com    wduke@pulmatrix.com
Chris Brinzey, Westwicke Partners   
(339) 970-2843   
IR@pulmatrix.com