Full Press Release Details
Pulmatrix Reports Third Quarter 2016 Financial Results and Business Update
LEXINGTON, Mass., Nov. 4, 2016 /PRNewswire/ Pulmatrix, Inc. (NASDAQ: PULM), a clinical stage biopharmaceutical company developing
innovative inhaled therapies to address serious pulmonary diseases, today announced it third quarter financial results and business update.
pleased with our continued progress and the awareness we are building around our proprietary iSPERSETM inhaled drug delivery platform, said Robert Clarke, PhD, Chief Executive Officer
of Pulmatrix. We continue to advance the use of this technology and continue to seek to leverage this platform to develop a differentiated product pipeline targeting the treatment of serious pulmonary disorders. Last quarter, in collaboration
with Mylan, we announced favorable pharmacokinetic data for PUR0200 in chronic obstructive pulmonary disease (COPD) which supports accelerated development in the EU via the Pharmacokinetic Bioequivalence Regulatory
Revenues for the third quarter of 2016 were $0.1 million, compared to $0.7 million for the third quarter of 2015. The decrease was the result of the decreased
revenue associated with the conclusion of the clinical study funded under our collaboration agreement with Mylan to develop PUR0200 for COPD.
and development expenses for the third quarter of 2016 were $1.5 million, compared to $2.2 million for the same period last year. The decrease was primarily due to decreases in clinical development costs and external service costs on the PUR1900
project. General and administrative expenses for the third quarter of 2016 were $1.6 million, compared to $3.1 million for the same period in 2015. The decrease was primarily due to a reduction in employee stock-based compensation expense and
non-recurring merger related expenses that were incurred during the third quarter of 2015.
Net loss for the third quarter of 2016 was $3.2 million
compared to a net loss of $4.9 million in the same period last year. The decrease in net loss is attributable to the noted operating expense decreases.
As of September 30, 2016, Pulmatrix had $7.3 million in cash and cash equivalents, compared to $18.9 million
as of December 31, 2015.
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.
PUR0200 is an iSPERSE formulation incorporating a marketed long-acting muscarinic antagonist (LAMA) bronchodilator. We believe it
demonstrates the highly efficient delivery that iSPERSE can achieve. Because nearly all of the dose reaches the site of action in the lung and is not swallowed or otherwise lost, PUR0200 can achieve the same effect as the marketed product at
20% of the dose administered. PUR0200 is currently being developed in Europe based on PK bioequivalence, and the US development program is being planned.
About Cystic Fibrosis
Cystic fibrosis is an inherited
disease that causes thickened mucus to form in the lungs, pancreas and other organs. Within the lungs, this mucus blocks the airways, causing infections and other issues that lead to lung damage, and difficulty to breathe. According to the
Cystic Fibrosis Foundation, the disease affects an estimated 70,000 people worldwide, predominantly in the United States and Europe (www.cff.org).
PUR1900 is an iSPERSE formulation
incorporating a large, complex anti-fungal compound that can be administered at high therapeutic dose to the lung while minimizing systemic side effects. It is estimated that nearly 50% of patients with cystic fibrosis (CF) experience pulmonary
fungal infections that can cause chronic bronchitis or allergic reactions, resulting in inflammation and poor long term outcomes. PUR1900 is the first inhaled anti-fungal product candidate for CF.
Pulmatrix is a clinical stage
biopharmaceutical company developing innovative inhaled therapies to address serious pulmonary disease using its patented iSPERSETM 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.
Financial Tables to Follow
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands, except share and per share data)
| At September 30, 2016 | At December 31, 2015 | |||||||
| (unaudited) | ||||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 7,313 | $ | 18,902 | ||||
| Prepaid expenses and other current assets | 1,022 | 1,560 | ||||||
| Total current assets | 8,335 | 20,462 | ||||||
| Property and equipment, net | 999 | 685 | ||||||
| Long-term restricted cash | 204 | 250 | ||||||
| Intangible assets | 7,534 | |||||||
| Goodwill | 15,942 | 15,942 | ||||||
| Total assets | $ | 25,480 | $ | 44,873 | ||||
| Liabilities and stockholders equity | ||||||||
| Current liabilities: | ||||||||
| Loan payable, net of debt discount | $ | 2,511 | $ | 1,029 | ||||
| Accounts payable | 401 | 1,090 | ||||||
| Accrued expenses | 1,193 | 1,486 | ||||||
| Total current liabilities | 4,105 | 3,605 | ||||||
| Loan payable, net of current portion, debt discount and issuance costs | 3,893 | 5,692 | ||||||
| Derivative liability | 11 | 11 | ||||||
| Deferred tax liability | 2,959 | |||||||
| Total liabilities | 8,009 | 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 148,962 and 229,744, at June 30, 2016 and December 31, 2015, respectively | 1 | 1 | ||||||
| Additional paid-in capital | 163,586 | 160,708 | ||||||
| Accumulated deficit | (146,116 | ) | (128,103 | ) | ||||
| Total stockholders equity (deficit) | 17,471 | 32,606 | ||||||
| Total liabilities, redeemable convertible preferred stock and stockholders equity | $ | 25,480 | $ | 44,873 |
CONDENSED CONSOLIDATED RESULTS OF OPERATIONS
thousands, except share and per share data)
| For the Three Months Ended June 30, | ||||||||
| 2016 | 2015 | |||||||
| Revenues | $ | 61 | $ | 651 | ||||
| Operating expenses | ||||||||
| Research and development | 1,507 | 2,193 | ||||||
| General and administrative | 1,550 | 3,119 | ||||||
| Total operating expenses | 3,057 | 5,312 | ||||||
| Loss from operations | (2,996 | ) | (4,661 | ) | ||||
| Interest expense | (225 | ) | (220 | ) | ||||
| Other income, net | 64 | (51 | ) | |||||
| Net loss | $ | (3,157 | ) | $ | (4,932 | ) | ||
| Net loss attributable to common stockholders | $ | (3,157 | ) | $ | (4,932 | ) | ||
| Net loss per share attributable to common stockholders, basic and diluted | $ | (0.21 | ) | $ | (0.34 | ) | ||
| Weighted average shares used to compute basic and diluted net loss per share attributable to common stockholders | 14,850,526 | 14,654,427 |
Chris Brinzey, Westwicke Partners