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.
"We are 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 Guidance."
Business Update
- FDA granted Orphan Drug Designation for PUR1900. In
August, the U.S. Food and Drug Administration (FDA) granted orphan
drug designation to Pulmatrix's wholly-owned drug candidate
PUR1900. PUR1900 combines an already approved anti-fungal drug with
its proprietary dry powder iSPERSETM delivery platform
to effectively deliver to the lungs a drug used to treat pulmonary
fungal infections in patients with cystic fibrosis (CF).
- Announced the addition of Dr. Matthew Sherman to its Board of Directors.
In October, Pulmatrix announced the appointment of Dr. Matthew Sherman to the Board of Directors. Dr.
Sherman is a board certified physician in medical oncology and
internal medicine and has held various positions at Harvard Medical School. Dr. Sherman brings to
Pulmatrix an extensive background and experience in drug
development, clinical research, and regulatory affairs.
- Pulmatrix presented new data on PUR1900 at the North
American Cystic Fibrosis Conference. In October, Pulmatrix
presented pre-clinical data for PUR1900 and the North American
Cystic Fibrosis Conference. The poster presentation compared the
activity of PUR1900 against the oral reference drug and measured
the deposition of the product in the lungs against systemic levels
to demonstrate the products potential advantages in treating CF
patients with fungal infections.
Financials
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.
Research 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.
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.
About PUR0200
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).
About PUR1900
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.
About Pulmatrix
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
(unaudited) (in 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
|
|
|
|
|
|
|
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
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SOURCE Pulmatrix, Inc.