LEXINGTON, Mass., Nov. 9,
2017 /PRNewswire/ -- Pulmatrix, Inc. (NASDAQ: PULM) today
reports its third quarter financial results and provided an
overview of recent operational highlights.
"During the third quarter, we made significant progress with our
clinical stage programs. We partnered with Vectura to develop
Pulmatrix's drug candidate, PUR0200, for chronic obstructive
pulmonary disease (COPD) for the U.S. market. Vectura will be
responsible for all future development costs to advance the product
for the U.S., thus allowing us to focus on the development of our
two lead pipeline programs – Pulmazole, an inhaled anti-fungal for
patients with ABPA, and PUR1800," said Robert W. Clarke, Ph.D.,
chief executive officer of Pulmatrix. "We believe that both
Pulmazole (formerly PUR1900) and PUR1800 have blockbuster
potential," Dr. Clarke added.
Q3 2017 Highlights
Partnered with Vectura Group plc ("Vectura") to develop
Pulmatrix's drug candidate, PUR0200, for chronic obstructive
pulmonary disease (COPD) for the U.S. market
Vectura and/or its partners will be responsible for all future
development costs to advance the product for the U.S. Pulmatrix
will provide the data package for PUR0200 and assist with the
transfer of development and manufacturing activities to
Vectura. As part of the agreement, a technology access fee of
$1 million will be payable to
Pulmatrix upon successful achievement of pre-agreed pharmaceutical
development criteria. Vectura will pay Pulmatrix a mid-teen
percentage share of any future revenues that Vectura receives
relating to future development and sale of PUR0200 and
PUR0200-related products including future combinations.
Received award from Cystic Fibrosis Foundation
Therapeutics (CFFT) to support the development of its lead
inhaled anti-fungal product candidate Pulmazole
Pulmazole is targeting the treatment of allergic
bronchopulmonary aspergillosis (ABPA) in patients with compromised
lung function. The award from CFFT supports advancing Pulmazole
toward a Phase 1/1B clinical study in healthy volunteers and
asthmatic patients to compare Pulmazole with oral itraconazole
dosing in early 2018.
Received notice of grant of two new patents for Pulmatrix
iSPERSE™ platform technology and PUR0200
program
Adding to the previously issued intellectual property protection
already received on Pulmatrix's iSPERSE drug delivery technology,
the new patent makes the technology even more versatile. A drug is
typically formulated in the iSPERSE matrix using
"excipients"—typically inert ingredients like salts that enhance
the drug's utility. The previous patents had provided intellectual
property protection for the use of two such excipients. The new
patent (US 9744130) adds protection for the use of two more
excipients.
The second new patent expands protections for Pulmatrix's
PUR0200 drug candidate for COPD. Pulmatrix had previously received
several key patents protecting PUR0200. The new patent (US 9737518)
broadens the intellectual property protection to include complete
protection for the composition of the drug and certain dose
ranges.
Additional Recent Highlights
Pulmazole received Qualified Infectious Disease Product
(QIDP) designation for a second indication by the U.S. Food &
Drug Administration
In October 2017, the company
received notification of a grant of QIDP status for Pulmazole for
treatment of pulmonary Aspergillus infections in patients
with ABPA. Pulmazole is a reformulation of the oral antifungal drug
itraconazole for inhaled delivery in iSPERSE. QIDP status conveys
five (5) additional years of market exclusivity for the product in
this indication. Pulmatrix had previously received QIDP status as
well as orphan drug designation from the FDA for Pulmazole
(PUR1900) to treat fungal infections in the airways of patients
with cystic fibrosis, a rare genetic disease estimated to affect
75,000-100,000 patients worldwide. This new QIDP status expands the
eligible ABPA population to include asthmatic patients; 1.5% of
adult asthmatics suffer from ABPA. Pulmazole is expected to enter
into a Phase IB clinical trial in early Q1 2018 with data readout
in mid-2018.
Appointed Dr. James Roach as
Chief Medical Officer
In November 2017, Dr. Roach joined
Pulmatrix to lead the clinical development of Pulmatrix's
innovative inhaled drugs for serious lung diseases, including ABPA
and COPD. Dr. Roach was most recently the Chief Medical Officer at
Veristat. Prior to joining Veristat, he served as Senior Vice
President, Development and Chief Medical Officer of Momenta
Pharmaceuticals, Senior Vice President, Medical Affairs at Sepracor
Pharmaceuticals, and Head of Medical Affairs at Millennium
Pharmaceuticals.
Financials
As of September 30, 2017,
Pulmatrix had $6.4 million in cash
and cash equivalents, compared to $4.2
million as of December 31,
2016.
Pulmatrix generated $0.3 million
in revenue in the third quarter of 2017, compared to $0.1 million for the third quarter of 2016. The
revenue in 2017 was associated with a grant received from the
Cystic Fibrosis Foundation Therapeutics, Inc. and the revenue in
2016 related to the clinical study funded under our collaboration
agreement to develop PUR0200 for COPD.
Research and development expenses for the third quarter of 2017
were $2.6 million, compared to
$1.5 million for the same period last
year. The increase was primarily due to increases in clinical
development costs on the Pulmazole project. General and
administrative expenses for the second quarter of 2017 were
$2.0 million, compared to
$1.6 million for the same period in
2016. The increase was primarily due to increases in employment and
professional consultant costs.
Net loss for the third quarter of 2017 was $4.5 million compared to a net loss of
$3.2 million in the same period last
year. The increase in net loss was attributable to the noted
operating expense increases, partially offset by the noted increase
in revenue.
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 serious lung diseases, including
Pulmazole (PUR1900), an inhaled anti-fungal for patients with ABPA,
and PUR1800, a narrow spectrum kinase inhibitor for patients with
obstructive lung diseases including asthma and COPD. In addition,
Pulmatrix has partnered with Vectura Group plc to develop
Pulmatrix's drug candidate, PUR0200, for COPD for the U.S.
market. 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 filings with the Securities and Exchange Commission,
including its annual report on Form 10-K filed by the Company with
the Securities and Exchange Commission on March 10, 2017, as may be supplemented or amended
by the Company's Quarterly Reports on Form 10-Q. 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,
2017
|
|
At December 31,
2016
|
|
(unaudited)
|
|
|
Assets
|
|
|
|
Current
assets:
|
|
|
|
Cash and cash
equivalents
|
$
6,360
|
|
$
4,182
|
Accounts
receivable
|
305
|
|
—
|
Prepaid expenses and
other current assets
|
754
|
|
577
|
Total current
assets
|
7,550
|
|
4,759
|
Property and
equipment, net
|
657
|
|
786
|
Long-term restricted
cash
|
204
|
|
204
|
Goodwill
|
10,914
|
|
10,914
|
Total
assets
|
$
19,325
|
|
$
16,663
|
|
|
|
|
Liabilities and
stockholders' equity
|
|
|
|
Current
liabilities:
|
|
|
|
Loan payable, net of
debt discount and issuance costs
|
$
3,896
|
|
$
2,586
|
Accounts
payable
|
1,027
|
|
747
|
Accrued
expenses
|
1,587
|
|
1,317
|
Total current
liabilities
|
6,510
|
|
4,650
|
Loan payable, net of
current portion, debt discount and issuance costs
|
—
|
|
3,217
|
Derivative
liability
|
35
|
|
35
|
Total
liabilities
|
6,545
|
|
7,902
|
Stockholders' Equity
(Deficit):
|
|
|
|
Common stock, $0.0001
par value — 100,000,000 shares authorized;
20,426,451 and 14,850,526 shares issued and
outstanding, including
vested restricted stock units of 0 and 99,308,
at September 30, 2017
and December 31, 2016,
respectively
|
2
|
|
1
|
Additional paid-in
capital
|
182,256
|
|
164,706
|
Accumulated
deficit
|
(169,478)
|
|
(155,946)
|
Total stockholders'
equity
|
12,780
|
|
8,761
|
Total liabilities and
stockholders' equity
|
$
19,325
|
|
$
16,663
|
|
|
|
|
CONDENSED
CONSOLIDATED RESULTS OF OPERATIONS
(unaudited)
(in thousands,
except share and per share data)
|
|
|
|
|
|
For the Three
Months Ended
September 30,
|
|
2017
|
|
2016
|
Revenues
|
$
335
|
|
$
61
|
Operating
expenses
|
|
|
|
Research and
development
|
2,618
|
|
1,507
|
General and
administrative
|
2,021
|
|
1,550
|
Total operating
expenses
|
4,639
|
|
3,057
|
Loss from
operations
|
(4,304)
|
|
(2,996)
|
Interest
expense
|
(153)
|
|
(225)
|
Other income
(expense), net
|
5
|
|
64
|
Net loss
|
$
(4,452)
|
|
$
(3,157)
|
Net loss per share
attributable to common stockholders, basic and diluted
|
$
(0.22)
|
|
$
(0.21)
|
|
|
|
|
Weighted average
shares used to compute basic and diluted net loss per
share attributable to common stockholders
|
20,200,893
|
|
14,850,526
|
|
|
|
|
|
|
|
|
Investor
Contact
|
|
Robert Clarke,
CEO
|
William Duke,
CFO
|
(781)
357-2333
|
(781)
357-2333
|
rclarke@pulmatrix.com
|
wduke@pulmatrix.com
|
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SOURCE Pulmatrix, Inc.