La Jolla Pharmaceutical Company (NASDAQ: LJPC) (the Company or
La Jolla), a leader in the development of innovative therapies
intended to significantly improve outcomes in patients suffering
from life-threatening diseases, today reported third quarter 2015
financial results and highlighted recent corporate progress.
Recent Corporate Progress
- La Jolla initiated a Phase 1 clinical
trial of LJPC-401, the Company’s novel formulation
of hepcidin, in patients at risk of iron overload due to
conditions such as hereditary hemochromatosis, beta thalassemia and
sickle cell disease. Preliminary results from this clinical trial
are anticipated by the end of 2015.
- La Jolla received a positive opinion
from the European Medicines Agency (EMA) Committee for Orphan
Medicinal Products (COMP), which the European Commission
subsequently adopted, for designation of LJPC-401 as an orphan
medicinal product for the treatment of beta thalassemia intermedia
and major.
- La Jolla and Vanderbilt University
entered into an exclusive, worldwide research and license agreement
covering Vanderbilt’s research program and intellectual property
rights relating to small-molecule kinase inhibitors designed to
selectively block specific members of the bone morphogenetic
protein (BMP) type-I receptor family, for the potential treatment
of fibrodysplasia ossificans progressiva (FOP), acquired
heterotopic ossification, muscular dystrophies including Duchenne
muscular dystrophy, anemia of chronic disease, cancer,
cardiovascular diseases and inflammatory bowel disease.
- La Jolla received orphan drug
designation from the U.S. Food and Drug Administration (FDA) Office
of Orphan Products Development on two novel compounds, which were
licensed from Vanderbilt University, for FOP.
- La Jolla completed an underwritten
public offering of approximately 2.9 million shares of common
stock, which includes the full exercise of the underwriters’
overallotment option, at a public offering price of $38.00 per
share. The Company received total net proceeds of approximately
$104.6 million from this offering.
“The second half of 2015 is off to an exciting and productive
start for La Jolla, highlighted by the initiation of our Phase 1
clinical trial for LJPC-401, continued progress with our Phase 3
clinical trial of LJPC-501, the receipt of a positive opinion for
designation of LJPC-401 as an orphan medicinal product in Europe
and the receipt of orphan drug designation for two of the recently
licensed compounds from Vanderbilt in the U.S.,” said George
Tidmarsh, M.D., Ph.D., La Jolla’s President and Chief Executive
Officer. “We look forward to building on this momentum, with the
anticipation of preliminary results from the LJPC-401 Phase 1
clinical trial by the end of this year and results from the
LJPC-501 Phase 3 clinical trial by the end of 2016.”
Results of Operations
As of September 30, 2015, La Jolla had $135.1 million in cash
and cash equivalents, compared to $48.6 million as of December 31,
2014. The increase in cash and cash equivalents was primarily due
to cash provided by our common stock offering that was completed in
September 2015, which was partially offset by net cash used for
operating activities. Based on current operating plans and
projections, La Jolla believes that its current cash and cash
equivalents are sufficient to fund operations into 2018.
La Jolla’s net cash used for operating activities for the three
and nine months ended September 30, 2015 was $5.5 million and $16.7
million, respectively, compared to net cash used for operating
activities of $2.8 million and $7.5 million, respectively, for the
same periods in 2014. La Jolla’s net loss for the three and nine
months ended September 30, 2015 was $10.5 million and $30.1
million, or $0.70 per share and $1.99 per share, respectively,
compared to a net loss of $5.1 million and $14.5 million, or $0.37
per share and $1.58 per share, respectively, for the same periods
in 2014. During the three months ended September 2015, La Jolla
recognized approximately $0.6 million of contract revenue, which
was pursuant to a services agreement under which La Jolla provides
research and development services to a related party. The net loss
includes noncash, share-based compensation expense of $3.1 million
and $10.3 million for the three and nine months ended September 30,
2015, respectively, compared to $1.7 million and $6.6 million of
noncash, share-based compensation expense, respectively, for the
same periods in 2014.
The increases in net cash used for operating activities and net
loss in 2015 as compared to 2014 were primarily due to increased
clinical development costs associated with the continuation of the
Phase 3 clinical trial of LJPC-501 in catecholamine-resistant
hypotension and the costs associated with the initiation of the
Phase 1 clinical trial of LJPC-401 in iron overload. In addition,
there were increases in personnel and related costs, which were
mainly due to the hiring of additional personnel and increased
facility costs to support the increased development and clinical
activities.
About La Jolla Pharmaceutical Company
La Jolla Pharmaceutical Company is a biopharmaceutical company
focused on the discovery, development and commercialization of
innovative therapies intended to significantly improve outcomes in
patients suffering from life-threatening diseases. The Company has
several product candidates in development. LJPC-501 is La Jolla’s
proprietary formulation of angiotensin II for the potential
treatment of catecholamine-resistant hypotension. LJPC-401 is La
Jolla’s novel formulation of hepcidin for the potential treatment
of conditions characterized by iron overload, such as hereditary
hemochromatosis, beta thalassemia and sickle cell disease.
LJPC-30Sa and LJPC-30Sb are Jolla’s next-generation gentamicin
derivatives for the potential treatment of serious bacterial
infections and rare genetic disorders, such as cystic fibrosis and
Duchenne muscular dystrophy. For more information on La Jolla,
please visit www.ljpc.com.
Forward Looking Statement Safe Harbor
This document contains forward-looking statements as that term
is defined in the Private Securities Litigation Reform Act of 1995.
These statements relate to future events or the Company’s future
results of operations. These statements are only predictions and
involve known and unknown risks, uncertainties and other factors,
which may cause actual results to be materially different from
these forward-looking statements. The Company cautions readers not
to place undue reliance on any such forward-looking statements,
which speak only as of the date they were made. Certain of these
risks, uncertainties, and other factors are described in greater
detail in the Company’s filings with the U.S. Securities and
Exchange Commission (SEC), all of which are available free of
charge on the SEC’s web site www.sec.gov. These risks include, but
are not limited to, risks relating to: the timing for commencement
of clinical studies, the anticipated timing for completion of such
studies, and the anticipated timing for regulatory actions; the
success of future development activities for LJPC-501, LJPC-401,
LJPC-30Sa and LJPC-30Sb; potential indications for which LJPC-501,
LJPC-401, LJPC-30Sa and LJPC-30Sb may be developed; and the
expected duration over which the Company’s cash balances will fund
its operations. Subsequent written and oral forward-looking
statements attributable to the Company or to persons acting on its
behalf are expressly qualified in their entirety by the cautionary
statements set forth in the Company's reports filed with the SEC.
The Company expressly disclaims any intent to update any
forward-looking statements.
LA JOLLA PHARMACEUTICAL COMPANY Unaudited
Condensed Consolidated Statements of Operations and Comprehensive
Loss
(in thousands, except per share
amounts)
Three Months Ended September
30, Nine Months Ended September 30, 2015
2014 2015 2014
Revenue Contract revenue - related party $ 647 $ —
$ 647 $ — Total revenue 647 —
647 —
Expenses Research and development 7,781
2,625 19,637 6,218 General and administrative 3,353 2,436
11,122 8,259 Total expenses 11,134
5,061 30,759 14,477 Loss from operations
(10,487 ) (5,061 ) (30,112 ) (14,477 ) Other income, net 13
9 33 13
Net loss and comprehensive loss
$ (10,474 ) $ (5,052 )
$ (30,079 ) $ (14,464 )
Basic and diluted net loss per share $ (0.70
) $ (0.37 ) $ (1.99
) $ (1.58 ) Shares used in computing
basic and diluted net loss per share 14,899 13,646
15,129 9,131
LA JOLLA PHARMACEUTICAL
COMPANY Condensed Consolidated Balance Sheets
(in thousands, except share and par value
amounts)
September 30, 2015
December 31, 2014 (Unaudited) ASSETS
Current assets: Cash and cash equivalents $ 135,055 $ 48,555
Restricted cash 237 37 Prepaid clinical expenses 360 1,528 Prepaid
expenses and other current assets 484 137 Total
current assets 136,136 50,257 Property and equipment, net 1,751 279
Other assets 57 —
Total assets $
137,944 $ 50,536
LIABILITIES AND SHAREHOLDERS' EQUITY Current liabilities:
Accounts payable $ 2,567 $ 730 Accrued expenses 1,145 926 Accrued
payroll and related expenses 629 424 Total current
liabilities 4,341 2,080 Shareholders’ equity: Common Stock, $0.0001
par value; 100,000,000 shares authorized, 18,241,509 and 15,225,980
shares issued and outstanding at September 30, 2015 and December
31, 2014, respectively 2 2 Series C-12 Convertible Preferred Stock,
$0.0001 par value; 11,000 shares authorized, 3,906 and 3,917 shares
issued and outstanding at September 30, 2015 and December 31, 2014,
respectively 3,906 3,917 Series F Convertible Preferred Stock,
$0.0001 par value; 10,000 shares authorized, 2,737 and 2,798 shares
issued and outstanding at September 30, 2015 and December 31, 2014,
respectively 2,737 2,798 Additional paid-in capital 643,651 528,353
Accumulated deficit (516,693 ) (486,614 ) Total shareholders’
equity
133,603 48,456 Total
liabilities and shareholders' equity $ 137,944
$ 50,536
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version on businesswire.com: http://www.businesswire.com/news/home/20151106005122/en/
La Jolla Pharmaceutical CompanyGeorge F. Tidmarsh, M.D.,
Ph.D.President & Chief Executive
Officer858-207-4264gtidmarsh@ljpc.comorDennis M. MulroyChief
Financial Officer858-433-6839dmulroy@ljpc.com
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