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 second quarter 2015
financial results and highlighted recent corporate progress.
Recent Corporate Progress
- La Jolla initiated its ATHOS
(Angiotensin II for the
Treatment of High-Output Shock) 3 trial, a multicenter, randomized,
double-blind, placebo-controlled, Phase 3 clinical trial of
LJPC-501, La Jolla’s proprietary formulation of angiotensin II, for
catecholamine-resistant hypotension (CRH).
- La Jolla filed an Investigational New
Drug Application (IND) for LJPC-401, La Jolla’s novel formulation
of hepcidin for the potential treatment of conditions characterized
by iron overload, such as hereditary hemochromatosis and beta
thalassemia, and expects to release preliminary results from a
Phase 1 study by the end of 2015. In preparation for this Phase 1
study, La Jolla completed animal toxicology studies that have
established the study’s proposed doses and demonstrated a
dose-dependent reduction in serum iron levels in all species
tested.
- La Jolla entered into exclusive
worldwide license agreements with the Indiana University Research
and Technology Corporation and the University of Alabama at
Birmingham to acquire intellectual property rights covering
LJPC-30Sa and LJPC-30Sb, La 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.
- La Jolla announced a reprioritization
of its product development programs that resulted in the
discontinuation of the development of its polysaccharide-based
galectin-3 inhibitors, GCS-100 and LJPC-1010. This reprioritization
has allowed La Jolla to reallocate resources to its other
development candidates that are more in line with its strategic
focus.
“The first half of 2015 was exciting and productive for La
Jolla, highlighted by the initiation of the ATHOS 3 trial, the
preparation of LJPC-401 for a Phase 1 study and the addition of our
next-generation gentamicin derivative program,” said George
Tidmarsh, M.D., Ph.D., La Jolla’s President and Chief Executive
Officer. “We look forward to building on this momentum and
continuing the advancement of each of our exciting programs during
the second half of the year.”
Results of Operations
As of June 30, 2015, La Jolla had $36.0 million in cash,
compared to $48.6 million as of December 31, 2014. The decrease in
cash was primarily due to net cash used for operating
activities.
La Jolla’s net cash used for operating activities for the three
and six months ended June 30, 2015 was $5.7 million and $11.2
million, respectively, compared to net cash used for operating
activities of $2.0 million and $4.7 million, respectively, for the
same periods in 2014.
La Jolla’s net loss for the three and six months ended June 30,
2015 was $10.7 million and $19.6 million, or $0.70 per share and
$1.29 per share, respectively, compared to a net loss of $4.3
million and $9.4 million, or $0.53 per share and $1.38 per share,
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 initiation of the
ATHOS 3 trial of LJPC-501 in CRH, the Phase 2b clinical trial of
GCS-100 in advanced chronic kidney disease, the continuing Phase
1/2 clinical trial of LJPC-501 in hepatorenal syndrome and
preclinical costs associated with LJPC-401. In addition, there were
increases in personnel and related costs, which were mainly due to
the hiring of additional personnel to support increased development
activities, and costs associated with relocating La Jolla’s
corporate headquarters in the second quarter of 2015.
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 and beta thalassemia. 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 the filing of
an Investigational New Drug Application (IND), commencement of
clinical studies and the anticipated timing for completion of such
studies; 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 June
30,
Six Months Ended June
30,
2015 2014 2015
2014 Expenses Research and development $ 6,686 $
1,597 $ 11,856 $ 3,593 General and administrative 3,972
2,689 7,769 5,823 Total expenses 10,658
4,286 19,625 9,416 Loss from operations
(10,658 ) (4,286 ) (19,625 ) (9,416 ) Other income, net 8 2
20 4
Net loss and comprehensive loss
$ (10,650 ) $ (4,284 )
$ (19,605 ) $ (9,412 )
Basic and diluted net loss per share $ (0.70
) $ (0.53 ) $ (1.29
) $ (1.38 ) Shares used in computing
basic and diluted net loss per share 15,251 8,122
15,246 6,835
LA JOLLA PHARMACEUTICAL
COMPANY Condensed Consolidated Balance Sheets
(in thousands, except share and par value
amounts)
June 30, 2015 December
31, 2014 (Unaudited) ASSETS Current
assets: Cash and cash equivalents $ 36,045 $ 48,555 Restricted cash
37 37 Prepaid clinical expenses 458 1,528 Prepaid expenses and
other current assets 622 137 Total current assets
37,162 50,257 Property and equipment, net 1,510 279 Other assets 57
—
Total assets $ 38,729
$ 50,536 LIABILITIES AND
SHAREHOLDERS' EQUITY Current liabilities: Accounts payable $
1,843 $ 730 Accrued expenses 285 926 Accrued payroll and related
expenses 410 424 Total current liabilities 2,538
2,080 Shareholders’ equity: Common Stock, $0.0001 par value;
100,000,000 shares authorized, 15,250,840 and 15,225,980 shares
issued and outstanding at June 30, 2015 and December 31, 2014,
respectively 2 2 Series C-12 Convertible Preferred Stock, $0.0001
par value; 11,000 shares authorized, 3,917 shares issued and
outstanding at June 30, 2015 and December 31, 2014 3,917 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
June 30, 2015 and December 31, 2014, respectively 2,737 2,798
Additional paid-in capital 535,754 528,353 Accumulated deficit
(506,219 ) (486,614 ) Total shareholders’ equity
36,191
48,456 Total liabilities and shareholders'
equity $ 38,729 $ 50,536
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version on businesswire.com: http://www.businesswire.com/news/home/20150807005103/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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