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 financial results
for the three and nine months ended September 30, 2016 and recent
corporate progress.
Recent Corporate Progress
In September 2016, La Jolla reported positive results from a
multicenter, open-label, dose-escalation Phase 1 trial of LJPC-401,
the Company’s novel formulation of synthetic human hepcidin, in
patients at risk for iron overload due to conditions such as
hereditary hemochromatosis (HH), beta thalassemia, sickle cell
disease (SCD) and myelodysplastic syndrome (MDS). Fifteen patients
were dosed at escalating dose levels ranging from 1 to 20 mg.
LJPC-401 was well tolerated, and there were no dose-limiting
toxicities observed. A dose-dependent, statistically significant
reduction in serum iron was observed (p=0.008 for dose response;
not adjusted for multiple comparisons). At the 20 mg dose level,
LJPC-401 reduced serum iron by an average of 58.1% from baseline to
hour 8 (p=0.001; not adjusted for potential regression to the mean
effect), and serum iron had not returned to baseline through day 7
(21.2% reduction from baseline to the end of day 7).
In September 2016, La Jolla reached agreement with the European
Medicines Agency (EMA) on the design of a pivotal trial of
LJPC-401, the Company’s novel formulation of synthetic human
hepcidin. The pivotal trial will be a randomized, controlled,
multicenter trial in beta thalassemia patients suffering from iron
overload, a major unmet need in an orphan patient population. The
primary endpoint will be a clinically relevant measurement directly
related to iron overload. La Jolla plans to initiate this pivotal
trial in mid-2017.
In October 2016, the EMA Committee for Orphan Medicinal Products
(COMP) issued a positive opinion recommending LJPC-401, synthetic
human hepcidin, for designation as an orphan medicinal product for
the treatment of SCD.
“The first nine months of 2016 have been productive for La
Jolla, highlighted by continued enrollment of our ATHOS 3 Phase 3
trial of LJPC-501 and encouraging results from our Phase 1 trial of
LJPC-401, which demonstrated a clear dose-dependent effect of
LJPC-401 on serum iron, a clinically important measure,” said
George Tidmarsh, M.D., Ph.D., La Jolla’s President and Chief
Executive Officer. “We look forward to building on this positive
momentum, with the anticipation of reporting results from our ATHOS
3 Phase 3 trial of LJPC-501 in the first quarter of 2017 and
initiation of our pivotal trial for LJPC-401 in mid-2017.”
Results of Operations
As of September 30, 2016, La Jolla had $85.0 million in cash and
cash equivalents, compared to $126.5 million as of December 31,
2015. The decrease in cash and cash equivalents was primarily due
to 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 nine
months ended September 30, 2016 was $40.1 million, compared to net
cash used for operating activities of $16.7 million for the same
period in 2015. La Jolla’s net loss for the three and nine months
ended September 30, 2016 was $21.3 million and $53.3 million, or
$1.23 per share and $3.10 per share, respectively, compared to a
net loss of $10.5 million and $30.1 million, or $0.70 per share and
$1.99 per share, respectively, for the same periods in 2015. During
the three and nine months ended September 30, 2016, La Jolla
recognized contract revenue of approximately $44,000 and $531,000,
respectively. The net loss includes non-cash, share-based
compensation expense of $3.9 million and $11.0 million for the
three and nine months ended September 30, 2016, respectively,
compared to $3.1 million and $10.3 million, respectively, for the
same periods in 2015.
The increases in net cash used for operating activities and net
loss in the 2016 periods as compared to the 2015 periods were
primarily due to increased development costs associated with our
ATHOS 3 Phase 3 trial of LJPC-501 in patients with
catecholamine-resistant hypotension and our Phase 1 trial of
LJPC-401 in patients with iron overload.
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 synthetic human hepcidin for the
potential treatment of conditions characterized by iron overload,
such as hereditary hemochromatosis, beta thalassemia, sickle cell
disease and myelodysplastic syndrome. LJPC-30S is our
next-generation gentamicin derivative program that is focused on
therapeutics for the potential treatment of serious bacterial
infections as well as 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; potential indications for
which the Company’s product candidates 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
(in thousands, except per share
amounts)
Three Months Ended September 30, Nine
Months Ended September 30, 2016
2015 2016 2015 Revenue Contract
revenue - related party $ 44 $ 647 $ 531 $ 647
Total revenue 44 647 531 647
Expenses Research and development 16,992 7,781 42,111 19,637
General and administrative 4,349 3,353 11,868
11,122 Total expenses 21,341 11,134 53,979
30,759 Loss from operations (21,297 ) (10,487 )
(53,448 ) (30,112 ) Other income, net 46 13 150
33
Net loss $ (21,251 )
$ (10,474 ) $ (53,298 )
$ (30,079 ) Basic and diluted net loss per
share $ (1.23 ) $ (0.70
) $ (3.10 ) $ (1.99
) Shares used in computing basic and diluted net loss per
share 17,211 14,899 17,211 15,129
LA JOLLA PHARMACEUTICAL COMPANY
Condensed Consolidated Balance Sheets
(in thousands, except share and par value
amounts)
September 30, 2016 December 31,
2015 (Unaudited) ASSETS Current assets: Cash
and cash equivalents $ 85,035 $ 126,467 Restricted cash 200 237
Prepaid clinical expenses 105 223 Prepaid expenses and other
current assets 1,396 618
Total current assets
86,736 127,545 Property and equipment, net 2,566 1,732 Other assets
219 70
Total assets $ 89,521
$ 129,347 LIABILITIES AND
SHAREHOLDERS’ EQUITY Current liabilities: Accounts payable $
1,998 $ 2,506 Accrued expenses 3,917 1,224 Accrued payroll and
related expenses 1,321 1,090 Total current
liabilities 7,236 4,820 Shareholders’ equity: Common
Stock, $0.0001 par value; 100,000,000 shares authorized, 18,254,009
and 18,244,009 shares issued and outstanding at September 30, 2016
and December 31, 2015, respectively 2 2 Series C-12 Convertible
Preferred Stock, $0.0001 par value; 11,000 shares authorized, 3,906
shares issued and outstanding at September 30, 2016 and December
31, 2015, and liquidation preference of $3,906 at September 30,
2016 and December 31, 2015 3,906 3,906 Series F Convertible
Preferred Stock, $0.0001 par value; 10,000 shares authorized, 2,737
shares issued and outstanding at September 30, 2016 and December
31, 2015, and liquidation preference of $2,737 at September 30,
2016 and December 31, 2015 2,737 2,737 Additional paid-in capital
657,464 646,408 Accumulated deficit (581,824 ) (528,526 )
Total shareholders’ equity
82,285 124,527
Total liabilities and shareholders’
equity $ 89,521 $ 129,347
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version on businesswire.com: http://www.businesswire.com/news/home/20161103006647/en/
La Jolla Pharmaceutical CompanyGeorge F. Tidmarsh, M.D.,
Ph.D.President & Chief Executive Officer(858)
207-4264gtidmarsh@ljpc.comandLa Jolla Pharmaceutical CompanyDennis
M. MulroyChief Financial Officer(858) 433-6839dmulroy@ljpc.com
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