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 first quarter 2016
financial results and highlighted recent corporate progress.
Recent Corporate Progress
- La Jolla’s ATHOS (Angiotensin II for the Treatment of High-Output Shock) 3 trial continued to enroll as
planned through the first quarter of 2016. The ATHOS 3 trial is La
Jolla’s multicenter, randomized, double-blind, placebo-controlled,
Phase 3 clinical trial of LJPC-501, the Company’s proprietary
formulation of angiotensin II, in catecholamine-resistant
hypotension (CRH), which was initiated in 2015. The Company
initiated the ATHOS 3 trial after reaching an agreement with the
U.S. Food and Drug Administration (FDA) on a Special Protocol
Assessment (SPA), in which the agreed-upon primary efficacy
endpoint in ATHOS 3 is an increase in blood pressure. Results of
ATHOS 3 are expected by the end of 2016.
- La Jolla reported interim results in
January 2016 of its multicenter, open-label, dose-escalation Phase
1 clinical trial of LJPC-401, the Company’s novel formulation of
hepcidin, in patients at risk for iron overload due to conditions
such as hereditary hemochromatosis, beta thalassemia, sickle cell
disease and myelodysplastic syndrome. These results suggested a
dose-dependent reduction in serum iron following a single dose of
LJPC-401. Complete results from this Phase 1 clinical trial, which
was initiated in October 2015, are expected in the second half of
2016.
“The first quarter was a productive start to 2016 for La Jolla,
highlighted by the continued enrollment of our ATHOS 3 trial and
encouraging interim data from our Phase 1 clinical trial of
LJPC-401,” said George Tidmarsh, M.D., Ph.D., La Jolla’s President
and Chief Executive Officer. “We look forward to continuing the
advancement of each of our exciting programs during the rest of
2016, culminating with the results from the ATHOS 3 trial that are
expected by the end of the year.”
Results of Operations
As of March 31, 2016, La Jolla had $113.1 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 three
months ended March 31, 2016 was $13.0 million, compared to net cash
used for operating activities of $5.5 million for the same period
in 2015. La Jolla’s net loss for the three months ended March 31,
2016 was $16.5 million, or $0.96 per share, compared to a net loss
of $9.0 million, or $0.59 per share, for the same period in 2015.
During the three months ended March 31, 2016, La Jolla recognized
contract revenue of approximately $0.2 million, which was pursuant
to a services agreement initiated in 2015 under which La Jolla
provides research and development services to a related party. The
net loss includes non-cash, share-based compensation expense of
$3.7 million for the three months ended March 31, 2016, compared to
$3.4 million for the same period in 2015.
The increases in net cash used for operating activities and net
loss in 2016 as compared to 2015 were primarily due to increased
development costs associated with the ATHOS 3 trial 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 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, 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 EndedMarch 31, 2016
2015 Revenue Contract revenue - related party
$ 234 $ — Total revenue 234 —
Expenses Research and development 12,694 5,170 General and
administrative 4,053 3,796 Total expenses 16,747
8,966 Loss from operations (16,513 ) (8,966 ) Other
income, net 32 11
Net loss $
(16,481 ) $ (8,955 ) Basic
and diluted net loss per share $ (0.96 )
$ (0.59 ) Shares used in computing basic and
diluted net loss per share 17,210 15,242
LA JOLLA PHARMACEUTICAL COMPANY
Condensed Consolidated Balance Sheets
(in thousands, except share and par value
amounts)
March 31,2016
December 31,2015
(unaudited) ASSETS Current assets: Cash and cash
equivalents $ 113,071 $ 126,467 Restricted cash 200 237 Prepaid
clinical expenses 64 223 Prepaid expenses and other current assets
1,408 618 Total current assets 114,743 127,545
Property and equipment, net 2,047 1,732 Other assets 217 70
Total assets $ 117,007 $
129,347 LIABILITIES AND SHAREHOLDERS’
EQUITY Current liabilities: Accounts payable $ 2,408 $ 2,506
Accrued expenses 2,411 1,224 Accrued payroll and related expenses
352 1,090 Total current liabilities 5,171 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 March 31, 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
March 31, 2016 and December 31, 2015, and liquidation preference of
$3,906 at March 31, 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 March 31, 2016
and December 31, 2015, and liquidation preference of $2,737 at
March 31, 2016 and December 31, 2015 2,737 2,737 Additional paid-in
capital 650,198 646,408 Accumulated deficit (545,007 ) (528,526 )
Total shareholders’ equity
111,836 124,527
Total liabilities and shareholders’ equity $
117,007 $ 129,347
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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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