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 2015
financial results and highlighted recent corporate progress and
near-term milestones.
Recent Corporate Highlights
- La Jolla reached agreement with the
U.S. Food and Drug Administration (FDA) on a Special Protocol
Assessment (SPA) for its ATHOS 3 trial, in which the agreed-upon
primary efficacy endpoint is increase in blood pressure.
- The ATHOS (Angiotensin II for the Treatment of High-Output Shock) 3 trial, La Jolla’s multicenter,
randomized, double-blind, placebo-controlled, Phase 3 clinical
trial of LJPC-501, La Jolla’s proprietary formulation of
angiotensin II, in catecholamine-resistant hypotension (CRH) was
initiated in March 2015.
- La Jolla’s multicenter, randomized,
double-blind, placebo-controlled, Phase 2b clinical trial of
GCS-100, La Jolla’s first-in-class galectin-3 inhibitor, in
diabetic patients with Stage 3b or 4 Chronic Kidney Disease (CKD)
was initiated in March 2015.
- The executive team of La Jolla was
strengthened with the appointment of Lakhmir Chawla, M.D. as its
Chief Medical Officer and Dennis Mulroy as its Chief Financial
Officer.
- La Jolla added four new members, Paul
Adams, M.D., Victor Gordeuk, M.D., Ashutosh Lal, M.D. and Gordon
McLaren, M.D., to its advisory board for the development of
LJPC-401, La Jolla’s novel formulation of hepcidin.
“The first quarter was an exciting start to 2015 for La Jolla,
highlighted by the initiation of both our LJPC-501 Phase 3
registration trial and our Phase 2b clinical trial of GCS-100 in
advanced CKD patients,” said George Tidmarsh, M.D., Ph.D., La
Jolla’s President and Chief Executive Officer. “With the recent
strengthening of our executive team and the LJPC-401 advisory
board, we look forward to building upon our recent progress and
continuing the advancement of all of our programs, including the
initiation of Phase 1 clinical trials for both LJPC-1010 and
LJPC-401 later this year.”
Results of Operations
At March 31, 2015, La Jolla had $42.7 million in cash, compared
to $48.6 million at December 31, 2014. The decrease in cash was
primarily due to cash used for operating activities for the three
months ended March 31, 2015. La Jolla’s net loss for the three
months ended March 31, 2015 was $9.0 million, or $0.59 per share,
compared to a net loss of $5.1 million, or $0.93 per share, for the
same period in 2014. The increase in net loss was primarily due to
increased clinical development costs associated with the initiation
of our ATHOS 3 trial, the initiation of our Phase 2b clinical trial
of GCS-100 in advanced CKD, the continuing Phase 1/2 clinical trial
of LJPC-501 in HRS and preclinical costs associated with LJPC-1010
and LJPC-401, as well as increases in personnel and related costs,
which were mainly due to additional headcount to support such
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
four product candidates in development. LJPC-501 is La Jolla’s
proprietary formulation of angiotensin II for the potential
treatment of catecholamine-resistant hypotension and hepatorenal
syndrome. GCS-100 is La Jolla’s first-in-class galectin-3 inhibitor
for the potential treatment of chronic kidney disease. LJPC-1010,
La Jolla’s second-generation galectin-3 inhibitor, is a more potent
and purified derivative of GCS-100 that can be delivered orally for
the potential treatment of nonalcoholic steatohepatitis and other
diseases characterized by tissue fibrosis. LJPC-401 is La Jolla’s
novel formulation of hepcidin for the potential treatment of
conditions characterized by iron overload, such as hemochromatosis
and beta thalassemia. 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 http://www.sec.gov. These risks
include, but are not limited to, risks relating to: the timing for
the filing of an IND, commencement of clinical studies and the
anticipated timing for completion of such studies; the success of
future development activities for LJPC-501, GCS-100, LJPC-1010 and
LJPC-401; and potential indications for which LJPC-501, GCS-100,
LJPC-1010 and LJPC-401 may be developed. 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 Statements of Operations and Comprehensive
Loss (in thousands, except per share amounts)
Three Months Ended March 31, 2015
2014 Expenses Research and development $ 5,170
$ 1,996 General and administrative 3,796 3,134 Total
expenses 8,966 5,130 Loss from operations (8,966 )
(5,130 ) Other income, net 11 2
Net loss and
comprehensive loss $ (8,955 ) $
(5,128 ) Basic and diluted net loss per share
$ (0.59 ) $ (0.93 )
Shares used in computing basic and diluted net loss per share
15,242 5,535
LA
JOLLA PHARMACEUTICAL COMPANY Condensed Balance
Sheets (in thousands, except share and par value
amounts) March 31, 2015 December
31, 2014 (Unaudited) ASSETS Current
assets: Cash and cash equivalents $ 42,712 $ 48,555 Restricted cash
37 37 Prepaid clinical expenses 1,449 1,528 Prepaid expenses and
other current assets 622 137 Total current assets
44,820 50,257 Property and equipment, net 659 279 Other assets 57
—
Total assets $ 45,536
$ 50,536 LIABILITIES AND
SHAREHOLDERS' EQUITY Current liabilities: Accounts payable $
2,459 $ 730 Accrued expenses 117 926 Accrued payroll and related
expenses — 424 Total current liabilities 2,576 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 March 31, 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
March 31, 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 March
31, 2015 and December 31, 2014, respectively 2,737 2,798 Additional
paid-in capital 531,873 528,353 Accumulated deficit (495,569 )
(486,614 ) Total shareholders’ equity
42,960
48,456 Total liabilities and shareholders'
equity $ 45,536 $ 50,536
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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