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 fourth quarter and
full year 2014 financial results and highlighted recent corporate
progress and near-term milestones.
Recent Corporate Highlights
- In February 2015, La Jolla reached
agreement with the U.S. Food and Drug Administration (FDA) on a
Special Protocol Assessment (SPA) for its planned Phase 3 clinical
trial of LJPC-501, La Jolla’s propriety formulation of angiotensin
II, for the treatment of catecholamine-resistant hypotension (CRH),
in which the agreed-upon primary efficacy endpoint will be increase
in blood pressure.
- In December 2014, La Jolla entered into
an exclusive worldwide license agreement with the George Washington
University for intellectual property rights covering the use of
angiotensin II (LJPC-501) for the therapeutic treatment of patients
with hypotension and shock.
- In November 2014, La Jolla presented
positive results from its randomized, placebo-controlled, Phase 2
clinical trial of GCS-100, La Jolla’s first-in-class galectin-3
inhibitor, in advanced chronic kidney disease (CKD) patients, in
which GCS-100 met its primary efficacy endpoint of a statistically
significant improvement in kidney function, at the American Society
of Nephrology’s Kidney Week Annual Meeting.
- In October 2014, La Jolla presented
positive data from a preclinical study of LJPC-501 for the
treatment of CRH.
“2014 was a very exciting year for La Jolla, highlighted by the
announcement of our LJPC-501 Phase 3 registration program, the
positive results from our Phase 2 clinical trial of GCS-100 in
advanced CKD patients and the close of our financing in July,” said
George Tidmarsh, M.D., Ph.D., La Jolla’s President and Chief
Executive Officer. “2015 is off to a great start as well,
highlighted by the FDA’s agreement on our Phase 3 clinical trial
design and planned analysis for LJPC-501. We look forward to the
start of our Phase 3 trial of LJPC-501 in CRH and our Phase 2b
trial of GCS-100 in advanced CKD, as well as the advancement of our
other programs.”
Near-Term Corporate Milestones
- In the first quarter of 2015, La Jolla
plans to initiate a multicenter, randomized, double-blind,
placebo-controlled, Phase 3 clinical trial of LJPC-501 in CRH, in
accordance with its recently obtained SPA.
- In the first quarter of 2015, La Jolla
plans to initiate a multicenter, randomized, double-blind,
placebo-controlled, Phase 2b clinical trial of GCS-100
in diabetic patients with Stage 3b or 4 CKD.
- In the second quarter of 2015, La Jolla
plans to file an Investigational New Drug Application (IND) with
the FDA and initiate a Phase 1 clinical trial of LJPC-1010, La
Jolla’s second-generation galectin-3 inhibitor.
- In the second half of 2015, La Jolla
plans to file an IND with the FDA and initiate a Phase 1 clinical
trial of LJPC-401, La Jolla’s novel formulation of hepcidin.
Results of Operations
At December 31, 2014, La Jolla had $48.6 million in cash,
compared to $8.6 million at December 31, 2013. The significant
increase in cash is due to the completion of an underwritten public
offering of common stock in July 2014, with net proceeds to La
Jolla of approximately $53.1 million.
La Jolla’s cash used in operating activities for the three
months ended December 31, 2014 was $5.4 million, compared to $2.0
million for the same period in 2013. Cash used in operating
activities for the year ended December 31, 2014 was $12.9 million,
compared to $4.7 million for the same period in 2013.
La Jolla’s comprehensive net loss attributable to common
shareholders for the three months ended December 31, 2014 was $6.8
million, or $0.45 per share, compared to a comprehensive net loss
attributable to common shareholders of $6.4 million, or $1.45 per
share, for the same period in 2013. Comprehensive net loss
attributable to common shareholders for the year ended December 31,
2014 was $21.3 million, or $2.00 per share, compared to a
comprehensive net loss attributable to common shareholders of $18.7
million, or $12.16 per share, for the same period in 2013.
The increase in cash used in operating activities and
comprehensive net loss attributable to common shareholders was
primarily due to increases in research and development expenses
related to the Phase 2 clinical trial of GCS-100 in advanced CKD,
the Phase 1/2 clinical trial of LJPC-501 in hepatorenal syndrome
(HRS), preclinical work on LJPC-1010 and LJPC-401 and intellectual
property in-licensing costs related to LJPC-501 and LJPC-401.
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. We have four
product candidates in development. LJPC-501 is our proprietary
formulation of angiotensin II for the potential treatment of
catecholamine-resistant hypotension and hepatorenal syndrome.
GCS-100 is our first-in-class galectin-3 inhibitor for the
potential treatment of chronic kidney disease. LJPC-1010, our
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 our novel
formulation of hepcidin for the potential treatment conditions
characterized by iron overload, such as hemochromatosis and beta
thalassemia. For more information on La Jolla, please visit
http://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 Statements of Operations and
Comprehensive Loss (In thousands, except per share amounts)
Three Months Ended
December 31, (unaudited)
Year Ended December 31, 2014
2013 2014 2013 Expenses:
Research and development $ 3,726 $ 2,059 $ 9,944 $ 4,362 General
and administrative 3,137 4,339 11,396 13,579
Total expenses 6,863 6,398 21,340
17,941 Loss from operations (6,863 ) (6,398 ) (21,340 )
(17,941 ) Other income, net 14 1 27 6
Net loss and comprehensive loss (6,849 ) (6,397 ) (21,313 )
(17,935 ) Convertible preferred stock dividends earned — —
— (801 )
Net loss attributable to common
shareholders $ (6,849 ) $
(6,397 ) $ (21,313 ) $
(18,736 ) Basic and diluted net loss per share
$ (0.45 ) $ (1.45 )
$ (2.00 ) $ (12.16 )
Shares used in computing basic and diluted net loss per share
15,226 4,397 10,667 1,540 La
Jolla Pharmaceutical Company Balance Sheets (In thousands,
except share and par value amounts)
December 31,
2014 2013 Assets Current assets: Cash
and cash equivalents $ 48,555 $ 8,629 Restricted cash 37 37 Prepaid
clinical expenses 1,528 — Prepaid expenses and other current assets
137 43 Total current assets 50,257 8,709 Property and
equipment, net 279 38
Total assets $ 50,536
$ 8,747
Liabilities and shareholders’
equity Current liabilities: Accounts payable $ 730 $ 834
Accrued expenses 926 187 Accrued payroll and related expenses 424
73 Total current liabilities 2,080 1,094
Commitments and contingencies Shareholders’ equity:
Common stock, $0.0001 par value;
100,000,000 and 12,000,000,000 sharesauthorized, 15,225,980 and
4,404,407 shares issued and outstanding atDecember 31, 2014 and
2013, respectively
2 4
Series C-12 Convertible Preferred Stock,
$0.0001 par value; 11,000 sharesauthorized, 3,917 and 7,016 shares
issued and outstanding at December 31,2014 and 2013, respectively,
and a liquidation preference of $3,917
3,917 7,016
Series F Convertible Preferred Stock,
$0.0001 par value; 10,000 sharesauthorized, 2,798 and 3,250 shares
issued and outstanding at December 31,2014 and 2013, respectively,
and a liquidation preference of $2,798
2,798 3,250 Additional paid-in capital 528,353 462,684 Accumulated
deficit (486,614 ) (465,301 ) Total shareholders’ equity 48,456
7,653
Total liabilities and shareholders'
equity $ 50,536 $ 8,747
La Jolla Pharmaceutical CompanyGeorge F. Tidmarsh, M.D.,
Ph.D.President & Chief Executive Officer(858)
207-4264GTidmarsh@ljpc.comorChester S. Zygmont, IIISenior Director
of Finance(858) 207-4262czygmont@ljpc.com
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