THE WOODLANDS, Texas,
May 3, 2011 /PRNewswire/ -- Lexicon
Pharmaceuticals, Inc. (Nasdaq: LXRX), a biopharmaceutical company
focused on discovering and developing breakthrough treatments for
human disease, today updated its drug development progress and
reported financial results for the three months ended March 31, 2011.
"Our pipeline of first-in-class drugs continues to make
significant progress. Results from a mechanistic study of a
tablet formulation of LX4211 in diabetes patients provided further
confirmation of the drug's unique dual mechanism of action, and
preparations to initiate a Phase 2b study of LX4211 in the second
quarter are on track," said Dr. Arthur T. Sands, president and
chief executive officer of Lexicon. "In addition, we
anticipate completing enrollment in the U.S. Phase 2a clinical
trial of LX1032 in patients with carcinoid syndrome in the second
quarter, with results expected shortly thereafter."
Key Progress in Clinical Pipeline
- Lexicon reported data from a clinical trial and mechanistic
study of a solid oral tablet formulation of LX4211, a dual
inhibitor of sodium-glucose cotransporters 1 and 2, showing that
LX4211 significantly increased GLP-1 (total and active) and PYY,
important mediators of glycemic and appetite control. The
drug also produced rapid and significant improvement in
post-prandial glucose (PPG) and fasting plasma glucose (FPG),
consistent with results observed in the previously completed Phase
2a study of a liquid formulation of LX4211. Pharmacokinetic
and pharmacodynamic data from the study indicated that the solid
oral formulation and the liquid formulation were comparable in key
parameters of hormonal release, PPG and FPG. Lexicon expects
to initiate a Phase 2b study of the tablet formulation in the
second quarter of this year.
- Lexicon commenced a Phase 1 study of LX1033, a back-up compound
to LX1031 that in vitro studies indicate has the potential to be
significantly more potent than LX1031. LX1031 and LX1033 are
each serotonin synthesis inhibitors that act locally in the
gastrointestinal tract to reduce serotonin production by inhibiting
tryptophan hydroxylase, a key enzyme in the biosynthesis of
serotonin. Lexicon anticipates completing the Phase 1 study
of LX1033 in the third quarter of this year.
- Lexicon expects to initiate a dose-ranging study in the third
quarter of this year to explore higher doses of LX2931 in
rheumatoid arthritis patients. Previously reported Phase 2a
results of LX2931, an inhibitor of sphingosine-1-phosphate lyase,
demonstrated a favorable safety profile at all doses tested and
suggested that rheumatoid arthritis patients treated with 150 mg of
LX2931 once daily showed improvement in the primary efficacy
endpoint of the study, the percentage of patients achieving an
American College of Rheumatology 20 (ACR20) response at week
12.
- Lexicon continued to enroll carcinoid syndrome patients in a
U.S.-based Phase 2a clinical trial of LX1032, an inhibitor of
tryptophan hydroxylase that reduces peripheral serotonin production
without affecting brain serotonin levels, and anticipates
completing enrollment in the second quarter of this year and
releasing results shortly thereafter. Lexicon also continued
to enroll carcinoid syndrome patients in a second E.U.-based
open-label clinical trial of LX1032.
Financial Results
Revenues: Lexicon's revenues for the three months
ended March 31, 2011 decreased 64
percent to $0.6 million from
$1.6 million for the corresponding
period in 2010. The decrease for the three months ended
March 31, 2011 was primarily
attributable to reduced revenues under Lexicon's alliance with
Taconic Farms.
Research and Development Expenses: Research and
development expenses for the three months ended March 31, 2011 increased 13 percent to
$23.9 million from $21.1 million for the corresponding period in
2010. The increase was primarily attributable to increased
external clinical and preclinical research and development costs
and increased severance costs resulting from Lexicon's continued
reallocation of resources from earlier-stage research towards its
most advanced drug discovery and development programs.
Increase in Fair Value of Symphony Icon Purchase
Liability: In connection with the acquisition of Symphony
Icon, Lexicon made an initial estimate of the fair value of the
liability for the associated base and contingent payments.
Changes in this liability, based on the development of the
programs and the time until such payments are expected to be made,
are recorded in Lexicon's consolidated statements of operations.
The increase in fair value of the Symphony Icon purchase
liability was $1.1 million for the
three months ended March 31, 2011.
General and Administrative Expenses: General and
administrative expenses for the three months ended March 31, 2011 decreased 14 percent to
$4.8 million from $5.5 million for the corresponding period in
2010. The decrease was primarily attributable to decreased
legal and patent fees.
Consolidated Net Loss: Net loss for the three
months ended March 31, 2011 was $29.6
million, or $0.09 per share,
compared to a net loss of $26.1
million, or $0.13 per share,
in the corresponding period in 2010. For the three months
ended March 31, 2011, net loss
included non-cash, stock-based compensation expense of $1.5 million, compared to $1.3 million in the corresponding period in 2010.
Cash and Investments: As of March 31, 2011, Lexicon had $188.9 million in cash and investments, as
compared to $211.1 million as of
December 31, 2010.
Lexicon Conference Call:
Lexicon management will hold a conference call to discuss
financial results for the first quarter of 2011 and program status
at 11:00 a.m. Eastern Time on
May 3, 2011. The dial-in number
for the conference call is 888-220-1244 (within the US/Canada) or 706-679-5615 (international).
The conference ID for all callers is 62216935. An
archived version of the conference call will be available on
Lexicon's corporate website at www.lexpharma.com through
May 31, 2011.
About Lexicon
Lexicon is a biopharmaceutical company focused on discovering
breakthrough treatments for human disease. Lexicon currently
has four drug candidates in mid-stage development for diabetes,
irritable bowel syndrome, carcinoid syndrome and rheumatoid
arthritis, all of which were discovered by Lexicon's research team.
Lexicon has used its proprietary gene knockout technology to
identify more than 100 promising drug targets. Lexicon has
focused drug discovery efforts on these biologically-validated
targets to create its extensive pipeline of clinical and
preclinical programs. For additional information about
Lexicon and its programs, please visit www.lexpharma.com.
Safe Harbor Statement
This press release contains "forward-looking statements,"
including statements relating to Lexicon's clinical development
of LX1031, LX1032, LX1033, LX2931, and LX4211, including
characterizations of the results of and projected timing of
clinical trials of such compounds, and the potential therapeutic
and commercial potential of LX1031, LX1032, LX1033, LX2931, and
LX4211. This press release also contains forward-looking
statements relating to Lexicon's growth and future operating
results, discovery and development of products, strategic alliances
and intellectual property, as well as other matters that are not
historical facts or information. All forward-looking
statements are based on management's current assumptions and
expectations and involve risks, uncertainties and other important
factors, specifically including those relating to Lexicon's
ability to successfully conduct clinical development of LX1031,
LX1032, LX1033, LX2931, and LX4211 and preclinical and clinical
development of its other potential drug candidates, advance
additional candidates into preclinical and clinical development,
obtain necessary regulatory approvals, achieve its operational
objectives, obtain patent protection for its discoveries and
establish strategic alliances, as well as additional factors
relating to manufacturing, intellectual property rights, and the
therapeutic or commercial value of its drug candidates, that
may cause Lexicon's actual results to be materially different from
any future results expressed or implied by such forward-looking
statements. Unless specifically indicated otherwise, results
reported as trends were not statistically significant. Information
identifying such important factors is contained under "Risk
Factors" in Lexicon's annual report on Form 10-K for the year ended
December 31, 2010, as filed with the
Securities and Exchange Commission. Lexicon undertakes no
obligation to update or revise any such forward-looking statements,
whether as a result of new information, future events or
otherwise.
Lexicon
Pharmaceuticals, Inc.
Selected
Financial Data
|
|
Consolidated
Statements of Operations Data
|
|
Three Months
Ended
March
31,
|
|
(In
thousands, except per share data)
|
|
2011
|
|
2010
|
|
|
|
(unaudited)
|
|
Revenues:
|
|
|
|
|
|
Collaborative
research
|
|
$ 516
|
|
$ 1,641
|
|
Subscription and license
fees
|
|
80
|
|
-
|
|
Total revenues
|
|
596
|
|
1,641
|
|
Operating expenses:
|
|
|
|
|
|
Research and development,
including stock-based compensation
of $839 and
$806, respectively
|
|
23,921
|
|
21,088
|
|
Increase in fair value of
Symphony Icon, Inc. purchase liability
|
|
1,058
|
|
-
|
|
General and
administrative, including stock-based compensation
of $633 and
$499, respectively
|
|
4,753
|
|
5,519
|
|
Total operating expenses
|
|
29,732
|
|
26,607
|
|
Loss from operations
|
|
(29,136)
|
|
(24,966)
|
|
Gain on investments, net
|
|
-
|
|
88
|
|
Interest income
|
|
87
|
|
217
|
|
Interest expense
|
|
(607)
|
|
(727)
|
|
Other income (expense),
net
|
|
27
|
|
(682)
|
|
Consolidated net loss
|
|
$ (29,629)
|
|
$ (26,070)
|
|
|
|
|
|
|
|
Consolidated net loss
per common share, basic and
diluted
|
|
$ (0.09)
|
|
$ (0.13)
|
|
|
|
|
|
|
|
Shares used in computing
consolidated net loss per common share, basic
and diluted
|
|
337,527
|
|
197,239
|
|
|
|
|
|
|
|
|
|
|
Consolidated
Balance Sheet Data
|
As of March
31,
|
|
As of
December 31,
|
|
(In
thousands)
|
2011
|
|
2010
|
|
|
(unaudited)
|
|
|
|
Cash and investments
|
$ 188,910
|
|
$ 211,111
|
|
Property and equipment,
net
|
51,815
|
|
53,427
|
|
Goodwill
|
44,543
|
|
44,543
|
|
Other intangible assets
|
53,557
|
|
53,557
|
|
Total assets
|
343,408
|
|
366,884
|
|
Deferred revenue
|
14,397
|
|
14,426
|
|
Current and long-term
debt
|
28,199
|
|
28,483
|
|
Other long-term
liabilities.
|
49,610
|
|
48,783
|
|
Accumulated deficit
|
(703,035)
|
|
(673,406)
|
|
Total stockholders'
equity
|
219,317
|
|
247,024
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
SOURCE Lexicon Pharmaceuticals, Inc.