THE WOODLANDS, Texas,
May 8, 2014 /PRNewswire/ -- Lexicon
Pharmaceuticals, Inc. (Nasdaq: LXRX), a biopharmaceutical company
focused on developing breakthrough treatments for human disease,
today updated its drug development progress and reported financial
results for the three months ended March 31, 2014.
"Consistent with our focus on late-stage drug development, we
have made continued, excellent progress in the enrollment of
patients in our pivotal Phase 3 trial for telotristat etiprate for
carcinoid syndrome," said Dr. Arthur T. Sands, president and chief
executive officer of Lexicon. "We are also looking forward to
advancing LX4211 into later-stage development in type 1 diabetes
based on the very encouraging results of our recently-completed
Phase 2 study."
Progress in Clinical Pipeline
- LX4211: Earlier this month, Lexicon announced positive top-line
results in a Phase 2 clinical trial of LX4211, a dual inhibitor of
sodium-glucose transporters 1 and 2, in patients with type 1
diabetes. LX4211 achieved the primary endpoint of reducing mealtime
insulin use as well as several secondary endpoints, including
improved glycemic control. In the placebo-controlled, double-blind,
28-day study, LX4211 reduced the total daily mealtime bolus insulin
dose by 32% compared to 6% for placebo (p=0.007), while
significantly improving glycemic control with a mean HbA1c
reduction of 0.55% in the LX4211-treated group compared to a
reduction of only 0.06% with placebo (p=0.002). These results were
accompanied by significant improvement in the time spent in a
target glucose range of 70-180 mg/dl, a significant reduction in
time in hyperglycemic range, and no increase in hypoglycemia.
Multiple measures indicated that LX4211 treatment resulted in
reduced variability in blood glucose levels. Overall, LX4211 was
well tolerated with no discontinuations of study medication due to
adverse events. Lexicon plans to meet with the FDA to discuss the
potential advancement of LX4211 into Phase 3 development for type 1
diabetes.
- Telotristat etiprate (LX1032): Lexicon made significant
progress in the enrollment of carcinoid syndrome patients in a
pivotal Phase 3 clinical trial of telotristat etiprate, an
inhibitor of tryptophan hydroxylase (TPH) that reduces peripheral
serotonin production without affecting brain serotonin levels.
Based on the current pace, Lexicon anticipates completing
enrollment in the pivotal TELESTAR study by the end of 2014.
Financial Results
Revenues: Lexicon's revenues for the three months
ended March 31, 2014 decreased 23
percent to $0.3 million from
$0.4 million for the corresponding
period in 2013, primarily due to lower revenues from Lexicon's
alliance with Taconic Farms.
Research and Development Expenses: Research and
development expenses for the three months ended March 31, 2014 increased 18 percent to
$24.0 million from $20.3 million for the corresponding period
in 2013, primarily due to increases in external clinical research
and development costs, as well as severance costs as a result of
the restructuring announced in January
2014 as Lexicon focuses its resources on late-stage drug
development.
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.
For the three months ended March 31,
2014, the fair value of the Symphony Icon purchase liability
increased by $1.1 million as compared
to an increase of $1.3 million in the
corresponding period in 2013.
General and Administrative Expenses: General and
administrative expenses for the three months ended March 31, 2014 increased 31 percent to
$5.7 million from $4.3 million for the corresponding period in
2013, primarily due to severance costs as a result of the
restructuring announced in January
2014.
Consolidated Net Loss: Net loss for the three
months ended March 31, 2014 was
$30.8 million, or $0.06 per share, compared to a net loss of
$26.0 million, or $0.05 per share, in the corresponding period in
2013. For the three months ended March 31,
2014 and 2013, net loss included non-cash, stock-based
compensation expense of $2.3 million
and $2.1 million, respectively.
Cash and Investments: As of March 31, 2014, Lexicon had $98.4 million in cash and investments, as
compared to $129.1 million in cash
and investments as of December 31,
2013.
Lexicon Conference Call
Lexicon management will hold a
conference call to discuss its clinical development progress and
financial results for the first quarter of 2014 at 11:00 a.m. Eastern Time on May 8, 2014. The dial-in number for the
conference call is 888-645-5785 (within the US/Canada) or 970-300-1531 (international).
The conference ID for all callers is 37713663. Investors can
access a live webcast of the call at www.lexpharma.com. An
archived version of the webcast will be available on the website
through June 8, 2014.
About Lexicon
Lexicon is a biopharmaceutical company
focused on developing breakthrough treatments for human
disease. Lexicon has clinical-stage drug programs for
diabetes, carcinoid syndrome, and other indications, 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. 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 LX4211 and telotristat etiprate
(LX1032), including characterizations of the results of and
projected timing of clinical trials of such compounds, and the
potential therapeutic and commercial potential of LX4211 and
telotristat etiprate (LX1032). In addition, 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 LX4211 and telotristat etiprate
(LX1032) and preclinical and clinical development of its other
potential drug candidates, 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. 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, 2013, 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)
|
|
2014
|
|
2013
|
|
|
(unaudited)
|
Revenues:
|
|
|
|
|
Collaborative research
|
|
$
172
|
|
$
284
|
Subscription and license fees
|
|
105
|
|
76
|
Total revenues
|
|
277
|
|
360
|
Operating
expenses:
|
|
|
|
|
Research and
development, including stock-based compensation
of $1,458 and $1,330,
respectively
|
|
23,953
|
|
20,327
|
Increase in fair
value of Symphony Icon, Inc. purchase liability
|
|
1,142
|
|
1,264
|
General and
administrative, including stock-based compensation
of $792 and $779,
respectively
|
|
5,654
|
|
4,324
|
Total operating expenses
|
|
30,749
|
|
25,915
|
Loss from
operations
|
|
(30,472)
|
|
(25,555)
|
Interest
income
|
|
8
|
|
53
|
Interest
expense
|
|
(457)
|
|
(506)
|
Other income,
net
|
|
86
|
|
34
|
Consolidated net
loss
|
|
$
(30,835)
|
|
$
(25,974)
|
|
|
|
|
|
Consolidated net loss
per common share, basic and diluted
|
|
$
(0.06)
|
|
$
(0.05)
|
|
|
|
|
|
Shares used in
computing consolidated net loss per common share, basic
and
diluted
|
|
513,955
|
|
512,428
|
|
|
|
Consolidated
Balance Sheet Data
|
As of March
31,
|
|
As of December
31,
|
(In
thousands)
|
2014
|
|
2013
|
|
(unaudited)
|
|
|
Cash and
investments
|
$
98,367
|
|
$
129,128
|
Property and
equipment, net
|
39,959
|
|
41,362
|
Goodwill
|
44,543
|
|
44,543
|
Other intangible
assets
|
53,557
|
|
53,557
|
Total
assets
|
243,600
|
|
274,160
|
Deferred
revenue
|
13,582
|
|
13,600
|
Current and long-term
debt
|
21,457
|
|
21,877
|
Other long-term
liabilities
|
34,017
|
|
32,386
|
Accumulated
deficit
|
(1,034,793)
|
|
(1,003,959)
|
Total stockholders'
equity
|
140,775
|
|
170,163
|
SOURCE Lexicon Pharmaceuticals, Inc.