Metabasis Therapeutics, Inc. (Nasdaq: MBRX), a biopharmaceutical company
focused on innovative therapies for metabolic diseases including
hyperlipidemia and diabetes, today announced financial results for the
first quarter ended March 31, 2009.
“At the beginning of the first quarter, we established a new strategic
plan and as part of that plan we significantly reduced our workforce and
core operating expenses,” said Mark Erion, Ph.D., president, chief
executive officer and chief scientific officer. “We continue to execute
on that plan, which is focused on initiating and completing a 12-week
Phase 2a proof-of-concept trial on MB07811, our liver-targeted thyroid
receptor agonist for hyperlipidemia, and on establishing corporate
partnerships for our glucagon antagonist program and for MB07803, our
Phase 2 product candidate for type 2 diabetes that targets the enzyme
fructose-1,6-bisphosphatase. Both programs were advanced considerably
this quarter with the identification of a potential product candidate
for our glucagon antagonist program, MB11262, and the completion of a
clinical trial on MB07803 that highlighted the glucose lowering
potential of this mechanism. The results of this trial will be presented
at the upcoming American Diabetes Association Meeting now that our late
breaking abstract has been accepted.”
Dr. Erion further stated, “In order to successfully execute on our
strategic plan, we intend to raise capital in the second quarter in an
amount sufficient to fund our operations through the Phase 2a
proof-of-concept trial on MB07811. We also intend to establish one or
more strategic collaborations in the second half of 2009 as well as to
secure research milestones from our existing partnerships with Merck &
Co. and Roche.”
The net loss for the first quarter ended March 31, 2009 was $8.2
million, or $0.23 per share, compared to a net loss of $11.1 million, or
$0.36 per share, for the first quarter ended March 31, 2008. As of March
31, 2009, Metabasis had cash and cash equivalents totaling $11.8 million.
2009 First Quarter and Year to Date Highlights
MB07811 (hyperlipidemia)
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Four articles on MB07811 were published in peer-reviewed journals
covering the design of MB07811 and pre-clinical findings demonstrating
liver targeting, cholesterol lowering in combination with statins, and
reduction of liver fat in obese mice.
MB07803 (type 2 diabetes)
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A clinical trial in which MB07803 was administered twice-daily for 14
days to patients with poorly-controlled type 2 diabetes resulted in
dose-related, clinically meaningful and statistically significant
reductions in day long glycemia (24-hour weighted mean glucose levels)
at all doses evaluated (50 mg, 200 mg and 400 mg, twice-daily). In
addition, clinically and statistically significant reductions in
fasting plasma glucose (FPG) were observed at the two highest doses.
In this study, MB07803 was shown to be safe at all doses tested and
well tolerated up to 200 mg twice-daily. MB07803 is Metabasis’
second-generation product candidate from a new class of drugs that the
Company discovered internally for the treatment of type 2 diabetes.
MB07803 is designed to reduce glucose production in the liver by
inhibiting the enzyme fructose-1,6-bisphosphatase (FBPase). Excess
glucose production is believed to be a major contributor to the
elevated glucose levels found in patients with type 2 diabetes.
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Pre-clinical studies identified a difference between MB07803 and the
first generation FBPase inhibitor, CS-917, that may translate to an
improved safety profile for MB07803. The difference is related to a
metabolite found in humans at high levels following treatment with
CS-917. The metabolite was shown to inhibit mitochondrial function and
alter lactate metabolism at concentrations within the range of those
observed in humans. The metabolite may be a contributing factor in the
two cases of lactic acidosis observed during co-administration of
CS-917 and metformin in a previous clinical trial. MB07803 generates a
similar metabolite in humans but at 100-fold lower levels than CS-917,
and at concentrations not expected to affect mitochondrial function.
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A late-breaking abstract has been accepted for presentation at the
American Diabetes Association’s 69th Scientific Sessions in
New Orleans, LA in early June 2009. The abstract, entitled “Pronounced
Glucose Reduction In Poorly Controlled T2DM with MB07803, ”A Novel
Fructose-1,6-bisphosphatase Inhibitor (FBPaseI) with Reduced Potential
for Acid-Base Disturbances vs. the 1st Generation FBPaseI CS-917”,
will be presented in poster format in the Clinical Therapeutics/New
Technology-Pharmacologic Treatment of Diabetes or its Complications
category.
2009 First Quarter Financial Results
Revenues for the first quarter ended March 31, 2009 were $1.9 million
compared to $0.9 million for the same period in 2008. The $1.0 million
increase in revenues for the first quarter ended March 31, 2009 as
compared to the same period in 2008 was mainly due to $1.5 million in
license fee and sponsored research revenues related to the HCV
collaboration with Roche entered into in August 2008 offset by a
decrease in license fee and sponsored research revenues related to the
AMPK collaboration with Merck & Co.
Research and development expenses for the first quarter ended March 31,
2009 were $7.4 million compared to $9.7 million for the same period in
2008. The $2.3 million decrease in research and development expenses for
the first quarter ended March 31, 2009 as compared to the same period in
2008 was mainly due to a $2.3 million decrease in personnel related
costs due to lower headcount as well as a $1.3 million decrease in
clinical development costs for the MB07811, MB07803 and MB07133 programs
and a $0.4 million decrease in non-cash stock-based compensation and
depreciation, offset by $1.4 million in costs associated with corporate
restructuring efforts.
General and administrative expenses for each of the first quarters ended
March 31, 2009 and 2008 were $2.5 million. The increased costs
associated with the corporate restructuring efforts completed in the
first quarter of 2009 offset the decrease in personnel related costs due
to lower headcount in the first quarter of 2009 compared to the same
period in 2008, resulting in no change in overall general and
administrative expenses.
In January 2009, the Company initiated a corporate restructuring that
reduced its workforce by 43%, which followed the initiation of a
separate restructuring plan the Company announced in November 2008. The
two restructuring plans resulted in an approximate 60% reduction of its
workforce, or 73 employees. The Company incurred restructuring charges
in the first quarter of 2009 of $1.6 million primarily related to
one-time employee termination costs, including severance and other
benefits. Restructuring charges of $1.4 million and $0.2 million are
included in research and development and general and administrative
expenses, respectively, for the first quarter of 2009.
As of March 31, 2009, Metabasis had cash and cash equivalents of $11.8
million, compared to cash, cash equivalents and securities
available-for-sale of $21.6 million as of December 31, 2008. The
decrease of $9.8 million was primarily due to the use of cash for
operations. Cash and cash equivalents as of March 31, 2009 will be
sufficient to fund the Company’s operations into July 2009, under the
current strategic plan. The Company intends to raise additional capital
during the second quarter of 2009 through undertaking a financing of
sufficient size to provide the necessary resources to fund its
operations through the Phase 2 proof-of-concept clinical trial on
MB07811.
About Metabasis (www.mbasis.com):
Metabasis is a biopharmaceutical company committed to the discovery,
development and commercialization of novel drugs for metabolic diseases
using its proprietary technology and its knowledge of processes and
pathways within the liver that are useful for liver-selective drug
targeting and treatment of metabolic diseases. The Company has
established a broad pipeline of product candidates and advanced
discovery programs targeting large markets with significant unmet needs.
The Company’s product pipeline includes clinical-stage product
candidates and advanced discovery programs for the treatment of
metabolic diseases such as diabetes and hyperlipidemia, as well as
product candidates and advanced discovery programs for the treatment of
liver diseases such as hepatitis and primary liver cancer. All of the
Company’s product candidates were developed internally using its
proprietary technology and know-how.
Forward-Looking Statements:
Statements in this press release that are not strictly historical in
nature constitute "forward-looking statements." Such statements include,
but are not limited to, references to the objectives of Metabasis’ new
strategic plan; the timing and results of Metabasis’ anticipated
clinical trials; Metabasis’ ability to raise additional funds through
establishing additional strategic partnerships or the potential sale of
equity and other funding sources; anticipated milestone payments
pursuant to existing strategic partnerships; Metabasis’ product
pipeline, capabilities and long term goals; the status of on-going and
future partnering activities, and the impact of the reorganization and
reduction in force, including the Company’s ability to reach milestones
and recommend compounds for clinical development notwithstanding the
reduction in force. Such forward-looking statements involve known and
unknown risks, uncertainties and other factors which may cause
Metabasis' actual results to be materially different from historical
results or from any results expressed or implied by such forward-looking
statements. These factors include, but are not limited to, risks and
uncertainties related to Metabasis' ability to obtain additional
financing to support its operations; the progress and timing of clinical
trials for Metabasis' product candidates; the fact that positive results
from preclinical studies and early clinical trials does not necessarily
mean later clinical trials will succeed; difficulties or delays in
development, testing, obtaining regulatory approval, producing and
marketing Metabasis' product candidates; serious adverse side effects or
inadequate efficacy of, or serious adverse events related to, Metabasis'
product candidates or proprietary technologies; the risk that Metabasis
will not be able to build more value or retain rights for direct
commercialization of its product candidates; Metabasis' dependence on
its licensees and collaborators for the clinical development and
registration of, as well as information relating to, certain of its
product candidates; potential conflicts with collaborators that could
delay or prevent the development or commercialization of Metabasis'
product candidates; the scope and validity of intellectual property
protection for Metabasis' product candidates, proprietary technologies
and their uses; competition from other pharmaceutical or biotechnology
companies; Metabasis’ ability to generate financing through
partnerships; Metabasis’ ability to maintain compliance with Nasdaq
Capital Market continued listing requirements; and other factors
discussed in the "Risk Factors" section of Metabasis' Annual Report on
Form 10-K for the fiscal year ended December 31, 2008. All
forward-looking statements are qualified in their entirety by this
cautionary statement. Metabasis is providing this information as of this
date of this release and does not undertake any obligation to update any
forward-looking statements contained in this release as a result of new
information, future events or otherwise.
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Metabasis Therapeutics, Inc.
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Condensed Balance Sheets
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(in thousands)
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March 31,
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December 31,
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2009
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2008
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(unaudited)
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Assets:
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Current assets:
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Cash and securities available-for-sale
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$
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11,768
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$
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21,599
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Other current assets
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1,018
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1,091
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Total current assets
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12,786
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22,690
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Property and equipment, net
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4,052
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4,779
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Other assets
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249
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273
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Total assets
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$
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17,087
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$
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27,742
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Liabilities and stockholders' equity:
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Current liabilities:
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Accounts payable and accrued liabilities
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$
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3,793
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$
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4,330
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Other current liabilities
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12,638
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9,568
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Total current liabilities
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16,431
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13,898
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Long-term liabilities
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4,655
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10,463
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Stockholders' (deficit) equity
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(3,999
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)
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3,381
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Total liabilities and stockholders' equity
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$
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17,087
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$
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27,742
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Metabasis Therapeutics, Inc.
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Condensed Statements of Operations
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(unaudited, in thousands, except per share amounts)
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Three Months Ended
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March 31,
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2009
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2008
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Revenues:
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License fees
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$
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1,089
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$
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417
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Sponsored research
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800
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525
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Total revenues
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1,889
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942
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Operating expenses:
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Research and development
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7,416
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9,745
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General and administrative
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2,523
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2,519
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Total operating expenses
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9,939
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12,264
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Loss from operations
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(8,050
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)
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(11,322
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)
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Total interest (expense) income, net
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(191
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)
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222
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Net loss
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$
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(8,241
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$
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(11,100
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)
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Basic and diluted net loss per share
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$
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(0.23
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)
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$
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(0.36
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)
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Shares used to compute basic and
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diluted net loss per share
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35,152
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30,758
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Metabasis Therapeutics, Inc.
Investor Relations & Corporate
Communications
858-622-2223