Recent Events:
- Results from the Phase 2a MB07803 clinical trial showing
significant reductions of fasting plasma glucose in patients
with type 2 diabetes were presented at The World Congress on
Controversies to Consensus in Diabetes, Obesity and
Hypertension
- Clinical trial was initiated to evaluate the safety of higher
doses of MB07803 in patients with type 2 diabetes
- Additional data from the successful Phase 1b clinical trial
for MB07811 demonstrated reductions in ApoB and Lp(a) in a
dose-dependent manner in addition to the previously reported
reduction in LDL cholesterol and triglycerides
- The Company is preparing to initiate a 12-week Phase 2a
clinical trial for MB07811 in patients after the first of the
year
- Collaboration was formed with Roche to develop compounds for
HCV using Metabasis' proprietary liver-targeting technology
- Restructuring of operations was announced, resulting in
reduction in work force of 35 employees and closing of Ann
Arbor facility to align resources with modified strategic
objectives and reduce costs
SAN DIEGO--(BUSINESS WIRE)--Nov. 12, 2008--Metabasis Therapeutics,
Inc. (Nasdaq: MBRX), announced today its financial results for the
third quarter ended September 30, 2008 and commented on third quarter
results and recent company events and accomplishments.
Financial Results:
Revenue was $1.4 million for the third quarter of 2008, down from
$2.7 million for the third quarter of 2007. The $1.3 million decrease
in the third quarter of 2008 was a result of lower license fee and
sponsored research revenue due to the completion of the research
portion of the Company's collaboration with Idenix, and lower
recognized license fee revenue as a result of the extension of the
Merck AMPK collaboration agreement and corresponding period over which
the revenue was recognized. These decreases were partially offset by
license fee and sponsored research revenue recognized in connection
with the Roche collaboration established in August 2008. Revenue was
$3.0 million for the nine months ended September 30, 2008, compared
with $7.7 million for the nine months ended September 30, 2007. The
$4.7 million decrease was mainly due to the completion of the Idenix
collaboration described above and the termination of the Company's
former collaboration arrangement with Schering Corporation, partially
offset by license fee and sponsored research revenue related to the
Roche collaboration.
Research and development expenses were $8.5 million for the third
quarter of 2008, compared with $10.9 million for the third quarter of
2007. Research and development expenses were $27.9 million for the
nine months ended September 30, 2008, compared with $31.4 million for
the nine months ended September 30, 2007. The decreases for the
quarter and the nine-month period compared with the prior year periods
were mainly due to a decrease in clinical and development expenses for
the MB07803, MB07811 and MB07133 programs, partially offset by
increases in personnel related costs, depreciation and occupancy
costs.
General and administrative expenses were relatively unchanged at
$2.7 million for the third quarter of 2008, compared with $2.8 million
for the third quarter of 2007. General and administrative expenses
were $7.7 million for the nine months ended September 30, 2008,
compared with $9.3 million for the nine months ended September 30,
2007. The $1.6 million decrease for the nine-month period compared
with the prior year period was mainly due to a decrease in
depreciation, occupancy costs and non-cash stock-based compensation.
Net loss for the third quarter of 2008 was $9.8 million or $0.28
per share compared to a net loss of $10.5 million or $0.34 per share
in the third quarter of 2007. Net loss for the nine months ended
September 30, 2008 was $32.5 million or $0.97 per share compared to a
net loss of $30.9 million or $1.01 per share for the prior year
period.
As of September 30, 2008, Metabasis had $32.8 million in cash,
cash equivalents and securities available-for-sale compared to $42.4
million as of December 31, 2007. The decrease is primarily
attributable to the use of cash to fund ongoing operations, net of
proceeds from the warrant exchange and concurrent private placement
completed in April 2008, the venture debt transaction completed in
March 2008 and up-front fees received from the newly established
collaboration with Roche.
Recent Company Highlights
- Results Presented on Phase 2a Clinical Trial for MB07803
The results of the Phase 2a clinical trial for MB07803 were
presented by Alan J. Garber, M.D., Ph.D., at The World Congress on
Controversies to Consensus in Diabetes, Obesity and Hypertension
(CODHy) held in Barcelona. Dr. Garber serves as Professor in the
Departments of Medicine, Biochemistry and Molecular Biology, and
Molecular and Cellular Biology, at Baylor College of Medicine in
Houston, Texas. MB07803 is Metabasis' FBPase inhibitor product
candidate for the treatment of type 2 diabetes. As previously
reported, the primary efficacy endpoint of the clinical trial was
achieved with administration of MB07803 once daily. As further
reported in the presentation at CODHy, administration of MB07803 at
200 mg resulted in a statistically significant and clinically
meaningful placebo-adjusted reduction in fasting plasma glucose (FPG)
of -28.9 mg/dL from baseline at day 28 (p=0.0177). In the subgroup of
patients with starting FPG over 180 mg/dL in the 200 mg dosing arm,
the placebo-adjusted reduction in FPG from baseline was -49.7 mg/dL
(p=0.0099) at day 28. MB07803 was safe and well tolerated in this
clinical trial. The overall adverse event profile was similar to that
of the placebo. No patients experienced an adverse event related to
hyperlacticemia based on pre-specified criteria of two consecutive
measures of fasting plasma lactate levels greater than 4.5 mM. No
cases of lactic acidosis occurred and there were no significant
gastrointestinal adverse events or drug-related hypoglycemia.
- Dosing Trial for MB07803 Initiated
Based on experience with this drug class, the Company believes
that a modest increase in drug exposure relative to that achieved in
the Phase 2a clinical trial may result in even greater glucose
lowering. To explore this possibility, the Company initiated a
clinical trial designed to evaluate the safety of MB07803 administered
to patients for 14 days at doses expected to result in higher drug
exposures. This clinical trial is expected to enroll at least 40
patients and to be completed early next year. The results will be used
to support dose selection for future clinical trials, including the
Phase 2b clinical trial that the Company plans to conduct in
collaboration with a partner.
- Additional Data Reported from the Phase 1b Clinical Trial for
MB07811
Earlier this year, the Company announced initial results of its
14-day, Phase 1b multiple-dose clinical trial in subjects with mild
hypercholesterolemia, which showed that over 14 days, MB07811 was safe
and well tolerated in this trial across the seven doses tested,
ranging from 0.25 mg up to 40 mg per day. In addition, dose-related
reductions in fasting low-density lipoprotein cholesterol (LDL-C) and
fasting triglyceride (TG) levels at day 15 were reported. Since that
initial announcement, continued evaluation of the clinical trial
results have provided evidence that MB07811 treatment resulted in
statistically significant reductions in two other measures of
atherosclerotic risk. The results showed placebo-adjusted
dose-dependent reductions in ApoB of 9-40% and lipoprotein (a) (Lp(a))
of 28-56% at doses of 2.5 mg and above. Metabasis plans to initiate a
12-week Phase 2a clinical trial of MB07811 in patients early next
year.
- Company Restructures Operations and Implements a Reduction in
Force
Metabasis also announced today a restructuring of operations that
will result in a reduction of 35 employees, which represents
approximately 30% of its total workforce, and the closing of the
satellite facility in Ann Arbor, Michigan. The restructuring is a
result of a strategic realignment to preserve cash and reduce ongoing
general and administrative and research and development operating
expenses with more reliance on third party providers to allow greater
flexibility in controlling costs. The Company anticipates incurring
restructuring charges of approximately $1.7 million, primarily
associated with personnel-related termination costs. The majority of
these costs will be recognized during the fourth quarter of 2008. The
main goals of the Company's strategic plan remain unchanged including
the further clinical evaluation of its core assets, MB07811 and
MB07803, with a focus on achieving key clinical milestones, continuing
its efforts in other research programs and pursuing its business
development initiatives as a means of accelerating and funding these
operating activities. In addition, the Company may pursue partnering
opportunities on certain programs at an earlier stage of development
than originally planned under the strategic plan. As a result of the
restructuring, Dr. Howard Foyt, vice president, clinical development
and Constance Bienfait, vice president, investor relations and
corporate communications will leave Metabasis to pursue other
opportunities, and Dr. Barry Gumbiner will be promoted to vice
president, clinical development and chief medical officer.
"We made progress on our clinical and preclinical programs for
metabolic disorders this quarter," commented Dr. Paul Laikind,
president and chief executive officer. "We were delighted to have Dr.
Garber present the results from our Phase 2a clinical trial for
MB07803, showing it to be safe and well tolerated in this trial while
providing an impressive reduction in fasting plasma glucose levels,
including in patients with more established disease. Moreover, we
believe that greater glucose lowering may be achieved at higher doses,
and we are now evaluating the safety of higher exposure levels in
patients. With regard to our novel product candidate for
hyperlipidemia, MB07811, significant dose-dependent reductions in both
ApoB and the atherosclerotic risk factor Lp(a) were seen in the Phase
1b clinical trial, along with the significant, dose-related reductions
in LDL-C and TGs we reported earlier. A lipid lowering profile that
includes significant reductions in LDL-C, TGs and Lp(a) could provide
physicians with an important new approach for controlling disease in
patients at risk for cardiovascular events, should MB07811 be
approved. We are preparing to initiate a 12-week Phase 2a clinical
trial for MB07811 and expect to enroll the first patients early next
year.
"We are also continuing our efforts on the partnering front, an
important element of our strategy to further develop our product
candidates and bolster our balance sheet, which is especially
important in these difficult capital market conditions. In August, we
were pleased to announce an agreement under which we are collaborating
with Roche in an effort to discover a new treatment for HCV by
applying our HepDirect(R) liver-targeting technology to certain Roche
compounds. Importantly, we are in discussions with companies regarding
strategic collaborations for certain of our other assets and hope to
have additional progress in this area to report by the end of this
year.
"Our excitement about our continued progress with our pipeline and
business development is tempered by today's announcement of our
restructuring and reduction in force. This action is a very difficult
and disappointing necessity given the challenging financial
environment under which we are operating. As a result, we have
adjusted our strategic objectives including outsourcing certain
components of our projects to third parties. It is important to note
that we remain committed to continued development of MB07803 and
MB07811 and will continue our efforts to discover and recommend for
development important new therapies either independently or with
current and future partners. In fact, notwithstanding the reduction in
force, we expect to reach value-driving milestones on both core
clinical programs, and expect to recommend several new compounds for
clinical development over the next 18 months. Our goal is to combine
the cost savings from the restructuring, current cash, and proceeds
from potential milestones from our current partnerships with one or
more additional partnerships to support operations through next year
without reliance on the equity markets. In the event that we fail to
receive any of the expected milestone payments and/or are unsuccessful
with our current business development efforts, our current resources
would allow us to operate until around the middle of 2009."
Conference Call:
The Metabasis management team will host a conference call and live
webcast to discuss third quarter 2008 financial results at 5:30 a.m.
Pacific Time (8:30 a.m. Eastern Time) tomorrow, November 13, 2008.
Individuals interested in participating in the call may do so by
dialing 866-356-3093 for domestic callers and 617-597-5381 for
international callers. Please specify to the operator "Metabasis" when
asked for a passcode. The conference call will be webcast live on the
Metabasis website at www.mbasis.com, under the Investors section, and
will be archived there for 30 days following the call. Please connect
to Metabasis' website several minutes prior to the start of the call
to ensure adequate time for any necessary software download.
About Metabasis (www.mbasis.com):
Metabasis is a biopharmaceutical company using its proprietary
technologies, scientific expertise and unique capabilities for
targeting the liver and liver pathways to develop novel therapies to
treat metabolic and other diseases. The Company has established a
broad pipeline of product candidates and advanced research programs
targeting large markets with significant unmet needs. Metabasis' core
area of focus is on the discovery and development of product
candidates to treat metabolic diseases such as hyperlipidemia and
diabetes, among others. Although not a core focus of the Company,
Metabasis has also discovered and is developing product candidates
indicated for the treatment of liver diseases such as hepatitis and
primary liver cancer, which it now intends to license or sell. All
product candidates have been developed internally using proprietary
technologies.
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 Metabasis' progress on
its strategic goals and pursuit of its corporate objectives; the
completion and results of clinical trials for MB07803 and MB07811 and
timelines and expectations for additional clinical trials of those
product candidates; the potential efficacy and benefits of, and the
potential market for, Metabasis' product candidates; the status of
ongoing and future partnering activities including the newly
established collaboration with Roche and collaborations being sought
for other programs and product candidates; 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 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 obtain additional financing to support its
operations; ability to generate financing through partnerships;
maintaining compliance with Nasdaq Global Market continued listing
requirements and other factors discussed in the "Risk Factors" section
of Metabasis' Quarterly Report on Form 10-Q for the three months ended
September 30, 2008 and in Metabasis' other filings with the Securities
and Exchange Commission. All forward-looking statements are qualified
in their entirety by this cautionary statement. Metabasis is providing
this information as of the 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.
Metabasis Therapeutics, Inc.
Condensed Balance Sheets
(in thousands)
September 30, December 31,
2008 2007
------------- ------------
(unaudited)
Assets:
Current assets:
Cash and securities available-for-sale $32,782 $42,438
Other current assets 1,369 1,157
------------- ------------
Total current assets 34,151 43,595
Property and equipment, net 5,285 6,356
Other assets 297 172
------------- ------------
Total assets $39,733 $50,123
============= ============
Liabilities and stockholders' equity:
Current liabilities:
Accounts payable and accrued liabilities $ 2,804 $ 4,934
Other current liabilities 12,482 6,593
------------- ------------
Total current liabilities 15,286 11,527
Long-term liabilities 12,289 6,495
Stockholders' equity 12,158 32,101
------------- ------------
Total liabilities and stockholders' equity $39,733 $50,123
============= ============
Metabasis Therapeutics, Inc.
Condensed Statements of Operations
(unaudited, in thousands, except per share amounts)
Three Months Ended Nine Months Ended
September 30, September 30,
------------------ -------------------
2008 2007 2008 2007
-------- --------- --------- ---------
Revenues:
Sponsored research $ 659 $ 937 $ 1,698 $ 2,813
License fees 743 1,417 1,333 4,550
Other revenue - 299 - 320
-------- --------- --------- ---------
Total revenues 1,402 2,653 3,031 7,683
Operating expenses:
Research and development 8,480 10,866 27,892 31,437
General and administrative 2,659 2,834 7,747 9,284
-------- --------- --------- ---------
Total operating expenses 11,139 13,700 35,639 40,721
-------- --------- --------- ---------
Loss from operations (9,737) (11,047) (32,608) (33,038)
Total interest income, net (97) 567 132 2,117
-------- --------- --------- ---------
Net loss $(9,834) $(10,480) $(32,476) $(30,921)
======== ========= ========= =========
Basic and diluted net loss per
share $ (0.28) $ (0.34) $ (0.97) $ (1.01)
======== ========= ========= =========
Shares used to compute basic
and diluted net loss per share 35,042 30,650 33,354 30,552
======== ========= ========= =========
CONTACT: Metabasis Therapeutics, Inc.
Constance C. Bienfait
Vice President
Investor Relations & Corporate Communications
858-622-5575
SOURCE: Metabasis Therapeutics, Inc.