Business News
Alseres Pharmaceuticals, Inc. Reports Second Quarter 2008 Operational and Financial Results
2008-08-13 15:25:00
Conference Call To Be Held Thursday, August 14, 2008 at 9:00 a.m. Eastern
Time
HOPKINTON, Mass., Aug. 13 /EMWNews/ -- Alseres
Pharmaceuticals, Inc. (Nasdaq: ALSE) today reports operational and
financial results for the quarter ended June 30, 2008 and provides further
information for fiscal year 2008.
"Alseres made solid progress in our programs during the second
quarter," commented Peter Savas, Chairman and Chief Executive Officer of
Alseres. "To strengthen our molecular imaging efforts we have added the
expertise of Dr. Thomas Tulip, previously with Lantheus Medical Imaging,
Inc. (formerly Bristol Myers Squibb Medical Imaging). Enrollment continues
to increase for the first phase of the Altropane POET-2 program. Recently,
Lundbeck's partner Teva Pharmaceutical Industries, Ltd. announced the
successful completion of ADAGIO, the phase III trial designed to
demonstrate that Azilect(R) can slow the progression of Parkinson's
disease. We believe that disease modifying drugs have the potential to
significantly increase the use of Altropane if approved. We believe all of
this has resulted in heightened interest from prospective partners in the
potential for Altropane to provide fundamental changes in clinical outcomes
for the 11 million Americans living with tremor disorders that are today
misdiagnosed up to 35-50% of the time. We also anticipate the initiation of
the streamlined Phase IIb trial of Cethrin. We believe that, if successful,
this trial will provide us with evidence that Cethrin is more effective
than a placebo in treating acute spinal cord injury."
Recent Corporate Highlights
-- Our preliminary planning for the Phase IIb trial of Cethrin called
for us to enroll up to 100 subjects in 80 sites worldwide. Ongoing inputs,
including the results to date in the Phase I/IIa trial, discussions with
the regulatory authorities and our expert advisors, now indicate that a
placebo-controlled trial to demonstrate the potential efficacy of Cethrin
can be accomplished with fewer patients and sites, and provide us with
results from the trial approximately a year earlier. We are now planning to
initiate a randomized, double-blind, placebo-controlled, Phase IIb trial in
subjects with acute cervical spinal cord injury (SCI) in the first quarter
of 2009 at sites across North America.
-- Thomas H. Tulip, PhD has joined the Company to lead our molecular
imaging business. Dr. Tulip has over 25 years of experience in the medical
imaging industry and comes to us from Lantheus. Thom will focus on ensuring
that the POET-2 program and the NDA submission for Altropane are completed.
He will also support our partnering efforts and prepare Altropane for
commercialization.
-- The first part of the POET-2 Phase III clinical program for
Altropane began enrollment in December 2007. Enrollment of up to 80
subjects to generate the set of Altropane training images is planned. These
images will be used to train the expert readers, as is customary for
clinical trials of molecular imaging agents. With all trial sites now
enrolling, we are noting increased subject recruitment and expect that we
will complete enrollment early in 2009.
-- In June 2008, the Company entered into a convertible promissory note
purchase agreement with Robert Gipson pursuant to which the Company could
borrow up to $5,000,000. In June 2008, the Company issued a convertible
promissory note in the aggregate principal amount of $5,000,000 to Robert
Gipson.
Financial Highlights of the Second Quarter 2008
-- Cash, cash equivalents and marketable securities at June 30, 2008
totaled $5.4 million as compared to $4.2 million at December 31, 2007.
Convertible notes payable totaled $33.2 million at June 30, 2008 as
compared to $23.3 million at December 31, 2007.
-- Net loss attributable to common stockholders was $6.1 million, or
$0.29 per share, for the second quarter of 2008, as compared to $5.3
million, or $0.30 per share, in the second quarter of 2007.
-- Research and development (R&D) expenses totaled $3.6 million in the
second quarter of 2008 as compared to $2.7 million in the second quarter of
2007. The increase in R&D expenses was primarily due to higher Cethrin
clinical costs offset by lower compensation and related costs.
-- General and administrative (G&A) expenses totaled $2.0 million for
the second quarter of 2008 as compared to $2.5 million in the second
quarter of 2007. The decrease in G&A expenses was primarily related to
lower costs related to our collaboration and fundraising efforts.
Alseres Pharmaceuticals Upcoming Milestones
-- The Company is currently identifying and finalizing contracts with
appropriate sites and investigators for the Phase IIb Cethrin study
expected to commence in the first quarter of 2009.
-- Twelve month interim data for the Phase I/IIa clinical trial of
Cethrin will be presented at two upcoming medical/scientific meetings:
Force Health Protection, August 11-15, 2008, Albuquerque, NM and the
International Spinal Cord Society (ISCoS) Annual Meeting, September 1-4,
2008, Durban, South Africa. Preclinical data on Rho inhibitors in bone
regeneration will be presented at the Australian and New Zealand Bone and
Mineral Society Annual Meeting, August 28-30, 2008, Melbourne, Australia.
-- We will continue enrollment in the first part of the POET-2 Phase
III clinical trial for our Altropane molecular imaging agent.
-- We are pursuing development and commercialization partnerships for
our molecular imaging, nerve repair and regenerative therapy assets. We
expect to continue confidential discussions with franchise leaders
interested in our molecular imaging and regenerative therapeutic pipelines.
We expect to advance discussions toward partnerships and scientific
collaborations over the course of the year.
Conference Call Access Information
The company will host a conference call to discuss results on August
14, 2008, at 9:00 a.m. Eastern Daylight Time. To access the conference
call, please dial 877-879-6201 for domestic and 719-325-4816 for
international calls. The code for this conference call is 4315502. Please
dial in 5 to 10 minutes prior to the scheduled start time. A replay of the
call will be posted on the Investor Relations section of our website,
http://www.alseres.com, within 48 hours following the conference call and will be
available through Thursday, August 28, 2008.
About Alseres Pharmaceuticals, Inc.
Alseres Pharmaceuticals, Inc. (ALSE) is engaged in the development of
therapeutic and diagnostic products primarily for disorders in the central
nervous system (CNS). The Company maintains a world-class intellectual
property position in the field of regenerative therapeutics. The Company's
energy and focus is reflected in several important initiatives. Cethrin, a
recombinant-protein-based drug designed to promote nerve repair after acute
spinal cord injury, demonstrated positive interim results in a Phase I/IIa
clinical trial. The Company's research and pre-clinical programs include,
Inosine for the treatment of spinal cord injury and stroke, Oncomodulin for
the treatment of ocular injury and disease and research programs directed
at a number of regenerative therapies including bone repair. The Company
has a robust molecular imaging development program targeting diagnosis of
Parkinson's disease and potentially dementia. The Company's lead molecular
imaging product candidate is Altropane which is in Phase III clinical
trials for the diagnosis of Parkinsonian Syndromes including Parkinson's
Disease. The Company has research collaborations with Harvard Medical
School and Children's Hospital Boston.
Forward-Looking Statements
The foregoing release contains certain forward-looking statements
within the meaning of the Private Securities Litigation Reform Act of 1995.
Forward- looking statements include statements regarding Alseres' future
expectations, beliefs, intentions, goals, strategies, plans or prospects
regarding the future, including the development and commercialization of
Altropane and Cethrin, the prospects of the Company's CNS and regenerative
therapeutics programs, the Company's strategies to develop and
commercialize axon regeneration technologies and the breadth of the
Company's technologies and intellectual property portfolio. Forward-looking
statements can be identified by terminology such as "anticipate,"
"believe," "could," "could increase the likelihood," "estimate," "expect,"
"intend," "is planned," "may," "should," "will," "will enable," "would be
expected," "look forward," "may provide," "would" or similar terms,
variations of such terms or the negative of those terms. Such
forward-looking statements involve known and unknown risks, uncertainties
and other factors including those risks, uncertainties and factors referred
to in the Company's Quarterly Report on Form 10-Q for the quarter ended
March 31, 2008 filed with the Securities and Exchange Commission under the
section "Risk Factors," as well as other documents that may be filed by
Alseres from time to time with the Securities and Exchange Commission. As a
result of such risks, uncertainties and factors, the Company's actual
results may differ materially from any future results, performance or
achievements discussed in or implied by the forward-looking statements
contained herein. Alseres is providing the information in this press
release as of this date and assumes no obligations to update the
information in this press release.
Alseres, Cethrin and Altropane are registered trademarks of Alseres
Pharmaceuticals, Inc.
Contact:
Sharon Correia - 508-497-2360 ext. 224
Alseres Pharmaceuticals, Inc.
[email protected]
Adam Friedman - 212-981-2529 ext. 18
Adam Friedman Associates
[email protected]
http://www.alseres.com/
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