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. scorreia@alseres.com Adam Friedman - 212-981-2529 ext. 18 Adam Friedman Associates adam@adam-friedman.com http://www.alseres.com/

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