THE WOODLANDS, Texas--(BUSINESS WIRE)--Aug 14, 2007 - Opexa Therapeutics, Inc. (NASDAQ:OPXA), a company involved in the development and commercialization of cell therapies, today reported financial results for the quarter ended June 30, 2007 and provided an update on its progress.
Highlights of the second quarter of 2007 and recent weeks include:
-- Positive top-line data from Phase I/II extension trial with Tovaxin(R) for multiple sclerosis
-- Completion of patient enrollment in Phase IIb trial with Tovaxin for multiple sclerosis
-- Opexa delivers two scientific presentations on progress of development of monocyte-derived pancreatic islet cells for diabetes
-- Appoints clinical advisory board to support diabetes program
David McWilliams, chief executive officer of Opexa, commented, "We reached several important milestones during the quarter as we continued to advance the development of our technologies. In the case of Tovaxin, our lead program for the treatment of multiple sclerosis, we completed patient enrollment in a 150-patient Phase IIb safety and efficacy study. The trial design is a U.S. multicenter, randomized, double-blind, placebo-controlled study of subcutaneous Tovaxin in subjects with Clinically Isolated Syndrome (CIS) or Relapsing/Remitting Multiple Sclerosis (RRMS). We expect top-line data from this trial to be available in the second half 2008. We also announced positive top-line data in an open-label Phase I/II extension clinical trial of Tovaxin. In this one-year, eight-subject extension clinical trial of relapsing remitting (RRMS) and secondary progressive (SPMS) subjects, Tovaxin therapy was shown to be safe and effective, experiencing a greater than 90% reduction in annualized relapse rate.
"We have also made excellent progress with our stem cell program, particularly in the area of diabetes," Mr. McWilliams continued. In June, we made two very important presentations to two separate stem cell conferences, which covered our recent research derived from our innovative adult stem cell program regarding the development of adult monocyte-derived islets, as beta-cell replacement therapy for diabetes mellitus. We are very encouraged by the preclinical data we are assembling and during the quarter appointed a clinical advisory board specifically to help us advance our diabetes program."
Second Quarter Financial Results
Opexa reported no revenues for the three months ended June 30, 2007 or in the comparable prior-year period. General and administrative expenses were $865,744 in the second quarter of 2007, compared with $3,169,832 in the second quarter of 2006. The decline is primarily due to a decrease in stock compensation expense, professional service fees and overhead expenses. The Company expects future general and administrative expenses to be higher as it prepares for commercialization of its products.
Research and development expenses were $3,712,208 in the 2007 second quarter, compared with $1,554,912 in the second quarter of 2006. The increase primarily was related to the costs of the Phase IIb clinical trial for Tovaxin, research and development in support of pre-clinical diabetes stem cell therapies and stock compensation expense recorded in 2007.
Opexa reported a net loss for the second quarter of 2007 of $4,906,076, or $0.73 per share, compared with a net loss for the second quarter of 2006 of $8,475,868 or $1.40 per share. The decrease in net loss primarily was due to a reduction in stock-based compensation expense and loss on derivative instruments, offset in part by the increase in costs of the Phase IIb trial for Tovaxin.
The Company had cash and cash equivalents of $8,918,101 as of June 30, 2007, compared with $12,019,914 million as of December 31, 2006.
Year-to-Date Financial Results
Opexa reported no revenues in the six months ended June 30, 2007 or in the comparable prior-year period. General and administrative expenses for the six months ended June 30, 2007 were $1,715,530, compared to $4,245,714 for the six months ended June 30, 2006. The decrease in G&A expenses was primarily due to a decrease in stock compensation expense, professional service fees and overhead expenses. The Company anticipates increases in general and administrative expenses as it continues to develop and prepare for commercialization of its technology.
Research and development expenses were $6,959,674 for the six months ended June 30, 2007, compared to $2,293,362 for the six months ended June 30, 2006. The increase in R&D expenses was primarily due to the costs of conducting the Phase IIb clinical trial for Tovaxin, research and development in support of pre-clinical diabetes stem cell therapies and stock compensation expense recorded in 2007.
Opexa reported a net loss for the six months ended June 30, 2007 of $9,288,064 or ($1.39) per share, compared with a net loss for the six months ended June 30, 2006 of $10,446,178, or ($2.57) per share. The decrease in net loss was primarily due to a reduction in stock-based compensation expense and loss on derivative instruments, offset in part by the increase in costs of the Phase IIb trial for Tovaxin.
About Opexa Therapeutics
Opexa Therapeutics develops and commercializes cell therapies to treat autoimmune diseases such as MS, rheumatoid arthritis, and diabetes. The Company is focused on autologous cellular therapy applications of its proprietary T-cell and stem cell therapies. The Company's lead product, Tovaxin, a T-cell therapy for multiple sclerosis is in Phase IIb trials. The Company holds the exclusive worldwide license for adult multipotent stem cells derived from mononuclear cells of peripheral blood. The technology allows large quantities of monocyte derived stem cells to be produced efficiently for use in autologous therapy, thus circumventing the threat of rejection. The Company is in preclinical development for diabetes mellitus.
Safe Harbor Statement
This press release contains "forward-looking statements," including statements about Opexa Therapeutics' 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. These 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 Opexa Therapeutics' ability to obtain additional funding, develop its stem cell technologies, achieve its operational objectives, and obtain patent protection for its discoveries, that may cause Opexa Therapeutics' actual results to be materially different from any future results expressed or implied by such forward-looking statements. Opexa Therapeutics undertakes no obligation to update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise.
(Tables to Follow) -0-
OPEXA THERAPEUTICS, INC.
(a development stage company)
STATEMENTS OF EXPENSES
Three and Six Months ended June 30, 2007 and 2006 and the
Period from January 22, 2003 (Inception) to June 30, 2007
(unaudited)
Three Months Three Months Six Months
Ended Ended Ended
June 30, June 30, June 30,
2007 2006 2007
------------ ------------ ------------
Research and development $ 3,712,208 $ 1,554,912 $ 6,959,674
General and administrative 865,744 3,169,832 1,715,530
Depreciation and amortization 462,370 460,442 923,476
Loss on disposal of assets 4,034 - 4,034
------------ ------------ ------------
Operating loss (5,044,356) (5,185,186) (9,602,714)
Interest income 141,971 198,785 320,794
Other income - 43,065 -
Loss on derivative liability - (3,532,348) -
Interest expense (3,691) (184) (6,144)
------------ ------------ ------------
Net loss $(4,906,076) $(8,475,868) $(9,288,064)
============ ============ ============
Basic and diluted loss per
share $ (0.73) $ (1.40) $ (1.39)
Weighted average shares
outstanding 6,696,784 6,039,561 6,696,784
Six Months Inception
Ended through
June 30, June 30,
2006 2007
------------- -------------
Research and development $ 2,293,362 $ 19,388,583
General and administrative 4,245,714 15,921,999
Depreciation and amortization 892,775 4,742,299
Loss on disposal of assets 362 486,343
------------- -------------
Operating loss (7,432,213) (40,539,224)
Interest income 218,406 1,097,015
Other income 46,450 77,003
Loss on derivative liability (3,278,208) -
Interest expense (613) (8,245,107)
------------- -------------
Net loss $(10,446,178) $(47,610,313)
============= =============
Basic and diluted loss per share $ (2.57) N/A
Weighted average shares outstanding 4,063,473 N/A
-0-
OPEXA THERAPEUTICS, INC.
(a development stage company)
BALANCE SHEETS
(unaudited)
June 30, December 31,
2007 2006
------------- -------------
Assets
Current assets:
Cash and cash equivalents $ 8,918,101 $ 12,019,914
Investment in marketable securities - 2,952,096
Other current assets 718,876 472,881
------------- -------------
Total current assets 9,636,977 15,444,891
Intangible assets, net accumulated
amortization of $4,358,119 and
$3,533,568, respectively 23,898,652 24,723,203
Property & equipment, net accumulated
depreciation of $483,275 and $395,284,
respectively 1,371,007 1,361,377
------------- -------------
Total assets $ 34,906,636 $ 41,529,471
============= =============
Liabilities and Stockholders' Equity
Current liabilities:
Accounts payable $ 1,273,766 $ 868,862
Stock payable 112,440 112,440
Accrued expenses 842,995 135,069
Note payable 1,500,000 1,500,000
Current maturity of loan payable 55,928 14,080
Derivative liability - 6,656,677
------------- -------------
Total current liabilities 3,785,129 9,287,128
Long term liabilities:
Loan payable 191,680 96,242
------------- -------------
Total liabilities 3,976,809 9,383,370
------------- -------------
Commitments and contingencies - -
Stockholders' equity:
Convertible preferred stock, no par
value, 10,000,000 shares authorized,
none issued and outstanding - -
Common stock, $0.50 par value,
100,000,000 shares authorized,
6,696,784 shares issued and
outstanding 3,348,351 3,348,351
Additional paid in capital 75,191,789 63,118,180
Deficit accumulated during the
development stage (47,610,313) (34,320,430)
------------- -------------
Total stockholders' equity 30,929,827 32,146,101
------------- -------------
Total liabilities and
stockholders' equity $ 34,906,636 $ 41,529,471
============= =============
Contact
Company Contact:
Opexa Therapeutics, Inc.
Lynne Hohlfeld, 281-719-3421
lhohlfeld@opexatherapeutics.com
or
Investor Relations Contacts:
Lippert/Heilshorn & Associates
Kim Sutton Golodetz, 212-838-3777
kgolodetz@lhai.com
or
Bruce Voss, 310-691-7100
bvoss@lhai.com
http://www.pharmalive.com/News/index.cfm?articleid=467598&categoryid=36%2C61#
posted by Bill at 7:33 PM
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