Exhibit 99.1
PharmaFrontiers Reports Second Quarter 2005 Financial Results; Provides Research
Update
THE WOODLANDS, Texas--(BUSINESS WIRE)--Aug. 16, 2005--PharmaFrontiers Corp.
(OTCBB:PFTR), a company involved in the development and commercialization of
cell therapies, today provides an update on its research programs and future
plans. In addition, the Company reports financial results for the three and six
months ended June 30, 2005.
Highlights of the second quarter of 2005 (April through June) include:
-- Positive interim results announced from two Phase I/II Multiple
Sclerosis trials with Tovaxin(TM);
-- Clinical Plans presented at the 19th Annual Meeting of the
Centers of Multiple Sclerosis Centers in Orlando, Florida in
June;
-- INC Research, Inc., a global CRO, selected as development
partner for Tovaxin;
-- Financing of $5.08 million completed;
-- Four new members added to Scientific Advisory Board.
Research and Development
During the quarter, PharmaFrontiers announced interim results from its two
Phase I/II trials for Multiple Sclerosis using its drug, Tovaxin. The studies
indicated that the drug was safe and well-tolerated and also concluded that
Myelin-Peptide Reactive T Cells (MRTCs) in patients with Multiple Sclerosis can
be depleted by Tovaxin treatment. Multiple Sclerosis Impact Scale (MSIS) and
Kurtzke Expanded Disability Status Scale (ECSS) clinical measures were improved.
Commenting on recent events, David B. McWilliams, chief executive officer of
PharmaFrontiers, said, "Our Tovaxin program is progressing very well. Our
interim data showed that the drug is well tolerated and demonstrated improvement
in patients. We believe this is significant because Multiple Sclerosis is a
disease for which current therapies are limited, and often cause extremely
unpleasant side effects. New therapies with benign profiles like Tovaxin are
urgently needed; this is supported by the fact that after our presentation at
the Annual Meeting of the Centers of Multiple Sclerosis Centers in June, we had
strong interest from 15 centers to participate in our trials. Our clinical
development program is advancing as planned and we will be presenting our data
at the 21st Congress of the European Committee/10th Annual Meeting of the
Americas Committee for Treatment and Research in Multiple Sclerosis. The meeting
will be held in Greece from September 28 through October 1, 2005. We then plan
to begin our Phase IIb/III clinical trails in late 2005 or early 2006."
Mr. McWilliams also described recent progress in PharmaFrontiers' stem cell
program, which the Company believes may provide the basis for therapies to treat
a variety of diseases and conditions such as diabetes and congestive heart
failure. "We are currently in the process of refining our operations for maximum
efficiency and productivity. We have cut our processing time from two to three
weeks down to just seven to ten days. In addition, we are producing consistently
high yields of stem cells from blood. We believe that we will produce 50 million
stem cells per 500 mls of blood. Now that these operating efficiencies have been
implemented, we plan to initiate animal studies shortly."
During the quarter, the Company formed a strategic relationship with INC
Research, Inc., a global contract research organization (CRO), to develop
Tovaxin. INC Research specializes in diseases of the central nervous system.
To support and advise on its research efforts, during the quarter,
PharmaFrontiers appointed four new members to its scientific advisory board.
They are: Eliezer Huberman, Ph.D., director of Biological & Biotechnological
Research at the Argonne National Laboratory and PharmaFrontiers' SAB chairman;
Norman Barton, M.D., Ph.D., executive vice president and chief medical officer
of CepTor Corporation; Daniel R. Marshak, Ph.D., senior vice president -
research and development, and chief technology officer for Cambrex; and Shelly
Heimfeld, Ph.D., director of the Stem Cell Program at Fred Hutchinson Cancer
Research Center in Seattle, Washington. Dr. Jingwu Zhang, professor of Neurology
and Immunology at Baylor College of Medicine and Scientific Director of the
Baylor-Methodist Multiple Sclerosis Center in Houston continues to serve as a
member of the SAB.
Financial Results
The Company's financial statements compare the three and six months ended
June 30, 2005 with results from its inception through June 30, 2004.
The Company reported no revenue for the three and six months ended June 30,
2005 or in its comparative period. General and administrative expenses during
the three and six months ended June 30, 2005 were $2.7 million and $4.3 million,
respectively, compared with $0.5 million and $1.1 million during the same
periods in 2004. The increase in general and administrative expenses is due
primarily to the start-up of operations, which included the hiring of new
personnel including employees and consulting fees to directors and scientific
advisory board members. The increase in operations is also attributable to the
acquisition of Opexa Pharmaceuticals and the assumption of its operations. Also
included are professional fees including legal, accounting and other consulting
services.
Research and development expense was $.6 million and $1.3 million for the
three and six months of 2005, respectively, compared with no expenses for the
same periods in 2004. The increase is primarily related to the acquisition of
Opexa Pharmaceuticals and the assumption of its operations and research and
development programs, including its ongoing Phase I/II clinical trial for
Tovaxin as well as the beginning of the pre-clinical studies for the cardiac and
diabetes stem cell therapies. Also included are professional fees incurred from
consulting services and legal fees to secure and expand license patent claims.
Interest expense was $4.5 million and $5.9 million, respectively, for the
three and six months ended June 30, 2005, compared with $.12 million and $.15
million during the same periods in 2004. The increase is mostly due to the
amortization of the remaining discount under the beneficial conversion feature
of the Company's Bridge Notes and the accrued interest on the Bridge Notes that
was converted into shares of Common Stock.
PharmaFrontiers had a net loss for the three and six months of 2005 of ($7.7
million) and $(11.5 million) or ($0.70) and ($1.08) per share (basic and
diluted), compared with a net loss of ($.7 million) and ($1.2 million) or (0.11)
or ($.24) per share (basic and diluted) for the same periods in 2004.
The Company had cash of $5.1 million on June 30, 2005, having completed a
private placement of equity, which raised $5.18 million during the quarter.
Subsequent to the close of the quarter, the Company raised an additional $.8
million through the sale of equity.
About PharmaFrontiers Corp.
PharmaFrontiers' strategy is to develop and commercialize cell therapies to
treat several major disease areas such as cardiac and pancreatic conditions and
Multiple Sclerosis. The company holds the exclusive worldwide license from the
University of Chicago through its prime contractor relationship with Argonne
National Laboratory for patents relating to the use of adult pluripotent stem
cells derived from patients' own circulating blood. PharmaFrontiers also owns
patented and proprietary individualized cell therapies that are in FDA Phase
I/II human dose ranging clinical trials to evaluate their safety and
effectiveness in treating MS.
Safe Harbor Statement
This press release contains "forward-looking statements," including
statements about PharmaFrontiers' 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 PharmaFrontiers' ability to obtain
additional funding, develop its stem cell technologies, achieve its operational
objectives, and obtain patent protection for its discoveries, that may cause
PharmaFrontiers' actual results to be materially different from any future
results expressed or implied by such forward-looking statements. PharmaFrontiers
undertakes no obligation to update or revise any such forward-looking
statements, whether as a result of new information, future events or otherwise.
CONTACT: PharmaFrontiers Corp., The Woodlands
C. William Rouse, 281-775-0608
brouse@pharmafrontiers.net
or
Lippert/Heilshorn & Associates
Investor Relations Contacts:
Kim Sutton Golodetz, 212-838-3777
kgolodetz@lhai.com
or
Bruce Voss, 310-691-7100
bvoss@lhai.com