Pipex Pharmaceuticals, Inc. (AMEX: PP), a specialty pharmaceutical
company developing innovative late-stage drug candidates for the
treatment of central nervous system (CNS) and autoimmune diseases,
today announced its clinical update and results for its second
quarter of 2008.
A conference call has been scheduled for 4:30 p.m. EDT today. In
order to participate in the conference call, please call toll free:
888-256-9124 and international dial-in: 913-312-0830. A replay of
the conference call will be archived for at least 15 days on
Pipex's website at www.pipexinc.com.
Second quarter and recent accomplishments included:
-- 43% reduction in quarterly cash operating expenses for the second
quarter 2008 to $826,046.
-- Completed submission and peer-review of a publication of results of
eighty patient, six month, prospective, randomized, double-blind clinical
trial of Oral Zinthionein for Dry Age-Related Macular Degeneration (AMD)
demonstrating a statistically significant improvement in visual acuity (p <
0.0001) and all measurements of global retinal function.
-- Expanded patent portfolio through the execution of an option to
license Oral Flupirtine patent estate for Diabetes, Diabetic Retinopathy,
Retinitis Pigmentosa and Glaucoma which includes 150 patient prior clinical
database.
-- Announced issuance of additional U.S. patent covering CD4 Inhibitor
Molecules.
-- Issuance of an additional U.S. patent covering uses of low-dose
estrogens including TRIMESTA in combination of TCR peptides.
-- Implemented cost realignment measurements including and 51% reduction
in headcount and reductions in outside consultants.
-- Appointed Co-Founder and Vice Chairman Nicholas Stergis as Chief
Executive Officer.
Pipex will be presenting at the following upcoming investor
conferences:
-- Fourth Annual Noble Financial Equity Conference at 3:00 p.m. (Pacific)
on Monday, August 18.
-- RedChip Emerging Markets Investor Conference on Thursday, August 21 at
9:30 am.
These investor presentations will be webcast and can be accessed
through our website located at www.pipexinc.com.
Nicholas Stergis, Chief Executive Officer of Pipex, commented,
"We are pleased to have announced positive double-blind,
placebo-controlled phase II clinical trial results for oral
Zinthionein in the treatment of dry age related macular
degeneration (AMD). We are equally pleased to have expanded our
intellectual property portfolio in the ophthalmology space through
an agreement to acquire issued and pending patent applications
relating to the ophthalmic uses of flupirtine with clinical data in
the treatment of diabetic retinopathy, retinitis pigmentosa and dry
AMD. We also continue to make progress in evaluating new
in-licensing opportunities of late-stage clinical compounds for
unmet medical diseases."
Mr. Stergis went on to say, "Our financial results are in-line
with our previous guidance. We intend to continue to advance our
products through the clinic and to seek non-dilutive sources of
funding for them through either peer reviewed grants as well as
continuing our discussions with potential corporate partners."
Below is a summary of our product candidates and their stages of
development:
Zinthionein
In an 80 patient, double-blind, placebo-controlled phase II
clinical trial, oral Zinthionein demonstrated a statistically
significant improvement in visual acuity at 6 months (p <
0.0001), along with an improvement in contrast sensitivity within 6
months (p < 0.0001) and photorecovery times within 6 months (p
< 0.0001) in this clinical trial. A full analysis of these
results are available in the July issue of Current Eye Research, a
peer reviewed ophthalmology journal.
From a commercial perspective, there are 10 million Americans
with AMD and 50 million at risk for developing AMD with no FDA
approved therapy. Currently available dry AMD therapies which sell
for approximately $1 per day have shown visual acuity disease
stabilization at 2 years. Oral Zinthionein is the subject of issued
US composition of matter patents, along with pending method of use
patent applications.
We are currently scaling-up GMP production to support additional
testing for Zinthionein.
TRIMESTA (oral, once-daily estriol)
TRIMESTA, our oral, once-daily bioidentical hormone estriol, is
currently in a seven U.S. center, placebo-controlled Phase II/III
clinical trial which is expected to enroll up to 150
relapsing-remitting Multiple Sclerosis (MS) patients. TRIMESTA is
being supported under a $5 million grant from the Southern
California Chapter of the National Multiple Sclerosis Society and
NIH. Oral estriol, the active ingredient in TRIMESTA, has been
approved throughout Europe and Asia for approximately 40 years but
is not available in the U.S.
This Phase II/III clinical trial builds upon our encouraging
results from an earlier single agent Phase IIa clinical trial in
female MS patients whereby TRIMESTA demonstrated a 79 percent
decrease in MS brain lesions in 3 months (p=0.02) and a 14 percent
improvement in cognitive function as measured by the PASAT scoring
system at 6 months (p=0.04). This dataset is also supplemented by a
definitive study of the effect of pregnancy on MS, known as the
PRIMS (Rate of Pregnancy-related Relapse in Multiple Sclerosis)
which was published in the New England Journal of Medicine (NEJM)
by Confavreux et al. In that study, relapse rates were determined
in 254 women with MS during pregnancy and for up to one year after
delivery. Relapse rates were shown to be significantly reduced
during the third trimester of pregnancy, by 71 percent (p <
0.001). The relapse rates then increased to 58 percent (p <
0.001) during the first three months post-partum before returning
to prepregnancy rates. Together, these data clearly demonstrated
that the latter part of pregnancy is associated with a significant
reduction in relapses, while there is a rebound increase in
relapses post-partum. Researchers have demonstrated the estriol
levels increase to their highest levels during the third trimester,
then drop-off to nearly zero during the post-partum period.
Oral Flupirtine
Oral flupirtine has received an IND with the FDA to conduct a
Phase II clinical trial with oral flupirtine in fibromyalgia
patients. This study is currently awaiting institutional review
board approval to initiate this double-blind placebo-controlled
Phase II clinical study which is designed to enroll up to 90
patients with fibromyalgia.
In the second quarter we expanded the potential clinical utility
of oral flupirtine through the option to in-license additional
intellectual property in ophthalmic disease indications which have
already demonstrated early proof of concept clinical studies in the
treatment of diabetic retinopathy, retinitis pigmentosa and dry
AMD.
Oral TTM (oral tetrathiomolybate)
We continue to evaluate the use of oral tetrathiomolybdate (Oral
TTM) in the treatment of Alzheimer's disease, Idiopathic Pulmonary
Fibrosis (IPF) and Huntington's disease, and are pursuing business
development activities to potentially support Oral TTM's further
testing in these indications.
Financial Results for Second Quarter 2008
The net loss applicable to common shareholders for the quarter
ended June 30, 2008 was $1,771,713, or $0.09 per share, of which
$945,667 represented non-cash expenses, resulting in cash operating
expenses for the second quarter of $826.046. This represents a 43%
reduction in cash operating expenses as compared to the $1,440,957
cash operating expenses for the first quarter 2008. Of the
$1,771,713 net loss applicable to common stockholders for the
quarter, $1,168,363 was attributable to research and development
expenses and $633,588 was attributable to general and
administrative expenses. The net loss applicable to common
shareholders for the six months ended June 30, 2008 was $4,861,169,
or $0.24 per share, compared to a net loss applicable to common
shareholders of $17,021,660, or $1.00 per share, for the comparable
quarter in 2007, representing a decrease of $12,160,491. The
decrease is primarily attributable to a non-cash charge of
$12,409,722 taken during the first quarter of 2007 related to the
acquisition of Effective Pharmaceuticals, Inc. The total of the
non-cash charge was reflected through equal and offsetting
adjustments to additional paid-in-capital with no net impact on
stockholders' equity. Research and development expenses increased
by $796,810 for the six months ended June 30, 2008 as compared to
the same period last year. Of this increase approximately $562,000
related to Pipex's Oral TTM NDA directed activities, as well as the
further development of Pipex's other product candidates,
Zinthionein, TRIMESTA(TM), anti-CD4 802-2, CORRECTA(TM), SOLOVAX,
and EFFIRMA(TM). In addition, stock-based compensation charges
increased by approximately $162,000 and allocated overhead
increased by approximately $128,000 as compared to the same period
last year. General and administrative expenses decreased by
$616,568 for the six months ended June 30, 2008 as compared to the
first half of 2007 which is primarily due to a decrease in
stock-based compensation expense of approximately $827,000 offset
by an increase in salaries and related payroll taxes of
approximately $174,000 and an increase in allocated overhead of
approximately $98,000.
At June 30, 2008, Pipex had cash of approximately $7.5 million,
compared to approximately $11.5 million at December 31, 2007. The
decrease of approximately $4.0 million during the first half of
2008 is attributable to net cash used in operations of
approximately $3.1 million, and $900,000 that we elected to use to
repay our outstanding equipment notes payable in full in order to
eliminate further monthly interest payments as well as the security
interest on our $2.0 million in equipment and leasehold
improvements primarily relating to our cGMP pharmaceutical
production facility in Ann Arbor, Michigan. The cash spend for the
quarter ended June 30, 2008 is approximately $1.3 million which was
all attributable to net cash used in operations. Of this amount,
approximately $501,000 was used to pay down existing accounts
payable and other current liabilities.
The net decrease in working capital for the second quarter of
2008 decreased to $823,763 as compared to the decrease in working
capital for the first quarter of 2008 which was $2,340,957
representing cash operating expenses of $1,440,957, and the
complete payoff of $900,000 of notes payable in the first quarter
of 2008.
We implemented significant downsizing and cost saving measures
announced March 11, 2008 in order to preserve our capital. Given
the severance and other trailing expenses associated with such
downsizing or discontinued oral TTM NDA activities, the full
benefit of our cost reduction measures have not been fully realized
in the second quarter of 2008. Given our current cash balance of
approximately $7.5 million as of June 30, 2008, we expect our
current working capital to be sufficient to fund operations for the
next 15 months.
About Pipex Pharmaceuticals, Inc.
Pipex Pharmaceuticals, Inc. is a specialty pharmaceutical
company that is developing proprietary, late-stage drug candidates
for the treatment of neurologic and fibrotic diseases. Pipex's
strategy is to exclusively in-license proprietary, clinical-stage
drug candidates and to complete the further clinical testing,
manufacturing and regulatory requirements and seek marketing
authorizations. Pipex is focused on treating Dry Age Related
Macular Degeneration (AMD), multiple sclerosis, fibromyalgia,
Alzheimer's disease, Huntington's disease, and neurologic Wilson's
disease. For further information, please visit,
www.pipexinc.com.
This release contains forward-looking statements within the
meaning of Section 21E of the Securities Exchange Act of 1934, as
amended, including statements regarding Pipex's plans for its
product candidates and statements regarding meeting with the FDA to
discuss a registration strategy for Zinthionein and initiating a
phase II clinical trial using oral flupirtine for the treatment of
fibromyalgia, along with the announcement of clinical data in
diabetic retinopathy, retinitis pigmentosa and dry AMD with
flupirtine, as well as in-licensing of additional late-stage
compounds. Words such as, but not limited to, "look forward to,"
"believe," "expect," "anticipate," "estimate," "intend," "plan,"
"targets," "likely," "will," "would," "should," and "could," and
similar expressions or words identify forward-looking statements.
Such forward-looking statements are based upon current expectations
that involve risks, changes in circumstances, assumptions and
uncertainties. Pipex is at an early stage of development and may
not ever have any products that generate significant revenue.
Important factors that could cause actual results to differ
materially from those reflected in Pipex's forward-looking
statements include, among others, a failure of Pipex's product
candidates to be demonstrably safe and effective, a failure to
obtain regulatory approval for the company's products or to comply
with ongoing regulatory requirements, a lack of acceptance of
Pipex's product candidates in the marketplace, a failure of the
company to become or remain profitable, Pipex's inability to obtain
the capital necessary to fund its research and development
activities, a loss of any of the company's key scientists or
management personnel, and other factors described in Pipex's report
on Form 10-Q for the year ended June 30, 2008. No forward-looking
statements can be guaranteed and actual results may differ
materially from such statements. The information in this release is
provided only as of the date of this release, and Pipex undertakes
no obligation to update any forward-looking statements contained in
this release on account of new information, future events, or
otherwise, except as required by law.
For Further Information Contact: Nicholas Stergis Chief
Executive Officer (734) 332-7800 Redington, Inc. (Investor
Relations) Thomas Redington 203-222-7399 www.redingtoninc.com
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