DOR BioPharma Reports Year End 2005 Financial Results and Accomplishments; DOR Provides Guidance on Regulatory Filings on orBec
March 30 2006 - 9:00AM
Business Wire
DOR BioPharma, Inc. (AMEX:DOR) ("DOR" or the "Company") announced
today its financial results for 2005. Revenues for 2005 were
$3,075,736 compared to $997,482 in 2004. The revenue in both years
was due to the September 2004 $5.2 million grant award from the
National Institute of Allergy and Infectious Diseases (NIAID) for
RiVax(TM), which was increased to $6.4 million in May 2005. This
increase was awarded based on a new renegotiated F&A rate with
the NIH which may be used for overhead expenditures. The Company's
net loss for 2005 was approximately $4.7 million, or $0.09 per
share, compared to $6.3 million, or $0.16 per share for 2004. The
improvement in the net loss was primarily related to the
contribution from the gross profit for the NIAID grant. The
contribution in 2005 was $1.0 million, compared to $60,000 in 2004.
Research and development expenses for 2005 were approximately $3.7
million compared to $3.7 million in 2004. General and
administrative expenses for 2005 were approximately $2.2 million
compared to $2.3 million in 2004. In 2004 the Company had a
preferred stock dividend that increased the loss by $0.5 million.
"2005 was a significant and transitional year for DOR," stated
Michael T. Sember, President and CEO. "We took careful steps with
the FDA toward preparation and submission of our NDA for orBec(R),
now scheduled for submission in the middle of the second quarter to
be followed closely by our MAA for the European territory. The
analysis of the data is complete and the e-publishing process of
the filing is underway. Our focus is on submitting a high-quality
and cohesive NDA that showcases the value and significance of
orBec(R) and to that end we are carefully taking the appropriate
time to ensure its thorough assembly." Regarding orBec's regulatory
progress, Mr. Sember commented, "orBec(R) has demonstrated a strong
and consistent mortality benefit with a 66% reduction in the risk
of mortality in our Phase III trial versus placebo. This result is
consistent with a 55% reduction in the risk of mortality from a
previous Phase II trial of oral beclomethasone dipropionate. These
data represent what we believe to be an extremely important outcome
for patients suffering from iGVHD. We are hopeful that these data
will be persuasive to the FDA and European regulatory authorities
even though we missed our primary endpoint of median time to
treatment failure at study day 50. As there is no approved therapy
for iGVHD and there is a high mortality rate associated with it, we
are optimistic about our chances for approval." Mr. Sember
continued, "While we faced hard choices with regard to our AMEX
listing, after consultation with many of our shareholders and Board
of Directors, we came to the conclusion that, given our relatively
low burn rate and upcoming NDA filing for orBec(R), that the
issuance of at least $6 million in equity in order to meet the
minimum stockholders equity requirement to maintain our listing on
AMEX would be too dilutive and create a concentration of ownership
that could impair the company's ability to enter into potential
future transactions that maximize the value to existing
stockholders and was therefore not in the best interests of
stockholders. We believe that our stock is dramatically undervalued
compared to other biotechnology companies in this stage of the drug
development cycle; and as we achieve our milestones and further
advance orBec(R) toward FDA approval, we believe that we will once
again be in a position to address listing on a larger exchange. We
have begun preparations and are planning for the commencement of
trading on the OTC bulletin board in a short time. We believe the
OTC bulletin board to be a fair, efficient, and comparable
marketplace for our stock that will offer the same amount of
liquidity that market participants had with AMEX." DOR's 2005
Development Highlights: -- In November 2005, DOR announced it had
completed a feasibility study with Dowpharma(SM) contract
manufacturing services, a business unit of The Dow Chemical Company
(NYSE:DOW), focused on the expression of three recombinant heavy
chain botulinum fragments used in the development of BT-VACC(TM),
DOR's proprietary mucosal botulinum vaccine. -- In July, DOR
announced that it achieved the important milestone of the
completion of downstream process development and fermentation with
its manufacturing partner Cambrex in the development and
manufacture of RiVax(TM). -- In July, DOR announced that it entered
into a joint development agreement with Dowpharma(SM) for the
development of BT-VACC(TM), DOR's oral vaccine against botulinum
toxin poisoning. -- In February, DOR announced that it had
initiated a rational drug design program to identify oral, small
molecule drugs to counter the deadly effects of botulinum toxin
exposure through a collaboration with Blue Dolphin, LLC, a firm
specializing in rational drug design. -- In January, DOR and
Cambrex BioSciences announced completion of an agreement for
process development and large scale production of RiVax(TM), DOR's
vaccine against ricin toxin. Recent 2006 Events: -- In January
2006, DOR announced that it had entered into a common stock
purchase agreement with Fusion Capital Fund II, LLC, a Chicago
based institutional investor, whereby Fusion Capital will buy up to
$6.0 million of the Company's common stock over a 15-month period.
-- In January, DOR announced positive new survival findings from a
Phase II clinical trial of oral beclomethasone and a pivotal Phase
III clinical trial of orBec(R). In the Phase II trial, there were
reductions in the risk of mortality of 55% and 43% at transplant
day-200 and one year post-randomization among patients randomized
to oral beclomethasone dipropionate, respectively. The comparable
survival data from the 129-patient Phase III pivotal trial were 66%
and 51% reductions in the risk of mortality at transplant day-200
and one-year post-randomization among patients randomized to
orBec(R), respectively. -- In January, DOR announced positive
results of its Phase I clinical trial of RiVax(TM), which
represented the first time a ricin toxin vaccine had ever been
clinically tested in humans. Results from the trial demonstrated
that RiVax(TM) is safe and immunogenic after immunization with
three monthly injections of vaccine, with volunteers developing
antibodies against ricin toxin. The functional activity of the
antibodies was confirmed by transferring serum samples from the
vaccinated volunteers into mice, which then survived exposure to
ricin toxin. Results of the study were published in the Proceedings
of the National Academy of Sciences. -- In January, DOR announced
that DOR and its collaborators had successfully completed the
second development milestone for its ricin vaccine, RiVax(TM),
under the Challenge Grant previously awarded to DOR in September
2004 by NIAID, a unit of the National Institutes of Health. About
DOR BioPharma, Inc. DOR BioPharma, Inc. is a biopharmaceutical
company addressing life-threatening side effects of cancer and
cancer treatments, serious gastrointestinal diseases and disorders,
and biomedical countermeasures. Our lead product, orBec(R) (oral
beclomethasone dipropionate), is a potent, locally-acting
corticosteroid being developed for the treatment of intestinal
Graft-versus-Host disease (iGVHD), a common serious complication of
bone marrow transplantation for cancer, as well as other GI
disorders characterized by severe inflammation. We plan to file a
new drug application (NDA) with the FDA for orBec(R) for the
treatment of iGVHD by mid second quarter 2006. Through our
BioDefense Division, we are developing biomedical countermeasures
pursuant to the paradigm established by the recently enacted
Project BioShield Act of 2004. Our biodefense products in
development are bioengineered vaccines designed to protect against
the deadly effects of ricin toxin and botulinum toxin, both of
which are considered serious bioterrorism threats. Our ricin toxin
vaccine, RiVax(TM), has successfully completed a Phase I clinical
trial in normal volunteers. We have also initiated a botulinum
toxin therapeutic development program based on rational drug
design. For further information regarding DOR BioPharma, please
visit the Company's website located at http://www.dorbiopharma.com.
This press release contains forward-looking statements, within the
meaning of Section 21E of the Securities Exchange Act of 1934, that
reflect DOR BioPharma's current expectations about its future
results, performance, prospects and opportunities, including
statements regarding the potential use of orBec(R) for the
treatment of iGVHD and the prospects for regulatory filings for
orBec(R). Where possible, DOR BioPharma has tried to identify these
forward-looking statements by using words such as "anticipates",
"believes", "intends", or similar expressions. These statements are
subject to a number of risks, uncertainties and other factors that
could cause actual events or results in future periods to differ
materially from what is expressed in, or implied by, these
statements. DOR BioPharma cannot assure you that it will be able to
successfully develop or commercialize products based on its
technology, including orBec(R), particularly in light of the
significant uncertainty inherent in developing vaccines against
bioterror threats, manufacturing and conducting preclinical and
clinical trials of vaccines, and obtaining regulatory approvals,
that its technologies will prove to be safe and effective, that its
cash expenditures will not exceed projected levels, that it will be
able to obtain future financing or funds when needed, that product
development and commercialization efforts will not be reduced or
discontinued due to difficulties or delays in clinical trials or
due to lack of progress or positive results from research and
development efforts, that it will be able to successfully obtain
any further grants and awards, maintain its existing grants which
are subject to performance, enter into any biodefense procurement
contracts with the U.S. Government or other countries, that it will
be able to patent, register or protect its technology from
challenge and products from competition or maintain or expand its
license agreements with its current licensors, that it will be able
to maintain its listing on the American Stock Exchange ("AMEX") by
completing a transaction which will provide it with shareholders'
equity of at least $6 million, or that its business strategy will
be successful. Important factors which may affect the future use of
orBec(R) for iGVHD include the risks that: because orBec(R) did not
achieve statistical significance in its primary endpoint in the
pivotal Phase III clinical study (i.e. a p-value of less than or
equal to 0.05), the FDA may not consider orBec(R) approvable based
upon existing studies, orBec(R) may not show therapeutic effect or
an acceptable safety profile in future clinical trials, if
required, or could take a significantly longer time to gain
regulatory approval than DOR BioPharma expects or may never gain
approval; DOR BioPharma is dependent on the expertise, effort,
priorities and contractual obligations of third parties in the
clinical trials, manufacturing, marketing, sales and distribution
of its products; or orBec(R) may not gain market acceptance; and
others may develop technologies or products superior to orBec(R).
DOR BioPharma presently is involved in financing negotiations which
could result in the issuance of a significant number of shares of
its equity securities, thereby diluting the equity interests of
present stockholders. These and other factors are described from
time to time in filings with the Securities and Exchange
Commission, including, but not limited to, DOR BioPharma's most
recent reports on Form 10-QSB and Form 10-KSB. DOR BioPharma
assumes no obligation to update or revise any forward-looking
statements as a result of new information, future events, and
changes in circumstances or for any other reason.
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