Dor (AMEX:DOR)
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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.