Dor (AMEX:DOR)
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DOR BioPharma Inc. (AMEX: DOR) ("DOR" or the "company")
announced today its financial results for the third quarter ended
Sept. 30, 2005. The company will host a conference call on
Wednesday, Nov. 16, 2005, at 10 a.m. EST to discuss recent
progress and developments. The call-in number for U.S. and Canadian
participants is 888-554-9236 and for international participants it
is 706-679-4837. A replay of the conference call will be available
on DOR's Web site for approximately 30 days following the call.
The company reported an improved net loss to shareholders of
$1,158,251 or $0.02 per share for the third quarter of 2005, compared
to $1,406,411 or $0.03 per share for the third quarter of 2004.
Revenues attributable to grants for the third quarter of 2005 were
$733,892, compared to zero in the third quarter of 2004. Research and
development costs for the third quarter of 2005 were $964,398 compared
to $894,384 for the third quarter of 2004. General and administrative
expenses for the third quarter 2005 were $441,489 compared to $526,162
for the third quarter of 2004. The third quarter results as with the
second quarter results improvements were due to the September 2004
$5,173,298 million grant award from the National Institute of Allergy
and Infectious Diseases (NIAID) for RiVax(TM). In May of 2005 the
grant was increased to $6,433,316 based on a new renegotiated
Facilities and Administrative (F&A) rate with the NIAID. Our cost of
revenues for the three months ended Sept. 30, 2005, was $545,812
compared to zero for the three months ended Sept. 30, 2004.
For the nine months ended Sept. 30, 2005, the company reported an
improved net loss to shareholders of $2,728,978 or $0.06 per share,
compared to $4,545,047 or $0.11 per share for the nine months ended
Sept. 30, 2004. For the nine months ended Sept. 30, 2005, revenues
increased to $2,270,135, compared to $66,095 for the nine months ended
Sept. 30, 2004. For the nine months ended 2005, research and
development costs decreased to $2,431,289, compared to $2,583,431 for
the nine months ended Sept. 30, 2004. In 2004, costs for research and
development were higher due to the completion of the pivotal Phase III
clinical trial of orBec(R). However, in the third quarter of 2005 our
research and development costs showed an increase as compared to the
same period in 2004. This was due to increased regulatory and other
consultant costs associated with the preparation of the NDA filing for
orBec(R). For the nine months ended Sept. 30, 2005, general and
administrative expenses decreased to $1,207,297, compared to
$1,503,360 for the nine months ended Sept. 30, 2004. For the nine
months ended Sept. 30, 2005, the cost of revenues was $1,465,664,
compared to $59,486 for the same nine-month period ended Sept. 30,
2004. These costs relate to payments made to subcontractors and
universities in connection with the aforementioned grants.
DOR's Third Quarter 2005 Highlights:
-- On July 20, 2005, 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).
-- On July 26, 2005, DOR announced that it entered into a joint
development agreement with Dowpharma for the development of
BT-VACC(TM), DOR's oral vaccine against botulinum toxin
poisoning.
Subsequent Events:
-- On Oct. 14, 2005, DOR announced that the orBec(R) IND was
transferred to FDA's Oncology Division. DOR also announced
completion of the Phase I Clinical trial of RiVax(TM). Interim
results from the trial demonstrated that RiVax(TM) is safe and
immunogenic after immunization with three monthly injections
of vaccine, with volunteers developing antibodies. DOR also
announced that it had received notice of grant from the FDA's
Orphan Products Division for its grant application dated April
6, 2004, entitled "Oral BDP for the Treatment of GI GVHD." The
grant totals $318,750 and supports the development of orBec(R)
for the treatment of intestinal Graft-versus-Host disease
(iGVHD).
-- On Nov. 1, 2005, DOR received notice from the American Stock
Exchange (the "AMEX") indicating that it no longer complies
with the AMEX's continued listing standards and that it
intends to proceed with removal of the company's stock from
listing and registration on the AMEX. DOR has appealed this
decision and requested a hearing and was recently notified
that its hearing date has been scheduled at the AMEX New York
office on Dec. 2, 2005.
-- On Nov. 2, 2005, DOR announced that it has signed a binding
letter of intent to acquire Gastrotech Pharma A/S
("Gastrotech"), a private Danish biotechnology company based
in Copenhagen, Denmark. Gastrotech develops therapeutics based
on peptide hormones to treat cancer and gastrointestinal (GI)
diseases and conditions. Gastrotech was founded on technology
developed at the Sahlgrenska University Hospital in Sweden,
which is known as the development cradle of Growth Hormone and
IGF-1 research.
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Selected Financial Data:
Statement of Operations Data
Quarter Ended Sept. 30, 2005:
Net loss applicable to common stockholders ($1,158,251)
Nine months Ended Sept. 30, 2005:
Net loss applicable to common stockholders ($2,728,978)
Balance Sheet Data
As of Sept. 30, 2005:
Cash and cash equivalents $1,833,128
Working capital $1,432,542
Total shareholders' equity $3,519,342
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About DOR BioPharma Inc.
DOR BioPharma Inc. is a biopharmaceutical company focused on the
development of therapeutic products and biomedical countermeasures for
areas of unmet medical need. 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
in early 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 completed the clinical portion of its Phase I clinical
trial in normal volunteers. We have also announced the initiation of a
new botulinum toxin therapeutic development program based on rational
drug design.
For further information regarding DOR BioPharma, please visit the
company's Web site 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 prior
to a date set by AMEX for a hearing regarding the continued listing on
AMEX of DOR BioPharma's common stock, 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's business strategy has
been revised to include the issuance of its securities to acquire
companies or assets. DOR BioPharma presently is involved in
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.