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. -0- *T 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 *T
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.
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