DOR BioPharma, Inc. Reports Second Quarter 2006 Financial Results and Reviews Achievements.MIAMI Miami, cities, United States Miami (mīăm`ē, –ə). 1 City (1990 pop. 358,548), seat of Dade co., SE Fla., on Biscayne Bay at the mouth of the Miami River; inc. 1896. -- DOR Dor or Dora, Canaanite seaport, ancient Palestine (modern Israel), N of Caesarea Palestinae. It was never a Jewish city but rather a Phoenician outpost. It was rebuilt by the Romans; still visible are the ruins of a temple and a theater. BioPharma, Inc. (OTCBB OTCBB See OTC Bulletin Board (OTCBB). :DORB DORB Data Object Request Broker ) ("DOR" or the "Company"), announced today its financial results for the second quarter ended June 30, 2006. Revenue for the second quarter of 2006 was approximately $0.1 million, compared to $1.4 million in the second quarter of 2005. However, revenue was $1.5 million for the six months ended 2006 compared to $1.5 million for the six months ended 2005. The revenue was earned from two grants, a National Institute of Allergy and Infectious Diseases (NIAID NIAID National Institute of Allergy and Infectious Diseases. ) grant awarded in September 2004 for $5.2 million for RiVax(TM), which was increased to $6.4 million in May 2005 for a renegotiated F&A rate which may be used for overhead expenditures, and for a September 2005 grant awarded from the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. for "Oral BDP BDP Botswana Democratic Party BDP Bund Der Pfadfinderinnen und Pfadfinder (German Scouts) BDP Boogie Down Productions BDP Bandwidth Delay Product BDP Beclomethasone Dipropionate BDP Business Development Program for the Treatment of GI GVHD GVHD graft-versus-host-disease. GVHD Graft-versus-host disease, see there ." The Company reported a net loss to shareholders of approximately $3.3 million or $0.05 per share for the second quarter of 2006, compared to $0.5 million or $0.01 per share for the second quarter of 2005. For the six months ended June 30, the net loss to shareholders was approximately $5.1 million or $0.09 per share for 2006 as compared to $1.6 million or $0.03 per share for the same period in 2005. Research and development costs for the second quarter were $1.8 million compared to $0.7 million for the second quarter of 2005. This increase was partially due to the increased regulatory filing and consultant costs associated with the preparation of the NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any filing for orBec(R), and an impairment expense for intangibles of $0.8 million. For the six months ended June 30, research and development expenses were approximately $3.1 million for 2006 as compared to $1.5 million for 2005. In the second quarter, an expense for in-process research and development of approximately $1.0 million was incurred for the purchase acquisition of the remaining outstanding common stock of the Company's Enteron en·ter·on n. The alimentary canal; the intestines. enteron the gut or alimentary canal; usually used in medicine with specific reference to the small intestine. subsidiary that the Company did not already own. General and administrative expenses for the second quarter of 2006 were $0.6 million compared to $0.4 million for the second quarter of 2005. For the six months ended June 30, general and administrative expenses were approximately $1.4 million as compared to $0.8 million for the same period of 2005. The increase from 2005 was due to a recovery of stock option expense for the variable treatment of options for employees in the amount of $0.3 million in 2005. "We are now in the final stages of the assembly and filing of our NDA for orBec(R) which is expected by the end of this month," stated Michael Sember, President and Chief Executive Officer of DOR. "We look forward to working with the FDA on its review of our NDA filing in the coming months." DOR's 2nd Quarter 2006 Development Highlights: --In April, DOR announced that it had completed a private placement to institutional investors with gross proceeds to the Company of approximately $3.65 million. --In April, DOR announced the first successful evaluation in animal tests of a nasal, bivalent bivalent /bi·va·lent/ (bi-va´lent) 1. divalent. 2. the structure formed by a pair of homologous chromosomes by synapsis along their length during the zygotene and pachytene stages of the first meiotic prophase. combination of its botulinum toxin Botulinum toxin (botulin) A neurotoxin made by Clostridium botulinum; causes paralysis in high doses, but is used medically in small, localized doses to treat disorders associated with involuntary muscle contraction and spasms, in addition to strabismus. vaccine, BT-VACC(TM), addressing two of the most prevalent serotypes of botulinum toxin, types A and B. --Also in April, DOR announced that the European Commission and the centralized European Agency for the Evaluation of Medicinal Products (EMEA (Europe, Middle East, Africa) Refers to that region of the world. For example, one might see products packaged differently for the UK, EMEA and Asia Pacific markets. ) has granted DOR incentives for Small and Medium Sized Enterprises (SME (1) (Small and Medium-sized Enterprise) See SMB. (2) (Subject Matter Expert) An individual who is well-versed in the policies and procedures of a particular department or division. ). SME status may accord companies reduced or deferred fees associated with marketing authorization applications, scientific advice and inspections. Subsequent Events: --In July, DOR announced that it had successfully completed its cGMP (current Good Manufacturing Practices) milestone for the production of RiVax(TM), DOR's vaccine against ricin toxin pursuant to a manufacturing collaboration with Cambrex BioSciences and supported by a $6.4 million NIAID grant. About DOR BioPharma, Inc. DOR BioPharma, Inc. is a biopharmaceutical company addressing life-threatening side effects Side effects Effects of a proposed project on other parts of the firm. of cancer and cancer treatments, serious gastrointestinal diseases and disorders, and biomedical bi·o·med·i·cal adj. 1. Of or relating to biomedicine. 2. Of, relating to, or involving biological, medical, and physical sciences. countermeasures. Our lead product, orBec(R) (oral beclomethasone dipropionate), is a potent, locally-acting corticosteroid corticosteroid /cor·ti·co·ster·oid/ (-ster´oid) any of the steroids elaborated by the adrenal cortex (excluding the sex hormones) or any synthetic equivalents; divided into two major groups, the glucocorticoids and being developed for the treatment of gastrointestinal Graft-versus-Host disease (GI GVHD), a common serious complication of bone marrow transplantation Bone Marrow Transplantation Definition The bone marrow—the sponge-like tissue found in the center of certain bones—contains stem cells that are the precursors of white blood cells, red blood cells, and platelets. 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 GI GVHD in August of 2006. Through our BioDefense Division, we are developing biomedical countermeasures pursuant to the paradigm established by the recently enacted Project BioShield Act The Project Bioshield Act was an act passed by the United States Congress in 2004 calling for the donation of over $5 billion for purchasing vaccines that would be used in the event of a bioterrorist attack. of 2004. Our biodefense products in development are bioengineered vaccines designed to protect against the deadly effects of exposure to 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 Noun 1. phase I clinical trial - a clinical trial on a few persons to determine the safety of a new drug or invasive medical device; for drugs, dosage or toxicity limits should be obtained phase I in normal volunteers. We have also initiated a botulinum toxin therapeutic development program based on rational drug design. For further information regarding DOR, 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, Inc.'s current expectations about its future results, performance, prospects and opportunities, including statements regarding the potential use of orBec(R) for the treatment of gastrointestinal GVHD and the prospects for regulatory filings for orBec(R). Where possible, DOR 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 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, or that its business strategy will be successful. Important factors which may affect the future use of orBec(R) for gastrointestinal GVHD 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 expects or may never gain approval; DOR 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). These and other factors are described from time to time in filings with the Securities and Exchange Commission, including, but not limited to, DOR's most recent reports on Form 10-QSB and Form 10-KSB. DOR 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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