DOR BioPharma, Inc. Reports First 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 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 first quarter ended March 31, 2006. Revenues for the first quarter of 2006 were approximately $1.4 million compared to $0.1 million in the first quarter of 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), and an 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. grant awarded in September 2005 for the "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 NIAID grant was increased to $6.4 million in May 2005 due to a renegotiated F&A rate which may be used for overhead expenditures. The Company reported a net loss to shareholders of approximately $1.7 million or $0.03 per share for the first quarter of 2006, compared to $1.0 million or $0.02 per share for the first quarter of 2005. Research and development costs for the first quarter were $1.2 million compared to $0.7 million for the first quarter of 2005. This increase was due to the increased regulatory and filing 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). General and administrative expenses for the first quarter 2006 were $0.8 million compared to $0.3 million for the first quarter of 2005. This increase was primarily due to non cash expense items consisting of a recovery of stock option expense for the variable treatment of options for employees in the amount of $0.3 million in 2005 and an expense of $0.1 million for stock options under SFAS SFAS Statement of Financial Accounting Standards SFAS Special Forces Assessment and Selection SFAS Student Financial Aid Services SFAS Sport Fishing Association of Singapore SFAS Safety Features Actuation System SFAS Statewide Fixed Assets System No. 123R in the first quarter of 2006. "2006 has begun in a significant way for DOR," stated Michael Sember, DOR's Chief Executive Officer. "We announced important and corroborative mortality data from Phase II and Phase III clinical trials of oral beclomethasone and orBec(R). In addition, we announced positive Phase I clinical data from our RiVax(TM) program. We are looking forward to the filing of our NDA for orBec(R), the assembly of which is in its final stages. We expect 2006 to be a pivotal year for DOR." DOR first quarter 2006 Development Highlights: --In January 2006, DOR announced that it had entered into a common stock purchase agreement with Fusion Capital Fund II, LLC (Logical Link Control) See "LANs" under data link protocol. LLC - Logical Link Control , 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 Noun 1. phase II clinical trial - a clinical trial on more persons than in phase I; intended to evaluate the efficacy of a treatment for the condition it is intended to treat; possible side effects are monitored phase II of oral beclomethasone and a pivotal Phase III clinical trial of orBec(R). --In January, DOR announced positive results of its 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 of RiVax(TM), which represented the first time a ricin toxin vaccine had ever been clinically tested in humans. --In January, DOR announced that DOR and its collaborators had successfully completed the second development milestone for its ricin ricin /ri·cin/ (ri´sin) a phytotoxin in the seeds of the castor oil plant (Ricinus communis), used in the synthesis of immunotoxins. ri·cin n. vaccine, RiVax(TM), under the Challenge Grant previously awarded to DOR in September 2004 by NIAID, a unit of the National Institutes of Health. Subsequent Events: --On April 10, 2006, DOR completed a Private Equity Financing of $3.6 million with institutional investors --On April 16, 2006, DOR announced the initiation of trading on the OTC Bulletin Board OTC Bulletin Board An electronic quotation listing of the bid and asked prices of OTC stocks that do not meet the requirements to be listed on the NASDAQ stock-listing system. under the new stock symbol DORB. --On April 24, 2006, DOR announced that it was granted 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. status by the European Commission and the 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. . 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 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 (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 gastrointestinal GVHD in the second quarter 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 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 gastrointestinal GVHD 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, 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 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). 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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