Ore Pharmaceutical Holdings Inc. (NASDAQ:ORXE) today reported financial results and provided an operational update for the third quarter ended September 30, 2009.
Highlights
During the third quarter of 2009, Ore Pharmaceutical Holdings Inc. (“Ore Holdings” or “Ore”) completed its transition into a pharmaceutical asset management company. The Company’s strategy is focused on acquiring interests in pharmaceutical assets whose value, Ore believes, it can significantly enhance through targeted development, with the goal of then monetizing these assets through sale or out-licensing transactions. Ore anticipates that it will fund these programs through designing, raising and investing alternative financing vehicles as a regular part of its ongoing activities as a company. Progress during the third quarter and since includes:
- Continued tight control of cash and expenses. Due to ongoing cost reductions, the collection of a note receivable and sale of an equity investment in the third quarter, the Company’s cash and marketable securities balance at the end of the third quarter was $7 million, which is $2.3 million higher than at the end of the second quarter. As a result of these aggressive cost controls and cash generation efforts, the Company now anticipates that it has sufficient financial resources to be able to fund operations into the first quarter of 2011;
- Received shareholder approval in October for, and completed, a reorganization whereby Ore Pharmaceuticals Inc. became a wholly owned subsidiary of a new company, Ore Holdings, with Ore Holdings becoming the new publicly traded, NASDAQ listed company with the symbol “ORXE”. This reorganization was undertaken primarily in order to better protect for shareholders the value of Ore’s approximately $324 million in gross net operating loss carryforwards;
- Continued on track to initiate a Phase Ib/IIa trial for ORE1001 in ulcerative colitis in the fourth quarter of 2009; and
- Established a research agreement with the Armed Forces Radiobiology Research Institute and the Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc. to evaluate ORE1001 as a potential countermeasure agent in treating radiation injury.
Portfolio Update
During the third quarter, the Company continued to advance its lead drug candidate, ORE1001. Ore is currently developing ORE1001 under its incubation program, in which the Company may conduct initial development on certain drug assets in order to determine the best investment pathway forward. Pathways may include monetizing the asset through partnership or out-licensing, or funding further development through one of the alternative financing vehicles that are central to Ore’s business strategy.
Ore is in the process of initiating a Phase Ib/IIa clinical trial for ORE1001 in ulcerative colitis – one of the two main disorders comprising Inflammatory Bowel Disease (“IBD”). This trial is designed as a randomized, double blind, placebo controlled trial of 50 patients with ulcerative colitis and is intended to assess the safety, tolerability and therapeutic activity of ORE1001 when administered by mouth as capsules. Ore selected ulcerative colitis as the initial indication for ORE1001 on the basis of multiple preclinical studies, although Ore believes that ORE1001 may also have efficacy in Crohn’s disease, the other major category of IBD. Ore currently anticipates that this trial will be completed in the third quarter of 2010.
In addition, during the third quarter Ore entered into a research agreement with the Armed Forces Radiobiology Research Institute (AFRRI) and the Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc. for ORE1001. Under the terms of this agreement, AFRRI will assess the utility of ORE1001 in preventing or treating adverse effects from exposure to ionizing radiation as part of their screening project funded by a National Institute of Allergy and Infectious Diseases (NIAID)-AFRRI interagency agreement.
The AFRRI agreement provides Ore with a means to evaluate ORE1001 as a potential countermeasure agent in treating radiation injury. ORE1001 has demonstrated beneficial effects in several animal models of gastrointestinal disease, including a model of radiation injury. Severe gastrointestinal injury can occur after exposure to ionizing radiation, such as from a nuclear accident or attack. AFRRI will perform testing in their established program investigating radiation effects and will share the data with Ore.