Coronado reported a net loss of $6.6 million, or $0.35 per share, for the first quarter of 2012 compared to a net loss of $22.5 million, or $4.71 per share, for the first quarter of 2011. Included in the net loss for the first quarter of 2011 was an in-process research and development (R&D) expense of $20.7 million in connection with the acquisition of the TSO (Trichuris suis ova or CNDO-201) related assets.
Research and development expenses were $4.6 million for the three months ended March 31, 2012 compared to $1.2 million for the three months ended March 31, 2011. General and administrative (G&A) expenses totaled $2.0 million for the three months ended March 31, 2012 compared to $0.6 million for the three months ended March 31, 2011. In the three months ended March 31, 2012, R&D included expenses related to the TSO and CNDO-109 clinical programs, and G&A included expenses related to the company's infrastructure growth, increased business activity and becoming a publicly-traded entity. At March 31, 2012, Coronado's cash and cash equivalents totaled $17.7 million.
In April 2012, Coronado received from Dr. Falk Pharma GmbH (Falk), its development partner, a recommendation from the independent data monitoring committee that conducted an interim analysis (blinded to Falk) of clinical data from the initial 120 patients in Falk's Phase 2 trial evaluating TSO in Crohn's disease. "The Company is pleased with this development and we are using the information and recommendations derived from the interim analysis to finalize the design of our planned Phase 2 trial of TSO in Crohn's disease," said Dr. Bobby W. Sandage, Jr., Coronado's President and CEO. "Because the committee noted a positive efficacy trend and no safety concerns in addition to its sample size recommendations, we are planning dosage and sample size adjustments to maximize the probability of observing a TSO-treatment effect. We have been focused on moving our drug candidates into large-scale clinical trials. Pending final discussions with the FDA, we currently plan to commence the trial in the third quarter of 2012 and to have top-line study results in the second half of 2013."
Recent Corporate Highlights:
- Signed a Collaboration Agreement with Falk and OvaMed GmbH (OvaMed) for the development of TSO for Crohn's disease and obtained exclusive rights and licenses under certain Falk patent rights, pre-clinical data and clinical data from Falk's clinical trials of TSO in Crohn's disease, including an ongoing Phase 2 clinical trial, for use in North America, South America and Japan
- Hosted an Analyst & Investor Event in New York City with key opinion leaders in the fields of immunology, gastroenterology and oncology
- Strengthened senior management team through appointment of Lucy Lu, M.D., as Executive Vice President and Chief Financial Officer and the promotion of Karin Hehenberger, M.D., Ph.D., to Executive Vice President and Chief Medical Officer
- Announced Phase 1 clinical trial results for TSO in Crohn's disease that demonstrated TSO is safe and well tolerated; oral presentation, entitled "Evaluation of Safety and Tolerability of Trichuris suis ova in Patients with Crohn's Disease," presented at the 8th International Congress on Autoimmunity
- Reported an Independent Data Monitoring Committee recommendation to continue the Falk Phase 2 Trial of TSO being conducted in Europe, noting no safety concerns and a positive efficacy trend; Falk adopted the committee's recommendations to increase the sample size and to conduct a subsequent interim analysis at the time the trial reaches approximately 250 patients
- Filed IND with the FDA for CNDO-109 to treat acute myeloid leukemia (AML); on track to initiate a Phase 1/2 allogeneic clinical trial for the treatment of patients with high risk AML in first complete remission in the second half of 2012
Coronado management will review its first quarter financial results and development programs via conference call and webcast today at 8:30 AM ET. To participate in the conference call, please dial (877) 312-5413 (toll free from the US and Canada), or (253) 237-1511 (for international callers). Investors may also access a live audio webcast of the call at www.coronadobiosciences.com on the Events & Webcasts page.
A replay of the webcast will be available shortly after the conclusion of the call. The webcast archive will remain available for one year. An audio replay will also be available shortly after the conclusion of the call and will be made available until May 23, 2012. The audio replay can be accessed by dialing (855) 859-2056 (toll free from the US and Canada), or (404) 537-3406 (for international callers) and entering Event ID 80148097.
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