Regado Biosciences, Inc. Announces Third Quarter 2014 Financial Results and Provides Corporate Update

BASKING RIDGE, N.J., Nov. 5, 2014 /PRNewswire/ -- Regado Biosciences, Inc. (Nasdaq: RGDO), today announced its third quarter 2014 financial results. A conference call and webcast to discuss the results will be held tomorrow, November 6, 2014, at 8:30 a.m. EST.

THIRD QUARTER 2014 FINANCIAL SUMMARY

Cash and cash equivalents at September 30, 2014, totaled $61.8 million compared to $30.8 million at December 31, 2013. Regado's net loss for the quarter ended September 30, 2014, was $21.1 million, or a net loss of $.59 per share, as compared to a net loss of $11.4 million, or a net loss of $1.43 per share, for the corresponding period in 2013 on both a basic and fully diluted basis.

Research and development expenses for the third quarter of 2014 were $17.7 million, compared to $9.6 million for the corresponding period in 2013. The increase in research and development expenses was primarily driven by the REGULATE-PCI clinical trial, which began in the third quarter of 2013. The clinical trial expenses for the quarter included site trial activities, data collection, Data and Safety Monitoring Board (DSMB) support and initial trial shutdown expenses. The increase also includes $0.7 million of restructuring charges associated with the reduction in force that was announced September 24, 2014. A write-down of clinical assets totaling $8.9 million is included in the third quarter 2014 results. The company has terminated the REGULATE-PCI trial and is in the process of closing down all associated activities.

General and administrative expenses for the third quarter of 2014 were $3.2 million, compared to $1.6 million for the corresponding period in 2013. The increase in general and administrative expenses included $1.1 million of restructuring charges associated with the reduction in force.

Corporate Updates

• REGULATE-PCI  On August 25, 2014, the Company announced the permanent termination of enrollment in its REGULATE-PCI Phase 3 trial for its lead program, Revolixys Kit. The decision was made based on a recommendation from the trial's DSMB following their analysis of the data from the first approximately 3,250 patients enrolled in what was intended to be a 13,200-patient trial comparing the safety and efficacy of Revolixys Kit with bivalirudin.
• Restructuring  On September 24, 2014, the Company announced a workforce reduction that commenced during the third quarter of 2014 and will be completed in the fourth quarter of 2014. This restructuring is associated with the termination of the REGULATE-PCI trial.
• Engagement of Bankers The Company announced the engagement of MTS Health Partners and Cowen & Co. to serve as strategic advisors in helping to identify strategic alternatives to maximize shareholder value.
• Change in Executive Management On October 10, 2014, the Company announced the appointment of Michael A. Metzger, president of Regado, to the additional post of chief executive officer and as a member of the Board of Directors. Mr. Metzger previously served as president and chief operating officer of Regado. He replaces David J. Mazzo, Ph.D., who resigned from the Company.

CONFERENCE CALL INFORMATION
Interested participants and investors may access the conference call by dialing (888) 347-1165 for domestic callers or (412) 902-4276 for international callers. The conference call will be webcast live under the investor relations section of the Regado website at www.regadobio.com and will be archived there for 60 days following the call.

ABOUT REGADO BIOSCIENCES

Regado Biosciences, Inc., is a development stage biotechnology company whose mission is to transform lives through the discovery and development of novel therapeutics. Regado applies its expertise to the development of therapies using actively controlled aptamer technology, which is designed to give physicians the ability to control the therapeutic effect in real time. More information can be found at www.regadobio.com.

Forward-Looking Statements:

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements reflect management's current expectations, as of the date of this press release, and involve certain risks and uncertainties. Forward-looking statements include statements herein with respect to financial projections and estimates and their underlying assumptions, future performance, the timing and amount of termination costs incurred in connection with our workforce reduction plan, the timing and amount of any decrease in annualized cash expenditures as a result of our workforce reduction plan, the timing for completion of the final closure of the REGULATE-PCI trial and outcome of the analysis of the unblinded database and the results of our ongoing efforts to identify and evaluate  strategic business alternatives. The Company's actual results could differ materially from those anticipated in these forward-looking statements as a result of various factors. Factors that could cause future results to materially differ from those projected in forward-looking statements include the timing and costs associated with our workforce reduction plan, the actual timing and costs associated with the final closure of the REGULATE-PCI trial, the timing and outcome of our unblinded database analysis and the outcome of our due diligence activities associated with exploring business strategic alternatives, as well as the "Risk Factors" described in the Company's Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 12, 2014, and in the Company's other periodic filings with the SEC. All forward-looking statements are expressly qualified in their entirety by this cautionary notice.

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