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Regado Biosciences, Inc. (RGDO) Announces Third Quarter 2013 Results


11/7/2013 6:51:49 AM

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BASKING RIDGE, N.J., Nov. 7, 2013 /PRNewswire/ -- Regado Biosciences, Inc. (Nasdaq: RGDO), a biopharmaceutical company focused on the late-stage clinical development of its first-in-class, actively controllable antithrombotic drug system, REG1, today announced its third quarter 2013 corporate and financial results. A conference call and webcast to discuss the third quarter 2013 results will be held today at 8:30 a.m. Eastern Time.

Today's third quarter 2013 update marks Regado's first financial reporting period as a publicly traded company following its initial public offering (IPO) effective on August 21, 2013. Highlights from the quarter include:

  • Successful IPO and Exercise of Over-Allotment Option: On August 27, 2013, Regado consummated its initial public offering of 10,750,000 shares of its common stock at a price to the public of $4.00 per share. Subsequently, on September 6, 2013, Regado announced the exercise of the over-allotment option granted to the underwriters to purchase 921,500 additional shares of common stock at a public offering price of $4.00 per share. Inclusive of the underwriters' overallotment, Regado received net proceeds of $41.1 million after deducting underwriting discounts of $3.3 million and offering costs approximated at $2.3 million.
  • Initiation of REGULATE-PCI Phase 3 Clinical Study of REG1: On September 17, 2013, Regado announced the enrollment of the first patient in its REGULATE-PCI clinical trial. The REGULATE-PCI clinical trial is a Phase 3, PROBE design (Prospective, Randomized, Open-label, Blinded-Endpoint) superiority study comparing the effects of Regado's REG1 to bivalirudin in patients undergoing percutaneous coronary intervention (PCI) electively or for the treatment of unstable angina (UA) or non-ST elevated myocardial infarction (N-STEMI). The REGULATE-PCI trial is expected to enroll 13,200 patients at approximately 500 investigational sites worldwide, and, if successful, the trial will serve as the basis for product registration applications throughout the world.
  • Appointment of Michael Mendelsohn, M.D. to Board of Directors: On November 5, 2013, Regado appointed Michael E. Mendelsohn, M.D., to the Company's Board of Directors, adding a world-renowned leader in cardiovascular research and the former Global Head of Cardiovascular Diseases for Merck & Co. to its leadership team.

David J. Mazzo, Ph.D., President and CEO of Regado Biosciences, commented, "The third quarter of 2013 was a truly transformational period for Regado as we accomplished two significant milestones that will have a long-lasting, positive impact on our company our successful initial public offering and the initiation of our global REGULATE-PCI Phase 3 clinical trial. Looking ahead, we are intently focused on the advancement of our REGULATE-PCI clinical trial as we target the enrollment of the 1000th patient during the second quarter of 2014. If REG1 achieves the successful results we expect, this trial could pave the way for REG1 to become the first major improvement in efficacy in more than a decade among anticoagulants used in PCI, potentially providing a new standard of care for anticoagulant use in PCI treatments."

THIRD QUARTER 2013 FINANCIAL SUMMARY
Regado's net loss for the third quarter ended September 30, 2013 was $11.4 million or a net loss of $1.43 per share, as compared to a net loss of $2.7 million or a net loss of $12.28 per share for the corresponding period in 2012, on both a basic and fully diluted basis.

Cash and cash equivalents at September 30, 2013 totaled $43.5 million compared to $14.8 million at December 31, 2012. Cash and cash equivalents at September 30, 2013 comprise of proceeds from the Company's initial public offering and remaining proceeds from its Series E financing in December 2012.

CONFERENCE CALL AND WEBCAST
Regado's senior management team will host a conference call and webcast to discuss its third quarter 2013 corporate and financial results today at 8:30 a.m. ET.

Interested participants and investors may access the conference call by dialing (877) 870-4263 (U.S.), (855) 669-9657 (Canada) or (412) 317-0790 (international). An audio webcast will be accessible via the Investors section of the Regado website, www.regadobio.com.

A telephonic replay of the call will be available for 90 days beginning approximately one hour following the end of the conference call. Access numbers for this replay are (877) 344-7529 (U.S./Canada) and (412) 317-0088 (international); conference ID: 10036564. The webcast replay will remain available for 90 days in the Investors section of the Regado website.

ABOUT REGADO BIOSCIENCES
Regado Biosciences, Inc. is a biopharmaceutical company focused on the development of novel, first-in-class, actively controllable antithrombotic drug systems for acute and sub-acute cardiovascular indications. Regado is pioneering the development of two-component drug systems consisting of a therapeutic aptamer and its specific active control agent. The company's lead product candidate, REG1, is a two-component system consisting of pegnivacogin, an anticoagulant aptamer specifically targeting coagulation Factor IXa, and its complementary oligonucleotide active control agent, anivamersen. REG1 is being developed for use in patients with a wide variety of acute coronary syndromes, or ACS, undergoing a percutaneous coronary intervention, or PCI, a hospital-based procedure used to mechanically open or widen obstructed coronary arteries. Regado's actively controllable product candidates have the potential to improve patient outcomes, enhance the patient experience and reduce overall treatment costs. More information can be found at www.regadobio.com.

For more information on Regado's Phase 3 REGULATE-PCI clinical study, please visit: http://www.clinicaltrials.gov/ct2/show/NCT01848106?term=Regado&rank=1

Cautionary Note Regarding Forward-Looking Statements
This report contains forward-looking statements. All statements other than statements of historical facts contained in this report, including statements regarding the timing of the reduction in workforce, the charges to be incurred and the estimated cost-savings are forward-looking statements. The words "anticipate," "believe," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "will," "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These statements are subject to certain risks and uncertainties that could cause actual results to differ materially from any future results, performance or achievements expressed or implied by the forward-looking statements. Given these uncertainties, you should not place undue reliance on these forward-looking statements. These forward-looking statements represent our estimates and assumptions only as of the date of this report and, except as required by law, we undertake no obligation to update or review publicly any forward-looking statements, whether as a result of new information or future events.

Contact:
Tiberend Strategic Advisors, Inc.

Investors - Joshua Drumm, Ph.D.
jdrumm@tiberend.com; (212) 375-2664

Media - Andrew Mielach
amielach@tiberend.com; (212) 375-2694

SOURCE Regado Biosciences, Inc.



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