Regado Biosciences announces year-end 2013 financial results and corporate highlights

Print 12 March 2014

BASKING RIDGE, N.J., March 12, 2014 /PRNewswire/ -- Regado Biosciences, Inc. (Nasdaq: RGDO), a biopharmaceutical company focused on the late-stage, Phase 3 clinical development of its first-in-class, actively controllable antithrombotic drug system, REG1, today announced its year-end 2013 corporate highlights and financial results. A conference call and webcast to discuss the results will be held March 13 at 8:30 a.m. EDT.

David J. Mazzo, Ph.D., Chief Executive Officer of Regado Biosciences, commented, "Last year was a remarkable and truly formative year for Regado. We evolved from a private company to a publicly traded company, grew our executive team, board of directors and medical advisory board by adding new expertise and capacity, and initiated our global REGULATE-PCI Phase 3 clinical trial. Enrollment is on track, and we are planning for the first interim analysis to take place during April of this year, as expected. Given the groundbreaking results from our Phase 2b study, we believe that the REGULATE-PCI (Phase 3) trial has a high probability of clinical and regulatory success and that REG1 could provide a new standard of care for patients undergoing PCI therapy."

YEAR-END 2013 FINANCIAL SUMMARY

Cash and cash equivalents at Dec. 31, 2013, totaled $30.7 million compared to $14.8 million at Dec. 31, 2012.  In addition, on Jan. 31, 2014, the Company raised an additional $20 million of gross proceeds in a private placement of common stock to new and existing investors. The company believes that the net proceeds of this offering, together with its existing working capital, will be sufficient to fund the REGULATE-PCI trial through the second interim analysis, which is expected to occur by the end of the third quarter of 2014.   

Regado's net loss for the year ended Dec. 31, 2013, was $34.4 million or a net loss of $4.59 per share as compared to a net loss of $13.1 million or a net loss of $59.03 per share for the corresponding period in 2012 on both a basic and fully diluted basis.

CORPORATE HIGHLIGHTS

• Successfully completed IPO and listing on the NASDAQ Capital Market: In late summer, Regado completed an IPO which resulted in net proceeds to the Company of approximately $41.1 millionand began trading on the NASDAQ Capital Market on Aug. 22, 2013, under the trading symbol "RGDO". 
• First patient enrolled in REGULATE-PCI Phase 3 clinical study of REG1: In September, Regado initiated its REGULATE-PCI clinical trial, a Phase 3 superiority study to compare the effects of Regado's REG1 to bivalirudin. This trial is expected to enroll 13,200 patients with enrollment completion targeted for the fall of 2015 and top-line data planned for the end of 2015.
• Strengthened Board of Directors: In the fourth quarter, Michael Mendelsohn, M.D., and Pierre Legault were appointed to the company's board of directors. Dr. Mendelsohn contributes significant cardiovascular therapeutics expertise, large pharmaceutical experience and academic achievement to the Company. Previously, Dr. Mendelsohn served as Senior Vice President and Global Franchise Head for Cardiovascular Diseases at Merck & Co. Prior to joining Merck in 2010, Dr. Mendelsohn spent 17 years at Tufts Medical Center, where he served as the first-ever Chief Scientific Officer and the Executive Director of the center's Molecular Cardiology Research Institute. Mr. Pierre Legault brings broad executive management experience, including 30 years of executing creative financing strategies, driving corporate development and constructing value-driving transactions for international biotechnology and pharmaceutical companies. Additionally, Mr. Legault has significant experience serving on boards of directors and audit committees of public companies. Mr. Legault is currently the Chief Executive Officer of NephroGenex, a late-stage, publicly traded biotech company, where he was previously Executive Chairman.
• Addition to the executive leadership team: In December, Regado appointed Michael A. Metzgeras President and Chief Operating Officer to oversee corporate and business development strategy as well as other key business functions. Mr. Metzger was previously Executive Vice President and Chief Operating Officer at Mersana Therapeutics and has nearly 20 years of experience within the life sciences sector.
• Notable interventional cardiologist joined medical advisory board: Deepak L. Bhatt, M.D., the Executive Director of Interventional Cardiovascular Programs at Brigham and Women's Hospital Heart and Vascular Center, was appointed to the medical advisory board. Dr. Bhatt has expertise in cardiovascular intervention and years of experience leading international cardiovascular clinical trials. 
• Additional Phase 2b RADAR results published: Further data from the Company's completed RADAR trial, demonstrating the safety of early sheath removal in patients treated with REG1, were published in the Journal of Invasive Cardiology.
• Broadened the patent portfolio protecting the core technology platform:  Regado received the issuance of U.S. patent 8,586,524, extending the patent coverage beyond nucleic acid-based modulators to now include peptide-, polypeptide- and protein-based control agents for the modulation of aptamer-based anticoagulants.
• IND acceptance for REG2: On Dec. 10, 2013, the U.S. Food and Drug Administration accepted the investigational new drug (IND) application for REG2, for which the Company plans to conduct additional clinical testing in sub-acute venous thrombosis indications in the future.
• REG1 designated by the FDA as a Fast Track Development Program: In March of 2014, REG1 for use in PCI was given Fast Track designation by the FDA.  The FDA's Fast Track process is designed to facilitate the development and expedite the review of drugs to treat serious conditions that fill an unmet medical need, with the overall goal of getting new drugs to patients earlier.  

Since initiation of the REGULATE-PCI study in September 2013 in the enzyme negative PCI patient population, the company has continued to enroll patients as planned. During 2014, a total of three interim analyses will be conducted based on the achievement of specific clinical enrollment milestones (1,000 pts., 3,300 pts. and 6,600 pts., respectively). After the enrollment of 1,000 patients, the Data Safety Monitoring Board (DSMB) will perform a general safety evaluation and, barring any identified safety issues, can authorize opening enrollment to all (enzyme negative and enzyme positive) PCI patients, excluding STEMI patients. This initial interim analysis is expected to take place early in the second quarter of 2014. The DSMB will also conduct analyses when 25% and 50% of patients have been enrolled in the third and fourth quarters of 2014, respectively.

CONFERENCE CALL INFORMATION
Interested participants and investors may access the conference call by dialing 877-870-4263 for domestic callers or 412-317-0790 for international callers. An audio webcast will be accessible via the Investor Relations section of the Regado website, www.regadobio.com, and will be archived there for 60 days following the call. 

ABOUT REGADO BIOSCIENCES
Regado Biosciences, Inc., is a biopharmaceutical company focused on the discovery and development of novel, oligonucleotide-based actively controllable therapeutics. Our initial focus is on applications in the acute and sub-acute cardiovascular therapeutic area. 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 currently being evaluated in the REGULATE-PCI trial, a worldwide Phase 3 study enrolling 13,200 patients with acute coronary syndromes (ACS) undergoing percutaneous coronary intervention (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 and enhance the patient experience, provide direct therapeutic control to physicians and reduce overall treatment costs. More information can be found at www.regadobio.com.

For more information on REGULATE-PCI, please visit:
http://www.clinicaltrials.gov/ct2/show/NCT01848106  

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 the timing of the REGULATE-PCI trial, the effect of the FDA's Fast Track designation for REG1, and the timing of and prospects for any regulatory approval of REG1. 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 "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. You are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date of this release. The Company has no obligation, and expressly disclaim any obligation, to update, revise or correct any of the forward-looking statements, whether as a result of new information, future events or otherwise.

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