BASKING RIDGE, N.J., Aug. 11, 2014 /PRNewswire/ -- Regado Biosciences, Inc. (Nasdaq: RGDO), a biopharmaceutical company focused on the Phase 3 clinical development of Revolixys™ Kit (previously known as REG1), its first-in-class, actively controllable antithrombotic drug system, today announced its second quarter 2014 corporate highlights and financial results. A conference call and webcast to discuss the results will be held August 12, 2014, at 8:30 a.m. EDT.
SECOND QUARTER 2014 FINANCIAL SUMMARYCash and cash equivalents at June 30, 2014, totaled $72.7 million compared to $30.7 million at December 31, 2013. Regado's net loss for the quarter ended June 30, 2014, was $21.4 million or a net loss of $.63 per share as compared to a net loss of $5.6 million or a net loss of $24.24 per share for the corresponding period in 2013 on both a basic and fully diluted basis.
Research and development expenses for the second quarter of 2014 were $18.5 million, compared to $4.3 million for the comparable 2013 period. The increase in research and development expenses was primarily the net result of the REGULATE-PCI clinical trial which began in Q3 2013. The clinical trial expenses include site start-up costs, patient reimbursement and clinical trial drug product. The company expects research and development expenses to be reduced during the period of the clinical hold which is currently in place.
General and administrative expenses for the second quarter of 2014 were $2.8 million, compared to $1.1 million for the comparable 2013 period. The increase in general and administrative expenses primarily reflected increased personnel as well as increased accounting, legal and other administrative costs associated with being a public company. The company expects general and administrative expenses to potentially increase during the remainder of the year in connection with the purported class action lawsuits and derivative lawsuit recently filed against the company.
Status of REGULATE-PCI On July 2, 2014, the Company announced that the Data Safety Monitoring Board, or DSMB, in agreement with the Company, was initiating a complete review of efficacy and safety data from the REGULATE-PCI trial. This review was initiated as a result of various serious adverse events, or SAEs, that were reported by certain site investigators at several sites around the world. As a result, the Company voluntarily suspended patient enrollment in the REGULATE-PCI trial until the DSMB completes its analysis and communicates its recommendations. In addition, on July 9, 2014, the United States Food and Drug Administration, or the FDA, informed the company that a clinical hold was placed on all patient enrollment and dosing of either study drug in the REGULATE-PCI trial. According to the FDA, this action was taken to formalize the involvement of the FDA in any decision to re-initiate enrollment and dosing in the trial in the future. During this period of data collection and analysis the Company and the principal investigators of the trial remain blinded. It is anticipated that the DSMB will complete their analysis by early September 2014.
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. 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 BIOSCIENCESRegado 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, Revolixys™ Kit, is a two-component system consisting of pegnivacogin, an anticoagulant aptamer specifically targeting coagulation Factor IXa, and its complementary oligonucleotide active control agent, anivamersen. Revolixys™ Kit is currently being evaluated in the REGULATE-PCI trial, a worldwide Phase 3 trial comparing safety and efficacy of Revolixys Kit vs. bivalirudin in 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 financial projections, guidance, estimates and their underlying assumptions, future performance, the progress of the REGULATE-PCI trial, enrollment in the REGULATE-PCI trial, the prospects for the completion of the REGULATE-PCI trial and any regulatory approval of Revolixys™ Kit and the successful commercialization of Revolixys™ Kit if approved. 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 outcome of the DSMB's currently ongoing analysis of REGULATE-PCI safety and efficacy data, the content of the DSMB's recommendations following such analysis, and the ultimate decision of the FDA to remove the clinical hold from the REGULATE-PCI trial, 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. 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 disclaims any obligation, to update, revise or correct any of the forward-looking statements, whether as a result of new information, future events or otherwise.
Investor Relations Contact:
Don Elsey, CFO
Regado Biosciences, Inc.
Regado Biosciences, Inc.
CONSOLIDATED BALANCE SHEETS
(In thousands, except share and per share data) June 30,
2013AssetsCurrent assets:Cash and cash equivalents
9,4626,211Total current assets
84,78439,128Property and equipment, net
209108Intangible assets, net
2,0421,823Other non-current assets
45,753Liabilities and Stockholders' EquityCurrent liabilities:Accounts payable
3019Current portion of long-term debt
4,5432,000Total current liabilities
17,26811,552Commitments and contingenciesStockholders' equity:Series F convertible preferred stock; stated value of $1,000, 1,000,000 shares authorized, 10,000 and
shares issued and outstanding at June 30, 2014 and December 31, 2013, respectively
24,832—Common stock, $0.001 par value; 500,000,000 shares authorized; 33,609,212 and 21,310,614 shares
issued and outstanding at June 30, 2014 and December 31, 2013, respectively
(182,258)(144,979)Total stockholders' equity
74,30834,201Total liabilities and stockholders' equity
Regado Biosciences, Inc.
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
(In thousands, except share and per share data) For the Three
June 30,For the Six
June 30,2014201320142013Total revenue$
8212;Operating expenses:Research and development
(18,505)(4,314)(31,621)(6,047)General and administrative
(2,838)(1,133)(5,386)(2,576)Total operating expenses
(21,343)(5,447)(37,007)(8,623)Loss from operations
(21,343)(5,447)(37,007)(8,623)Other (expense) income:Interest income
—60—60Total other expense
(8,892)Deemed dividend related to beneficial conversion feature of
Series F convertible preferred stock
——(14,840)—Net loss attributable to stockholders(21,432)(5,602)(52,120)(8,892)Net loss attributable to preferred stockholders
1,26973;__2,032___Net loss attributable to common stockholders- basic and diluted
(8,892)Comprehensive loss applicable to all stockholders(21,432)(5,602)(52,120)(8,892)Loss per share - basic and diluted
(39.31)Weighted-average common shares - basic and diluted
|SOURCE Regado Biosciences, Inc.|
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