Regado Biosciences, Inc. Secures $51 Million Series E Financing

       Regado Biosciences, Inc. Secures $51 Million Series E Financing

New Investor Leads Round to Fund Phase 3 Development of REG1

PR Newswire

BASKING RIDGE, N.J., Dec. 19, 2012

BASKING RIDGE, N.J., Dec. 19, 2012 /PRNewswire/ --Regado Biosciences, Inc., a
privately held company leading the development of antithrombotic aptamers with
active control agents, announced it has secured a landmark $51 million Series
E financing. The round was led by new investor RusnanoMedInvest, a subsidiary
of the state-run Russian investment firm RUSNANO, and included participation
from another new, US-based investor, Baxter Healthcare's venture initiative,
Baxter Ventures. Existing investors Edmond de Rothschild Investment Partners,
Domain Associates, Quaker Partners, Aurora Funds and Caxton Advantage Life
Sciences Fund also participated in the round.

"We are proud to say this financing is among the largest private rounds to be
completed in 2012," said David J. Mazzo, PhD, President and CEO of Regado.
"We welcome new investors RusnanoMedInvest and Baxter Ventures as we advance
REG1 into Phase 3 development. We also thank our existing investors for their
continued confidence in our execution strategy and shared enthusiasm for
uncovering REG1's full potential. We believe the magnitude of this investment
and our continued ability to attract new investors is a testament to the
outstanding clinical results and potential game-changing therapeutic value we
have demonstrated to date for REG1."

Proceeds from the financing will support Regado's "REGULATE – PCI" Phase 3
clinical study of REG1. This is the company's lead development program for
REG1 in arterial thrombosis and is being developed for use in percutaneous
coronary intervention (PCI) in the acute coronary syndrome (ACS) population.
Regado is also pursuing an additional parallel development program for REG1
for use in Open Heart Surgery. While the vast majority of the funding will be
used for the Phase 3 development of REG1 for PCI, some funding will be used to
advance other development programs in the Regado pipeline such as REG1 for
TAVI (transaortic valve implantation) and REG3 in diabetic vasculopathy.

In the completed Phase 2b RADAR clinical study, REG1 demonstrated nearly
complete Factor IXa inhibition with a dose of 1 mg/kg of pegnivacogin and,
when followed by reversal with anivamersen, resulted in dose-dependent
reduction in both the rate of major bleeding events and the incidence of
ischemic events when compared to patients treated with heparin. REG1's Phase
2b results show trends which may indicate significant pharmacoeconomic
benefits, including improved administration convenience, faster onset of
action, instantaneous reversal, immediate sheath pull at the end of the PCI
procedure, faster patient ambulation, reduced need for closure devices,
improved facility and staff efficiency and better overall outcomes.

Dr. Mazzo concluded, "The groundbreaking data from our Phase 2b RADAR study
strengthened our belief that REG1 is the only anticoagulant available or in
development that can simultaneously decrease the incidence of ischemic and
bleeding events associated with PCI in the ACS population. Given that the
Phase 3 REGULATE-PCI program will resemble the Phase 2b in subject population,
endpoints, dosing and duration of follow-up, we fully expect to confirm REG1's
superior profile and paradigm-changing potential pertaining to the way
anticoagulation is practiced in the acute care setting."

About REGULATE – PCI
The Phase 3 program was designed based on the advice of leading physicians
active in the development of anticoagulants for PCI and information obtained
at a successful end-of-Phase 2 meeting with FDA. It will consist of a single,
mortality/morbidity study of REG1 that will examine standard ischemic
efficacy, including all cause death, stroke, non-fatal myocardial infarction
(MI) and urgent TVR, and safety (major bleeding) endpoints. Pharmacoeconomic
indicator endpoints will also be examined. Patients will be enrolled at ~500
sites worldwide with enrollment expected to complete 24 months after
initiation.

ABOUT REGADO BIOSCIENCES
Regado Biosciences, Inc. is a private biopharmaceutical company pioneering a
new therapeutic technology with the creation and development of proprietary
controllable aptamer drug systems. Each system comprises a
nuclease-stabilized RNA aptamer, the therapeutic effect of which can be
reversed partially or completely in real time by its specific and
complementary oligonucleotide active control agent. This technology is being
applied to injectable antithrombotics (including anticoagulants and
antiplatelet agents) in the acute and sub-acute care cardiovascular setting, a
multi-billion dollar world-wide market in need of drugs with improved safety
profiles and a greater degree of therapeutic control. The products in
Regado's pipeline are designed to act as optimized antithrombotics, uniquely
and concomitantly minimizing the risk of ischemia and bleeding, and, by
allowing patient specific tuning of the desired therapeutic effect, provide a
safe and unique approach to personalized medicine.

ABOUT REG1, REG2 and REG3
Regado's lead program, the anticoagulant system REG1, consists of two agents
both administered by IV bolus, the first being a potent highly selective
Factor IXa inhibitor (pegnivacogin) with the second being its complementary
active control agent (anivamersen). Anivamersen can be used to selectively
reverse (completely or partially) the anticoagulant effect of pegnivacogin.
REG1, poised to begin Phase 3 following a successful Phase 2b trial (the
RADAR trial), is intended for application in arterial thrombosis indications,
such as Acute Coronary Syndrome patients undergoing Percutaneous Coronary
Intervention. A clinical program in Open Heart Surgery [including coronary
artery bypass grafting (CABG) and valve repair/replacement] is also under
development. REG2, Regado's second product candidate, consists of a
subcutaneously administered depot formulation of pegnivacogin paired with the
IV bolus formulation of anivamersen. REG2 has completed single escalating
dose phase 1 clinical testing (the first successful subcutaneous application
of an aptamer in humans) and is planned to be studied in a multiple escalating
dose clinical trial. It is intended for use in venous thrombosis indications
such as venous thromboembolism (VTE) prophylaxis in patients undergoing
abdominal surgery. REG3, Regado's third program, consists of a specific GPVI
inhibitor and its active control agent (RB571 and RB515, respectively). REG3
is planned to enter phase 1 human clinical testing during 2013 with an initial
target indication of treating diabetic vasculopathies.

ABOUT APTAMERS
Pegnivacogin is a member of a class of compounds called aptamers. Aptamers
are single stranded oligonucleotides that adopt a specific conformation
enabling direct, specific inhibition of the targeted protein. A key unique
feature of aptamers derives from the fact that they are formed from nucleic
acids. As such, their pharmacologic activity can be controlled by a matched,
complementary oligonucleotide active control agent (the Watson-Crick base pair
complement of a fraction of the agent to be controlled), which can bind to the
aptamer, removing it from its target and reversing its biologic effects.
Anivamersen is the complementary specific active control agent of
pegnivacogin.

More information can be found at www.regadobio.com

Contact: Ellen McDonald, Chief Business Officer, Regado Biosciences,
1-908-580-2113, emcdonald@regadobio.com

Investor and Media Contact:
Joshua Drumm, Ph.D. / Andrew Mielach
Tiberend Strategic Advisors, Inc.
(212) 827-0020
jdrumm@tiberend.com
amielach@tiberend.com

SOURCE Regado Biosciences, Inc.

Website: http://www.regadobio.com
 
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