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Regado CEO sees IPO as a Success

Despite discounted offering, investors warm to biotech as it starts pivotal trial ahead of schedule.

MARIE DAGHLIAN

The Burrill Report

Shares of the cardiovascular drug developer Regado Biosciences surged 95 percent in the month since the company completed its IPO. Investors are warming to the company as analysts initiate coverage with strongly positive recommendations and the company enrolled the first patient in a large late-stage trial of its lead experimental combination drug system for use during coronary artery surgery.

When the New Jersey-based company went public in mid-August, however, it had to slash its target price and more than double the number of shares it planned to offer in order to raise about $47 million. While some saw this as a lack of investor interest during a time when the market was in the midst of a biotech IPO fever—especially for “sexy” stories like gene therapy, epigenetics, and cancer stem cells—David Mazzo, president and CEO of Regado, has a different take.

Mazzo believes the IPO was a success because it achieved its two primary objectives: raising enough money to begin a late-stage trial and allowing the company to tap funding sources available only to public companies.

“Moving into this phase 3 trial is what the IPO was all about,” says Mazzo. And he is pleased the company has begun the late-stage trial, enrolling the first patient two weeks ahead of schedule. The trial, expected to enroll 13,200 patients in about 500 clinical sites worldwide, is the pivotal test of its lead candidate REG1.

REG1 is an aptamer-based two drug system that pairs a Factor IXa inhibitor anticoagulant and its specific active control agent. The idea is to give the doctor ultimate control in regulating the risk of ischemia, the restriction of blood supply to the tissues, and the risk of excessive bleeding during angioplasty and other coronary interventions.

The trial, which Regado will run through its network of academic investigators in the United States and contract research organizations globally, is expected to be completed in 2015. Interim results on the first 1,000 patients are expected during the second quarter of 2014. It will be expensive and Mazzo plans on raising money again before it is completed.

Mazzo sees potential for REG1 as a blockbuster and as the gold standard in standard of care for coronary artery procedures. The compound has shown consistently positive results in mid-stage trials compared to Angiomax from The Medicines Company, the current standard of care.

Mazzo says there’s no competition for REG1, which is backed by a solid patent estate. Its advantage, he says, is the claim it can make about controlling the reversibility of anticoagulation. “We actually administer our second agent at the end of the procedure, which gives the physician the ability to readjust anticoagulation in real time to any level they want,” says Mazzo. “It’s like having a tuner on the anticoagulation, dialing it up or down based upon the guidance we’ll get in the phase 3 trial and also upon the physician’s interpretation of the needs of the patient.”

With REG1, Regado will be offering personalized medicine, adjusted in real time to suit the patient at that given situation, and backed up with well-protected IP that can change the outcomes for patients suffering coronary events. “I think we’re pretty damn sexy,” says Mazzo.



September 20, 2013
http://www.burrillreport.com/article-regado_ceo_sees_ipo_as_a_success.html

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