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GEN News Highlights : Sep 27, 2013

Regado Axes 15% of Staff, Focuses on Phase III Trial

Regado Biosciences said it will lay off 5 of its 32 full-time employees—about 15% of its workforce—just over a month after a disappointing initial public offering that raised less than what the company had hoped.

In an 8-K filing yesterday with the U.S. Securities and Exchange Commission, Regado said most of the affected employees “work in drug discovery roles at the company’s laboratory facility in North Carolina.” Regado also said the company needed to cut costs to continue moving into the pivotal clinical development phase of its furthest-advanced experimental drug.

“The goal of the company’s reduction in workforce is to enable the company to focus its management and financial resources on advancing its lead product candidate, REG1, in its single, open-label, 13,200-subject Phase [III] trial of REG1, or the REGULATE-PCI trial,” Regado stated.

Regado said Sept. 17 it enrolled its first patient in REGULATE-PCI, which is led by co-principal investigators John H. Alexander, M.D., of Duke University Medical Center; A. Michael Lincoff, M.D., of The Cleveland Clinic; and Roxana Mehran, M.D., of Mount Sinai School of Medicine. The Phase III trial will compare the effects of REG1 to bivalirudin in patients undergoing percutaneous coronary intervention (PCI) electively or for the treatment of unstable angina or non-ST elevated myocardial infarction (N-STEMI).

REG1 is a two-agent treatment consisting of highly selective Factor IXa inhibitor (pegnivacogin) and a complementary active control agent (anivamersen). Both are administered by IV bolus.

Regado shrunk its workforce some five weeks after completing an IPO that raised only $47 million, compared with the $70 million to $80 million it had hoped to raise for REGULATE-PCI. The company initially planned to sell five million shares at between $14 and $16 per share. But the stock launched on Aug. 22 with an initial share price of just $4, prompting the company to raise its number of offered shares to 10.75 million.

In December, Regado closed on $51 million of Series E venture financing led by new investor RusnanoMedInvest, a subsidiary of state-run Russian investment firm RUSNANO. Regado said at the time that “the vast majority” of the funding will be used for the Phase III development of REG1 for PCI, though some of the money was envisioned to advance other development programs, one of them REG1 for transaortic valve implantation (TAVI).

As a result of the layoffs, Regado said, it will incur about $254,225 in charges—cash charges of about $250,000 in severance costs, and $4,225 in non-cash, stock-based compensation charges. Those charges are expected to be recorded in the third quarter.

“The company believes that the reduction in workforce will result in annualized savings of approximately $625,000 beginning in the second quarter of 2014,” Regado stated.