Celsion Updates Clinical Trial Data and Slashes 20% of Workforce

Published: Sep 09, 2015

Celsion Updates Clinical Trial Data and Slashes 20% of Workforce
September 9, 2015
By Mark Terry, BioSpace.com Breaking News Staff

Lawrenceville, N.J.-based Celsion Corporation announced today that it completed the integration of its June 2014 acquisition of EGEN, Inc., and as part of the consolidation, had cut 15 to 20 percent of its staff and annual operational costs.

In June 2014, Celsion, which focuses on cancer drug development, acquired Huntsville, Ala.-based EGEN, Inc., a privately-held company that develops nucleic acid-based therapeutics for cancer and other diseases. Celsion acquired EGEN’s Phase Ib DNA-based immunotherapy product, EGEN-001 and its therapeutic platform technologies, TheraPlas and TheraSilence.

The deal totaled $14 million, with $10.6 million upfront in Celsion common stock and $3.4 million in cash. An additional $30.4 million in potential milestone obligations are payable to EGEN.

The consolidation and reorganization appears to primarily be at the Huntsville facility. The clinical development, commercialization, including its Early Access Programs for ThermoDox, business development and administrative capabilities have been relocated to Lawrenceville, N.J.

In addition, Celsion released updates regarding its clinical development program for the company’s OVATION Study, a Phase Ib dose escalating trial that combines GEN-1 with neo-adjuvant therapies in patients recently diagnosed with ovarian cancer. That study expects to begin enrollment in the second half of 2015. The first site of the study is at the University of Alabama at Birmingham, and had already begun. Three more sites are expected soon.

One of the goals of the study it to determine a starting dose for a follow-up Phase I/II study that combines GEN-1 with Avastin and Doxil. It also plans to begin a second study in ovarian cancer using GEN-1 in combination with Avastin and Doxil in platinum-resistant ovarian cancer patients.

Also, Celsion is wrapping up a series of pre-clinical safety and efficacy trials with GEN-1 with standard of care to treat newly resected glioblastoma multiforme (GBM) brain cancer patients, and plans to start a third Phase I trial in 2016.

“Over the past 12 months, since our acquisition of EGEN, Inc., we have carefully evaluated our current organizational structure and collective management competencies to determine the most efficient path forward for our broad, diversified product pipeline,” said Michael Tardugno, chairman, president and chief executive officer of Celsion in a statement. “Our new organization will be both lean and focused on generating clinical data from our GEN-1 platform. As an IL-12 immunotherapy, GEN-1 has broad potential in multiple tumor types, and our clinical strategy is designed to accelerate its development, establish its clinical utility in various indications and drive it toward the market.”

has had a fairly volatile year, although, despite spikes, appears to be on an overall downward trend. Shares traded on Jan. 28, 2015 for $2.20, rose steeply to $3.15 on Feb. 20, then dropped on Mar. 16 to $2.49. Shares rose again to $3.15 on April 15, then dropped to $2.19 on July 8, and to $1.87 on Aug. 24. Currently shares are trading for $2.15.

The Maxim Group in a research note published yesterday gave Celsion a “buy” rating and set a target price of $12. HC Wainwright confirmed a “buy” rating and set a $8 price target back in May. On July 14, Zacks lowered its rating from a “hold” to a “sell.” BTIG Research analysts on July 13 set a “buy” rating and a $10 price target. And Cantor Fitzgerald repeated a “buy” rating in a research note on Aug. 6, with a $7 price target.

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