U.S. Markets closed

Celldex's Q1 Loss Widens

Zacks Equity Research

Celldex Therapeutics, Inc.’s (CLDX) shares continued to decline after the company reported a wider-than-expected loss for the first quarter of 2014. Shares, which declined 2.4% immediately after the release of first quarter results, slipped a further 0.9% in the following trading session. Overall, shares were down 3.3%.

The company posted a loss of 33 cents per share in the first quarter of 2014, wider than the year-ago quarter loss of 23 cents and the Zacks Consensus Estimate of a loss of 26 cents per share.

First quarter revenues plunged 82.8% from the year-ago quarter to $0.4 million. Celldex recorded lower royalties from GlaxoSmithKline (GSK) for Rotarix due to the termination of its agreement with Glaxo. The Zacks Consensus Estimate for revenues for the reported quarter was nil.

Quarterly Details

R&D expenses increased 92.1% year over year to $27.1 million. This increase was attributable to the development of rindopepimut and glembatumumab vedotin and the expansion of the study on varlilumab.

G&A expenses increased 46% year over year to $4.6 million. This was primarily driven by higher personnel-related expenses, professional services and commercial planning costs for rindopepimut and glembatumumab vedotin.

Pipeline Updates

Celldex provided an update on its pipeline. The company continues to expect the patient enrolment for the phase III registration study (ACT IV) on rindopepimut for EGFRvIII (v3) positive glioblastoma multiforme (GBM.V) to be completed by mid-2014.

Meanwhile, Celldex is enrolling patients (both treatment naive and those refractory to Avastin) for its phase II study (ReACT) on rindopepimut for recurrent GBM. Data from this study is expected by the end of 2014.

In the second half of 2014, Celldex intends to initiate phase II studies on glembatumumab vedotin for metastatic melanoma and squamous cell lung cancer. The company is currently conducting a registration study (:METRIC) on glembatumumab for metastatic triple negative breast cancer that over-expresses the tumor associated marker glycoprotein NMB (gpNMB).

Additionally, Celldex has plans to start multiple phase I/II studies on varlilumab in combination with various agents in the second half of 2014.

Moreover, a pilot study on CDX-301 alone and in combination with Mozobil is slated to commence in the third quarter of 2014 for hematopoietic stem cell transplantation.

Celldex currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the biotech sector include Alexion Pharmaceuticals, Inc. (ALXN) and Gilead Sciences Inc. (GILD). Both carry a Zacks Rank #1 (Strong Buy).

Read the Full Research Report on CLDX
Read the Full Research Report on ALXN
Read the Full Research Report on GILD
Read the Full Research Report on GSK

Zacks Investment Research