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Celldex (CLDX) Shares Up as Q4 Loss Narrows; Sales Beat

Celldex Therapeutics, Inc.CLDX posted fourth-quarter 2016 loss of 30 cents per share, narrower than both the Zacks Consensus Estimate of a loss of 34 cents and the year-ago loss of 33 cents.

Total revenue in the fourth quarter of 2016 rose 5.6% year over year to $1.9 million, beating the Zacks Consensus Estimate of $1.09 million. Revenues were generated mainly under the clinical trial collaboration with Bristol-Myers Squibb Company BMY . However, the company recorded lower revenues under the research and development agreement with Rockefeller University in the quarter.

Shares rose 3% in after-hours trading on Wednesday, in response to the strong quarterly results. However, Celldex Therapeutics' shares are down 6.7% so far this year. This compares unfavorably with a 10.2% increase registered by the Zacks classified Biomed/Genetics industry during this period.

Research and development expenses inched up 2.9% from the year-ago period to $24.6 million. General and administrative spend rose 7.2% to $11.9 million.

At the end of 2016, Celldex had cash, cash equivalents and marketable securities of $189.8 million compared with $203.2 million as of Sep 30, 2016. Celldex expects that this cash plus anticipated proceeds from future sales of its common stock under the agreement with Cantor will be enough to fund working capital requirements and planned operations through 2018. However, the guidance assumes that Celldex will pay future Kolltan contingent milestones, if any, in stock and not cash.

Full-Year 2016 Results

Full-year 2016 loss per share was $1.27 per share, narrower than the Zacks Consensus Estimate of a loss of $1.32 as well as the year-ago loss of $1.31 per share.

Full-year 2016 revenues came in at $6.8 million, also beating the Zacks Consensus Estimate of $6.0 million and up 23.6% from the year-ago period.

Pipeline Update

Celldex's most advanced pipeline candidate is glembatumumab vedotin, currently being evaluated for the treatment of triple negative breast cancer (phase IIb - METRIC study) and metastatic melanoma (phase II). Enrolment in the METRIC study is expected to be completed in September this year. In the melanoma study, the company said it has added two new cohorts, a glembatumumab plus varlilumab arm - data expected in fall 2017 - and a glembatumumab plus checkpoint inhibitor arm, including either Bristol-Myers' Opdivo or Merck & Co, Inc.'s MRK Keytruda. At the call, the company mentioned that it may bring in a partner for glembatumumab.

Apart from glembatumumab vedotin, Celldex has several promising candidates in its pipeline, including varlilumab and CDX-1401 (phase II - multiple solid tumors) among others.

Varlilumab is being evaluated in combination with Opdivo in a phase II study that includes cohorts in five indications - colorectal cancer, ovarian cancer, head and neck squamous cell carcinoma, renal cell carcinoma and glioblastoma. Celldex plans to complete enrolment across all cohorts in the phase II portion of the study in the first quarter of 2018. Meanwhile, the company expects to present data from the phase 1 study of varlilumab/Opdivo combination study in mid-2017.

Meanwhile at the call, the company said that it is not advancing the phase I combination studies of varlilumab/Roche's RHHBY Tecentriq and varlilumab/Sutent in renal cell carcinoma to phase II.

In Nov 2016, the company acquired Kolltan Pharmaceuticals, Inc., a privately held, clinical-stage company. Following the acquisition, Celldex gained rights to two of Kolltan's cancer pipeline candidates - CDX-0158 and CDX-3379. Celldex also acquired Kolltan's multi-faceted TAM program.

Celldex Therapeutics, Inc. Price, Consensus and EPS Surprise

Celldex Therapeutics, Inc. Price, Consensus and EPS Surprise | Celldex Therapeutics, Inc. Quote

In Nov 2016, Celldex presented positive pre-clinical data on a new candidate, CDX-1140, a fully human antibody that targets CD40 and demonstrated potent agonist activity. Celldex expects CDX-1140 to be an important addition to the company's growing immunotherapy pipeline. Importantly, the company said that its plans to start clinical development this year.

Celldex carries a Zacks Rank #2 (Buy). You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here .

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.


The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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