Celldex (CLDX) Q2 Loss Narrows, Revenues Beat, Shares Up

Celldex Therapeutics, Inc. (NASDAQ:CLDX) incurred second-quarter 2017 loss of 23 cents per share, which was narrower than the Zacks Consensus Estimate of a loss of 25 cents as well as the year-ago loss of 32 cents per share. Lower costs and higher revenues led to the narrower loss in the quarter.

Total revenue in the quarter rose 171.4% year over year to $3.8 million, beating the Zacks Consensus Estimate of $0.82 million. The manufacturing service agreement with the International AIDS Vaccine Initiative led to higher revenues in the quarter.

Shares of the biotech company rose 4.3% in after-hours trading on Tuesday.

However, the stock has not done too well this year so far. It has declined 27.7% year to date against the 9.7% increase registered by the industry.

Research and development expenses declined 2.7% from the year-ago period to $25.0 million. General and administrative spend declined 16.7% to $6.5 million.

As of Jun 30, 2017, Celldex had cash, cash equivalents and marketable securities of $154.0 million compared with $167.0 million as of Mar 31, 2017. Celldex expects that this cash plus anticipated proceeds from the 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 in cash.

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, with top-line data expected in the second quarter of 2018.

Data from the phase II metastatic melanoma study of glemba, as a single agent, was presented in June at the annual meeting of the American Society of Clinical Oncology (ASCO). Glemba performed well in the single agent setting with 11% response rate, a 52% disease control rate and a median duration of response of six months in patients who have failed three or four prior lines of therapy. The study also includes two new cohorts, a glembatumumab plus varlilumab arm - data expected by year end - and a glembatumumab plus checkpoint inhibitor arm, including either Bristol-Myers Squibb Company’s (NYSE:BMY) Opdivo or Merck & Co, Inc.’s (NYSE:MRK) Keytruda.

Apart from glembatumumab vedotin, Celldex has several promising candidates in its pipeline, including varlilumab and CDX-014 (phase I—advanced renal cell carcinoma) among others.

Varlilumab is being evaluated in combination with Bristol-Myers 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 presented data from the phase 1 potion of varlilumab/Opdivo combination study at ASCO in June. The data showed that the combination was well tolerated at all tested dose levels without any increased autoimmunity or inappropriate immune activation.

With the Kolltan acquisition in Nov 2016, Celldex gained rights to two of Kolltan’s cancer pipeline candidates, CDX-0158 and CDX-3379. While CDX-0158 is being evaluated in a phase I study for refractory gastrointestinal stromal tumors/GIST and other KIT positive tumors (data expected by year end), a phase II study on CDX-3379 in patients with recurrent/metastatic head and neck squamous cell cancer who are refractory to Eli Lilly & Company (NYSE:LLY) /Bristol-Myers’ Erbitux is expected to be initiated in the fourth quarter

Celldex carries a Zacks Rank #4 (Sell).

You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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