Celldex (CLDX) Q1 Loss In Line, Revenues Beat, Shares Up

Celldex Therapeutics, Inc. (NASDAQ:CLDX) posted first-quarter 2017 loss of 28 cents per share, which was in line with the Zacks Consensus Estimate but wider than the year-ago loss of 35 cents per share.

Total revenue in the quarter rose 15.3% year over year to $1.5 million, beating the Zacks Consensus Estimate of $0.57 million. Revenues were generated mainly under the clinical trial collaboration with Bristol-Myers Squibb Company (NYSE:BMY) and the research and development agreement with Rockefeller University in the quarter.

Shares rose more than 3% in after-hours trading on Tuesday. However, Celldex Therapeutics’ shares are down 11.1% so far this year. This compares unfavorably with a 2% increase registered by the Zacks classified Medical - Biomedical and Genetics industry during this period.

Research and development expenses declined 5.6% from the year-ago period to $25.8 million. General and administrative spend declined 22.6% to $7.2 million.

At the Mar 31, 2017, Celldex had cash, cash equivalents and marketable securities of $167.0 million compared with $189.8 million as of Dec 31, 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.

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 data expected in the second quarter of 2018. In the melanoma phase II study, the company said it will present data from the single-agent cohort of glembatumumab vedotin in June at the annual meeting of the American Society of Clinical Oncology (ASCO). The study also includes 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 (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 expects to present data from the phase 1 potion of varlilumab/Opdivo combination study at ASCO in June.

With the Kolltan acquisition in Nov 2016, Celldex gained rights to two of Kolltan’s cancer pipeline candidates, CDX-0158 (phase I; refractory gastrointestinal stromal tumors/GIST and other KIT positive tumors) and CDX-3379 (to enter phase II in 2017 in solid tumors; being evaluated as a single agent and in combination with various other drugs like Erbitux, Tarceva, Zelboraf, and Herceptin). Celldex also acquired Kolltan’s multi-faceted TAM program.

Celldex carries a Zacks Rank #3 (Hold).

Stock to Consider

A better-ranked stock in the pharmaceutical sector is Akari Therapeutics, Plc (NASDAQ:AKTX) with a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Shares of Akari Therapeutics have risen 62.3% this year so far.

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