Celldex (CLDX) Q3 Loss Narrows, Revenues Beat, Shares Up

Celldex Therapeutics, Inc. (NASDAQ:CLDX) incurred third-quarter 2017 loss (adjusted for one-time items) of 14 cents per share, which was narrower than the Zacks Consensus Estimate of a loss of 24 cents as well as the year-ago loss of 29 cents per share. Lower costs and higher revenues led to the narrower loss in the quarter.

Total revenue in the quarter rose 77.3% year over year to $3.9 million, beating the Zacks Consensus Estimate of $1.17 million. The manufacturing service agreement with the International AIDS Vaccine Initiative led to higher revenues in the quarter.

Shares of the biotech company rose 10% in after-hours trading on Tuesday.

However, the stock has not done too well this year so far. It has declined 26% year to date against the 3.3% increase registered by the industry.

Research and development expenses declined 12.4% from the year-ago period to $21.9 million due to lower varlilumab contract manufacturing and clinical studies expenses. General and administrative spend declined 4.3% to $5.3 million due to lower commercial planning costs and stock-based compensation expenses.

As of Sep 30, 2017, Celldex had cash, cash equivalents and marketable securities of $140.5 million compared with $154.0 million as of Jun 30, 2017. Celldex expects that this cash plus $11.3 million in net proceeds raised from sales of its common stock this month under the agreement with Cantor will be enough to fund working capital requirements and planned operations through 2018.

Pipeline Update

Celldex’s most advanced pipeline candidate is antibody drug conjugate, 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 key METRIC study closed this August, with data expected in the second quarter of 2018. In the melanoma study, Celldex added two new cohorts, a glembatumumab plus varlilumab arm and a glembatumumab plus checkpoint inhibitor arm, including either Bristol-Myers’ (NYSE:BMY) Opdivo or Merck’s (NYSE:MRK) Keytruda.

Apart from glembatumumab vedotin, other promising candidates in its pipeline, include varlilumab and CDX-014 (phase I—advanced renal cell carcinoma) 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.

Along with the earnings release, Celldex announced data from a phase II study evaluating a combination of glembatumumab vedotin and varlilumab in melanoma patients who have progressed on checkpoint inhibitors. Of the 31 eligible patients only one had a confirmed partial response. Another two patients had partial response at a single timepoint. The median progression-free survival was 2.6 months, with 52% of patients having stable disease for six weeks or more. The full data set will be presented at the Society for Immunotherapy of Cancer (SITC) annual meeting this week.

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, a phase II study on CDX-3379 in patients with recurrent/metastatic head and neck squamous cell cancer who are refractory to Eli Lilly (NYSE:LLY) /Bristol-Myers’ Erbitux is expected to be initiated by year end.

Celldex carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Wall Street’s Next Amazon (NASDAQ:AMZN)

Zacks EVP Kevin Matras believes this familiar stock has only just begun its climb to become one of the greatest investments of all time. It’s a once-in-a-generation opportunity to invest in pure genius.

Click for details >>