Celldex Therapeutics, Inc. CLDX declined 2.5%, following its earnings release on Nov 12. The company incurred a loss of 75 cents per share in third-quarter 2019, narrower than the Zacks Consensus Estimate of a loss of 84 cents but wider than the year-ago loss of 66 cents.
Total revenues in the quarter declined 42% year over year to $0.5 million and missed the Zacks Consensus Estimate of $0.94 million. The year-over-year decline was due to a decrease in revenues from the collaboration agreement with Bristol-Myers
BMY and contract with the International AIDS Vaccine Initiative.
Celldex’s share price performance has been disappointing so far this year. The stock has declined 21.5% against the
industry’s 1.4% growth.
Research and development expenses were down 6.7% year over year to $11.1 million in the quarter mainly due to lower personnel costs, and a decline in clinical study and contract manufacturing-related expenses. General and administrative expenses were $3.4 million, down 8.1% year over year, mainly attributable to lower personnel and marketing expenses.
As of Sep 30, 2019, Celldex had cash, cash equivalents and marketable securities of $72.9 million compared with $81.3 million as of Jun 30, 2019.
The company believes that its cash position as of the end of September plus anticipated net proceeds from future sales of its common stock under the agreement with Cantor will be adequate to fund working capital requirements as well as planned operations through 2020.
Celldex is focused on the development of CDX-1140 and CDX-3379. Although the candidates are in early to mid-stage studies, the company is progressing well with the studies.
On its third-quarter earnings call, the company announced that it completed the monotherapy arm of the phase I study, evaluating CDX-1140 in patients with recurrent, locally advanced or metastatic solid tumors and B cell lymphomas. A dose of 1.5 mg/kg of the candidate has been identified as the recommended dose for phase II study. The company will enroll patients with head and neck squamous cell carcinoma (HNSCC) in this study.
Meanwhile, another arm of the phase I study, evaluating CDX-1140 in combination with CDX-301, is progressing as expected. The company amended the phase I study design during the quarter to include a cohort, which will evaluate CDX-1140 in combination with Merck’s (
MRK Quick Quote MRK - Free Report) Keytruda in patients refractory to PD-1/PDL-1 treatment. Enrollment in the cohort is expected to start in the first quarter of 2020.
Currently, enrollment is underway in a phase II study, evaluating CDX-3379 in combination with Eli Lilly’s
LLY Erbitux, for the treatment of advanced head and neck squamous cell cancer. Interim data announced in June supported further evaluation of CDX-3379. Based on the data, Celldex expanded the patient population to focus on the development of CDX-3379 in biomarker selected patient population and has initiated enrollment of patients.
During the quarter, the FDA accepted an investigational new drug application filed by Celldex to initiate a phase Ia study to evaluate monoclonal antibody candidate, CDX-0159, in inflammatory diseases. The company expects to initiate the study by the end of the year.
Celldex currently carries a Zacks Rank #3 (Hold). You can see
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