Some investors might love biotech stocks for their lottery ticket-like returns when a company strikes medical gold. A lottery ticket, however, costs only a buck or two, while getting a biotech company wrong can hurt a lot more than that. Case in point: Celldex Therapeutics (NASDAQ:CLDX) shares lost almost half of their value this morning, after the drug maker reported that the Company’s randomized, Phase 2b METRIC Study of glembatumumab vedotin compared to Xeloda® (capecitabine) in patients with metastatic triple-negative breast cancers that overexpress gpNMB failed to meet its primary endpoint.
Celldex CEO Anthony Marucci commented, “Triple-negative breast cancer is a very difficult disease to treat, and we are extremely disappointed for patients that the METRIC Study was not successful […] On behalf of Celldex, I want to express our gratitude to the METRIC investigators, patients and families who participated in this study. Based on these results, we have also made the decision to discontinue the glembatumumab vedotin program across all indications and are currently prioritizing our pipeline, which includes five candidates in ongoing clinical studies. In line with this, we are evaluating our operational and workforce needs to extend our financial resources and direct them to continued pipeline advancement. Once we solidify these plans, we intend to update investors.”
Celldex’s clinical-stage pipeline includes the following compounds:
- Varlilumab, a CD27 agonist, currently completing a Phase 2 study in combination with Opdivo® in multiple indications with data expected to be presented at multiple medical meetings in 2018;
- CDX-3379, an ErbB3 inhibitor, which is expected to complete enrollment in the first stage of a Phase 2 study in combination with Erbitux® in head and neck cancer during the third quarter of 2018;
- CDX-014, a TIM-1 targeted agent, which is actively enrolling patients in a Phase 1 study in renal cell and ovarian clear cell carcinomas;
- CDX-1140, a CD40 agonist, which is actively enrolling patients in a Phase 1 study in various solid tumors; and,
- CDX-301, a dendritic cell mobilizer, currently being studied in an investigator-sponsored study in combination with radiation therapy in advanced non-small cell lung cancer. Data from this study were presented in a plenary session at the AACR Annual Meeting on Sunday, April 15, 2018.
Celldex believes its pipeline prioritization and organizational restructuring efforts will extend financial resources beyond the guidance issued in the Company’s year-end 2017 earnings press release and associated filings. The Company plans to provide revised guidance in its first quarter 2018 financial results in early May.
When it comes to Wall Street’s bet, the odds were on this biotech player, with TipRanks analytics showcasing CLDX as a Strong Buy. Out of 5 analysts polled in the last 12 months, 4 are bullish on Celldex stock while one remains sidelined.