Celldex Therapeutics, Inc.'s Most Important Takeaway From Q3 Isn't a Number

Investors view quarterly updates from clinical-stage biotechs in a very different way than they do for other companies. The bottom line isn't nearly as important for these small biotechs as are pipeline progress and cash position.

That was certainly the case for Celldex Therapeutics (CLDX -2.78%) when it announced second-quarter results in August. And it's still true now, with Celldex reporting its third-quarter results before the market opened on Tuesday. Here are the highlights.

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Celldex Therapeutics results: The raw numbers

Data source: Celldex Therapeutics. 

What happened with Celldex Therapeutics this quarter?

Celldex posted significantly higher revenue in the third quarter of 2017 as compared to the prior-year period. This increase stemmed mainly from manufacturing service agreements with the International AIDS Vaccine Initiative and Frontier Biotechnologies, Inc. 

Although the company again reported a big loss, its bottom line looked a little better than the third quarter of 2016. This was largely a factor of the increase in revenue. Celldex also spent less than it did in the prior-year period. Research and development expenses dropped 12.4% year over year to $21.9 million. The company reported third-quarter general and administrative costs of $5.3 million, a 24.3% decrease from the same period in 2016.

Celldex ended the third quarter with cash, cash equivalents, and marketable securities totaling $140.5 million. The biotech used $24.4 million during the third quarter to fund operations. This was offset partially by an influx of $11.2 million in cash from a stock offering made under the company's existing agreement with Cantor Fitzgerald.

The most significant milestone for Celldex during the third quarter was the completion of enrollment in the phase 2b Metric study of glembatumumab vedotin (glemba) in patients with metastatic triple negative breast cancers that overexpress gpNMB. Overexpression of the protein gpNMB is linked to several tumor types and is highly expressed in triple-negative breast cancer. 

What management had to say

Celldex co-founder and CEO Anthony Marucci referenced the completion of enrollment in the Metric study in his comments accompanying the quarterly results:

We believe glemba holds considerable promise as a potential new targeted therapy for patients with this devastating disease and continue to look forward to top-line data from [the Metric] study in the second quarter of 2018. In early October, Dr. Margo Heath-Chiozzi joined Celldex to lead our global regulatory strategy. With nine product approvals under her leadership, Dr. Heath-Chiozzi brings an exceptional command of the regulatory environment and will play an important role in defining potential approval paths for glemba and our earlier pipeline.

Marucci added, "We look forward to a busy end of year as we prepare for the glemba data read out and advance multiple earlier stage studies, including the initiation of two new studies by year-end -- a Phase 2 study of CDX-3379 in recurrent head and neck squamous cell cancer and a Phase 1 study of CDX-1140 in solid tumors."

Looking forward

Celldex stock continues to be highly volatile, with shares rising in September but falling in October. That's not unusual for a clinical-stage biotech. These fluctuations aren't important in the grand scheme of things. What really matters for Celldex is how its experimental drugs perform in clinical studies.

The primary thing to watch is the Metric study. As Marucci said, Celldex anticipates announcing top-line data from the study in the second quarter of 2018. However, those results could come earlier or later based on the rate of events in the study. This is a pivotal study, which means that if all goes well, Celldex would submit glemba for regulatory approval based on the study's results.