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Rintega Loss Casts Shadow on Celldex Therapeutics' Q1 Results

By Keith Speights - May 6, 2016 at 10:23AM

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The biotech focused on its other pipeline candidates after canceling a key clinical trial for lead drug Rintega in Q1.

Image source: Celldex Therapeutics.

Celldex Therapeutics (CLDX -15.80%) stock is now valued around 75% below where it started 2016. So when the clinical-stage biotech announced its first-quarter results on Thursday, investors were hoping for some positive news.

Were there any bright spots in those results? Here are the highlights.

Celldex results: The raw numbers


Q1 2016 Actuals

Q1 2015 Actuals

Growth (YOY)


$1.3 million

$0.5 million


Net loss from continuing operations

($34.7 million)

($30.2 million)


Net loss per share




YOY: Year over year. Data source: Yahoo! Finance.

What happened with Celldex this quarter?
The big news for Celldex in the first quarter related to the canceled phase 3 clinical trial for Rintega. Without the promise of Rintega, Celldex suffered an enormous setback.

However, the biotech has other candidates in its pipeline. Highlights from those programs from Celldex's first-quarter update include:

  • Completed enrollment for the phase 2 study of glembatumumab vedotin (glemba) in metastatic melanoma.
  • Continued patient enrollment in the phase 2b clinical trial for glemba in treating metastatic triple-negative breast cancers.
  • Opened patient enrollment in April for the phase 2 portion of a clinical study targeting multiple cancers using a combination of varlilumab (varli) and Bristol-Myers Squibb's (BMY -0.21%) Opdivo. 
  • Presented data in April from the phase 1 study of varli and Opdivo targeting treatment of solid tumors.
  • Enrolling patients in several other studies of varli, including a phase 1/2 study of varli and Roche's atezolizumab.

On the financial front, Celldex's jump in revenue stemmed primarily from the company's collaboration with Bristol, a research and development deal with Rockefeller University, and an increase in grant revenue. The most important financial news for the biotech, though, was its cash position. Celldex reported cash, cash equivalents, and marketable securities of $254 million at the end of the first quarter. The company says that that amount should fund operations through the first half of 2018.

What management had to say
Celldex president and CEO Anthony Marucci focused on the positives, despite the bad news from earlier this year. Marucci stated:

While the recent setback of the Rintega program was certainly a disappointment, the company is focused on executing across the breadth and depth of our pipeline, including six ongoing company-led clinical trials: the pivotal Metric study in triple negative breast cancer, two Phase 2 studies across a broad range of indications, and multiple Phase 1/2 studies that are actively enrolling patients.

Looking forward
Although the disappointment with Rintega certainly stung, Celldex has several things going for it in the days ahead. Its cash stockpile puts the small biotech in better shape than many of its peers. Marucci said that the company thinks the cash position should allow Celldex to not only complete current studies, but also initiate some new studies.

The partnership with Bristol-Myers Squibb is another plus. Bristol's Opdivo looks to be a big winner. Opdivo raked in $475 million in its first full year on the market. If the varli/Opdivo combo study proves successful, it would be huge for Celldex.

Glemba and varli aren't the only candidates in Celldex's pipeline. The biotech also has two other cancer drugs -- CDX-401 and CDX-301.

All in all, Celldex still has a pretty strong pipeline. Investors would have loved for Rintega to have advanced to market, but every biotech faces the risk of clinical failures. The key for Celldex now is to forge ahead with its other assets. And that's exactly what the company plans to do.

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Stocks Mentioned

Celldex Therapeutics, Inc. Stock Quote
Celldex Therapeutics, Inc.
$22.70 (-15.80%) $-4.26
Bristol Myers Squibb Company Stock Quote
Bristol Myers Squibb Company
$76.84 (-0.21%) $0.16

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