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The big story for Celldex Therapeutics (CLDX +1.95%) this year has been the major setback from its canceled phase 3 study of Rintega. That bad news caused the biotech's stock to plummet. Celldex announced its second-quarter results after the market closed on Monday. Was there some good news for investors? Here are the highlights.
Celldex results: The raw numbers
| Metric |
Q2 2016 Actuals |
Q2 2015 Actuals |
Growth (YOY) |
|---|---|---|---|
|
Revenue |
$1.4 million |
$2.2 million |
(36.4%) |
|
Net loss from continuing operations |
($32 million) |
($32.4 million) | -- |
|
Net loss per diluted share |
($0.32) |
($0.33) |
-- |
DATA SOURCE: CELLDEX THERAPEUTICS.
What happened with Celldex this quarter
As with previous quarters, Celldex's revenue stemmed mainly from its partnerships with Bristol-Myers Squibb (BMY 0.16%) and Rockefeller University. Despite bringing in less money from those relationships than the same period last year, Celldex managed to improve its bottom line slightly in the second quarter by holding down expenses.
While controlling expenses is usually a good thing, in this case the positive year-over-year comparison serves as a reminder of Rintega's failure. Celldex reported lower clinical costs and commercial planning costs compared with the prior-year period, no doubt in large part because of its March decision to cancel the phase 3 study of Rintega in treating newly diagnosed glioblastoma.
The most important financial result for a clinical-stage biotech is usually its cash position. Celldex continues to look good in that category. The company's cash, cash equivalents, and marketable securities as of June 30 totaled $220.1 million, down from $254 million at the end of the first quarter.
Other highlights from Celldex's second quarter included:
- Continuing enrollment in the phase 2b study of glembatumumab vedotin (also known as glemba) in patients with metastatic triple negative breast cancers that overexpress gpNMB, a protein-coding gene associated with poor outcomes for several indications.
- Meeting the primary endpoint of the phase 2 study of glemba in treating metastatic melanoma.
- Beginning enrollment of the phase 2 study of varlilumab (varli) and Bristol-Myers Squibb's Opdivo in treating multiple types of cancer.
- Completing enrollment for the phase 1 dose-escalation portion of a clinical study of varli and Roche's Tecentriq in treating multiple solid tumors.
- Continuing to enroll patients in a phase 1/2 study of varli and Bristol's Yervoy. The phase 2 portion will also include Celldex's CDX-1401 immunotherapy.
- Beginning phase 1 enrollment for CDX-014 in advanced clear cell and papillary renal cell carcinoma.
What management had to say
Anthony Marucci, co-founder and CEO of Celldex, underscored the potential for his company:
"Celldex continues to build one of the most robust pipelines in immuno-oncology, most recently advancing CDX-014 into the clinic in renal cell carcinoma. In collaboration with our investigators, we also presented a significant body of data in the second quarter with eight presentations across both AACR and ASCO that spoke to the broad utility of our product candidates in combination immunotherapy and highlighted a number of the novel targets we are pursuing."
Marucci added:
"We continue to enroll patients to the pivotal METRIC study of glembatumumab vedotin in triple negative breast cancer, with a focus on a number of new sites in Europe that were added over the last quarter and look forward to presenting data from the phase 2 study of glembatumumab vedotin in metastatic melanoma later this year."
Looking forward
Celldex has to be viewed in a much different light without Rintega. However, the biotech still has several positive things going for it. Celldex claims a solid pipeline with multiple candidates, something that many small biotechs don't have. The relationships with large pharmaceutical companies, especially Bristol-Myers Squibb, are also pluses.
Bristol's setback with Opdivo failing as a first-line treatment for lung cancer makes its partnership with Celldex more important for the big drugmaker. Giovanni Caforio, CEO of Bristol-Myers Squibb, noted after the news about Opdivo became public that focusing on combination therapies is now a key priority for his company.
Celldex is in good shape financially to continue funding operations and development. In previous quarters the company said that its cash position should be enough to carry it through 2018. However, in its second-quarter earnings release, Celldex stated that the cash position "combined with the anticipated proceeds from future sales of our common stock under our $60 million sales agreement with Cantor Fitzgerald & Co." should fund operations through 2018. Investors might want to be on the lookout for another stock offering down the road.
