Celldex Therapeutics, Inc. Earnings: Waiting to ACT

Celldex Therapeutics (CLDX -1.99%) reported third-quarter earnings on Thursday. While the biotech handed in its profit and loss statement as it's required to, it was the update on the pipeline that investors were most interested in.

Celldex Therapeutics results: The raw numbers

Source: Company press release.

What happened with Celldex Therapeutics this quarter?

• Celldex updated guidance on when it expects to conduct the second interim look at ACT IV, the pivotal trial testing Rintega in newly diagnosed glioblastoma. The peek at the data will occur when 75% of the deaths for the complete protocol have occurred. Management thinks that'll occur in late 2015, with the analysis available in early 2016. With each interim look, less of a difference between Rintega and the placebo groups is required to call the trial successful, so even though the trial wasn't stopped for positive efficacy after the first interim look, there's still a chance it can happen for the second peek at the data. And even if that's not successful, it doesn't mean the trial won't eventually be successful when the full data reads out.
• The phase 2 ReACT study testing Rintega in patients with recurrent glioblastoma, which was presented at ASCO, showed a statistically significant improvement in overall survival. More data will be presented at the Annual Scientific Meeting of the Society for Neuro-Oncology later this month, but it seems unlikely the data will change much, given the clear benefit seen in the later-stage glioblastoma patients.
• Celldex's immuno-oncology drug varlilumab is being tested in multiple clinical trials with other immuno-oncology drugs. There's a phase 1/2 study combining varlilumab with Bristol-Myers Squibb's (BMY -0.27%) Opdivo enrolling late-stage melanoma patients. Celldex and Bristol-Myers Squibb are sharing the cost of the study. Varlilumab is also being tested in a phase 1/2 trial with Roche's atezolizumab, which is in the same class as Opdivo. The deal with Roche isn't quite as good as the one with Bristol-Myers Squibb because Roche is only providing drug for the study that's set to start this quarter.

What management had to say
Anthony Marucci, president and CEO, highlighted the progress on ACT IV and ReACT: "As we move closer to final data from the ACT IV study in newly diagnosed glioblastoma, we continue to build on the potential promise of RINTEGA in the recurrent setting and look forward to presenting long-term survival data from the ReACT study at the SNO meeting later this month."

While most of the focus is on Rintega, Marucci also pointed to advancement for the rest of the pipeline: "In the third quarter, we continued to execute on all fronts, including enrolling patients to seven ongoing Celldex-sponsored clinical trials."

Looking forward
Clearly, the ACT IV readout is the most important upcoming event for Celldex, but it isn't the typical biotech binary event because Celldex still has one more shot at a successful trial even if the interim results aren't positive enough to stop the trial.

Celldex has $305 million in the bank and burned through $27.8 million in the third quarter, so the biotech doesn't have to raise any cash in the near future.