Celldex Therapeutics (NASDAQ: CLDX) reported earnings on Thursday, but all eyes are on the second interim analysis of the ACT IV study testing Rintega in patients with glioblastoma that's due to be released this month.
Celldex Therapeutics results: The only number that really matters
|
Q4 2015 Actuals |
Q4 2014 Actuals |
Growth (YOY) | |
|---|---|---|---|
|
Cash, Cash Equivalents, and Marketable Securities |
$290 million |
$201 million |
44% |
What happened with Celldex Therapeutics this quarter?
- The ACT IV study was designed to have two interim peaks at the data after 50% and 75% of the deaths that will end the study. The 75% threshold was reached in late 2015, and Celldex is just waiting for the data to be processed by the independent Data Safety and Monitoring Board.
- Celldex reported long-term survival data from the phase 2 study of Rintega with 25% of patients still alive after two years compared to none of the patients in the control group. While that won't help get the drug on the market if ACT IV fails, it should give investors some confidence that ACT IV will succeed, especially at the full data readout.
- While the focus is on Rintega, Celldex does have an earlier-stage pipeline, including varlilumab, which recently began a phase 1/2 clinical trial in combination with Roche's atezolizumab in patients with late-stage kidney cancer. That's the fifth combination study that the company has initiated.
- Management believes the cash on hand is enough to fund the company through 2017 although it might have to raise cash to launch Rintega -- but presumably that would be at higher prices and therefore with less dilution to shareholders.
IMAGE SOURCE: CELLDEX.
What management had to say
"As you know, we do not know the outcome yet from the second interim analysis of the ACT IV study. We understand our shareholders are eagerly awaiting this outcome, and I can assure you we are too. We are confident that the DSMB will meet very soon, and when they do, we will report the outcome in a press release," Anthony Marucci, Celldex's president and CEO said. "Regardless, whether at the second interim or the final analysis, we fundamentally believe that we have an approvable drug in Rintega."
Not knowing when -- or potentially if -- Rintega will be approved makes it hard to plan for the launch. "As we near the finish line, we have taken a measured approach to preparing for potential commercialization," Marucci said. The "measured approach" might result in a slower launch but is the prudent move so Celldex doesn't spend cash when it's not needed.
Looking forward
It's hard to look beyond the ACT IV interim results, but Celldex does have four other drugs in the clinic, and plans to add a fifth, CDX-014, with a phase 1/2 study in kidney cancer later this year. Unfortunately, they're all phase 2 or earlier studies, so there won't be much large value-driving data in 2016 if ACT IV doesn't pan out.
