Celldex Therapeutics, Inc. Message Board

There was a lot of information in this cc, I will mention the highlights regarding the late stage drugs in this post. I'll cover the mid and early stage drugs in a subsequent post.

1. Financials: final tally on the offering after completing the oversubscribed portion is $103.5M. CLDX has $189M in cash and 80.6 million shares outstanding after the offering. Current CLDX valuation based on these numbers is $845M.

2. Rindo:
- pivotal ACTIV trial is enrolling well at 142 centers internationally
- accrual will be completed YE'13
- BLA filing in '15
- product launch preparations: market assessment shows that oncologists are very likely to prescribe Rindo to their GBM pts upon approval. Also, a survey of payers showed that rindo is well positioned as far as reimbursement.

3. CDX-011:
- pivotal accelerated approval trial will start in 2H'13
- 300 pts high GPNMB/TNBCm, randomized 2:1: 200 pts CDX-011: 100 pts Xeloda (Xeloda suboptimal as monotherapy even as first line, even less effective as 2/3rd line- shrewd choice by CLDX to use this as comparator)
- "either/or" endpoints of PFS or ORR for accelerated approval (CDX011 needs to hit only one of these endpoints for approval)
- 75-100 academic and community centers will participate
- accrual will take 14-18 months
- BLA submitted late '15/early '16
- accelerated approval trial will be followed by large PIII trial that will be expanded to all high GPNMB BC pts

4. Pricing guidance:
- Rindo: $80-100k (based primarily on cost of Avastin in GBM)
- CDX-011: $90-100k (based on last 2 drugs approved as ADC's)

Bottom line: effective drugs, robust cash position to push them through regulatory pathway to market, oncologists eager to prescribe them and payers willing to pay top dollar. Plus I like the tough talk regarding partnerships, this will yield great terms for CLDX down the line!