Slide 1: 2014 Business/Financial Results and 2015 Corporate Strategy Presentation
2014 Business/Financial Results and 2015 Corporate Strategy Presentation February 24, 2015
Slide 2: Forward Looking Statement
Forward Looking Statement This communication contains "forward-looking" statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical fact are statements that could be forward-looking statements. You can identify these forwa
Slide 3: 2014 – Another Significant Year for Celldex
2014 – Another Significant Year for Celldex 3 Enrollment completed – 745 EGFRvIII patients Screened >4,800 patients from more than 200 clinical trial sites across 22 countries (30% positivity) Most comprehensive study conducted by a biotech to date Positive interim data at SNO 2014 All endpoints fav
Slide 4: Commercial Preparation Underway
2014 – Another Significant Year for Celldex 4 Commercial Preparation Underway Optimizing product uptake, minimizing access hurdles and supporting customers through innovative high-touch service programs while achieving financial targets Have hired key talent with focused expertise Goal: field a lean
Slide 5: Glembatumumab Vedotin and Varlilumab 2014 Highlights
5 Glembatumumab Vedotin Continued site activation – almost 100 to date Now open in the United States, Australia and Canada; plans to enter the EU Program expanding into other indications 2014 – Another Significant Year for Celldex Varlilumab Proof of concept data at ASCO 2014 & SITC 2014 Phase 1/2 s
Slide 6: CDX-301 and CDX-1401 2014 Highlights
6 CDX-301 Pilot study of CDX-301 alone and with Mozobil® in HSCT initiated Investigator sponsored Phase 1/2 study of CDX-301/Hiltonol®/radiation in B-cell lymphoma ongoing Hiltonol® is a registered trademark of Oncovir; Mozobil® is a registered trademark of Genzyme Corporation CDX-1401 Phase 1 study
Slide 7: ACT IV Update
ACT IV Update 7 745 patients enrolled to reach the required 374 patients with minimum residual disease Patients with minimum residual disease required for the analysis of the primary overall survival (OS) endpoint All patients will be included in a secondary analysis of OS as well as progression-fre
Slide 8: ReACT Interim Data SNO 2014—PFS: Bev-Naïve Relapsed GBM
ReACT Interim Data SNO 2014—PFS: Bev-Naïve Relapsed GBM (Group 1) HR = 0.67 (0.39, 1.14) p = 0.134*** Primary Endpoint: PFS-6 (Crude rate) Rintega + bevacizumab (n=35) 9/33 (27%)* p = 0.048** control + bevacizumab (n=37) 4/35 (11%)* * 6-month status pending for 4 patients (2 in each treatment arm) *
Slide 9: ReACT Interim Data SNO 2014—Improved OS: Bev-Naïve Relapsed GBM
ReACT Interim Data SNO 2014—Improved OS: Bev-Naïve Relapsed GBM (Group 1) Median (95% CI) Rintega + bevacizumab (n=35) 12.0 (9.7, --) control + bevacizumab (n=37) 8.8 (6.8, 11.4) HR = 0.47 (0.25, 0.91) p = 0.0208 Patients have not yet experienced progression of disease on study treatment 9 Overall S
Slide 10: ReACT Interim Data SNO 2014—Anti-Tumor Effect
ReACT Interim Data SNO 2014—Anti-Tumor Effect Bev-Naïve Relapsed GBM (Group 1) Data based on Investigator Review; Third Party Review Pending Rintega + bevacizumab control + bevacizumab ORR (confirmed CR/PR)* 7/29 (24%) 5/30 (17%) Any response (>50% shrinkage) including those not sustained at subsequ
Slide 11: ReACT Interim Data—Early Anti-EGFRvIII Titer Response Correlates with Survival
ReACT Interim Data SNO 2014—Early Anti-EGFRvIII Titer Response Correlates with Survival (Group 1) Bevacizumab-Naïve HR (95% CI): 0.47 (0.18, 1.27) p = 0.128 Median OS Months (95% CI) 6-Month OS (%) Good Titers* (n=14) 20.8 (9.9, 20.8) 95% All others (n=21) 10.4 (5.8, --) 69% * Based on the generatio
Slide 12: Glembatumumab Vedotin Update
Glembatumumab Vedotin Update 12 Breast cancer Revised protocol design reviewed by FDA and central European regulators 95 sites now open to screening in the US, Canada and Australia; plans to open in EU Expanded development Metastatic melanoma study initiated Squamous cell lung cancer CRADA with the
Slide 13: Varlilumab Update
Varlilumab Update 13 Phase 1 Study Very well tolerated; clear biologic activity and promising signs of clinical activity in advanced, treatment-refractory patient populations CR in Hodgkin lymphoma – 18.9+ months PR in renal cell carcinoma – 11+ plus months; continuing to decrease in tumor volume St
Slide 14: CDX-1401 Update
CDX-1401 Update 14 Phase 1 Study Phase 1 data suggest CDX-1401 may predispose patients to better outcome on subsequent therapy with checkpoint inhibitors 6 of 8 patients received checkpoint blockade following CDX-1401 treatment had significant clinical responses Expanded development Phase 1/2 study
Slide 15: CDX-301 Update
CDX-301 Update 15 Pilot study of CDX-301 in hematopoietic stem cell transplant in combination with Mozobil initiated Investigator sponsored Phase 1/2 study of intratumoral injection of CDX-301 and Hiltonol in combo with low-dose radiotherapy for patients with low-grade B-cell lymphoma ongoing
Slide 16: New Addition to the Pipeline: CDX-014
New Addition to the Pipeline in 2016: CDX-014 ADC directed to a novel renal cell carcinoma and ovarian target TIM-1 (T-cell Immunoglobulin Mucin-1) expression upregulated in several human cancers, most notably renal cell and ovarian carcinomas; has very restricted expression in healthy tissues Manuf
Slide 17: 2014 Q4 and YE Financials
2014 Q4 and YE Financials as of 12/31/2014 17 Net loss of $31.8M Q4 2014 vs $22.1M Q4 2013 Net loss of $118.1M for 2014 vs $81.6M for 2013 $201.0M in cash, cash equivalents and marketable securities 89.6M shares outstanding
Slide 18: 2015 Milestones Overview
2015 Milestones Overview Rintega Continue execution on the ACT IV Phase 3 registration study in frontline GBM. First interim: mid-year 2015 Report final data from ReACT Phase 2 study in recurrent GBM mid-year 2015 Continued preparation for potential commercial launch of Rintega Glembatumumab vedotin
Slide 19: 2014 Business/Financial Results and 2015 Corporate Strategy Presentation
2014 Business/Financial Results and 2015 Corporate Strategy Presentation February 24, 2015