Analyst Conference Summary

conference date: November 7, 2017 (press release only)
for quarter ending: September 30, 2017 (Q3, third quarter 2017)

Forward-looking statements

Overview: A clinical stage biotechnology company

Basic data (GAAP):

Revenue was $3.9 million, up sequentially from $3.8 million and up from $ 2.2 million year-earlier. All revenue was from license agreements, contracts or grants.

Net income was negative $26.4 million, up sequentially from negative $28.6 million and up from negative $29.6 million year-earlier.

EPS was negative $020., up sequentially from negative $0.23, and up from negative $0.29 year-earlier.

Guidance:

Cash should fund operations through 2018, assuming Koltan milestones are paid in stock.

Conference Highlights:

CEO Anthony Marucci stated: "In late August, we completed enrollment in our Phase 2 METRIC study of glembatumumab vedotin in triple negative breast cancer. We believe glemba holds considerable promise as a potential new targeted therapy for patients with this devastating disease and continue to look forward to topline data from this study in the second quarter of 2018. We look forward to a busy end of year as we prepare for the glemba data read out and advance multiple earlier stage studies, including the initiation of two new studies by year-end—a Phase 2 study of CDX-3379 in recurrent head and neck squamous cell cancer and a Phase 1 study of CDX-1140 in solid tumors."

Celldex remains open to bringing in a partner for glembatumumab vedotin.

Celldex is working with Bristol-Myers to do a broad Phase 1/ 2 combination study of varlilumab (CDX-1127) with nivolumab (Opdivo) for a variety of cancers. Positive Phase 1 data was presented at ASCO. Phase 2 cohorts is enrolling for 5 types of cancer and should complete enrollment in Q1 2018.

Glembatumumab vedotin (CDX-011) Phase 2 studies [METRIC] reached target enrollment for metastatic triple negative breast cancer overexpressing gpNMB in August. Top line data should be available in mid-2018, but is dependent of the rate of events.

"Glemba" or CDX-011 for metastatic melanoma (post checkpoint therapy) Phase 2 study second arm, combined with Opdivo or Keytruda for patients who failed prior checkpoint therapy continued.

A third arm combines glemba with Varlilumab, reported data in November at SITC. Only one patient had a partial response, and two had single timepoint partial responses, but 52% experienced stable disease. This was a heavily pretreated, checkpoint-refractory, metastatic melanoma population.

Glembatumumab vedotin Phase 2 study for metastatic uveal melanoma results were released in October. There was a 6% objective response rate and 35% stable disease. Median PFS was 3.2 months, median OS 11.8 months.

A Phase 1/2 study of CDX-014, an ADC targeting TIM-1, for renal cell carcinoma should complete Phase 1 enrollment by the end of 2017.

CDX-0158 (formerly KTN0158) for KIT positive gastrointestinal stromal tumors Phase 1 study continued, with data showing no tumor shrinkage. A modification, CDX-0159, will seek to start a Phase 1 trial in 2018.

CDX-3379 (formerly KTN3379) is planned to move to a Phase 2 study in Q4 for head and neck squamous cell cancer, in combination with Erbitux.

A CDX-011 (Varlilumab) Phase 1 study in squamous cell lung cancer continued. CDX-011 is also in NCI sponsored studies for uveal melanoma and pediatric osteosarcoma.

CDX-301 is in several early studies, one for HSCT (hematopoeitic stem cell transplantation) and one for B-cell lymphomas.

CDX-1140 will open a Phase 1 trial by year end, testing against a variety of CD-40 expressing cancers.

Preclinical focus is on the TAM (Tyro3, AXL, MerTK targets) program, and bispecific antibodies.

Cash ended at $141 million, down $13 million sequentially from $154 million. $11.2 million was raised from common stock sale under the Cantor agreement. Cash should fund operations through 2018, assuming Koltan milestones are paid in stock.

Operating expenses of $32.8 million consisted of: $25.0 million for R&D; $6.5 million for general and administrative; and $0.2 million amortization. There was $0.4 million other revenue.

Q&A:

There was no conference, just a press release.

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