Analyst Conference Summary

Celldex Therapeutics

conference date: August 8, 2017 @ 1:30 PM Pacific Time
for quarter ending: June 30, 2017 (Q2, second quarter 2017)

Forward-looking statements

Overview: A clinical stage biotechnology company reports enrollment completed on its Phase 2 breast cancer study.

Basic data (GAAP):

Revenue was $3.8 million, up sequentially from $1.5 million and up from $1.4 million year-earlier. All revenue was from license agreements, contracts or grants.

Net income was negative $28.6 million, up sequentially from negative $34.3 million and up from negative $32.0 million year-earlier.

EPS was negative $0.23, up sequentially from negative $0.28, and up from negative $0.32 year-earlier.



Conference Highlights:

CEO Anthony Marucci stated: "In June, we presented data from glemba's Phase 2 program in checkpoint refractory metastatic melanoma and the Phase 1 dose-escalation varlilumab/Opdivo combination study in solid tumors, both in oral presentations at ASCO. We anticipate a productive second half of the year as we complete enrollment across multiple early-stage studies and look forward to topline data from the METRIC study in the first half of 2018." Findings will be supported by a diagnostic test.

Sam Martin is the new VP and CFO.

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. However, patients who were already screened at that point will also be allowed to enroll, so formal enrollment completion will be in September, 2017. Top line data should be available about 8 months after enrollment is closed.

"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 enrollment. Phase 1 data at ASCO showed some stable disease and partial responses. The Phase 2 portion of this arm is enrolling. A third arm combines glemba with Varlilumab, which should generate data in the fall of 2017. At ASCO in June mature Phase 2 data was presented, exceeding the primary endpoint (barely, by one patient) with 11% of patients showing an objective response. Median overall survival was 9 months. Patients with rashes did better than those without.

A Phase 1/2 study of CDX-014 (glembatumumab vedotin), 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 tumors Phase 1 study continued, with data expected by year-end.

CDX-3379 (formerly KTN3379) is planned to move to a Phase 2 study in Q4.

A CDX-011 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-014 started a Phase 1 study in renal cell carcinoma should complete enrollment by the end of 2017.

Preclinical focus is on CDX-1140, the TAM (Tyro3, AXL, MerTK targets) program, and bispecific antibodies. 1140 could go to Phase 1 later this year.

Cash ended at $154 million, down $13 million sequentially from $167 million. $8.7 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.


Check-point refractory melanoma trial enrollment, data readout? Complete enrollment by end of 2017, data in 2018.

Rash cause? The skin reacts with the drug, so it may be an indicator.

Only one patient converted from a PR to a CR.

Koltan milestones due? We don't see milestones to be paid to Koltan until some time in 2018.

Glemba manufacturing? We are spending the money we budgeted for this year. Larger amounts can be spent later.

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Disclaimer: My analyst call summaries may include both our condensations of statements made by company representatives and my own analysis. They are not covered by any warranty. I cannot guarantee anything said by company representatives is true. I try not to make errors, but it is possible. This is investment journalism, not financial advice.

Copyright 2017 William P. Meyers