Analyst Conference Summary

Celldex Therapeutics

conference date: March 7, 2018 @ 1:30 PM Pacific Time
for quarter ending: December 31, 2017 (Q4, fourth quarter 2017)

Forward-looking statements

Overview: A clinical stage biotechnology company with significant data due in Q2 2018.

Basic data (GAAP):

Revenue was $3.5 million, down sequentially from $3.9 million and up from $1.9 million year-earlier. All revenue was from license agreements, contracts or grants.

Net income was negative $3.8 million, up sequentially from negative $26.4 million and up from negative $32.3 million year-earlier.

EPS was negative $0.03, up sequentially from negative $0.20, and up from negative $0.30 year-earlier.


Believes is funded through 2019, including possible further stock offereings through Cantor agreement.

Conference Highlights:

CEO Anthony Marucci stated: ""We also made considerable progress across our pipeline in the fourth quarter, including initiating the Phase 2 study of CDX-3379 in combination with Erbitux for patients with advanced head and neck squamous cell carcinoma and the Phase 1 study of CDX-1140, a CD40 agonist antibody that we believe holds great potential as an immune activating agent. Both of these antibodies are engineered to be best-in-class molecules. Recently, we completed enrollment in the glemba plus checkpoint inhibitor cohort in our Phase 2 metastatic melanoma study and also in all cohorts in the varlilumab plus Opdivo collaborative Phase 2 study with BMS. In 2018, we expect to present data across multiple programs and execute across our clinical pipeline of novel biologics to improve outcomes and change the standard of care for patients who suffer from life-threatening diseases."

The triple-negative breast cancer study primary endpoint data "will be available in the second quarter of 2018." That is from the METRIC Phase 2 study of "glemba" (see more below).

There was a GAAP, non-cash income tax benefit of $19.1 million in the quarter.

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. 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 Q2 2018. "Assuming positive data, Celldex plans to work with the FDA on a regulatory strategy that would support submitting a Biologics License Application (BLA) in the second half of 2019."

"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 completed enrollment.

A third arm combines glemba with Varlilumab, reported data in November at SITC. Only one patient had a partial response, and two had single time point partial responses, but 52% experienced stable disease. This was a heavily pretreated, checkpoint-refractory, metastatic melanoma population. A fourth arm in combination with CDX-301 was opened in the quarter for melanoma.

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 completed Phase 1 enrollment, but added a cohort of ovarian cancer patients.

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) initiated an open-label 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. Phase 2 combination study with Opdivo for a variety of cancers completed enrollment. Data should be reported at several points in 2018.

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

CDX-1140 started a Phase 1 trial in November, testing against a variety of CD-40 expressing cancers. An expansion phase is also planned, and may start combination cohorts later this year.

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

Cash ended at $139.4 million, down sequentially from $141 million. $18.4 million was raised from common stock sale under the Cantor agreement. Cash should fund operations through 2018, assuming Koltan milestones are paid in stock. The year ended with 138.5 million shares outstanding.

After the quarter ended Celldex raised another $6.1 million under the Cantor common stock sales agreement.

Operating expenses of $29.0 million consisted of: $23.5 million for R&D; $5.9 million for general and administrative; and $0.2 million amortization, plus a gain of $0.6 million on remeasuring a contingent consideration. There was $2.6 million other revenue. The income tax benefit was $19.1 million.


Screen rate for Glemba in breast cancer v. melanoma? Expression rate for gpNMB in melanoma is so high, about 85%, we are not even screening.

Go forward decisions by cohorts, or all at once, for Varlilumab? We will try to do on a real-time basis.

Glemba overall survival timing? We don't know yet.

Would not try to correlate breast cancer and melanoma given the high expression rate for gpNMB.

How much detail will be in the top line Glemba results? We will have PFS, response rate, and safety, but not overall survival (OS). We will give more data, if we have it, at a later medical meeting.

Glemba partnership? We would be willing to launch on our own, but would like a partner outside the U.S.

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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 2018 William P. Meyers