Analyst Conference Summary

Celldex Therapeutics

conference date: March 7, 2019
for quarter ending: December 31, 2018 (Q4, fourth quarter 2018)

Forward-looking statements

Overview: Back to advancing an early-stage pipeline.

Basic data (GAAP):

Revenue was $1.2 million, up sequentially from $0.9 million and down from $2.8 million year-earlier. All revenue was from license agreements, contracts or grants.

Net income was negative $9.4 million, down sequentially from negative $7.2 million and up from negative $22.9 million year-earlier.

EPS was negative $0.81, down sequentially from negative $0.04, and down from negative $0.42 year-earlier.

Share count, post reverse split, was 11.6 million.


Cash should last through 2020.

Conference Highlights:

CEO Anthony Marucci, Celldex Therapeutics CEO, stated: "Data from both the CDX-1140 and MerTK programs were presented at SITC in November and we look forward to providing an update on CDX-1140 at AACR in early April. In the ongoing Phase 1 study of CDX-1140 in solid tumors and B cell lymphomas, we have completed six of the potential eight monotherapy dose levels and the first of six potential combination dose levels with CDX-301 and are pleased with the safety and biological profile we have observed to date. We also continue to follow patients in the Phase 2 study of CDX-3379 in advanced head and neck squamous cell cancer and plan to present data from this study at a medical meeting in the coming months. We believe 2019 will be an important year for Celldex with data anticipated across multiple programs."

Has sufficient cash to take pipeline to important inflection points, after restructuring.

Transfered to Nasdaq Capital Market due to low share price. Reverse split 15 to 1 in February 2019.

Hopes to file a new IND from its preclinical pipeline every 12 to 18 months.

Celldex is working with Bristol-Myers to do a broad Phase 1/2 combination study of varlilumab with nivolumab (Opdivo) for a variety of cancers. Phase 2 cohorts is enrolling for 5 types of cancer. Targets CD27. Data presented at ASCO in June showed improved biomarker levels, response rates, and progression free survival in the ovarian cancer cohort. HNSCC (head and neck squamous cell carcinoma) and renal cell carcinoma cohort showed some responses or stable disease. Glioblastoma cohort data was released on November 17 at Society for Neuro-oncology.

CDX-3379 (formerly KTN3379) continued an open-label Phase 2 study for head and neck squamous cell cancer, in combination with Erbitux. Completed enrollment for first stage of study, with one confirmed complete response. Blocks ErbB3 (HER3). Data is being analyzed before proceeding further.

CDX-301 is in several early investigator-sponsored studies, one for HSCT (hematopoeitic stem cell transplantation), one for B-cell lymphomas, and NSCLC. May do future studies combining with 1140. Data to date in 6 dosing cohorts shows safety and biomarker activity.

CDX-1140 continued Phase 1 trial enrollment, testing against a variety of CD-40 expressing cancers including lymphomas. The six lowest dose cohorts have completed enrollment, started cohort 7. An expansion phase is also planned. Started combination cohort with CDX-301. Role is to activate dendritic cells. Less toxic than other CD40 therapies. Data so far shows safety and biomarker activity; will update in April 2019. Study allows for expansion cohorts in specific tumor types.

Preclinical MerTK data was presented in November 2018 with more to come at AACR.

Preclinical drugs are being readied to enter clinical trials: CDX-0159, CDX-527 and other bispecific antibodies, and therapies targetting Tyro3, AXL.

Cash ended at $94.0 million, down sequentially from $105.6 million. In the quarter $3.6 million was rasied by selling stock under the Cantor agreement.

Operating expenses of $13.9 million consisted of: $11.2 million for R&D; $4.3 million for general and administrative; plus a gain of $1.7 million on remeasuring a contingent consideration. Operating loss was $12.1 million. There was $2.7 million other revenue. The income tax benefit was $0 million.


Bispecific safety color? We have no added safety concerns so far for CDX-527. Additional activity is due to better CD27 costimulation with PDL1 binding.

3379 data, what are looking for? Comprehensive biomarker analysis; the head and neck cancer field, which is evolving.

1140 program dosing? Biomarker data is mainly serum based so far. The best data will come from biopsies, which we are just beginning. We want to know we are truly modifying the tumor microenvironment.

1140 safety v. other CD40 therapies? We wanted to be able to do higher systemic exposure. We are getting a linear dose response so far, which is what we want vs. other potential therapies.

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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 2019 William P. Meyers