Analyst Conference Summary

conference date: November 7, 2018
for quarter ending: September 30, 2018 (Q3, first quarter 2018)

Forward-looking statements

Overview: Back to advancing an early-stage pipeline.

Basic data (GAAP):

Revenue was $0.9 million, down sequentially from $2.8 million and down from $3.9 million year-earlier. All revenue was from license agreements, contracts or grants.

Net income was negative $7.2 million, up sequentially from negative $16.4 million and up from negative $26.4 million year-earlier.

EPS was negative $0.04, up sequentially from negative $0.11, and up from negative $0.20 year-earlier.

Guidance:

Cash should last through 2020.

Conference Highlights:

CEO Anthony Marucci, Celldex Therapeutics CEO, stated: "We made considerable progress in the third quarter, particularly in the development program for CDX-1140, our promising antibody targeted to CD40. We have completed four of the potential eight monotherapy dose levels in the ongoing Phase 1 study and remain encouraged by the safety and biological profile we have observed to date. We look forward to sharing interim data at the SITC Annual Meeting later this week. During the third quarter, we also began enrolling patients in a combination cohort of CDX-1140 with our dendritic cell mobilizer, CDX-301. We are very interested to explore the potential of CDX-1140 in the presence of greater dendritic cell activity. Additionally, we are nearing completion of enrollment to the first stage of the Phase 2 study of CDX-3379 in advanced head and neck squamous cell cancer and anticipate data from this portion of the study in the first quarter of 2019. We are also advancing several preclinical programs that we believe can play an important role in enhancing the immune system’s response to cancer, including CDX-0159, our TAM program targeting Tyro3, AXL and MerTK, and our growing bispecific antibody program"

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

Plans to transfer to Nasdaq Capital Market due to low share price; reserves option to reverse-split.

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 will be available 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. Nearing completion of enrollment. Blocks ErbB3 (HER3). After the first stage of the Phase 2 study completes enrollment, data will be analyzed before proceeding further. Clinical data from phase 1b was presented at AACR in April, showing safety and reduction of ErbB3 levels. Of 12 patients 11 showed stable disease and one showed tumor shrinkage.

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 presented at AACR in April for NSCLC showed progression-free survival at 4 months achieved by 56% (or 5 of 9) of patients. Also 56% achieved PRs (partial responses).

CDX-1140 continued Phase 1 trial enrollment, testing against a variety of CD-40 expressing cancers. The four lowest dose cohorts have completed enrollment. An expansion phase is also planned. Started combination cohort with CDX-301. Will release more data at SITC this week. Role is to activate dendritic cells. Less toxic than other CD40 therapies.

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

Cash ended at $105.6 million, down sequentially from $114.0 million.

Operating expenses of $8.7 million consisted of: $11.9 million for R&D; $3.7 million for general and administrative; plus a gain of $6.9 million on remeasuring a contingent consideration. Operating loss was $7.8 million. There was $0.5 million other revenue. The income tax benefit was $0 million.

Q&A:

none

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