Analyst Conference Summary

conference date: May 7, 2019
for quarter ending: March 31, 2019 (Q1, first quarter 2019)

Forward-looking statements

Overview: Back to advancing an early-stage pipeline.

Basic data (GAAP):

Revenue was $1.4 million, up sequentially from $1.2 million and down from $4.1 million year-earlier. All revenue was from license agreements, contracts or grants.

Net income was negative $17.2 million, down sequentially from negative $9.4 million and up from negative $118.1 million year-earlier.

EPS was negative $1.40, down sequentially from negative $0.81, and down from negative $12.61 year-earlier.

Guidance:

Cash should last through 2020.

Conference Highlights:

CEO Anthony Marucci, Celldex Therapeutics CEO, stated: "Celldex presented positive data across multiple programs at AACR in April, including from our promising CDX-1140 program. We have successfully cleared a critical hurdle for CD40 agonists, reaching dose levels with good systemic exposure that are biologically active and well tolerated. Importantly, these dose levels exceed the maximum tolerated dose levels reported with other CD40 agonists, which we believe may support enhanced tissue and tumor penetration. We are also pleased with the results to date in our unique combination of CDX-1140 with CDX-301, where CDX-301 amplifies the numbers of dendritic cells in patients prior to their activation with CDX-1140. To this end, we continue to believe that CDX-1140 can play a very important role in cancer immunotherapy, especially in combination with drugs that target other key immune pathways and are actively planning additional combination cohorts to begin later this year. We also recently completed the first stage of the Phase 2 study of CDX-3379 and are pleased that this portion of the study met the clinical criteria that are required to progress the study to the next stage. We look forward to presenting more detailed data from this study at ASCO in early June. We are currently conducting a thorough analysis of the overall CDX-3379 program in collaboration with our clinical advisors to determine the optimal path for this candidate."

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, monotherapy arm almost complete. 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; updated in April 2019 at AACR. Study allows for expansion cohorts in specific tumor types.

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

Preclinical data for CDX-527 bispecific candidate and its TAM program were presented at the AACR Annual Meeting 2019 in April. CDX-527 uses Celldex's proprietary highly active anti-PD-L1 and CD27 human antibodies to couple CD27 co-stimulation with blockade of the PD-L1/PD-1 pathway.

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

Cash ended at $85.1 million, down sequentially from $94.0 million. In the quarter $4.2 million was rasied by selling stock under the Cantor agreement.

Operating expenses of $19.4 million consisted of: $11.2 million for R&D; $4.9 million for general and administrative; asset impairment $1.8 million; $1.5 million on remeasuring a contingent consideration. Operating loss was $17.9 million. There was $0.7 million other revenue. The income tax benefit was $0 million.

Q&A:

No conference was held.

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