Analyst Conference Summary

conference date: August 7, 2019 @ 1:30 PM Pacific Time
for quarter ending: June 30, 2019 (Q2, second quarter 2019)

Forward-looking statements

Overview: Back to advancing an early-stage pipeline.

Basic data (GAAP):

Revenue was $0.7 million, down sequentially from $1.4 million and down from $2.8 million year-earlier. All revenue was from license agreements, contracts or grants.

Net income was negative $11.8 million, up sequentially from negative $17.2 million and up from negative $16.4 million year-earlier.

EPS was negative $0.84, up sequentially from negative $1.40, and up from negative $1.67 year-earlier.

Guidance:

Believe can fund operations through the end of 2020.

Conference Highlights:

CEO Anthony Marucci, Celldex Therapeutics CEO, stated: "We presented exciting data from our CDX-3379 program in head and neck squamous cell carcinoma at ASCO, where we observed intriguing clinical activity across a number of patients with similar gene mutation patterns. As a result, we have expanded the study to allow for a deeper evaluation of these biomarkers for patient selection. This could be important for the field as patients with refractory head and neck cancer face extremely limited treatment options and a particularly poor prognosis. We also reported data from multiple programs at AACR, including from our ongoing dose escalation study of CDX-1140. We recently successfully completed the monotherapy dosing cohorts and are advancing nicely through the combination cohorts with our dendritic cell growth factor, CDX-301. We are currently finalizing plans to initiate a combination cohort with a checkpoint inhibitor and look forward to presenting data from the ongoing program this fall."

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

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

Celldex plans to submit an IND and initiate a Phase 1a study of CDX-0159 by year-end 2019. CDX-0159 is a monoclonal antibody that specifically binds the KIT receptor and potently inhibits its activity. The KIT receptor tyrosine kinase is expressed in a variety of cells, including mast cells. In certain inflammatory diseases, such as chronic idiopathic urticaria (CIU), mast cell degranulation plays a central role in the onset and progression of the disease.

Celldex is working with Bristol-Myers to complete a Phase 2 combination study of varlilumab with nivolumab (Opdivo) for a variety of cancers. Phase 2 cohorts is enrolling for 5 types of cancer; several completed enrollment and reported preliminary data. Targets CD27.

CDX-3379 (formerly KTN3379) expanded an open-label Phase 2 study for head and neck squamous cell cancer, in combination with Erbitux (Cetuximab). Completed enrollment for first stage of study, with one confirmed complete response. Blocks ErbB3 (HER3). Patients had multiple prior therapies. Data was presented at ASCO in June 2019 that indicated clinical activity (responses in 4 of 7 patients with FAT1 mutations), particularly in association with certain biomarkers including Notch mutations.

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 monotherapy arm completed enrollment. An expansion phase is also planned. Three combination cohorts in solid tumors (0.09, 0.18 and 0.36 mg/kg) with CDX-301 have been completed; higher doses ongoing. Role is to activate dendritic cells. Less toxic than other CD40 therapies. Data so far shows safety and strong activity; updated in April 2019 at AACR. Study allows for expansion cohorts in specific tumor types and combining with a checkpoint inhibitor. Could present more data in November 2019.

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. Could have an IND in 2020.

Preclinical drugs are being readied to enter clinical trials: bispecific antibodies, and therapies targetting Tyro3, AXL. CDX0159 to inhibit Kit has a Phase 1 trial plan.

Cash ended at $81.3 million, down sequentially from $85.1 million. Cash used in operating activities was $11.0 million. In the quarter $7.2 million was rasied by selling stock under the Cantor agreement.

Operating expenses of $13.0 million consisted of: $10.1 million for R&D; $3.9 million for general and administrative; gain on investment $1 million; Operating loss was $12.3 million. There was $0.5 million other revenue. The income tax benefit was $0 million.

In June decided to consolidate facilities to Fall River. Will result in cost savings starting in second half of 2020.

Q&A:

1140 safety profile, dose level vs. competitors? We are seeing biological activity associated with activation reported in other criminal trials. It has increased with higher doses. But we have not reached a limiting dose based on safety.

3379 population sizes, diagnostics? Head and neck has FAT1 seen in one-third, Notch in about one-quarter. Will do next-generation sequencing in our study. We will collaborate with a clinical diagnostic company if our results are positive.

[There was just one analyst asking questions]

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