Analyst Conference Summary

conference date: March 26, 2020 press release only
for quarter ending: December 31, 2019 (Q4, fourth quarter 2019)

Forward-looking statements

Overview: Continues to make advances in preclinical, early and mid-stage cancer therapy programs.

Basic data (GAAP):

Revenue was $0.9 million, down sequentially from $0.5 million and down from $1.8 million year-earlier. All revenue was from license agreements, contracts or grants.

Net income was negative $10.4 million, up sequentially from negative $11.4 million and down from negative $9.4 million year-earlier.

EPS was negative $0.64, up sequentially from negative $0.75, and up from negative $0.81 year-earlier.

Guidance:

Believe can fund operations through Q1 2021.

Conference Highlights:

CEO Anthony Marucci, Celldex Therapeutics CEO, stated: "We are pleased that following exciting data in late 2019 from the CDX-1140 program that suggest this candidate is a best in class CD40 agonist. We also continue to advance the Phase 2 program of our ErbB3 inhibitor, CDX-3379, exploring a potential biomarker strategy in head and neck squamous cell carcinoma. Last month, we completed dosing in the Phase 1 healthy volunteer study of our KIT inhibitor, CDX-0159, which we intend to study in mast cell driven disorders. In addition to demonstrating a favorable safety profile, if CDX-0159 is able to decrease tryptase levels in healthy volunteers, a surrogate for systemic mast cell load, we believe this drug candidate could have significant potential in mast cell driven diseases. Based on the promising results observed to date, we have expanded development of CDX-0159 and are planning to initiate studies in chronic urticaria. We are also preparing to advance CDX-527, the first candidate from our bispecific platform, into the clinic."

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

The monotherapy arm of the Phase 1 dose-escalation study of CDX-1140 in patients with recurrent, locally advanced or metastatic solid tumors and B cell lymphomas has been completed with positive data and a recommended Phase 2 dose of 1.5 mg/kg. The combination cohort with CDX-301 has been generally well tolerated to date and the cohort is progressing on track. Patient enrollment is ongoing in the final cohort of CDX-1140 at 1.5 mg/kg plus CDX-301. Positive interim data from the study were presented at the Society for Immunotherapy of Cancer's (SITC) 34th Annual Meeting on November 8, 2019. As of the cut-off date for data reporting, 38 patients with advanced refractory solid tumors had pre- and post-treatment scans available. Two of five patients with head and neck squamous cell carcinoma (HNSCC) treated with monotherapy at doses of 0.72 mg/kg or higher experienced clinical benefit. One patient experienced dramatic shrinkage of a large, protruding neck mass on physical exam after two doses of CDX-1140 at 1.5 mg/kg with documented evidence of tumor necrosis/cavitation on CT scan. The second patient experienced cavitation of greater than 50% of lung metastases on CT scan after one dose of CDX-1140 3 mg/kg. An additional response was seen for gastroesophageal carcinoma and six patients had stable disease.

The CDX-1140 combination study with Keytruda (pembrolizumab) is expected to start enrolling in Q1 2020.

Celldex completed dosing in a Phase 1a study of CDX-0159. 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. Celldex plans to further study CDX-0159 in chronic spontaneous urticaria (CSU) and chronic inducible urticaria (CINDU), both mast cell-related diseases, and plans to initiate studies by year end.

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) continued 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.

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 $64.4 million, down sequentially from $72.9 million. During Q4 2019 $2.4 million was generated by stock sales. Cash used in operating activities was $

Operating expenses of $13.9 million consisted of: $10.3 million for R&D; $3.2 million for general and administrative; gain on contingent $0.3 million; Operating loss was $13.9 million. There was $0.3 million other revenue. The income tax benefit was $0 million.

In June 2019 decided to consolidate facilities to Fall River. Will result in cost savings starting in second half of 2020.

Q&A:

None

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