Analyst Conference Summary

conference date: November 11, 2019 press release only
for quarter ending: September 30, 2019 (Q3, third quarter 2019)

Forward-looking statements

Overview: Reported some good data on early-stage drugs.

Basic data (GAAP):

Revenue was $0.5 million, down sequentially from $0.7 million and down from $0.9 million year-earlier. All revenue was from license agreements, contracts or grants.

Net income was negative $11.4 million, up sequentially from negative $11.8 million and down from negative $7.2 million year-earlier.

EPS was negative $0.75, up sequentially from negative $0.84, and up from negative $0.66 year-earlier.

Guidance:

Believe can fund operations through the end of 2020.

Conference Highlights:

CEO Anthony Marucci, Celldex Therapeutics CEO, stated: "Celldex achieved a significant milestone last week, reporting data at SITC that CDX-1140 has exceeded the hurdles we defined for Phase 1 monotherapy development and has the potential to be a best in class CD40 agonist. We are very encouraged by the results we have seen to date across the study and have expanded the trial to more broadly explore the clinical activity we observed in head and neck squamous cell carcinoma and to include a combination cohort with Keytruda under a clinical trial collaboration with Merck. We also continue to make excellent progress in our Phase 2 program of our ErbB3 inhibitor, CDX-3379, and reported the potential for a promising biomarker strategy in head and neck squamous cell carcinoma at ASCO this summer. Earlier this month, our IND for our KIT inhibitor, CDX-0159, was accepted by the FDA and we look forward to initiating a Phase 1 trial by year-end. "

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 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 submitted an IND in Q4 2019 and will initiate 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 idiopathic urticaria (CIU), a mast cell-related disease, after establishing dosing in healthy subjects.

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 $72.9 million, down sequentially from $81.3 million. Cash used in operating activities was $11.1 million. In the quarter $2.5 million was rasied by selling stock under the Cantor agreement.

Operating expenses of $12.4 million consisted of: $11.1 million for R&D; $3.4 million for general and administrative; gain on contingent $2.1 million; Operating loss was $11.8 million. There was $0.4 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:

None

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