Analyst Conference Summary

conference date: November 5, 2020. Press Release only.
for quarter ending: September 30, 2020 (Q3, third quarter 2020)

Sold mine on 9/16/2020. Monitoring, could buy again.
Forward-looking statements

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

Basic data (GAAP):

Revenue was $0.7 million, up sequentially from $0.2 million and up from $0.5 million year-earlier. All revenue was from license agreements, contracts or grants.

Net income was negative $14.2 million, down sequentially from negative $11.0 million and down from negative $11.4 million year-earlier.

EPS was negative $0.36, up sequentially from negative $0.50, and up from negative $0.75 year-earlier.

Guidance:

Believe can fund operations through 2023.

Conference Highlights:

CEO Anthony Marucci, Celldex Therapeutics CEO, stated: "In the third quarter, building on the compelling CDX-0159 data presented at EAACI, we initiated two Phase 1b studies in chronic spontaneous urticaria and chronic inducible urticaria which will provide the foundation for several important data readouts in 2021. We also advanced the first candidate from our bispecific program, CDX-527, into the clinic in solid tumors and continued to expand the ongoing CDX-1140 program, adding a combination cohort with chemotherapy in pancreatic cancer. In addition, we are completing our work prioritizing opportunities to expand development of CDX-0159 into additional therapeutic areas. Our analysis supports that there are multiple mast cell driven indications that have the potential to be dramatically impacted by an agent that targets the root cause of the disease—the mast cell itself—and we remain on track to start a third study in a mast cell disease setting next summer."

Has sufficient cash to take pipeline to important inflection points.

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. Also a cohort with Keytruda (pembrolizumab) is actively recruiting in Q2 2020. A combination of CDX-1140 with chemotherapy in first line metastatic pancreatic cancer is planned.

Celldex started dosing in a Phase 1b study of CDX-0159 in chronic spontaneous urticaria (CSU). CDX-0159 is a monoclonal antibody that specifically binds the KIT receptor and potently inhibits its activity. Results from a Phase 1a dose escalation study of CDX-0159 were featured in a late breaking presentation in June at the EAACI Annual Congress 2020. CDX-0159 demonstrated a favorable safety profile as well as profound and durable reductions of plasma tryptase, indicative of systemic mast cell ablation. The KIT receptor tyrosine kinase is expressed in a variety of cells, including mast cells. Celldex plans to further study CDX-0159 in chronic inducible urticaria (CINDU) by year end.

CDX-3379 (formerly KTN3379) "We are discontinuing development of CDX-3379," was in 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-527 started a Phase 1 trial in August 2020 in advanced or metastatic solid tumors. 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: bispecific antibodies, and therapies targetting Tyro3, AXL. CDX0159 to inhibit Kit has a Phase 1 trial plan.

Cash ended at $200 million, down sequentially from $207 million.

Operating expenses of $15 million consisted of: $11 million for R&D; $4 million for general and administrative; loss on contingent $0.6 million; Operating loss was $14 million. There was $0.1 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, press release only

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