Analyst Conference Summary

conference date: March 29, 2021. Press Release only.
for quarter ending: December 31, 2020 (Q4, fourth 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 $3.8 million, up sequentially from $0.7 million and up from $0.9 million year-earlier. All revenue was from license agreements, contracts or grants.

Net income was negative $21.9 million, down sequentially from negative $14.2 million and down from negative $10.4 million year-earlier.

EPS was negative $0.55, up sequentially from negative $0.36, and up from negative $0.64 year-earlier.

Guidance:

Believe can fund operations through 2023.

Conference Highlights:

CEO Anthony Marucci, Celldex Therapeutics CEO, stated: "Celldex made significant progress across our pipeline in 2020 and today continued this momentum with the announcement of compelling interim results from our ongoing Phase 1b study of CDX-0159 in chronic inducible urticaria where we have observed an 80% complete response rate and a well-tolerated safety profile to date. These data support the novel mechanism of CDX-0159 and the potential broad applicability of this compound in mast cell driven diseases. Based on these results, we are expanding the study to also include patients with cholinergic urticaria and look forward to presenting updated results from the cold induced and symptomatic dermographism cohorts this summer. We also anticipate results from the ongoing Phase 1b study in chronic spontaneous urticaria by the end of the year and are on track to initiate a third study in prurigo nodularis in the fourth quarter. In 2020, we also continued to advance our oncology programs, presenting data from our CDX-1140 program supporting this candidate as a best in class CD40 agonist and initiating a Phase 1 study of CDX-527, the first candidate from our bispecific platform, into the clinic. We anticipate data updates from both of these programs later this year and look forward to what promises to be a busy and exciting time for the Company."

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 recruiting.

Celldex reported interim data from the Phase 1b study of CDX-0159 in cold contact urticaria (CSU) in March 2021. 80% complete response, well tolerated. 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 inducible urticaria (CINDU). In February 2021 announced planned Phase 1 dosing in prurigo nodularis. In October 2020 started dosing in chronic spontaneous uticaria.

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 $194 million, down sequentially from $200 million.

Operating expenses of $15 million consisted of: $10 million for R&D; $4 million for general and administrative; intangible asset impairment $15 million; Operating loss was $25 million. There was $2 million other revenue. The income tax benefit was $1 million.

Q&A:

none, press release only

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