Analyst Conference Summary

conference date: May 6, 2020 press release only
for quarter ending: March 31, 2020 (Q1, first quarter 2020)

Forward-looking statements

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

Basic data (GAAP):

Revenue was $2.7 million, up sequentially from $0.9 million and up from $1.4 million year-earlier. All revenue was from license agreements, contracts or grants.

Net income was negative $12.6 million, down sequentially from negative $10.4 million and up from negative $17.2 million year-earlier.

EPS was negative $0.73, up sequentially from negative $0.64, and downfrom negative $1.40 year-earlier.

Guidance:

Believe can fund operations through Q1 2021.

Conference Highlights:

CEO Anthony Marucci, Celldex Therapeutics CEO, stated: "We completed enrollment and treatment of all subjects in the Phase 1 healthy volunteer study of our KIT inhibitor, CDX-0159, which we intend to study in mast cell driven disorders. Results from this study have been accepted as a late-breaking poster presentation with voice over at the EAACI Annual Congress 2020 and will be presented in early June by Dr. Marcus Maurer, a leading medical expert in urticaria. We are excited about the promising data observed to date and, based on these results, have expanded development of CDX-0159. We are planning to initiate studies in chronic urticaria later this year. We are also completing preparations to advance CDX-527, the first candidate from our bispecific platform, into a Phase 1 study in refractory, advanced cancers and look forward to initiating this study in the second half of 2020. Finally, we continue to enroll patients in the ongoing studies of CDX-1140 and CDX-3379 and plan to report data updates from these programs later this year."

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. 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 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. Phase 1 results were positive; a poster will be released in June 2020 at EAACI. 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 received a $1.8 million milestone payment from Rockefeller University in March 2020. This was for two HIV agents relicensed to Gilead. More milestones are royalties are possible.

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 $53.7 million, down sequentially from $64.4 million.

Operating expenses of $15.6 million consisted of: $11.7 million for R&D; $3.7 million for general and administrative; loss on contingent $0.2 million; Operating loss was $12.9 million. There was $0.2 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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