Analyst Conference Summary

conference date: August 6, 2020 @ 1:30 PM Pacific Time
for quarter ending: June 30, 2020 (Q2, second quarter 2020)

Owned when this was written, but sold mine on 9/16/2020.
Forward-looking statements

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

Basic data (GAAP):

Revenue was $0.2 million, down sequentially from $2.7 million and up from $0.7 million year-earlier. All revenue was from license agreements, contracts or grants.

Net income was negative $11.0 million, up sequentially from negative $12.6 million and up from negative $11.8 million year-earlier.

EPS was negative $0.50, up sequentially from negative $0.73, and up from negative $0.84 year-earlier.

Guidance:

Believe can fund operations through Q1 2021.

Conference Highlights:

CEO Anthony Marucci, Celldex Therapeutics CEO, stated: "In the second quarter of 2020, we presented data from our KIT inhibitor, CDX-0159, in a late breaking session at the EAACI Annual Congress that suggested significant potential to dramatically impact mast cell driven disorders. These data provided important proof of concept for the CDX-0159 program and helped support a $150 million public offering driven by high quality health care investors to fully fund the Company's planned operations through 2023. We are on track to initiate two studies in chronic urticaria later this year and are vetting additional mast cell driven indications to support expanded development in 2021. We continue to focus our resources on the programs we believe hold the most promise for patients and shareholders and have prioritized the development of CDX-0159, CDX-1140, and the first candidate from our bi-specific program, CDX-527. We are discontinuing development of CDX-3379, which is in an exploratory study with cetuximab to assess the utility of biomarkers in head and neck cancer. The side effect profile of the combination remains challenging even with prophylactic treatment and, when considered with the emerging clinical activity, we believe our resources are best utilized to expand the development of CDX-0159 and our other pipeline programs. To this end, we intend to start the two planned studies of CDX-0159 this fall and to initiate a combination cohort of CDX-1140 with chemotherapy in treatment naïve metastatic pancreatic cancer and a Phase 1 study of CDX-527 in refractory, advanced cancers later this year. These programs will support data read outs later this year and in 2021,"

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) "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.

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 $ million, down sequentially from $53.7 million.

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

I am minimizing coverage for now, may sell mine.

OpenIcon Analyst Conference Summaries Main Page

Search

More Analyst Conference Pages: