Analyst Conference Summary

conference date: February 28, 2022 @ 1:30 PM Pacific Time
for quarter ending: December 31, 2021 (Q4, fourth quarter 2021)

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

Overview: Continues to make advances in preclinical and early stage therapy programs.

Basic data (GAAP):

Revenue was $0.3 million, sequentially from $na million and down from $3.8 million year-earlier. All revenue was from license agreements, contracts or grants.

Net income was negative $20 million, down sequentially from negative $na million and up from negative $22 million year-earlier.

EPS was negative $0.43, up sequentially from negative $na, and up from negative $0.55 year-earlier. Share count approx 46.7 million up y/y from 39.6 milion.

Guidance:

Has sufficient cash to take pipeline to important inflection points.

Conference Highlights:

CEO Anthony Marucci, Celldex Therapeutics CEO, stated: "We remain excited to report data from our chronic spontaneous urticaria Phase 1b study early this summer. In July 2021, we raised $287 million in gross proceeds from a public offering which provides us with a very strong foundation to further develop our scientific and clinical programs. After successfully completing key readiness activities, including the development of a CDX-0159 subcutaneous formulation, we remain on track to initiate our Phase 2 urticaria programs in the second quarter of 2022."

CDX0159 to inhibit KIT has a Phase 1b trial began enrolling for prurigo nodularis in December 2021. Data planned for release at EAACI 2022. Phase 2 trial for chronic inducible urticaria and chronic spontaneous urticaria planned for Q2 2022. Target is mast cells. Also testing a subcutaneous dose. Planning a study in eosinophilic esophagitis (160,000 patients in US) to start in Q4 2022.

In the Phase 1 study of CDX-1140 in patients with recurrent, locally advanced or metastatic solid tumors and B cell lymphomas, the monotherapy cohort, the combination cohort with CDX-301 and the safety run-in combination cohort with gemcitabine/nab-paclitaxel have been completed. Expansion cohorts include CDX-1140 with Keyruda (pembrolizumab) in patients with squamous cell head and neck cancer and non-small cell lung cancer.

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. As of Q2 2022 the dose escalation cohort was complete and an expansion cohort in ovarian cancer was initiated.

Preclinical drugs are being readied to enter clinical trials: bispecific antibodies, and therapies targetting Tyro3, AXL.

Cash ended at $408 million, down sequentially from $na million.

Operating expenses of $21 million consisted of: $15 million for R&D; $6 million for general and administrative; intangible asset impairment gain $0.2 million; Operating loss was $21 million. There was $0.2 million other revenue. The income tax benefit was $0 million.

Q&A selective summary:

Phase 1b EAACI data prurigo? We allowed patients to enroll who are refractory to biologics. 4.5 mg cohort data is not needed to move forward as 3 mg and subcutaneous data should be sufficient.

Any below normal white blood cell counts? Subjects starting close to the bottom of the range are most likely to dip below, but it is temporary.

Biomarkers in EoE? None that would predict the classes within the diagnosed population. We might understand biomarkers better as we progress.

At least in mice it takes about 1 month for sperm count to resume. Sperm recovery would occur after the antibody clears, which could take a long time. Will have more data later this year. No observed effects on female subjects' reproduction.

We have not decided on which uticarias to include in Phase 3 yet.

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