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Have You Checked Checkpoint Therapeutics Yet?

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Shares of Checkpoint Therapeutics Inc. (CKPT), a majority controlled subsidiary of Fortress Biotech Inc. (FBIO), are well off their highs recorded last September, and trade around $3.

Checkpoint is a clinical-stage immuno-oncology biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for patients with solid tumor cancers.

The Company has two clinical drug candidates namely, CK-101 and CK-301.

CK-101:

CK-101, a third-generation EGFR inhibitor, for the treatment of non-small cell lung cancer (NSCLC) patients carrying the susceptible EGFR mutations, is under phase I/II study.

Checkpoint holds an exclusive worldwide license (barring certain Asian countries) to CK-101, which it acquired from NeuPharma Inc. in 2015.

The preliminary safety and efficacy data from the Phase 1/2 clinical trial of CK-101 in advanced non-small cell lung cancer is expected to be presented at the International Association for the Study of Lung Cancer (IASLC) 19th World Conference on Lung Cancer on September 24.

The only approved 3rd generation EGFR inhibitor for patients with EGFR mutant lung cancer is Tagrisso, a once-daily tablet developed by AstraZeneca. This drug raked in annual sales of $955 million in 2017, and $760 million in the first half of 2018.

CK-301:

CK-301, a fully human anti-PD-L1 antibody, for lung cancer and other solid tumors, is under phase I study.

The Company licensed the exclusive worldwide rights to CK-301 from Dana-Farber in March 2015.

CK-301 belongs to the same class as that of Roche's Tecentriq, Pfizer/Merck's Bavencio and AstaZeneca's Imfinzi, all of which are approved drugs.

Data from the initial CK-301 expansion cohort is expected to be reported around year-end 2018.

If all goes well as planned, the Company expects initiating registration trials for both, CK-101 and CK-301, in 2019.

The other compounds in the pipeline are:

-- CK-302, a fully human agonistic antibody that is designed to bind and trigger signaling in GITR expressing cells, being developed for oncology indications, under preclinical development. The rights to this compound were licensed from Dana-Farber in March 2015.

-- CK-102, a small molecule selective inhibitor of PARP-1 and PARP-2 enzymes in early clinical development for solid tumors. The rights to this drug candidate were licensed from Teva Pharmaceutical Industries Ltd. (through its subsidiary Cephalon, Inc.)

-- CK-103, a novel, selective and potent small molecule inhibitor of BET bromodomains, for the treatment of various advanced and metastatic solid tumor cancers, under pre-clinical development. It was licensed from Jubilant Biosys Limited in May 2016.

-- Anti-CAIX antibody, for the treatment of patients with renal cell carcinoma, currently in preclinical development. The Company licensed the exclusive worldwide rights to certain anti-CAIX antibodies from Dana-Farber in March 2015.

Key Numbers:

*Accumulated deficit: $74.43 million
*Cash on hand: $28.3 million
Shares outstanding: 25.11 million
** Shares Short: 22.73k

(*As of June 30, 2018; **Jul 13, 2018)

CKPT has traded in a range of $2.22 to $10.50 in the last one year. The stock closed Wednesday's trading at $3.77, down 0.53%.

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