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FATE Reports Wider-Than-Expected Q4 Loss on Higher Expenses

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Fate Therapeutics (FATE - Free Report) reported a loss of 61 cents per share in the fourth quarter of 2020, wider than the year-ago loss of 37 cents and the Zacks Consensus Estimate of a loss of 38 cents.

Increased Research & Development and General & Administrative expenses led to the wider loss.

The company earned collaboration revenues of $15.9 million in the fourth quarter, easily beating the Zacks Consensus Estimate of $5 million and $2.8 million reported in the year-ago quarter. Revenues are primarily derived from the company’s collaborations with Janssen, a unit of Johnson & Johnson (JNJ - Free Report) and Ono Pharmaceutical.

Research & Development expenses surged to $38.9 million from $25.2 million in the year-ago quarter.

General & Administrative expenses jumped to $10.3 million from $6.7 million in the year-ago quarter.

Full-Year 2020 Results

Revenues increased to $31.4 million from $10.7 million in the prior year and surpassed the Zacks Consensus Estimate of $20.9 million. 

Loss per share widened to $2.10 from $1.44 in 2019 and came in wider than the Zacks Consensus Estimate of $1.88 per share.

Pipeline Update

Fate is developing iPSC-derived CAR NK and CAR T-cell product candidates for the treatment of cancer.

In December 2020, the company reported positive interim data from its phase I study of FT516 in combination with rituximab for patients with relapsed / refractory B-cell lymphoma (BCL) who have previously failed or progressed on CD20-targeted monoclonal antibody therapy. As of the Nov 16 cut-off date, three patients in the second dose cohort (90 million cells per dose) and one patient in the third dose cohort (300 million cells per dose) had each received two FT516 treatment cycles, each cycle consisting of three days of outpatient lympho-conditioning, one dose of rituximab and three once-weekly infusions of FT516 with IL-2 cytokine support. Three of four relapsed/refractory patients achieved an objective response, including two complete responses, following the second FT516 treatment cycle. The two-cycle treatment regimen was well tolerated, supporting the potential to safely administer up to six doses of FT516 in the outpatient setting.

The phase I dose-escalation study is designed to assess the safety and determine the maximum dose of FT516 as a monotherapy for the treatment of relapsed / refractory acute myeloid leukemia (AML) and in combination with CD20-targeted monoclonal antibody therapy for the treatment of relapsed / refractory BCL (NCT04023071). Dose escalation is ongoing at 900 million cells per dose in both disease regimens.

In December 2020, the FDA allowed a second Investigational New Drug (IND) application for the evaluation of three once-weekly doses of FT538 in combination with daratumumab for the treatment of relapsed / refractory AML.

The agency has also allowed the company’s IND application for evaluation of FT576 in patients with relapsed / refractory multiple myeloma who have failed at least two lines of therapy.

Our Take

Higher R&D expenses hit the bottom line in the fourth quarter. Nevertheless, cellular immunotherapies promise huge potential and hence, the successful development of its product candidates will be a significant boost for the company.

Companies like Gilead Sciences, Inc. (GILD - Free Report) and Bristol-Myers Squibb Company (BMY - Free Report) are currently focusing on developing cellular immunotherapies to treat cancer.

Shares of the company have soared 198.8% in the past year compared with the industry’s growth of 11.5%.

 

Fate currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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