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FATE Reports Wider-Than-Expected Q1 Loss, Beats on Revenues

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Fate Therapeutics FATE reported a loss of 48 cents per share in the first quarter of 2021, wider than the year-ago loss of 44 cents and the Zacks Consensus Estimate of a loss of 42 cents.

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

The company earned collaboration revenues of $11.1 million in the first quarter, easily beating the Zacks Consensus Estimate of $7 million and up from $2.5 million reported in the year-ago quarter. Revenues are primarily derived from the company’s collaborations with Janssen, a unit of Johnson & Johnson JNJ, and Ono Pharmaceutical.

Research & Development expenses surged to $44.8 million from $29.3 million in the year-ago quarter.

General & Administrative expenses jumped to $12.5 million from $7.7 million in the year-ago quarter.

Cash, cash equivalents and investments at the end of the first quarter were $888.4 million. This amount includes net proceeds of approximately $432 million from the January 2021 underwritten public offering.

Pipeline Update

The phase I study of FT516 as a monotherapy (NCT04023071) has completed enrollment in the first and second dose cohorts (90 million and 300 million cells per dose, respectively) and dose escalation is ongoing with enrollment in the third dose cohort (900 million cells per dose).

The phase I study of FT538 as a monotherapy (NCT04614636) is enrolling in the first dose cohort (100 million cells per dose).

Dose escalation is ongoing with enrollment in the fourth dose cohort (900 million cells per dose) in the phase I study to assess the safety and determine the maximum dose of FT516 in combination with CD20-targeted monoclonal antibody therapies for the treatment of relapsed / refractory B-cell lymphoma (BCL) (NCT04023071).

Fate has submitted a protocol amendment to the FDA to assess the administration of multi-dose treatment schedules for FT596. Dose escalation of the single-dose treatment schedule is ongoing with enrollment in the third dose cohort (300 million cells) as monotherapy and in combination with rituximab for the treatment of BCL, and in the first dose cohort (30 million cells) as a monotherapy for the treatment of chronic lymphocytic leukemia (CLL).

The phase II PROTECT study, designed to assess the safety and efficacy of ProTmune, did not meet the primary endpoint of prevention from acute GvHD and hence, Fate is discontinuing the development of the same.

Our Take

Higher R&D expenses hit the bottom line in the first 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 and Bristol-Myers Squibb Company BMY are currently focusing on developing cellular immunotherapies to treat cancer.

Shares of Fate have lost 14.5% in the year so far compared with the industry’s decline of 6.7%.

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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