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FATE Q2 Earnings Beat on Lower Expenses, Revenues Miss
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Fate Therapeutics (FATE - Free Report) reported a loss of 54 cents per share in the second quarter of 2023, narrower than the Zacks Consensus Estimate of a loss of 58 cents and the year-ago loss of 79 cents.
The loss narrowed year over year due to lower R&D expenses.
The company earned collaboration revenues of $0.9 million in the second quarter, which missed the Zacks Consensus Estimate of $7 million and was down from $18.5 million reported in the year-ago quarter.
Revenues were derived from the company’s preclinical development activities for a second collaboration candidate targeting an undisclosed solid tumor antigen under its collaboration with ONO Pharmaceutical.
R&D expenses declined 49.7% to $40.9 million in the year-ago quarter. G&A expenses increased 11.1% to $22.6 million.
Cash, cash equivalents and investments as of Jun 30, 2023, were $385.2 million.
Shares of Fate have plunged 65% year to date compared with the industry’s decline of 13.1%.
Image Source: Zacks Investment Research
Pipeline Update
FATE is focused on the development and manufacture of universal, off-the-shelf cell products using its proprietary induced pluripotent stem cell (iPSC) product platform. Its immuno-oncology pipeline includes off-the-shelf, iPSC-derived natural killer (NK) cells and T-cell product candidates. These candidates are designed to synergize with well-established cancer therapies, including immune checkpoint inhibitors and monoclonal antibodies and to target tumor-associated antigens using chimeric antigen receptors (CARs).
In May, the FDA accepted the company’s investigational new drug (IND) application to evaluate FT522 in combination with CD20-targeted monoclonal antibody therapy in patients with relapsed/refractory B-cell lymphoma. The dose-escalation stage of the study is designed to assess the safety and activity of FT522 with and without the administration of intensive conditioning chemotherapy to patients. Fate is conducting phase I study start-up activities at multiple sites and plans to initiate patient enrollment with a three-dose treatment schedule at 300 million cells per dose.
The phase I study on FT576, a multiplexed-engineered, B-cell maturation antigen-targeted CAR NK cell product candidate for relapsed/refractory multiple myeloma, is currently enrolling patients.
Fate Therapeutics, Inc. Price, Consensus and EPS Surprise
A phase I study of FT819, a T-cell product candidate manufactured from a clonal master iPSC line, is currently enrolling patients in single-dose escalation cohorts at 540 million cells in B-cell lymphoma and at 360 million cells in chronic lymphocytic leukemia.
With ONO Pharmaceutical, Fate is co-developing FT825/ONO-8250, a multiplexed-engineered, iPSC-derived CAR T-cell product candidate targeting human epidermal growth factor receptor 2 (HER2)-expressing solid tumors. IND-enabling activities for FT825/ONO-8250 are underway and both companies expect to submit an IND application to the FDA in the second half of 2023 to jointly commence a phase I study for the treatment of patients with HER2-positive solid tumors.
We remind investors that, in January 2023, Fate announced the termination of its agreement with Janssen. Both companies signed an agreement in April 2020 to collaborate on the development of iPSC-derived CAR NK- and CAR T-cell product candidates for the treatment of cancer.
In connection with the termination of its collaboration with Janssen Biotech, Fate discontinued all collaboration activities, including withdrawing an IND application, which was previously allowed by the FDA for a first collaboration product for treating B-cell lymphoma.
Following a strategic review of its wholly-owned iPSC-derived NK cell and T-cell programs, Fate has also decided to discontinue FT516, FT596, FT538 and FT536 NK cell product candidates. As part of its corporate restructuring, the company reduced its workforce to approximately 220 employees.
Over the past 60 days, loss estimates for ACAD have narrowed to 41 cents from 56 cents for 2023. ACAD topped earnings estimates in two of the last four quarters and missed in the remaining two, the average surprise being 20.33%.
Over the past 90 days, loss estimates for FOLD in 2023 have increased by 21 cents to 48 cents. FOLD topped earnings estimates in two of the last four quarters, missing the other two. Shares of Amicus gained 13.5% in the year so far.
Over the past 30 days, earnings estimates for DVAX have narrowed to 34 cents from 56 cents. Shares of Dynavax have gained 40% in the year so far.
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FATE Q2 Earnings Beat on Lower Expenses, Revenues Miss
Fate Therapeutics (FATE - Free Report) reported a loss of 54 cents per share in the second quarter of 2023, narrower than the Zacks Consensus Estimate of a loss of 58 cents and the year-ago loss of 79 cents.
The loss narrowed year over year due to lower R&D expenses.
The company earned collaboration revenues of $0.9 million in the second quarter, which missed the Zacks Consensus Estimate of $7 million and was down from $18.5 million reported in the year-ago quarter.
Revenues were derived from the company’s preclinical development activities for a second collaboration candidate targeting an undisclosed solid tumor antigen under its collaboration with ONO Pharmaceutical.
R&D expenses declined 49.7% to $40.9 million in the year-ago quarter. G&A expenses increased 11.1% to $22.6 million.
Cash, cash equivalents and investments as of Jun 30, 2023, were $385.2 million.
Shares of Fate have plunged 65% year to date compared with the industry’s decline of 13.1%.
Image Source: Zacks Investment Research
Pipeline Update
FATE is focused on the development and manufacture of universal, off-the-shelf cell products using its proprietary induced pluripotent stem cell (iPSC) product platform. Its immuno-oncology pipeline includes off-the-shelf, iPSC-derived natural killer (NK) cells and T-cell product candidates. These candidates are designed to synergize with well-established cancer therapies, including immune checkpoint inhibitors and monoclonal antibodies and to target tumor-associated antigens using chimeric antigen receptors (CARs).
In May, the FDA accepted the company’s investigational new drug (IND) application to evaluate FT522 in combination with CD20-targeted monoclonal antibody therapy in patients with relapsed/refractory B-cell lymphoma. The dose-escalation stage of the study is designed to assess the safety and activity of FT522 with and without the administration of intensive conditioning chemotherapy to patients. Fate is conducting phase I study start-up activities at multiple sites and plans to initiate patient enrollment with a three-dose treatment schedule at 300 million cells per dose.
The phase I study on FT576, a multiplexed-engineered, B-cell maturation antigen-targeted CAR NK cell product candidate for relapsed/refractory multiple myeloma, is currently enrolling patients.
Fate Therapeutics, Inc. Price, Consensus and EPS Surprise
Fate Therapeutics, Inc. price-consensus-eps-surprise-chart | Fate Therapeutics, Inc. Quote
A phase I study of FT819, a T-cell product candidate manufactured from a clonal master iPSC line, is currently enrolling patients in single-dose escalation cohorts at 540 million cells in B-cell lymphoma and at 360 million cells in chronic lymphocytic leukemia.
With ONO Pharmaceutical, Fate is co-developing FT825/ONO-8250, a multiplexed-engineered, iPSC-derived CAR T-cell product candidate targeting human epidermal growth factor receptor 2 (HER2)-expressing solid tumors. IND-enabling activities for FT825/ONO-8250 are underway and both companies expect to submit an IND application to the FDA in the second half of 2023 to jointly commence a phase I study for the treatment of patients with HER2-positive solid tumors.
We remind investors that, in January 2023, Fate announced the termination of its agreement with Janssen. Both companies signed an agreement in April 2020 to collaborate on the development of iPSC-derived CAR NK- and CAR T-cell product candidates for the treatment of cancer.
In connection with the termination of its collaboration with Janssen Biotech, Fate discontinued all collaboration activities, including withdrawing an IND application, which was previously allowed by the FDA for a first collaboration product for treating B-cell lymphoma.
Following a strategic review of its wholly-owned iPSC-derived NK cell and T-cell programs, Fate has also decided to discontinue FT516, FT596, FT538 and FT536 NK cell product candidates. As part of its corporate restructuring, the company reduced its workforce to approximately 220 employees.
Zacks Rank & Stocks To Consider
Fate currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the healthcare sector are Acadia Pharmaceuticals (ACAD - Free Report) , Amicus Therapeutics (FOLD - Free Report) and Dynavax Technologies (DVAX - Free Report) , currently carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Over the past 60 days, loss estimates for ACAD have narrowed to 41 cents from 56 cents for 2023. ACAD topped earnings estimates in two of the last four quarters and missed in the remaining two, the average surprise being 20.33%.
Over the past 90 days, loss estimates for FOLD in 2023 have increased by 21 cents to 48 cents. FOLD topped earnings estimates in two of the last four quarters, missing the other two. Shares of Amicus gained 13.5% in the year so far.
Over the past 30 days, earnings estimates for DVAX have narrowed to 34 cents from 56 cents. Shares of Dynavax have gained 40% in the year so far.