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FATE Q2 Earnings Beat on Lower Expenses, Collaboration Revenues Grow
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Fate Therapeutics (FATE - Free Report) reported a loss of 33 cents per share in the second quarter of 2024, narrower than the Zacks Consensus Estimate of a loss of 47 cents. The company reported a loss of 54 cents per share in the year-ago period.
The loss narrowed year over year due to higher collaboration revenues and lower R&D expenses.
The company earned collaboration revenues of $6.8 million, which beat the Zacks Consensus Estimate of $1 million. The figure also increased from $0.9 million reported in the year-ago quarter.
The strong top-line results can be attributed to the achievement of a $5 million milestone payment in connection with the clinical development of FT825/ONO-8250 and the conduct of preclinical development activities for a second collaboration candidate targeting an undisclosed solid tumor antigen under its collaboration with Ono.
R&D expenses declined 15.4% to $34.6 million. G&A expenses decreased 23.7% to $17.2 million.
Cash, cash equivalents and investments as of Jun 30, 2024, totaled $352.0 million.
Shares of Fate have lost 10.7% year to date compared with the industry’s decline of 3.9%.
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.
A phase I study of FT819, a T-cell product candidate for patients with systemic lupus erythematosus (SLE), is currently enrolling patients. The first patient enrolled in the study was a 27-year-old woman diagnosed with lupus nephritis (over ten years ago). She received conditioning chemotherapy followed by a single dose of FT819 at 360 million cells.
The patient remains on study. There has not been any grade ≥3 adverse event or incidence of any grade of cytokine release syndrome (CRS), immune effector-cell associated neurotoxicity syndrome (ICANS), or graft-versus-host disease (GvHD). FATE plans to present clinical and translational data from the Phase 1 study at a medical conference in the second half of 2024.
FATE also amended the clinical protocol of its phase I autoimmunity study on FT819 to include single-agent cyclophosphamide as a third conditioning regimen.
The company successfully completed dose escalation in its phase I B cell malignancies study on FT819 and has focused further on clinical development of FT819, exclusively in autoimmunity.
With ONO Pharmaceutical, Fate is co-developing FT825/ONO-8250, a multiplexed-engineered, iPSC-derived CAR T-cell product candidate. FATE is conducting a multi-center, phase I study to assess the safety, pharmacokinetics and activity of FT825/ONO-8250 as monotherapy and in combination with monoclonal antibody therapy in patients with advanced solid tumors.
Three patients have been treated in the phase I study with a single dose of FT825 / ONO-8250 as monotherapy at the first dose level of 100 million cells. FATE plans to present clinical and translational data from the phase I study at a medical conference in the second half of 2024.
A phase I study of FT522 in patients with relapsed/refractory B-cell lymphoma is also ongoing. The first patient has now been treated in the first three-dose cohort at 300 million cells per dose without conditioning chemotherapy. In addition, the first patient has now been treated in the second three-dose cohort at 900 million cells per dose with conditioning chemotherapy (Regimen A). No dose-limiting toxicity or event of any grade of CRS, ICANS, or GvHD has been reported.
FATE plans to submit an investigational new drug application to the FDA in the third quarter of 2024 for the treatment of a basket of B cell-mediated autoimmune diseases with FT522, without any administration of conditioning chemotherapy to patients.
Entrada’s loss per share estimate for 2024 has narrowed from 27 cents to 13 cents in the past 90 days, and the same for 2025 has narrowed from $3.62 to $3.21.
Krystal Biotech’s earnings per share for 2024 have decreased to $2.07 from $2.39 in the past 30 days. Shares of KRYS have surged 51.1% year to date.
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FATE Q2 Earnings Beat on Lower Expenses, Collaboration Revenues Grow
Fate Therapeutics (FATE - Free Report) reported a loss of 33 cents per share in the second quarter of 2024, narrower than the Zacks Consensus Estimate of a loss of 47 cents. The company reported a loss of 54 cents per share in the year-ago period.
The loss narrowed year over year due to higher collaboration revenues and lower R&D expenses.
The company earned collaboration revenues of $6.8 million, which beat the Zacks Consensus Estimate of $1 million. The figure also increased from $0.9 million reported in the year-ago quarter.
The strong top-line results can be attributed to the achievement of a $5 million milestone payment in connection with the clinical development of FT825/ONO-8250 and the conduct of preclinical development activities for a second collaboration candidate targeting an undisclosed solid tumor antigen under its collaboration with Ono.
R&D expenses declined 15.4% to $34.6 million. G&A expenses decreased 23.7% to $17.2 million.
Cash, cash equivalents and investments as of Jun 30, 2024, totaled $352.0 million.
Shares of Fate have lost 10.7% year to date compared with the industry’s decline of 3.9%.
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.
A phase I study of FT819, a T-cell product candidate for patients with systemic lupus erythematosus (SLE), is currently enrolling patients. The first patient enrolled in the study was a 27-year-old woman diagnosed with lupus nephritis (over ten years ago). She received conditioning chemotherapy followed by a single dose of FT819 at 360 million cells.
The patient remains on study. There has not been any grade ≥3 adverse event or incidence of any grade of cytokine release syndrome (CRS), immune effector-cell associated neurotoxicity syndrome (ICANS), or graft-versus-host disease (GvHD). FATE plans to present clinical and translational data from the Phase 1 study at a medical conference in the second half of 2024.
FATE also amended the clinical protocol of its phase I autoimmunity study on FT819 to include single-agent cyclophosphamide as a third conditioning regimen.
The company successfully completed dose escalation in its phase I B cell malignancies study on FT819 and has focused further on clinical development of FT819, exclusively in autoimmunity.
With ONO Pharmaceutical, Fate is co-developing FT825/ONO-8250, a multiplexed-engineered, iPSC-derived CAR T-cell product candidate. FATE is conducting a multi-center, phase I study to assess the safety, pharmacokinetics and activity of FT825/ONO-8250 as monotherapy and in combination with monoclonal antibody therapy in patients with advanced solid tumors.
Three patients have been treated in the phase I study with a single dose of FT825 / ONO-8250 as monotherapy at the first dose level of 100 million cells. FATE plans to present clinical and translational data from the phase I study at a medical conference in the second half of 2024.
A phase I study of FT522 in patients with relapsed/refractory B-cell lymphoma is also ongoing. The first patient has now been treated in the first three-dose cohort at 300 million cells per dose without conditioning chemotherapy. In addition, the first patient has now been treated in the second three-dose cohort at 900 million cells per dose with conditioning chemotherapy (Regimen A). No dose-limiting toxicity or event of any grade of CRS, ICANS, or GvHD has been reported.
FATE plans to submit an investigational new drug application to the FDA in the third quarter of 2024 for the treatment of a basket of B cell-mediated autoimmune diseases with FT522, without any administration of conditioning chemotherapy to patients.
Zacks Rank & Stocks to Consider
Fate currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the biotech sector are Entrada Therapeutics (TRDA - Free Report) and Krystal Biotech (KRYS - Free Report) , both carrying a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
Entrada’s loss per share estimate for 2024 has narrowed from 27 cents to 13 cents in the past 90 days, and the same for 2025 has narrowed from $3.62 to $3.21.
Krystal Biotech’s earnings per share for 2024 have decreased to $2.07 from $2.39 in the past 30 days. Shares of KRYS have surged 51.1% year to date.