Fate Therapeutics FATE reported a loss of 40 cents per share in the third quarter of 2024, narrower than the Zacks Consensus Estimate of a loss of 42 cents. The company reported a loss of 46 cents per share in the year-ago period.
The loss narrowed year over year due to higher collaboration revenues.
The company earned collaboration revenues of $3.1 million, which beat the Zacks Consensus Estimate of $1 million. The figure also increased from $1.9 million reported in the year-ago quarter.
Revenues were derived from preclinical development activities for a second collaboration candidate targeting an undisclosed solid tumor antigen under its collaboration with Ono.
R&D expenses increased 1.1% to $34.6 million. G&A expenses increased 9.8% to $20.8 million.
Cash, cash equivalents and investments as of Sept. 30, 2024, totaled $330.5 million.
Shares of Fate have lost 36.3% year to date compared with the industry’s decline of 3.7%.
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FATE's Pipeline Update
FATE is focused on developing and manufacturing universal, off-the-shelf cell products using its proprietary induced pluripotent stem cell (iPSC) product platform. Its immuno-oncology pipeline includes 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 ongoing.
The first three patients, all of whom were suffering from active lupus nephritis (LN) despite having been treated with multiple standard-of-care therapies, received fludarabine-free conditioning consisting of either bendamustine or cyclophosphamide alone, followed by a single dose of FT819 at 360 million cells. All three patients continue to be on study. FATE did not observe dose-limiting toxicities (DLTs) or any grade of cytokine release syndrome (CRS), immune effector-cell associated neurotoxicity syndrome (ICANS), or graft-versus-host disease (GvHD).
The first patient treated in the ongoing phase I autoimmunity study on FT819 was a 27-year-old woman diagnosed with lupus nephritis (over ten years ago). She received fludarabine-free conditioning chemotherapy followed by a single dose of FT819 at 360 million cells. The patient remains on study.
FATE also amended the clinical protocol of its phase I autoimmunity study on FT819 to include a second treatment arm (Regimen B) to assess the safety, pharmacokinetics, and anti-B cell activity of a single dose of FT819 as an add-on to maintenance therapy without conditioning chemotherapy in patients with SLE.
Fate is co-developing FT825/ONO-8250, a multiplexed-engineered, iPSC-derived CAR T-cell product candidate, with ONO Pharmaceutical. The company is conducting a multi-center, phase I study to assess the safety, pharmacokinetics and activity of FT825/ONO-8250 in patients with advanced solid tumors.
The company presented initial clinical data from three heavily pre-treated patients at a medical conference. All three patients were previously treated with at least five prior lines of therapy, including HER2-targeted treatment. Each patient was administered conditioning chemotherapy and a single dose of FT825 / ONO-8250 at the first dose level of 100 million cells.
As of a data cutoff date of Oct. 25, 2024, FT825 / ONO-8250 demonstrated a favorable safety profile with no DLTs and no event of any grade of CRS, ICANS, or GvHD.
Enrollment is ongoing at the second dose level of 300 million cells as monotherapy and at the first dose level of 100 million cells combined with epidermal growth factor receptor (EGFR)-targeted monoclonal antibody therapy.
A phase I study of FT522 in patients with relapsed/refractory B-cell lymphoma is ongoing. FATE is enrolling patients in the second three-dose cohort at 900 million cells per dose with conditioning chemotherapy (Regimen A) and in the first three-dose cohort at 300 million cells per dose without conditioning chemotherapy (Regimen B). No DLT or event of any grade of CRS, ICANS, or GvHD was reported in the phase I study.
Meanwhile, the FDA allowed the company’s investigational new drug (IND) application to assess the safety, pharmacokinetics, and activity of FT522 across a basket of B cell-mediated autoimmune diseases. The phase I study is intended to treat patients with multiple doses of FT522 without conditioning chemotherapy as an add-on to rituximab induction therapy (Regimen A) and maintenance therapy in combination with rituximab (Regimen B).
Zacks Rank & Stocks to Consider
FATE currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks from the biotech sector are Immunocore Holdings plc IMCR, ANI Pharmaceuticals, Inc. ANIP and Castle Biosciences, Inc. CSTL, each carrying a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for Immunocore’s 2024 loss per share have narrowed from $1.67 to 96 cents. Loss per share estimates for 2025 have narrowed from $2.35 to $1.70 during the same time frame. Year to date, shares of IMCR have lost 49.3%.
In the past 60 days, estimates for ANI Pharmaceuticals’ 2024 earnings per share have moved up from $4.59 to $4.71. Earnings per share estimates for 2025 have increased from $4.82 to $5.65 during the same time.
ANIP’s earnings beat estimates in each of the trailing four quarters, the average surprise being 20.27%.
In the past 60 days, estimates for Castle Biosciences’ 2024 loss per share have narrowed from 58 cents to 8 cents. Loss per share estimates for 2025 have narrowed from $2.13 to $1.88 during the same time frame. CSTL’s earnings beat estimates in each of the trailing four quarters, the average surprise being 172.72%.
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