Fate Therapeutics FATE reported a loss of 31 cents per share (excluding impairment loss) in the fourth quarter of 2024, narrower than the Zacks Consensus Estimate of a loss of 44 cents. The company reported a loss of 45 cents per share in the year-ago period.

Including the impairment loss of $14.7 million, loss per share was 44 cents.

The company earned collaboration revenues of $1.9 million, surpassing the Zacks Consensus Estimate of $1 million. The figure also increased from $1.7 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 Pharmaceutical.

R&D expenses increased 5.6% to $33.6 million. G&A expenses decreased 14.9% to $15.3 million.

Cash, cash equivalents and investments as of Dec. 31, 2024, totaled $306.7 million. Fate expects the current cash balance to sustain an operating runway through 2026.

Shares of Fate have lost 88.7% year to date compared with the industry’s decline of 7.6%.

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FATE’s Key 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 company has initiated dose expansion in up to 10 patients at 360 million cells, based on clinical data from the first three patients treated with FT819 in the ongoing multi-center, phase I study.

The dose expansion stage is designed to evaluate the safety and efficacy of a fludarabine (flu)-free conditioning regimen, consisting of either bendamustine or cyclophosphamide alone, followed by a single dose of FT819.

FATE is also assessing the safety, pharmacokinetics, and anti-B cell activity of FT819 at 900 million cells in dose escalation. It presented data from the first three patients at the American Society of Hematology Annual Meeting.  As of a data cutoff date of Dec. 4, 2024, FATE did not observe dose-limiting toxicities (DLTs) or any event of any grade of cytokine release syndrome (CRS), immune effector-cell associated neurotoxicity syndrome (ICANS), or graft-versus-host disease (GvHD).  

FATE also amended the clinical protocol of its phase I autoimmunity study on FT819 to include a new treatment arm 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.

In December 2024, FATE reached an agreement with the FDA to allow for the clinical investigation of additional B cell-mediated autoimmune diseases under the current phase 1 clinical trial of FT819.

The company has submitted an amended clinical protocol to the FDA that enables the conduct of independent dose-expansion cohorts for SLE as well as anti-neutrophilic cytoplasmic antibody-associated vasculitis (AAV), idiopathic inflammatory myositis (IIM), and systemic sclerosis (SSc).

Fate plans to initiate dose-expansion cohorts in one or more of AAV, IIM and SSc in 2025. The regulatory body also agreed to allow the investigation of a multi-dose treatment cycle and for re-treatment upon disease progression, making the treatment dosing paradigm more aligned with traditional biological therapies. The FDA also permitted the expansion of study eligibility criteria, including the inclusion of patients between the ages of 12 and 17.  

Fate is co-developing FT825/ONO-8250, a multiplexed-engineered, iPSC-derived CAR T-cell product candidate, with ONO Pharmaceutical. It 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.

Enrollment is currently ongoing at the third dose level of 900 million cells as monotherapy and at the second dose level of 300 million cells in combination with epidermal growth factor receptor (EGFR)-targeted monoclonal antibody therapy.

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.

In November 2024, FATE presented initial translational data from its ongoing multi-center, phase I study of FT522 in patients with relapsed/refractory B-cell lymphoma (NCT05950334). Data showed that live FT522 cells with anti-B cell activity were detected in the patients’ peripheral blood through Day 15. This data demonstrated the potential of FT522 to persist and function in the presence of an unmatched, fully intact immune system. FATE intends to assess any further clinical development of FT522 in relapsed/refractory BCL upon completion of dose escalation at the second dose level of 900 million cells.

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).

FATE's 2024 Results

Loss per share in 2024 was $1.64, marginally wider than the Zacks Consensus Estimate of a loss of $1.63. The loss remained flat on a year-over-year basis. Collaboration revenues earned were $13.6 million, which surpassed the Zacks Consensus Estimate of $12.,53 million. The top line was down from $63.5 million in 2023.  

Zacks Rank & Stocks to Consider

FATE currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the biotech sector are Gilead Sciences GILD and BioMarin Pharmaceutical BMRN, each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Gilead Sciences

In the past 30 days, Gilead Sciences’ EPS estimate for 2025 has increased from $7.55 to $7.86. During the same timeframe, the figure for 2026 has increased to $8.17 from $7.82.

GILD’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 19.47%.

BioMarin Pharmaceutical

In the past 30 days, estimates for BioMarin Pharmaceutical’s 2025 EPS have increased from $4.01 to $4.24. Estimate for 2026 EPS has increased to $5.25 from $5.20 during the same timeframe. BMRN’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 32.36%.

 

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