Faeth Reports Wider Third-Quarter Loss as R&D Expenses Rise
The clinical-stage oncology company reported a $20.4 million net loss, or $0.79 a share, for the quarter ended September 30, 2026.
Faeth Therapeutics (FTH), a clinical-stage oncology company developing multi-node therapies including its lead program PIKTOR, reported a net loss of $20.4 million, or $0.79 a share, for the quarter ended September 30, 2026, compared with a net loss of $16.0 million, or $2.84 a share, in the quarter ended June 30, 2026.
Weighted-average common shares outstanding, basic and diluted, were 25,840,555 for the September quarter, compared with 5,643,222 for the June quarter.
Research and development expenses rose to $11.7 million from $9.2 million. The company said the year-over-year increase was primarily driven by development costs for PIKTOR and other Faeth programs, including clinical trial, chemistry, manufacturing and controls and preclinical expenses, together with higher personnel costs, partially offset by lower clinical trial costs for legacy Sensei programs.
General and administrative expenses were $10.4 million, versus $9.2 million in the prior quarter. The company attributed the year-over-year increase primarily to higher personnel costs and increased external administrative fees, primarily legal fees.
Cash, cash equivalents and marketable securities were $174.8 million as of September 30, 2026, down from $186.4 million as of June 30, 2026.
The company said it presented pharmacokinetic and pharmacodynamic analysis that informed selection of 3 mg sapanisertib and 200 mg serabelisib three days a week as the recommended Phase 2 dose for PIKTOR in the PIK-201 trial. It also said the FDA granted Fast Track designation to PIKTOR in combination with paclitaxel for patients with advanced or recurrent endometrial cancer whose tumors harbor a PI3K/AKT/mTOR pathway alteration and who have previously been treated with platinum-based chemotherapy and an immune checkpoint inhibitor.
Chief Executive Officer Anand Parikh said the company presented PK/PD analysis that informed the PIKTOR dose in the Phase 2 PIK-201 trial and received Fast Track designation for PIKTOR plus paclitaxel in biomarker-selected advanced endometrial cancer. He said the company looks forward to reading out topline data from the Phase 2 PIK-201 trial in endometrial cancer by year-end, and to reporting initial safety and efficacy data from the PIK-101 trial in HR+/HER2- breast cancer in 2027.
Faeth said it presented preclinical data on PIKTOR in HR+/HER2- breast cancer models at the European Society for Medical Oncology Congress 2026. In those models, the company said PIKTOR suppressed key signaling nodes in the PAM pathway, including AKT, at rates comparable to or exceeding those observed with tested single-node inhibitors.
PIKTOR is an investigational, proprietary, all-oral combination of serabelisib, a selective PI3K-alpha inhibitor, and sapanisertib, an mTORC1/mTORC2 inhibitor, designed to inhibit multiple nodes of the PI3K/AKT/mTOR pathway. The company said PIKTOR is being evaluated in a Phase 2 trial in second-line advanced endometrial cancer, with topline data anticipated by year-end 2026, and in a Phase 1b/2 trial in HR+/HER2- advanced breast cancer, in which the first patient was dosed in April 2026 and interim data is anticipated in 2027.
Faeth said it appointed Deepak Tiwari as Senior Vice President, Technical Operations, and Matt Biegler as Senior Vice President, Investor Relations, and added Karen Vousden, Ph.D., and Adam Schayowitz, Ph.D., MBA, to the Board of Directors.
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