Faeth Therapeutics reported a larger quarterly loss as it increased spending on its cancer-drug programs, while ending September with substantially more cash and marketable securities than at year-end 2025. The clinical-stage company also highlighted progress for PIKTOR, its lead oncology program, including a regulatory designation and upcoming trial results.
The main near-term milestone is topline data from a Phase 2 trial of PIKTOR in endometrial cancer, which Faeth expects by the end of 2026. Initial safety and efficacy data from a separate breast cancer trial are expected in 2027.
Key details
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Endometrial cancer trial: Faeth expects topline results by year-end from its Phase 2 PIK-201 trial of PIKTOR in endometrial cancer. The company said analysis of pharmacokinetic and pharmacodynamic data helped set the trial’s recommended dose: 3 mg of sapanisertib and 200 mg of serabelisib, taken three days a week.
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FDA Fast Track designation: The FDA granted the designation to PIKTOR in combination with paclitaxel for certain patients with advanced or recurrent endometrial cancer. The eligible patients have tumors with a PI3K/AKT/mTOR pathway alteration and have previously received platinum-based chemotherapy and an immune checkpoint inhibitor. Fast Track is intended to facilitate development and review; it is not an approval of the treatment.
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Breast cancer program: Faeth presented preclinical findings for PIKTOR in hormone receptor-positive, HER2-negative breast cancer models. In those models, the drug suppressed key pathway signals, including AKT, at levels comparable to or greater than those seen with tested single-target inhibitors. PIKTOR was also tested in combination with SERDs and CDK inhibitors. These are laboratory-model results, not clinical evidence of patient benefit. Faeth expects initial safety and efficacy data from its PIK-101 trial in this cancer type in 2027.
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Leadership and board: Faeth appointed Deepak Tiwari as senior vice president of technical operations and Matt Biegler as senior vice president of investor relations. Karen Vousden and Adam Schayowitz joined the board.
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Cash position: Cash, cash equivalents and marketable securities totaled $174.8 million at September 30, compared with $21.2 million at December 31, 2025. The company did not state in this update how long that balance is expected to fund operations.
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Quarterly spending and loss: Research and development expenses rose to $11.7 million from $2.5 million a year earlier, mainly reflecting costs for PIKTOR and other programs, including clinical trials, manufacturing-related work, preclinical research and personnel. General and administrative expenses increased to $10.4 million from $2.3 million, primarily because of higher personnel and outside administrative costs, including legal fees.
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Net loss and shares: Faeth’s net loss was $20.4 million, or 79 cents per share, compared with a loss of $4.6 million, or $3.62 per share, in the year-earlier quarter. The average share count rose to about 25.8 million from 1.3 million. That increase in shares is important context for the lower loss per share: the company’s total quarterly loss grew, even as the per-share figure declined.
What changes for investors
Faeth’s update puts more emphasis on upcoming clinical evidence: the endometrial cancer readout is expected by year-end, while the breast cancer program remains at an earlier stage, with clinical data expected in 2027. The larger cash balance and higher research spending reflect the company’s current financial position and investment in development, but the update does not provide a cash-runway estimate.