On November 3, 2026 Faeth Therapeutics (Nasdaq: FTH), a clinical-stage oncology company developing multi-node therapies for cancer patients, including its lead program PIKTOR, reported financial results for the quarter ended September 30, 2026, and highlighted recent corporate accomplishments and 2026 milestones.
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"Since our last quarterly update, we presented PK/PD analysis that informed the PIKTOR dose in our Phase 2 PIK-201 trial and received Fast Track designation for PIKTOR plus paclitaxel in biomarker-selected advanced endometrial cancer," said Anand Parikh, Chief Executive Officer. "The PAM pathway is dysregulated in up to 50% of solid tumors, and feedback reactivation and resistance mutations may limit single-node inhibitors. We designed PIKTOR, an all-oral, multi-node inhibitor, to address those limitations, and we believe it has the potential to give patients a differentiated treatment option. We look forward to reading out topline data from our Phase 2 PIK-201 trial in endometrial cancer by year-end, and to reporting initial safety and efficacy data from our PIK-101 trial in HR+/HER2- breast cancer in 2027."
Recent Corporate Updates:
Presented preclinical data on PIKTOR in HR+/HER2- breast cancer models at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2026 (Abstract 431P). PIKTOR was tested as monotherapy and in combination with SERDs and CDK inhibitors. In these preclinical models, PIKTOR suppressed key signaling nodes in the PAM pathway, including AKT, at rates comparable to or exceeding those observed with tested single-node inhibitors
Presented PK/PD analysis at the 2026 Summit for Novel Therapeutics in Oncology & Precision Medicine in Cancer (STOP Cancer) 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
FDA granted Fast Track designation to PIKTOR in combination with paclitaxel for the treatment of patients with advanced or recurrent endometrial cancer whose tumors harbor a PI3K/AKT/mTOR (PAM) pathway alteration and who have previously been treated with platinum-based chemotherapy and an immune checkpoint inhibitor
Hosted a virtual key opinion leader event on multi-nodal inhibition for the treatment of endometrial cancer featuring Marcus Goncalves, M.D., Ph.D., of NYU Langone Health and a scientific co-founder of Faeth. A replay is available here
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
Third Quarter 2026 Financial Results
Cash, Cash Equivalents and Marketable Securities: Cash, cash equivalents and marketable securities were $174.8 million as of September 30, 2026, as compared to $21.2 million as of December 31, 2025.
Research and Development Expenses (R&D): R&D expenses for the quarter ended September 30, 2026 were $11.7 million, compared to $2.5 million for the quarter ended September 30, 2025. The increase in R&D expenses was primarily driven by development costs for PIKTOR and other Faeth programs, including clinical trial, chemistry, manufacturing and controls (CMC) and preclinical expenses, together with higher personnel costs, partially offset by lower clinical trial costs for legacy Sensei programs.
General and Administrative Expenses (G&A): G&A expenses for the quarter ended September 30, 2026, were $10.4 million, compared to $2.3 million for the quarter ended September 30, 2025. The increase in G&A expenses was primarily attributable to higher personnel costs and increased external administrative fees, primarily legal fees.
Net Loss: Net loss was $20.4 million, or $0.79 per basic and diluted share, for the quarter ended September 30, 2026, compared with a net loss of $4.6 million, or $3.62 per basic and diluted share, for the quarter ended September 30, 2025.
Weighted-average common shares outstanding, basic and diluted, were 25,840,555 for the quarter ended September 30, 2026, compared with 1,261,290 for the quarter ended September 30, 2025.
Condensed Statements of Operations
(Unaudited, in thousands except share and per share data)
For the Three Months
Ended September 30,
2026
2025
Operating expenses:
Research and development
$
11,736
$
2,536
General and administrative
10,350
2,315
Total operating expenses
22,086
4,851
Loss from operations
(22,086
)
(4,851
)
Total other income
1,688
282
Net loss
(20,398
)
(4,569
)
Net loss per share, basic and diluted
$
(0.79
)
$
(3.62
)
Weighted-average common shares outstanding, basic and diluted
25,840,555
1,261,290
Selected Condensed Balance Sheet Data
(Unaudited, in thousands)
September 30,
2026 December 31,
2025
Cash and cash equivalents
$
14,180
$
8,668
Marketable securities
160,615
12,516
Total assets
178,949
22,902
Total liabilities
11,085
4,310
Series B redeemable convertible preferred stock
6,767
—
Total stockholders’ equity
161,097
18,592
About PIKTOR
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. This multi-node approach is designed to address the signaling feedback reactivation and treatment-emergent resistance mutations that may limit the efficacy of single-node PI3K/AKT/mTOR pathway inhibitors. According to published literature, the PAM pathway is dysregulated in up to 50% of all solid tumors, making it one of the most prevalent therapeutic targets in oncology.
PIKTOR is being evaluated in a Phase 2 trial in second-line advanced endometrial cancer (Study FTH-PIK-201), with topline data anticipated by year-end 2026. PIKTOR is also being evaluated in a Phase 1b/2 trial in HR+/HER2- advanced breast cancer (Study FTH-PIK-101), in which the first patient was dosed in April 2026 and interim data is anticipated in 2027.
(Press release, Faeth Therapeutics, NOV 3, 2026, View Source [SID1234674104])