Faeth Therapeutics Inc
08/04/2026 | Press release | Distributed by Public on 08/04/2026 05:41
Faeth Therapeutics Reports Second Quarter 2026 Financial Results and Operational Updates (Form 8-K)
Faeth Therapeutics Reports Second Quarter 2026 Financial Results and Operational Updates
- Topline results from the Phase 2 PIK-201 trial in endometrial cancer on track for year-end -
- First patient dosed in the Phase 1b/2 PIK-101 trial in HR+ breast cancer -
- Company changed name to Faeth Therapeutics, Inc. on June 15, 2026; common stock began trading under the ticker symbol "FTH" on June 16, 2026 -
AUSTIN, Texas-(BUSINESS WIRE)-August 4, 2026- Faeth Therapeutics (Nasdaq: FTH), a clinical-stage oncology company developing PIKTOR, an investigational all-oral, multi-node inhibitor of the PI3K/AKT/mTOR pathway, today announced financial results for the quarter ended June 30, 2026, and highlighted recent corporate accomplishments and 2026 milestones.
"Our combination with Sensei Biotherapeutics marked an important milestone in the history of Faeth Therapeutics," said Anand Parikh, Chief Executive Officer. "With the concurrent $200 million PIPE financing, we now have the capital to interrogate the multi-nodal hypothesis in multiple cancers. We look forward to reading out topline data from our Phase 2 PIK-201 trial in endometrial cancer, which is expected by year-end."
Mr. Parikh continued, "We are also excited to have expanded development of PIKTOR into its second indication with the first patient dosed in our PIK-101 trial in HR+ breast cancer in April. We look forward to reporting initial safety and efficacy data from PIK-101 in 2027."
Recent Corporate Updates:
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In April, the Company dosed the first patient in its Phase 1b/2 Trial of PIKTOR in HR+/HER2- Advanced Breast Cancer |
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In June, stockholders approved the conversion of the Series B preferred stock issued in the February 2026 acquisition of Faeth Therapeutics and concurrent private placement into common stock |
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In June, the Company changed its name to Faeth Therapeutics, Inc. and began trading under the ticker symbol "FTH" |
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In June, Anand Parikh, Faeth co-founder, was appointed Chairman, President and Chief Executive Officer, and Brian Stephenson, Ph.D., CFA was appointed Chief Financial Officer. Additionally, the board was strengthened with the addition of former FDA Commissioner Stephen M. Hahn, M.D., and Saira Ramasastry. |
Second Quarter 2026 Financial Results
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Cash, Cash Equivalents and Marketable Securities: Cash, cash equivalents and marketable securities were $186.4 million as of June 30, 2026, as compared to $21.2 million as of December 31, 2025. |
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Research and Development Expenses (R&D): R&D expenses for the quarter ended June 30, 2026 were $9.2 million, compared to $2.5 million for the quarter ended June 30, 2025. The increase in R&D expenses was primarily driven by clinical trial and manufacturing (CMC) costs supporting the development of PIKTOR, together with higher personnel costs, partially offset by lower clinical trial costs for SNS-101. |
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General and Administrative Expenses (G&A): G&A expenses for the quarter ended June 30, 2026, were $9.2 million, compared to $2.7 million during the quarter ended June 30, 2025. The increase in G&A expense was primarily attributable to increased personnel costs and increased professional fees related to financing and reporting activities. |
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Net Loss: Net loss was $16.0 million, or $2.84 per basic and diluted share, for the quarter ended June 30, 2026, compared with a net loss of $4.9 million, or $3.91 per basic and diluted share, for the quarter ended June 30, 2025. |
Weighted-average common shares outstanding, basic and diluted, were 5,643,222 for the quarter ended June 30, 2026, compared with 1,260,867 for the quarter ended June 30, 2025.
Condensed Statements of Operations
(Unaudited, in thousands except share and per share data)
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For the Three Months Ended June 30, |
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| 2026 | 2025 | |||||||
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Operating expenses: |
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Research and development |
$ | 9,180 | $ | 2,533 | ||||
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General and administrative |
9,205 | 2,673 | ||||||
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Total operating expenses |
18,385 | 5,206 | ||||||
|
Loss from operations |
(18,385 | ) | (5,206 | ) | ||||
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Total other income |
2,378 | 270 | ||||||
|
Net loss |
(16,007 | ) | (4,936 | ) | ||||
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Net loss per share, basic and diluted |
$ | (2.84 | ) | $ | (3.91 | ) | ||
|
Weighted-average common shares outstanding, basic and diluted |
5,643,222 | 1,260,867 | ||||||
Selected Condensed Balance Sheet Data
(Unaudited, in thousands)
|
June 30, 2026 |
December 31, 2025 |
|||||||
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Cash and cash equivalents |
$ | 26,903 | $ | 8,668 | ||||
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Marketable securities |
159,538 | 12,516 | ||||||
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Total assets |
189,306 | 22,902 | ||||||
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Total liabilities |
9,581 | 4,310 | ||||||
|
Series B redeemable convertible preferred stock |
6,767 | - | ||||||
|
Total stockholders' equity |
172,958 | 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. According to published literature, this 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 in the second half of 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.
About Faeth Therapeutics
Faeth Therapeutics, Inc. (Nasdaq: FTH) is a clinical-stage biotechnology company focused on improving outcomes for cancer patients through multi-node inhibition of critical oncogenic pathways. The Company's lead program is PIKTOR, an investigational all-oral combination of serabelisib and sapanisertib in development for endometrial and breast cancer. Faeth was co-founded in 2019 by Anand Parikh and Oliver Maddocks, Ph.D., together with scientific founders Lewis Cantley, Ph.D., the discoverer of the PI3K pathway; Siddhartha Mukherjee, M.D., D.Phil.; Karen Vousden, Ph.D.; Scott Lowe, Ph.D.; and Greg Hannon, Ph.D. For more information, please visit www.faeththerapeutics.com and follow the Company on LinkedIn.
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