Faeth's PIKTOR plus paclitaxel combo gains FDA fast track status. The designation applies to those who have previously undergone platinum-based chemotherapy and an immune checkpoint inhibitor. Faeth Therapeutics has received the US Food and Drug Administration's (FDA) fast track designation for the sapanisertib and serabelisib (PIKTOR) with paclitaxel combination to treat advanced or recurrent endometrial cancer. The designation applies specifically to patients whose tumours contain a phosphatidylinositol 3-kinase / protein kinase B / mechanistic target of rapamycin (PI3K/AKT/mTOR) pathway alteration. It also applies to those who have previously undergone platinum-based chemotherapy and an immune checkpoint inhibitor. Faeth Therapeutics is currently conducting a Phase II trial of this treatment approach, known as Study FTH-PIK-201, in second-line advanced endometrial cancer. The company anticipates releasing top line results from this trial by the end of this year. Faeth Therapeutics CEO Anand Parikh said: "Fast track designation for PIKTOR reflects the significant unmet need in advanced endometrial cancer for patients whose disease has progressed despite platinum-based chemotherapy and an immune checkpoint inhibitor. "We believe PIKTOR's multi-node approach to the PI3K/AKT/mTOR pathway is well suited to this population as our preclinical data suggests that PIKTOR can resensitise patients to chemotherapy." PIKTOR is described as an investigational, all-oral combination therapy and is designed to inhibit several nodes of the PI3K/AKT/mTOR pathway, which, according to published literature, is altered in up to half of all solid tumours. In addition to the endometrial cancer trial, PIKTOR is being tested in a Phase Ib/II study for hormone receptor positive / human epidermal growth factor receptor 2 negative (HR+/HER2-) advanced breast cancer, referred to as Study FTH-PIK-101. The first patient in this study was dosed in April, with interim results expected in 2027. Faeth Therapeutics focuses on multi-node therapies for cancer, with PIKTOR as its leading development programme. Give your business an edge with its leading industry insights.

Faeth Therapeutics has appointed Deepak Tiwari as Senior Vice President, Technical Operations, and Matt Biegler as Senior Vice President, Investor Relations. The clinical-stage biotechnology company is preparing for upcoming milestones in its PIKTOR clinical programme. Tiwari will oversee chemistry, manufacturing and controls, as well as supply chain activities. He brings approximately 30 years of biopharmaceutical experience from companies including Bayer, Baxter International, and Sucampo Pharmaceuticals. Biegler joins from Oppenheimer & Co., where he worked as a senior analyst covering emerging biotechnology companies. He previously spent more than five years in clinical research operations at Parexel International. Faeth's lead programme, PIKTOR, is an investigational all-oral combination treatment in development for endometrial and breast cancer.

Faeth Therapeutics to Present PK/PD Modeling That Informed PIKTOR Dose Selection in Ongoing FTH-PIK-201 Trial at Upcoming Scientific Conference. 1 hour ago Faeth Therapeutics to Present PK/PD Modeling That Informed PIKTOR Dose Selection in Ongoing FTH-PIK-201 Trial at Upcoming Scientific Conference - The data will be presented at the 2026 Summit for Novel Therapeutics in Oncology and Precision Medicine in Cancer conference on August 8 - These data collectively informed PIKTOR dose selection in the ongoing Phase 2 trial in second-line advanced endometrial cancer (Study FTH-PIK-201) Faeth Therapeutics (Nasdaq: FTH), a clinical-stage oncology company developing PIKTOR, an investigational all-oral, multi-node inhibitor of the PI3K/AKT/mTOR pathway, will present translational data and pharmacokinetic/pharmacodynamic (PK/PD) analysis for PIKTOR, its oral combination of serabelisib and sapanisertib, at the 2026 Summit for Novel Therapeutics in Oncology & Precision Medicine in Cancer (STOP Cancer), held August 7-8 in New York. The poster titled "Exposure/Response Analysis of an Oral Multi-Node PI3K/AKT/mTOR Pathway Inhibitor Combination of Serabelisib and Sapanisertib" will be presented on August 8 between 10:25 and 11:30 AM at the New York Marriott Marquis in New York, NY (Poster #9). Data to be reported include a PK/PD analysis that integrates skin biopsy data and PK modeling from earlier third-party clinical trials of serabelisib and sapanisertib. Together, these data informed selection of 3 mg sapanisertib and 200 mg serabelisib three days a week as the recommended Phase 2 dose for PIKTOR in the ongoing Phase 2 trial in second-line advanced endometrial cancer, Study FTH-PIK-201 (NCT06463028). A copy of the poster will be made available in the Investors section of Faeth's website at the start of the poster session. 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 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. 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. Cautionary Note Regarding Forward-Looking Statements This press release contains 'forward-looking statements' within the meaning of the federal securities laws, including the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include all statements that are not historical facts and may be identified by words such as 'anticipate,' 'believe,' 'expect,' 'intend,' 'plan,' 'may,' 'will,' 'would,' 'could,' 'should,' 'estimate,' 'potential,' 'target,' 'on track' and similar expressions, although not all forward-looking statements contain these words. These statements include, but are not limited to, statements regarding: the content, timing and presentation of data at the STOP Cancer conference; the Company's interpretation of preclinical, pharmacokinetic and pharmacodynamic data and the conclusions the Company draws from that data, including with respect to dose and schedule selection for PIKTOR; the Company's expectations regarding its pipeline and development plans, including the Phase 2 trial of PIKTOR in advanced endometrial cancer and the anticipated timing of topline data, and the Phase 1b/2 trial of PIKTOR in HR+/HER2- advanced breast cancer and the anticipated timing of interim data; and the potential therapeutic benefits, tolerability profile and differentiation of PIKTOR. Forward-looking statements are based on management's current expectations and assumptions and are subject to a number of risks and uncertainties, many of which are beyond the Company's control, that could cause actual results to differ materially from those expressed or implied. These risks and uncertainties include, among others, risks related to clinical development and the conduct, timing and results of clinical trials; the risk that results from preclinical studies, earlier clinical trials, modeling or other exploratory analyses may not be predictive of results in ongoing or future clinical trials; the Company's need for additional financing; its limited operating history and history of operating losses; risks related to the integration of Faeth; the Company's ability to satisfy applicable Nasdaq listing requirements and to maintain the listing of its common stock; and the other risks and uncertainties described under the headings 'Risk Factors' and 'Summary of Risk Factors' in the Company's Annual Report on Form 10-K filed with the Securities and Exchange Commission (the 'SEC') on March 30, 2026, its Quarterly Report on Form 10-Q filed with the SEC on August 4, 2026, and its definitive proxy statement filed with the SEC on April 27, 2026, as well as in the Company's subsequent filings. Forward-looking statements speak only as of the date of this press release, and the Company undertakes no obligation to update any forward-looking statement, except as required by law. Investor Contact: Matthew Biegler, SVP, Investor Relations [email protected] Media Contact: Patrick Schmidt, Consort Partners [email protected] View source version on businesswire.com: https://www.businesswire.com/news/home/20260807091302/en/