Faeth Therapeutics (Nasdaq: FTH) reported that the U.S. Food and Drug Administration has granted Fast Track designation for its lead program PIKTOR, the combination of sapanisertib and serabelisib, together with paclitaxel. The designation covers treatment of patients with advanced or recurrent endometrial cancer whose tumors harbor a PI3K/AKT/mTOR pathway alteration and who have previously received platinum-based chemotherapy and an immune checkpoint inhibitor.
According to Faeth Therapeutics, PIKTOR is being evaluated in an ongoing Phase 2 trial in second-line advanced endometrial cancer, known as Study FTH-PIK-201, with topline data expected by year-end 2026. The company highlights the unmet medical need in this biomarker-selected, previously treated patient population and notes preclinical data suggesting that PIKTOR may resensitize tumors to chemotherapy.
Faeth Therapeutics (Nasdaq: FTH) announced two senior leadership appointments as it prepares for upcoming PIKTOR clinical milestones. Deepak Tiwari was named Senior Vice President, Technical Operations, and will oversee chemistry, manufacturing and controls (CMC) and supply chain activities supporting PIKTOR’s clinical development and potential future commercialization.
Matt Biegler was appointed Senior Vice President, Investor Relations, leading engagement with current and prospective investors. Tiwari brings about 30 years of biopharmaceutical experience across CMC, technical operations, manufacturing and supply chain at multiple global and specialty companies, while Biegler joins from Oppenheimer & Co. after a career in biotechnology equity research and earlier roles in clinical research operations.
Faeth Therapeutics (Nasdaq: FTH) announced that its Board’s Compensation Committee granted inducement stock options to two new employees for an aggregate of 11,000 shares of common stock. The options were granted effective August 4, 2026 under the company’s 2026 Inducement Plan pursuant to Nasdaq Listing Rule 5635(c)(4).
The options have an exercise price of $25.50 per share, equal to the closing price on the grant date, and a 10‑year term. Vesting covers 25% of each award on the first anniversary of the employee’s start date, with the remaining 75% vesting in 36 substantially equal monthly installments, subject to continued service and the applicable plan and award agreements.
Faeth Therapeutics (Nasdaq: FTH), a clinical-stage oncology company, will present translational and pharmacokinetic/pharmacodynamic (PK/PD) data for PIKTOR, its all-oral multi-node PI3K/AKT/mTOR pathway inhibitor combination of serabelisib and sapanisertib, at the 2026 Summit for Novel Therapeutics in Oncology & Precision Medicine in Cancer (STOP Cancer) in New York on August 8.
The poster, titled “Exposure/Response Analysis of an Oral Multi-Node PI3K/AKT/mTOR Pathway Inhibitor Combination of Serabelisib and Sapanisertib” (Poster #9), will be presented between 10:25 and 11:30 AM at the New York Marriott Marquis. According to Faeth Therapeutics, PK/PD analysis integrating skin biopsy data and pharmacokinetic modeling from earlier third-party clinical trials informed selection of the recommended Phase 2 PIKTOR dose: 3 mg sapanisertib and 200 mg serabelisib three days per week for the ongoing Phase 2 second-line advanced endometrial cancer trial, Study FTH-PIK-201 (NCT06463028). A copy of the poster will be available in the Investors section of the company’s website at the start of the poster session.
Faeth Therapeutics (Nasdaq: FTH) reported Q2 2026 cash, cash equivalents and marketable securities of $186.4 million as of June 30, 2026, up from $21.2 million at December 31, 2025, supported by a concurrent $200 million PIPE financing completed with its combination with Sensei Biotherapeutics.
The company is advancing PIKTOR, dosing the first patient in April in its Phase 1b/2 PIK-101 trial for HR+/HER2- advanced breast cancer and targeting year-end 2026 topline Phase 2 PIK-201 data in endometrial cancer. Q2 R&D and G&A expenses each rose to $9.2 million, and net loss widened to $16.0 million. Faeth changed its name and ticker to FTH in June and refreshed leadership and its board.
Faeth Therapeutics (Nasdaq: FTH) granted stock options to two new employees under its 2026 Inducement Plan, in line with Nasdaq Listing Rule 5635(c)(4). The awards cover an aggregate of 25,500 shares of common stock, granted on July 20, 2026 at an exercise price of $28.19 per share, equal to the closing market price that day. The options vest 25% on the first anniversary of each employee’s start date, with the remaining 75% vesting in 36 substantially equal monthly installments, subject to continued service.
Faeth Therapeutics (Nasdaq:FTH) granted stock options to six new employees under its 2026 Inducement Plan, compliant with Nasdaq Listing Rule 5635(c)(4).
The awards cover 180,350 shares total, at exercise prices matching the June 25 and June 29, 2026 closing prices, with four-year vesting.
Faeth Therapeutics (Nasdaq:FTH), formerly Sensei Biotherapeutics, changed its name and will begin trading under ticker FTH on June 16, 2026. Stockholders approved conversion of Series B preferred shares issued in the February 2026 Faeth acquisition and concurrent private placement, which raised about $200 million.
The company is advancing PIKTOR, an oral multi-node PI3K/AKT/mTOR inhibitor, with topline Phase 2 data in advanced endometrial cancer expected in the second half of 2026 and interim Phase 1b/2 data in HR+/HER2- breast cancer expected in 2027. A new executive team and refreshed board, including former FDA Commissioner Stephen M. Hahn, M.D., is in place.