Faeth Therapeutics — Third Quarter 2026 Earnings Summary

Financial Performance:

• Cash, cash equivalents, and marketable securities totaled $174.8 million as of September 30, 2026, compared to $21.2 million as of December 31, 2025.
• Research and development (R&D) expenses were $11.7 million for the quarter ended September 30, 2026, compared to $2.5 million for the same period in 2025.
• General and administrative (G&A) expenses were $10.4 million for the quarter ended September 30, 2026, compared to $2.3 million for the same period in 2025.
• Net loss was $20.4 million ($0.79 per basic and diluted share) for the quarter ended September 30, 2026, compared to a net loss of $4.6 million ($3.62 per basic and diluted share) for the quarter ended September 30, 2025.
• Weighted-average common shares outstanding, basic and diluted, increased to 25,840,555 for the quarter ended September 30, 2026, from 1,261,290 in the same period in 2025.
• Total operating expenses were $22.1 million for the quarter ended September 30, 2026, compared to $4.9 million for the quarter ended September 30, 2025.
• Total other income was $1.7 million for the quarter ended September 30, 2026, compared to $0.3 million for the quarter ended September 30, 2025.
• Total assets were $178.9 million as of September 30, 2026, compared to $22.9 million as of December 31, 2025.
• Total liabilities were $11.1 million as of September 30, 2026, compared to $4.3 million as of December 31, 2025.
• Total stockholders' equity was $161.1 million as of September 30, 2026, compared to $18.6 million as of December 31, 2025.
• Series B redeemable convertible preferred stock was $6.8 million as of September 30, 2026, compared to $0 as of December 31, 2025.

Guidance and Future Outlook:

• Topline results from the Phase 2 PIK-201 trial in endometrial cancer are expected by year-end 2026.
• Initial safety and efficacy data from the PIK-101 trial in HR+/HER2- breast cancer are anticipated in 2027.
• Management expects the PAM pathway to be dysregulated in up to 50% of solid tumors.

Business Segments and Product Lines:

• PIKTOR, an all-oral multi-node inhibitor combining serabelisib and sapanisertib, is the company's lead program.
• PIKTOR is being evaluated in a Phase 2 trial (PIK-201) for second-line advanced endometrial cancer.
• PIKTOR is being evaluated in a Phase 1b/2 trial (PIK-101) for HR+/HER2- advanced breast cancer, with the first patient dosed in April 2026.
• Preclinical data presented at ESMO 2026 showed PIKTOR suppressed key signaling nodes in the PAM pathway, including AKT, at rates comparable to or exceeding single-node inhibitors in HR+/HER2- breast cancer models.
• PK/PD analysis presented at the 2026 STOP Cancer summit informed the selection of a recommended Phase 2 dose of 3 mg sapanisertib and 200 mg serabelisib three days a week for the PIK-201 trial.
• R&D expense increases were driven by development costs for PIKTOR and other programs, including clinical trials, CMC, and preclinical expenses, partially offset by lower clinical trial costs for legacy Sensei programs.

Market and Competitive Landscape:

• The PAM pathway is dysregulated in up to 50% of solid tumors, representing a prevalent therapeutic target in oncology.
• Feedback reactivation and resistance mutations may limit the efficacy of single-node inhibitors, which PIKTOR is designed to address.

Risks and Challenges:

• Risks include clinical development and the conduct, timing, and results of clinical trials.
• Results from preclinical studies may not be predictive of results in ongoing or future clinical trials.
• The company relies on third parties for the supply of investigational agents used in combination studies.
• Risks related to the company's cash position, anticipated cash runway, and need for additional financing.
• The company has a limited operating history and a history of operating losses.
• Risks related to the integration of Faeth and the ability to satisfy Nasdaq listing requirements.

Management Commentary and Tone:

• CEO Anand Parikh stated that the company presented PK/PD analysis that informed the PIKTOR dose in the Phase 2 PIK-201 trial and received Fast Track designation.
• Management believes PIKTOR has the potential to give patients a differentiated treatment option by addressing limitations of single-node inhibitors.
• Management expressed anticipation for reading out topline data from the Phase 2 PIK-201 trial by year-end and reporting initial data from the PIK-101 trial in 2027.

Other Key Points:

• The FDA granted Fast Track designation to PIKTOR plus paclitaxel for the treatment of patients with advanced or recurrent endometrial cancer whose tumors harbor a PAM pathway alteration and who have previously been treated with platinum-based chemotherapy and an immune checkpoint inhibitor.
• The company appointed Deepak Tiwari as Senior Vice President, Technical Operations, and Matt Biegler as Senior Vice President, Investor Relations.
• Karen Vousden, Ph.D., and Adam Schayowitz, Ph.D., MBA, were added to the Board of Directors.
• The company hosted a virtual key opinion leader event on multi-nodal inhibition for the treatment of endometrial cancer featuring Marcus Goncalves, M.D., Ph.D.
• Faeth Therapeutics was co-founded in 2019 by Anand Parikh and Oliver Maddocks, Ph.D., along with scientific founders Lewis Cantley, Ph.D., Siddhartha Mukherjee, M.D., D.Phil., Karen Vousden, Ph.D., Scott Lowe, Ph.D., and Greg Hannon, Ph.D.