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Flare Therapeutics to Present Correlative Biomarker Analysis from the FX-909 Phase 1A Clinical Study at Upcoming SITC 2025 40th Anniversary Annual Meeting

CAMBRIDGE, Mass., Oct. 30, 2025 (GLOBE NEWSWIRE) -- Flare Therapeutics Inc. (FlareTx), a clinical-stage biotechnology company targeting transcription factors to discover precision medicines for oncology and other therapeutic areas, today announced a poster presentation of the correlative biomarker analysis from the FX-909 Phase 1A clinical study at the upcoming Society for Immunotherapy of Cancer (SITC) 2025 40th Anniversary Annual Meeting being held November 5-9, 2025 in National Harbor, MD.

The presentation at SITC will build on the first disclosure of the part A data from the ongoing Phase 1 study for FX-909, which were recently presented at the AACR-NCI-EORTC International Conference, and include novel insights regarding FX-909’s immune modulatory mechanism of action. FX-909 is a first-in-class orally available small molecule inhibitor of peroxisome proliferator-activated receptor gamma (PPARG), the master regulator of the luminal lineage, currently in a Phase 1B study for the treatment of locally-advanced or metastatic urothelial cancer (UC). 

SITC poster presentation details are as follows:

Abstract Title: Phase 1 Clinical Data Show FX-909, a First-in-Class Oral PPARG Inhibitor, Drives Immune Modulation and Pro-Inflammatory Cytokine Induction in IO-Experienced Patients with Advanced Urothelial Carcinoma
Abstract Number: 1318
Session: Exhibits & Poster Viewing
Presenter: Matthew L Milowsky
Date, Time: Saturday, November 8, 2025 from 10:00 a.m. to 6:35 p.m. ET
Location: Lower Level Atrium, Prince George’s ABC

About Flare Therapeutics Inc.
Flare Therapeutics is a clinical-stage biotechnology company exclusively focused on drugging transcription factors to fully unlock the therapeutic potential of this previously elusive target class. The company’s lead program, FX-909, is a first-in-class orally available small molecule inhibitor of PPARG, the master regulator of the luminal lineage, that is initially being developed for locally advanced or metastatic urothelial cancer. FX-909 has achieved clinical proof-of-concept in a Phase 1A study as a monotherapy and is actively dosing patients in a Phase 1B to determine the recommended Phase 2 dose in a biomarker-defined population. The second lead program, FX-111, is a novel and highly differentiated potent and selective degrader for ARON, the transcriptionally active, hormone-bound androgen receptor. This approach offers the potential to overcome key vulnerabilities of conventional therapies that target AROFF and has broad potential across prostate cancer at all stages. FX-111 is undergoing Investigational New Drug (IND)-enabling studies for initial development for the treatment of metastatic castration-resistant prostate cancer (mCRPC). These two programs, along with an earlier-stage portfolio targeting transcription factors involved in oncology and other therapeutic areas, leverages Flare Therapeutics’ integrated discovery platform of capabilities that identifies novel validated ligands to the undrugged proteome. For more information, please visit www.flaretx.com and follow us on LinkedIn.

Contacts:

Investors:
Sarah McCabe
investorrelations@flaretx.com

Media:
Timothy Cockroft
media@flaretx.com


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