AsherBio

Flare Therapeutics Announces Three Upcoming Poster Presentations at AACR Annual Meeting 2026

Cambridge, MA, April 6, 2026 — Flare Therapeutics Inc. (FlareTx), a clinical-stage biotechnology company targeting transcription factors to discover precision medicines for oncology and other therapeutic areas, today announced that it will present three posters at the upcoming American Association for Cancer Research (AACR) Annual Meeting 2026, which is being held from April 17-22, 2026, in San Diego, CA.

The poster presentations will include preclinical data for the company’s two lead programs, FX-909, a first-in-class, orally available PPARG inhibitor designed to target the underlying luminal lineage biology of urothelial cancer and FX-111, a novel and highly differentiated potent and selective degrader for ARON, the transcriptionally active, hormone-bound androgen receptor for prostate cancer.

FX-909 Presentation Details:

Luminal urothelial carcinoma (UC), characterized by high PPARG expression, represents the majority of UC cases and is associated with poor clinical outcomes. In a Phase 0 study, FX-909, a first-in-class oral PPARG inhibitor, demonstrated intratumoral penetration and on-target activity, including dose-dependent PPARG modulation, increased tumor apoptosis, and enhanced CD8⁺ T-cell infiltration. Notably, combination with anti-PD-1 further amplified immune activation and suppression of tumor proliferation pathways. These findings support the potential of FX-909 to modulate the tumor microenvironment and warrant further clinical evaluation in UC.

Title: Phase 0 Intratumoral Microdevice Study of FX-909 in Bladder Cancer Demonstrates On-Target Anti-Tumor Activity and Immune Modulation, Enhanced in Combination with Anti-PD-1

  • Abstract ID: CT111 / 3
  • Session: Phase 0 and First-in-Human Phase I Clinical Trials
  • Date, Time: April 20, 2026, 2:00 p.m. – 5:00 p.m. PT
  • Location: Section 51

FX-111 Presentation Details:

Metastatic castration-resistant prostate cancer (mCRPC) remains largely driven by androgen receptor (AR) signaling, with resistance to current AR inhibitors posing a major clinical challenge. Real-world data identified distinct AR/KLK3-defined subgroups, with AR copy number amplification linked to increased AR signaling and poorer outcomes, reinforcing the central role of AR-driven biology in disease progression and identifying a high-risk, AR-driven population.

Title: AR copy number amplification and AR/KLK3 expression patterns reveal mechanisms of AR signaling inhibitor (ARSI) resistance and highlight the need for AR-directed therapeutic innovation in metastatic castration resistance prostate cancer (mCRPC)

  • Abstract ID: 3910 / 16
  • Session: Molecular Targeted Therapy
  • Date, Time: April 20, 2026, 2:00 p.m. – 5:00 p.m. PT
  • Location: Section 47

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, particularly in high-risk AR-driven disease, and has broad potential across prostate cancer at all stages.

Title: Discovery of FX-111, a first-in-class heterobifunctional degrader of transcriptionally active androgen receptor (ARON), to treat patients with AR-driven prostate cancer

  • Abstract ID: 5784 / 11
  • Session: Proximity-Induced Drug Discovery 2
  • Date, Time: April 21, 2026, 2:00 p.m. – 5:00 p.m. PT
  • Location: Section 15

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, a 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

AsherBio

Flare Therapeutics Presents Updated FX-909 Phase 1A Data in Late-Breaking Oral Presentation at 2026 ASCO Genitourinary Cancers Symposium

– Data support emergence of differentiating clinical benefit with a favorable safety and tolerability profile for patients with advanced UC

Cambridge, MA, Feb. 27, 2026 — Flare Therapeutics Inc. (FlareTx), a clinical-stage biotechnology company targeting transcription factors to discover precision medicines for oncology and other therapeutic areas, today announced the presentation of updated clinical data and associated biomarkers from the Phase 1A study of FX-909, a first-in-class orally bioavailable potent and selective small molecule inhibitor of peroxisome proliferator-activated receptor gamma (PPARG), a master regulator of the luminal lineage, in locally-advanced or metastatic urothelial cancer (UC).

Matthew Galsky, M.D., FASCO, Professor of Medicine at the Icahn School of Medicine at Mount Sinai, will present the late-breaking abstract in a rapid oral presentation titled “Updated clinical results and associated biomarkers from an ongoing phase 1 study of FX-909, a first-in-class peroxisome proliferator-activated receptor gamma (PPARG) inhibitor, in patients (pts) with advanced urothelial carcinoma (adv UC)” today at the 2026 American Society of Clinical Oncology Genitourinary (GU) Cancers Symposium in San Francisco, CA.

“These data offer encouraging signs that FX-909 may help shrink or control tumors in patients with advanced UC, with enriched responses in tumors with a luminal lineage as defined by PPARG overexpression. FX-909 is the first and only agent addressing the underlying transcriptional driver of urothelial cancer,” said Dr. Galsky. “As an oral agent with an acceptable safety and tolerability profile, FX-909 has the potential to offer a much-needed new therapeutic option for patients with advanced UC, and over time, may extend into earlier lines of treatment.”

As of the data cut-off date of November 10, 2025, 46 patients with advanced UC received FX-909 monotherapy across four once-daily dose levels (30 mg, 50 mg, 70 mg and 100 mg), with a median of three prior lines of therapy (range 1-8), including prior enfortumab vedotin and anti-PD(L)1 therapy in 35% of patients. Key highlights from the presented data include:

  • Antitumor activity in biomarker-defined patients with PPARGhigh tumors: Among efficacy-evaluable patients, and using a provisional tumor proportion score (TPS) cutoff of ≥60% to define PPARGhigh status, 18 of 25 PPARGhigh patients showed tumor regressions, including five confirmed partial responses. An additional confirmed complete response was observed in a patient with non-measurable disease.
  • Reinforcement of luminal lineage biology and genomic context: PPARGhigh tumors show strong concordance with luminal biology features providing a more enhanced means of identifying PPARG activated tumors beyond genomic alterations that are linked to the PPARG signaling axis.
  • Acceptable safety profile observed: At the 30 mg and 50 mg dose levels, the most common grade 3 treatment-related adverse events (TRAEs) included anemia (18.9%), thrombocytopenia (16.2%) and fatigue (10.8%). Other common treatment-emergent adverse events included diarrhea (32.4%), hypertriglyceridemia (27%) and hyperglycemia (24.3%). The 30 mg cohort showed fewer grade 3 TRAEs (35.3%), longer time to onset (median 52 days; range 44–85), and fewer dose interruptions (29.4%) and dose reductions (11.8%).
  • Emergence of meaningful clinical benefit: Among the 25 patients in the PPARGhigh subgroup, five remained on treatment at the time of data cut-off. Three patients at the 30 mg dose were on treatment for 5.3+, 5.8+ and 12.7+ months, one patient at the 50 mg dose for 5.5+ months, and one patient at the 70 mg dose for 7.6+ months. The one confirmed CR with non-measurable disease remained on treatment for 8.4+ months (70 mg – reduced to 30 mg after two cycles) at the time of the data cut-off.
  • Molecular responses confer clinical benefit: On-treatment declines in circulating tumor DNA (ctDNA) at cycle 2/3 were associated with clinical benefit. 25 advanced UC patients had paired baseline and cycle 2 or 3 plasma samples for ctDNA analysis using the CARIS Assure test. 80% (12/15) of the PPARGhigh subgroup achieved a ctDNA complete response (3 CCR, 9 CPR) per LB-RECIST criteria ref – Gouda et al Ann Oncol (2024).

FX-909 is currently in a Phase 1B expansion study evaluating safety and efficacy in second line or beyond to determine the recommended Phase 2 dose in a biomarker-defined PPARGhigh locally advanced (unresectable) or metastatic UC patient population. The Phase 1 Part B study adopts a randomized 2-stage design. A validated immunohistochemistry (IHC)-based test has been developed to identify patients eligible for enrollment in the expansion study. The company expects interim data in a biomarker-defined population from the randomized portion of the Phase 1B in mid-2026.

More information about the trial is available at clinicaltrials.gov using the identifier NCT05929235.

About Advanced Urothelial Cancer

Advanced urothelial cancer (UC) is an aggressive and challenging form of bladder cancer, representing approximately 25% of all bladder cancers diagnosed each year. In the United States, bladder cancer accounts for approximately 84,000 new cases each year, with urothelial carcinoma being the predominant histologic type. In advanced or metastatic stages, the disease is notably difficult to treat, with over 50% of patients experiencing disease progression within six to nine months of first-line chemotherapy. The five-year survival rate for metastatic UC remains poor, with estimates below 6%. While the introduction of checkpoint inhibitors and targeted therapies has expanded treatment options, clinical outcomes remain suboptimal, underscoring an urgent need for additional and more effective treatment options. Molecular subtyping has revealed that luminal tumors, or tumors that are characterized by high PPARG expression, comprise approximately 65% of advanced urothelial cancers. These luminal tumors are often or invariably characterized by activation of the PPARG (peroxisome proliferator-activated receptor gamma) pathway, which plays a critical role in maintaining tumor identity, promoting tumor growth, and contributing to immune evasion. Novel approaches such as PPARG inhibition are emerging as promising strategies to improve outcomes for patients that have UC with high PPARG expression. It is estimated that the United States alone, there are approximately 14,000 new cases of advanced urothelial cancer with high PPARG expression diagnosed each year, based on the portion of luminal subtypes and overall incidence data.

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, a 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

 

AsherBio

Flare Therapeutics Appoints Stephen L. Eck, M.D., Ph.D., as Chief Medical Officer

Cambridge, MA, January 9, 2026 — Flare Therapeutics Inc. (FlareTx), a clinical-stage biotechnology company targeting transcription factors to discover precision medicines for oncology and other therapeutic areas, today announced the appointment of Stephen L. Eck, M.D., Ph.D., as Chief Medical Officer. Dr. Eck brings more than three decades of oncology drug discovery and development leadership across academia, biotechnology and large pharmaceutical companies.

“Throughout my career, I’ve been driven by the goal of bringing better therapies to people living with cancer,” said Dr. Eck. “Flare Therapeutics is advancing a highly differentiated clinical-stage pipeline grounded in novel biology, including FX-909, a novel PPARG inhibitor designed to target the underlying driver of urothelial cancer, and FX-111, which uniquely targets ARON – the transcriptionally activated androgen receptor – to address prostate cancer across all stages of disease. I’m excited to work with the team to thoughtfully and rigorously advance these programs through the clinic.”

In his new role, Dr. Eck will lead Flare Therapeutics’ clinical strategy and development efforts, overseeing clinical trial design and execution and interactions with global health authorities. In connection with this appointment, Michael L. Meyers, M.D., Ph.D. will retire from his role as Chief Medical Officer, effective January 31, 2026.

“Stephen has spent his career turning cutting-edge science into real treatment options for patients and his deep oncology expertise, from target discovery through late-stage development and approval, will be invaluable as we continue to advance and expand our pipeline, led by FX-909 and FX-111. We look forward to his contributions, leadership and engagement with our stakeholders,” said Doug Manion, M.D., FRCP (C), Chief Executive Officer and Board Member of Flare Therapeutics. “I also want to congratulate Michael on his retirement and thank him for his steady leadership and dedication to patients throughout his time at FlareTx. He leaves a strong foundation for our next chapter.”

Stephen Eck, M.D., Ph.D., was most recently Senior Vice President, Clinical Development and Chief Medical Officer at MacroGenics. Previously, Dr. Eck served as Chief Medical Officer of Immatics US, a company focused on TCR-based immunotherapies, and as President and Chief Executive Officer of Aravive Biologics. Prior to these roles, Dr. Eck was Vice President and Global Head of Oncology Medical Sciences at Astellas Pharma, managing a portfolio of assets which included enzalutamide (Xtandi®), erlotinib (Tarceva®) and gilteritinib (Xospata®). Dr. Eck has also held leadership positions in drug development as Vice President of Translational Medicine and Pharmacogenomics at Eli Lilly and as Head of Clinical Oncology at Pfizer. He began his professional career at Monsanto in cancer target discovery and later joined the University of Pennsylvania, where he was the Anne B. Young Assistant Professor of Cancer Research and the Director of the Cancer Gene Therapy Program. Dr. Eck previously served as a director for Circulogene, and on the boards of directors for the Personalized Medicine Coalition and Luminex Corporation. Dr. Eck currently serves on the board of 1cBio and the Central Pennsylvania Clinic. He is a Fellow of the American Association for the Advancement of Science. Dr. Eck holds a B.A. from Kalamazoo College, an M.S. and a Ph.D. from Harvard University, and an M.D. from the University of Mississippi School of Medicine with Internal Medicine Residency and Hematology/Oncology Fellowship training at the University of Michigan.

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

AsherBio

Flare Therapeutics to Present at 44th Annual J.P. Morgan Healthcare Conference

Cambridge, MA, Jan. 8, 2026 — Flare Therapeutics Inc. (FlareTx), a clinical-stage biotechnology company targeting transcription factors to discover precision medicines for oncology and other therapeutic areas, today announced that Doug Manion, M.D., FRCP (C), Chief Executive Officer and Board Member, will present a company overview at the upcoming 44th Annual J.P. Morgan Healthcare Conference on Thursday, January 15, 2026, at 8:00 a.m. PT in San Francisco, CA.

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

AsherBio

Flare Therapeutics to Participate in Piper Sandler 37th Annual Healthcare Conference

Cambridge, MA, Nov. 25, 2025 — Flare Therapeutics Inc. (FlareTx), a clinical-stage biotechnology company targeting transcription factors to discover precision medicines for oncology and other therapeutic areas, today announced that Douglas Manion, M.D., FRCP (C), Chief Executive Officer, will present a company overview at the upcoming Piper Sandler 37th Annual Healthcare Conference on Thursday, December 4, 2025, at 12:10 p.m. ET in New York, NY. Daphne Karydas, President and Chief Financial Officer, will also be available for meetings with investors.

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

AsherBio

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

  • Demonstrates PPARG inhibition as a potential strategy to overcome immune resistance in advanced UC
  • Supports the planned Phase 1 cohort of FX-909 in combination with pembrolizumab; initiating in the first quarter of 2026

Cambridge, MA, November 7, 2025 — Flare Therapeutics Inc. (FlareTx), a clinical-stage biotechnology company targeting transcription factors to discover precision medicines for oncology and other therapeutic areas, today announced the presentation of a correlative biomarker analysis from the Phase 1A clinical study of FX-909, a first-in-class orally available small molecule inhibitor of peroxisome proliferator-activated receptor gamma (PPARG), the master regulator of the luminal lineage, in locally-advanced or metastatic urothelial cancer (UC). This analysis includes novel insights regarding FX-909’s immune modulatory mechanism of action and demonstrate that FX-909 exerts immune-modulatory activity as a single agent, supporting the rationale for combination with an anti-PD-1 inhibitor in advanced UC.

Matthew L. Milowsky, M.D., Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, will present these results in a poster presentation titled “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” on Saturday, November 8, 2025 from 10:00 a.m. to 6:35 p.m. ET at the Society for Immunotherapy of Cancer (SITC) 2025 40th Anniversary Annual Meeting in National Harbor, MD.

“Along with the recently presented clinical activity data for FX-909, it is particularly exciting to now present this correlative data showing the induction of pro-inflammatory cytokines and chemokines and the promotion of T-cell expansion. This analysis supports PPARG inhibition as a potential strategy to overcome immune resistance and provides a rationale for the planned cohort evaluating FX-909 in combination with pembrolizumab. I look forward to seeing this cohort initiate early in 2026,” commented Dr. Milowsky.

“Having recently disclosed that FX-909 has achieved clinical proof of concept as a monotherapy, we are very pleased to now share IO-experienced patient level evidence that support our translational hypothesis regarding the immune modulatory mechanism of action of FX-909. We look forward to generating data from our planned cohort of FX-909 in combination with pembrolizumab and believe this approach could provide a “one-two punch” to overcome IO resistance,” said Michaela Bowden, Ph.D., Chief Development Officer of Flare Therapeutics.

Phase 1A Study

Correlative biomarker evaluations were conducted on a subset of IO-experienced advanced UC patients enrolled in the Phase 1A open-label 3+3 dose-escalation study. This analysis evaluated baseline molecular features of archival tumors and longitudinal proteomic and single-cell immune profiles to elucidate the immune-modulatory mechanism of FX-909.

Key highlights include:

  • Baseline molecular profiling confirmed that PPARGhigh tumors are of luminal lineage and display a cold immune phenotype consistent with lack of response to anti-PD-1 inhibition
  • FX-909 treatment activated IFNy-induced inflammatory pathways in all patients evaluated, including important IO biomarkers of response such as CXCL9, CXCL10 and TNFa amongst others
  • FX-909 treatment induces expansion of activated CD4 and CD8 T-cells and a corresponding decrease in circulating monocytes was observed in PPARGhigh tumors with confirmed responses

Taken together these results demonstrate that FX-909 exerts immune modulatory activity as a single agent supporting the rationale for combination with an anti-PD-1 inhibitor in advanced urothelial carcinoma.

FX-909 Next Steps

FX-909 is currently being evaluated in a Phase 1B expansion study evaluating safety and efficacy in second line or beyond to determine the recommended Phase 2 dose in a biomarker-defined PPARGhigh locally advanced (unresectable) or metastatic UC patient population. The Phase 1 Part B study adopts a randomized 2-stage design.  A validated immunohistochemistry (IHC)-based test has been developed to identify patients eligible for enrollment in the expansion study. The company expects interim efficacy data in a biomarker-defined population at the recommended Phase 2 dose in the first quarter of 2026.

In the first quarter of 2026, the company expects to initiate enrollment of a Phase 1 combination cohort that will investigate the safety, tolerability, immunologic effects and preliminary efficacy of escalating doses of FX-909 in combination with standard dose KEYTRUDA® (pembrolizumab) in patients with advanced urothelial carcinoma. As announced on October 21, 2025, Merck (known as MSD outside of the United States and Canada) has agreed to provide its anti-PD-1 therapy KEYTRUDA for this combination cohort under the clinical trial collaboration and supply agreement.

More information about the trial is available at clinicaltrials.gov using the identifier NCT05929235.

About Advanced Urothelial Cancer

Advanced urothelial cancer (UC) is an aggressive and challenging form of bladder cancer, representing approximately 25% of all bladder cancers diagnosed each year. In the United States, bladder cancer accounts for approximately 84,000 new cases each year, with urothelial carcinoma being the predominant histologic type. In advanced or metastatic stages, the disease is notably difficult to treat, with over 50% of patients experiencing disease progression within six to nine months of first-line chemotherapy. The five-year survival rate for metastatic UC remains poor, with estimates below 6%. While the introduction of checkpoint inhibitors and targeted therapies has expanded treatment options, clinical outcomes remain suboptimal, underscoring an urgent need for additional and more effective treatment options. Molecular subtyping has revealed that luminal tumors, or tumors that are characterized by high PPARG expression, comprise approximately 65% of advanced urothelial cancers. These luminal tumors are often or invariably characterized by activation of the PPARG (peroxisome proliferator-activated receptor gamma) pathway, which plays a critical role in maintaining tumor identity, promoting tumor growth, and contributing to immune evasion. Novel approaches such as PPARG inhibition are emerging as promising strategies to improve outcomes for patients that have UC with high PPARG expression. It is estimated that the United States alone, there are approximately 14,000 new cases of advanced urothelial cancer with high PPARG expression diagnosed each year, based on the portion of luminal subtypes and overall incidence data.

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.

KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

Contacts:

Investors:

Sarah McCabe

investorrelations@flaretx.com

Media:

Timothy Cockroft

media@flaretx.com

AsherBio

Flare Therapeutics to Participate in Upcoming Investor Conferences in November

Cambridge, MA, November 3, 2025 — Flare Therapeutics Inc. (FlareTx), a clinical-stage biotechnology company targeting transcription factors to discover precision medicines for oncology and other therapeutic areas, today announced that company management will present at the following two healthcare conferences in November:

  • Guggenheim’s 2nd Annual Healthcare Innovation Conference on Monday, November 10, 2025 at 1:30 p.m. ET in Boston, MA
  • Stifel Annual Healthcare Conference on Tuesday, November 11, 2025 from 3:20 p.m. ET in New York, NY

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, leverage 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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