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Cambridge, MA, August 27, 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 the company will participate in the following investor conferences in September:
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:
media@flaretx.com
Clinical proof-of-concept achieved in Phase 1A study for FX-909, a first-in-class orally available small molecule inhibitor of PPARG
Cambridge, MA, August 5, 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 it has dosed the first patients in its Phase 1B clinical trial evaluating FX-909, a first-in-class orally available small molecule inhibitor of PPARG, a master regulator of the luminal lineage, for the treatment of locally-advanced or metastatic urothelial cancer (UC). More information about the trial is available at clinicaltrials.gov using the identifier NCT05929235.
“The initiation of the Phase 1B expansion study marks an important milestone as we seek to improve the treatment of advanced urothelial cancer with our lead program FX-909,” said Doug Manion, M.D., FRCP (C), Chief Executive Officer and Board Member. “We are prospectively screening for patients with high expression of PPARG, the hallmark of the luminal lineage, which accounts for approximately 65% of cases of advanced UC. We believe our PPARG inhibitor approach in this defined patient population represents a significant step toward addressing the disease at its source. By introducing a novel nuclear hormone receptor therapy—akin to the critical roles AR and ER play in prostate and breast cancers, respectively—we are expanding the therapeutic landscape to directly target the cell of origin and address the underlying disease biology.”
FX-909 has achieved clinical proof-of-concept in a Phase 1A study, as a monotherapy, based on pre-specified criteria. The company expects to present these data at a scientific conference in 2025. The Phase 1B study will evaluate safety and efficacy to determine the recommended Phase 2 dose in a biomarker-defined population. A validated immunohistochemistry (IHC)-based test is being deployed to prospectively select patients with the lineage determining transcription factor that drives the initiation and progression of these tumor types. The study will evaluate 30 mg and 50 mg (QD) doses in a 2-stage design, enrolling approximately 40 patients in total.
The company expects to report efficacy data in a biomarker-defined population at the recommended Phase 2 dose in the first quarter of 2026.
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
Media:
Cambridge, MA, May 28, 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 the company will participate in meetings with investors at the upcoming Jefferies Global Healthcare Conference on Tuesday, June 3, 2025, 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, 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 progressing into Phase 1B to determine the recommended Phase 2 dose in a biomarker-defined population, and will include a combination arm with an anti-PD1-targeting agent. The second lead program, FX-111, is a novel and highly differentiated potent and selective degrader for ARON, the transcriptionally active, hormone-bound conformation of the 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:
Media:
Cambridge, MA – November 25, 2024 – Flare Therapeutics Inc., a clinical-stage biotechnology company targeting transcription factors to discover precision medicines for oncology and other therapeutic areas, today announced that the company will participate in two upcoming investor conferences in December:
About Flare Therapeutics Inc.
Flare Therapeutics is a biotechnology company exclusively focused on drugging transcription factors to fully unlock the therapeutic potential of this previously elusive target class. Flare Therapeutics’ integrated discovery engine converges rich genetic, biochemical, and chemical insights to reveal druggable pockets and identify small molecule ligands capable of modulating transcription factors of high therapeutic potential. Flare Therapeutics’ proteomic and mass spectrometry platform is powered by a proprietary library of electrophilic compounds unique to Flare Therapeutics. Since its inception, Flare Therapeutics has rapidly established an emerging pipeline of programs, highlighted by FX-909, a first-in-class investigational orally bioavailable small molecule inhibitor of PPARG, a master regulator of the luminal lineage in advanced urothelial cancer that is currently in a Phase I study. Additionally, Flare Therapeutics has advanced a second program with a differentiated mechanism for prostate cancer entering the Investigational New Drug (IND)-enabling stage, along with an earlier-stage portfolio targeting transcription factors involved in oncology and other therapeutic areas. For more information, please visit www.flaretx.com and follow us on LinkedIn.
Contacts:
Investors:
investorrelations@flaretx.com
Media:
media@flaretx.com
Collaboration will leverage Flare Therapeutics’ proteomic and mass spectrometry platform and expertise, powered by its proprietary library of electrophilic compounds, to discover novel small molecules aimed at transcription factor targets in oncology
Flare Therapeutics to receive US $70 million upfront, and potential milestone payments exceeding US$1.8 billion, as well as royalties
Cambridge, MA – November 12, 2024 – Flare Therapeutics Inc., a clinical-stage biotechnology company targeting transcription factors to discover precision medicines for oncology and other therapeutic areas, today announced it has entered into a strategic discovery collaboration with Roche (SIX: RO, ROG; OTCQX: RHHBY). This partnership will leverage Flare Therapeutics’ proteomic and mass spectrometry platform and expertise, powered by its proprietary library of electrophilic compounds, to discover novel small molecule drugs aimed at previously undrugged transcription factor targets in oncology.
“Roche is an ideal partner for Flare Therapeutics because we share a commitment to tackling the most challenging disease areas with novel approaches and overcoming the difficulties of drugging transcription factors. Our platform and expertise have rapidly generated a clinical-stage pipeline, demonstrating the strong potential of our approach. This collaboration will accelerate the expansion of our capabilities, enabling us to develop treatments for transcription factors implicated in indications with high unmet needs. Together with Roche’s expertise, our objective is to successfully pursue challenging transcription factor targets, with the ultimate goal of providing novel interventions for patients who are not currently served by standard-of-care therapies,” said Rob Sims, Ph.D., Chief Scientific Officer and Co-founder of Flare Therapeutics.
“We are excited to join forces with Flare Therapeutics, combining our leading expertise and global reach in oncology with Flare Therapeutics’ deep knowledge in drug discovery for difficult-to-drug transcription factor targets. Transcription factors play a crucial role in various oncological diseases and have the potential to address high unmet medical needs. We are looking forward to developing therapeutic options never possible before,” said Boris L. Zaïtra, Head of Roche Corporate Business Development.
As part of the collaboration, Flare Therapeutics will receive a US$70 million upfront cash payment and is eligible to receive discovery, development, and commercialization milestone payments potentially exceeding US$1.8 billion and royalties. Flare Therapeutics will lead discovery and preclinical activities targeting multiple transcription factor targets in oncology, while Roche will pursue the further preclinical and clinical development and commercialization of potential products from the collaboration, leveraging its industry-leading capabilities in oncology.
Additionally, Flare Therapeutics retains a right to co-fund development for one target under the collaboration in exchange for increased royalties in the United States for this target. Flare Therapeutics will retain ownership of its existing pipeline, including its lead clinical-stage program, FX-909, in advanced urothelial cancer, its prostate cancer program entering IND-enabling studies, and other programs in discovery and early development in oncology and other therapeutic areas.
About Flare Therapeutics Inc.
Flare Therapeutics is a biotechnology company exclusively focused on drugging transcription factors to fully unlock the therapeutic potential of this previously elusive target class. Flare Therapeutics’ integrated discovery engine converges rich genetic, biochemical, and chemical insights to reveal druggable pockets and identify small molecule ligands capable of modulating transcription factors of high therapeutic potential. Flare Therapeutics’ proteomic and mass spectrometry platform is powered by a proprietary library of electrophilic compounds unique to Flare Therapeutics. Since its inception, Flare Therapeutics has rapidly established an emerging pipeline of programs, highlighted by FX-909, a first-in-class investigational orally bioavailable small molecule inhibitor of PPARG, a master regulator of the luminal lineage in advanced urothelial cancer that is currently in a Phase I study. Additionally, Flare Therapeutics has advanced a second program with a differentiated mechanism for prostate cancer entering the Investigational New Drug (IND)-enabling stage, along with an earlier-stage portfolio targeting transcription factors involved in oncology and other therapeutic areas. For more information, please visit www.flaretx.com and follow us on LinkedIn.
Investors:
investorrelations@flaretx.com
Media:
Peg Rusconi
peg.rusconi@deerfieldgroup.com
Deerfield Group
Cambridge, MA – November 6, 2024 – Flare Therapeutics Inc., a clinical-stage biotechnology company targeting transcription factors to discover precision medicines for oncology and other therapeutic areas, today announced that the company will participate in two upcoming investor conferences in November:
About Flare Therapeutics Inc.
Flare Therapeutics is a biotechnology company exclusively focused on drugging transcription factors to fully unlock the therapeutic potential of this previously elusive target class. Flare Therapeutics’ integrated discovery engine converges rich genetic, biochemical, and chemical insights to reveal druggable pockets and identify small molecule ligands capable of modulating transcription factors of high therapeutic potential. Flare Therapeutics’ proteomic and mass spectrometry platform is powered by a proprietary library of electrophilic compounds unique to Flare Therapeutics. Since its inception, Flare Therapeutics has rapidly established an emerging pipeline of programs, highlighted by FX-909, a first-in-class investigational orally bioavailable small molecule inhibitor of PPARG, a master regulator of the luminal lineage in advanced urothelial cancer that is currently in a Phase I study. Additionally, Flare Therapeutics has advanced a second program with a differentiated mechanism for prostate cancer entering the Investigational New Drug (IND)-enabling stage, along with an earlier-stage portfolio targeting transcription factors involved in oncology and other therapeutic areas. For more information, please visit www.flaretx.com and follow us on LinkedIn.
Contacts:
Investors:
investorrelations@flaretx.com
Media:
media@flaretx.com
Cambridge, MA – June 3, 2024 – Flare Therapeutics Inc., a clinical-stage biotechnology company targeting transcription factors to discover precision medicines for cancer and other diseases, today announced that Daphne Karydas, President and Chief Financial Officer, will present a company overview at the upcoming Goldman Sachs 45th Annual Global Healthcare Conference on Monday, June 10, 2024 at 3:20 p.m. ET in Miami, FL.
About Flare Therapeutics Inc.
Flare Therapeutics is a biotechnology company exclusively focused on drugging transcription factors (TFs) to fully unlock the therapeutic potential of this previously elusive target class. Flare Therapeutics’ integrated discovery engine converges rich genetic, biochemical, and chemical insights to reveal druggable pockets and identify small molecule ligands capable of modulating TFs of high therapeutic potential. Flare Therapeutics’ proteomic and mass spectrometry platform is powered by a proprietary library of electrophilic compounds unique to Flare Therapeutics. The team has rapidly established an emerging pipeline of programs, highlighted by FX-909, a first-in-class investigational orally bioavailable small molecule inhibitor of PPARG, a master regulator of the luminal lineage in advanced urothelial cancer that is currently in a Phase I study. For more information, please visit www.flaretx.com and follow us on LinkedIn.
Investors:
investorrelations@flaretx.com
Media:
Peg Rusconi
Verge Scientific Communications
peg.rusconi@vergescientific.com
Cambridge, MA – April 23, 2024 – Flare Therapeutics Inc., a clinical-stage biotechnology company targeting transcription factors to discover precision medicines for cancer and other diseases, today announced the appointment of Douglas Manion, M.D., FRCP (C), as Chief Executive Officer, effective immediately. Dr. Manion brings over two decades of experience in pharmaceutical research and development, having held leadership roles across several biotechnology and pharmaceutical companies. He succeeds interim CEO Abbie Celniker, Ph.D., a partner at Third Rock Ventures, who will continue to serve as Chair of the Company’s Board of Directors.
“I am delighted to welcome Doug to FlareTx and want to express my deepest confidence in his ability to lead the company during this next stage of growth. Over the course of his career, he has gained substantial company building and drug development expertise, which will be invaluable as FlareTx continues to grow as an organization and advances its clinical-stage pipeline and capabilities in drugging transcription factors,” said Dr. Celniker. “I look forward to working with him and the leadership team as they drive the company’s strong momentum.”
“There has been rapid growth at FlareTx since the company was launched and I am excited for this opportunity to lead such an exceptional and cross-functional team as we advance FX-909 toward clinical proof of concept data in the second half of this year and fully recognize the potential of our discovery engine as we seek to change the paradigm in drugging transcription factors,” said Dr. Manion. “I share in the team’s vision to rapidly transform this novel science into approved medicines for people with cancer and other diseases.”
Dr. Manion joins Flare Therapeutics from Aclaris Therapeutics, Inc. (NASDAQ: ACRS), where he was President and Chief Executive Officer. Before that, he was Executive Vice President of Research and Development at Arena Pharmaceuticals, Inc., where he oversaw all research and development activities until its acquisition by Pfizer Inc. Dr. Manion joined Arena after serving as Chief Executive Officer of Kleo Pharmaceuticals, a private immuno-oncology company, from 2017 until its acquisition by Biohaven Holdings in January 2021. Previously Dr. Manion was Senior Vice President, Head of Specialty Development and Head of R&D Japan and China at Bristol-Myers Squibb. During his 11-year tenure at BMS, he held leadership roles overseeing global clinical research, clinical development, pharmacovigilance and biostatistics, across various therapeutic areas, including virology, immunology, neurology, cardiology, metabolic diseases, genetically-defined diseases and fibrosis. Dr. Manion’s previous biopharmaceutical experience includes progressive leadership roles at GlaxoSmithKline, DuPont Pharmaceuticals, and DuPont Merck Pharmaceuticals. He is Board Certified in Internal Medicine and completed an Infectious Diseases Fellowship at the University of Ottawa in Ontario, Canada followed by post-doctoral training at Massachusetts General Hospital and Harvard Medical School.
About Flare Therapeutics Inc.
Flare Therapeutics is a biotechnology company exclusively focused on drugging transcription factors (TFs) to fully unlock the therapeutic potential of this previously elusive target class. Flare Therapeutics’ integrated discovery engine converges rich genetic, biochemical, and chemical insights to reveal druggable pockets and identify small molecule ligands capable of modulating TFs of high therapeutic potential. Flare Therapeutics’ proteomic and mass spectrometry platform is powered by a proprietary library of electrophilic compounds unique to Flare Therapeutics. The team has rapidly established an emerging pipeline of programs, highlighted by FX-909, a first-in-class investigational orally bioavailable small molecule inhibitor of PPARG, a master regulator of the luminal lineage in advanced urothelial cancer that is currently in a Phase I study. For more information, please visit www.flaretx.com and follow us on LinkedIn.
Investors:
Media:
Peg Rusconi
Verge Scientific Communications
peg.rusconi@vergescientific.com
— Data support the potential to explore lead Phase 1 monotherapy asset FX-909 in combination with an anti-PD1 agent —
Cambridge, MA – April 9, 2024 – Flare Therapeutics Inc., a clinical-stage biotechnology company targeting transcription factors to discover precision medicines for cancer and other diseases, today shared data identifying immunosuppressive cell phenotypes associated with high PPARG expression in urothelial cancer (UC) patients treated with anti-PD1 therapy in a poster presentation at the American Association for Cancer Research (AACR) Annual Meeting 2024 taking place April 5-10 in San Diego, California.
“Translational insights from our single cell analysis shed further light on the role that PPARG expression plays in the immune cell phenotypes of advanced UC patients following anti-PD1 therapy,” said Michaela Bowden, Ph.D., Chief Development Officer at Flare Therapeutics. “The ongoing study of our lead asset FX-909 – which is currently being evaluated as a monotherapy in a Phase 1 clinical study – includes an exploratory biomarker approach to assess the effect of PPARG inhibition on the innate and adaptive immune response of the patients enrolled, and may inform the ability to expand this novel treatment into a potential combination treatment strategy in the future.”
The poster, titled, “PPARG-high circulating monocytes exhibit an immunosuppressive phenotype in urothelial cancer patients treated with anti-PD1,” offers a comprehensive analysis of PPARG expression in peripheral blood mononuclear cells (PBMCs) of advanced UC patients. PPARG has been previously associated with immune-mediated resistance and is upregulated in a variety of immune cells such as monocytes, macrophages, and lymphocytes, where it plays a role in their maturation and function.
Flare Therapeutics scientists showed that circulating classical monocytes harboring high levels of PPARG expression exhibited an immunosuppressive phenotype in UC patients who received anti-PD1 therapy. Findings corroborate molecular real-world data presented at the SITC 2023 Annual Meeting that demonstrated high PPARG expression in patients with muscle-invasive UC is associated with an immunosuppressive tumor microenvironment and shorter real-world progression-free survival to anti-PD1 treatment.
Additional key takeaways from the poster are as follows:
About Flare Therapeutics Inc.
Flare Therapeutics is a biotechnology company exclusively focused on drugging transcription factors (TFs) to fully unlock the therapeutic potential of this previously elusive target class. Flare Therapeutics’ integrated discovery engine converges rich genetic, biochemical, and chemical insights to reveal druggable pockets and identify small molecule ligands capable of modulating TFs of high therapeutic potential. Flare Therapeutics’ proteomic and mass spectrometry platform is powered by a proprietary library of electrophilic compounds unique to Flare Therapeutics. The team has rapidly established an emerging pipeline of programs, highlighted by FX-909, a first-in-class investigational orally bioavailable small molecule inhibitor of PPARG, a master regulator of the luminal lineage in advanced urothelial cancer that is currently in a Phase I study. For more information, please visit www.flaretx.com and follow us on LinkedIn.
Investors:
Media:
Peg Rusconi
Verge Scientific Communications
peg.rusconi@vergescientific.com
Cambridge, MA – March 5, 2024 – Flare Therapeutics Inc., a clinical-stage biotechnology company targeting transcription factors to discover precision medicines for cancer and other diseases, today announced a poster presentation identifying immunosuppressive cell phenotypes associated with high PPARG expression in urothelial cancer (UC) patients treated with anti-PD1 therapy at the upcoming American Association for Cancer Research (AACR) Annual Meeting 2024 taking place April 5-10 in San Diego, California.
Presentation details are as follows:
Abstract Title: PPARG-high circulating monocytes exhibit an immunosuppressive phenotype in urothelial cancer patients treated with anti-PD1
Abstract Number: 5627
Presenter: Ani Phuong Nguyen, Director, Computational Biology, Flare Therapeutics
Date, Time: Tuesday, April 9, 2024, 1:30pm – 5:00pm PDT (4:30pm – 8:00pm EDT)
Location: Poster Section 15, Poster Board #6, San Diego Convention Center
About Flare Therapeutics Inc.
Flare Therapeutics is a biotechnology company exclusively focused on drugging transcription factors (TFs) to fully unlock the therapeutic potential of this previously elusive target class. Flare Therapeutics’ integrated discovery engine converges rich genetic, biochemical, and chemical insights to reveal druggable pockets and identify small molecule ligands capable of modulating TFs of high therapeutic potential. Flare Therapeutics’ proteomic and mass spectrometry platform is powered by a proprietary library of electrophilic compounds unique to Flare Therapeutics. The team has rapidly established an emerging pipeline of programs, highlighted by FX-909, a first-in-class investigational orally bioavailable small molecule inhibitor of PPARG, a master regulator of the luminal lineage in advanced urothelial cancer that is currently in Phase I study. For more information, please visit www.flaretx.com and follow us on LinkedIn.
Investors:
investorrelations@flaretx.com
Media:
Peg Rusconi
Verge Scientific Communications
peg.rusconi@vergescientific.com
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