FX-909

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, Mass., Nov. 12, 2024 /PRNewswire/ -- 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 and follow us on LinkedIn. Investors: [email protected] Media: Peg Rusconi [email protected] Deerfield Group SOURCE Flare Therapeutics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Roche is aligning with Flare Therapeutics to work on small molecules for cancer by going after transcription factor targets, the companies said Tuesday morning. Cambridge, MA-based Flare has a proprietary set of electrophilic compounds and will use its proteomic and mass spectrometry tools to help Roche create new drugs. The Swiss drug giant will pay Flare $70 million upfront, and as much as $1.8 billion in potential milestones and royalties. Flare can get “significantly higher royalties” if it opts to co-fund the development of a medicine for one of the pre-defined targets in the pact, chief financial officer Daphne Karydas told Endpoints News . She declined to disclose that target, but Karydas said it could apply to “quite large patient populations” across multiple tumor types. The biotech, launched in 2021 by Third Rock Ventures, is working on drugging stubborn transcription factors, proteins that help drive DNA toward RNA. Flare goes after switch sites, which are druggable pieces within the transcription factor complexes that help manage function. The influx of capital extends Flare’s runway to the first half of 2026, following its March 2023 Series B that totaled $123 million , Karydas said. A next financing will be “tethered to the evolving clinical profile” of the company’s lead asset, FX-909, an oral small molecule for solid tumors. Flare could raise a Series C, a crossover round or an IPO, she said. The upfront and near-term payments give Flare flexibility on that decision, which likely won’t be made until after the startup gets a good look at Phase 1 data for FX-909, Karydas said. CEO Doug Manion said Flare expects to release those data early next year. “We believe that we already have effective doses at the relatively low doses of which we started,” Manion said, and the team has seen good pharmacokinetic and pharmacodynamic data. Beyond FX-909, Flare anticipates entering the clinic with a drug for prostate cancer in 2026, Manion said. The 60-employee biotech is also exploring cardiometabolic and inflammatory diseases, Karydas said. Flare could get into those areas through partnerships, she said. “We certainly want to make sure that we digest and get off to a phenomenal start with our partner Roche, but there is significant substance in our preclinical pipeline,” Karydas said.