August 15, 2024

Chicago – Pathos AI, Inc. (www.pathos.com), a biotechnology company focused on revolutionizing precision medicine in cancer by harnessing the power of machine learning to transform drug development, announced today the world-wide license of PRT811, a potent, selective, and orally bioavailable brain penetrant SAM-competitive PRMT5 inhibitor from Prelude Therapeutics.


PRT811 (renamed P-500) was developed by Prelude Therapeutics and completed a Phase 1 trial in March 2023. The trial enrolled patients with solid tumors including high-grade glioma and uveal melanoma and has potential application in other indications with high unmet need. Out of 16 patients with high-grade glioma with isocitrate dehydrogenase mutations (IDH+) in the Phase 1 trial, two confirmed complete responses (CR) were observed. At last follow-up, 1 response is ongoing and has lasted 31.0 months while the duration of response for the second CR patient was 7.5 months. Additionally, 1 patient achieved an unconfirmed partial response (PR).


In addition, out of 23 uveal melanoma patients (10 patients with splicing factor 3B subunit 1 (SF3B1) splicing mutations and 13 without an SF3B1 mutation), one confirmed PR (duration of response of 10 months) and a second unconfirmed PR were observed, both in patients SF3B1 mutations.


In the entire safety population (N=86), the most common adverse events of any grade, with an incidence of >20% were nausea (60.5%), vomiting (46.5%) fatigue (36.0%), constipation (29.1%), and thrombocytopenia (24.4%), and were predominantly grade 1-2. The most common adverse events (grade ≥3), occurring >5% were thrombocytopenia (9.3%), anemia (9.3%), and fatigue (5.8%).


“These results from Prelude’s Phase 1 study are promising news for high-grade glioma patients and clinicians, who still have limited treatment options with chemotherapy and radiation that hasn’t changed in decades. With our AI Platform, we aim to increase the already encouraging response rate of P-500 through a novel biomarker-driven strategy, ultimately bringing this medicine to patients as efficiently as possible,” said Ryan Fukushima, Pathos CEO.


“Prelude’s discovery engine has delivered a number of first- or best-in-class precision medicines including PRT811, a molecule that has shown early promise in the treatment of high-grade glioma. We are confident that Pathos AI, sharing our passion for precision medicine and commitment to serving cancer patients with high unmet need, is an ideal company to drive the development of this molecule forward for patients.” said Sean Brusky, Prelude CBO. “The resources from this transaction will support advancing Prelude’s pipeline.”



About P-500


P-500 (previously PRT811) is a selective, brain-penetrant small molecule inhibitor of protein arginine methyltransferase 5 (PRMT5) that has the potential to provide clinical benefit for patients with advanced solid tumors, including high-grade glioma and uveal melanoma.


PRMT5 is an enzyme that adds methyl groups to proteins in cells using a molecule called S-adenosylmethionine (SAM) which regulates protein function and interactions. Several processes that support cancer cell growth and spread depend on PRMT5, making P-500 relevant not only to advanced high-grade glioma and uveal melanoma (in which objective responses to P-500 were observed in the Phase 1 clinical trial) but also to a number of other cancer indications. Preclinical studies have demonstrated PRMT5 inhibition can sensitize cancer cells to other treatments, expanding the application of P-500 to combination therapy in additional indications.



About Pathos


Pathos is a clinical-stage biotechnology company focused on re-engineering drug development, leveraging the power of AI technologies to bring precision medicines to market through partnership with biopharmaceutical companies. Pathos has raised $40 million to accelerate the development of precision medicines and to expand its platform, combining computational approaches across multimodal real-world data and patient-derived biological models. Additional information can be found at www.pathos.com.

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Pathos AI Announces Strategic Collaborations with Bristol Myers Squibb and Tempus AI to Advance AI-Driven Drug Development Beginning with Alzheimer’s Disease and Other Neurological Conditions

October 23, 2026
Tempus to build a de-identified dataset from hundreds of thousands of patients with neurological conditions; Pathos to license the dataset under a five-year, $55 million agreement Pathos’s AI expertise and agentic AI platform, Foundry, combined with Bristol Myers Squibb’s (BMS) neuroscience drug development expertise to be applied to understanding disease progression and advancing new therapies BMS leads Pathos’s Series E financing and gains non-exclusive strategic access to Pathos’s AI platform, Pathos Foundry, across its broader portfolio, along with three-year exclusive rights to support its neuroscience development programs NEW YORK, October 23, 2026 — Pathos AI, a clinical-stage AI and technology company advancing its own therapeutic pipeline, today announced multi-year strategic collaborations with Bristol Myers Squibb (NYSE: BMY, “BMS”) and Tempus AI, Inc. (NASDAQ: TEM, “Tempus”) to build a specialized, curated dataset and agentic AI capabilities for Alzheimer’s disease and other neurological conditions. BMS also leads Pathos’s Series E financing and gains access to Pathos Foundry across its broader R&D portfolio. Tempus will apply the infrastructure and expertise it has built in oncology to create a comprehensive, de-identified, longitudinal dataset from hundreds of thousands of patients with neurological conditions, designed to track outcomes over time and accelerate biological insight. Pathos will license the data from Tempus under a five-year, $55 million agreement. Pathos will apply its AI platform, Pathos Foundry, to interrogate the dataset at scale, generate and test hypotheses on disease biology, and inform the design of more targeted, adaptive clinical trials. Pathos built and validated this approach in oncology, where it guides decisions across the company’s clinical-stage pipeline, including adapting trial design in real time to improve its projected probability of success. The collaboration builds on BMS's broader strategy to combine advanced AI with deep scientific and disease-area expertise to make faster, higher-confidence decisions that drive innovation for patients. BMS is helping expand the application of Pathos Foundry into neuroscience, securing three-year exclusive rights in an area where the company brings deep research, clinical-development expertise and a growing portfolio of programs in Alzheimer’s disease and other neurological conditions. Through multi-year access to the platform across its broader portfolio and the specialized dataset developed through the definitive agreements, BMS aims to generate deeper insights into disease progression, identify patients most likely to benefit from potential therapies and design more precise clinical trials. “Neurological diseases demand more than any one company can bring on its own: the best longitudinal data, AI that can reason over it at scale, and the drug development expertise to turn insight into medicines,” said Iker Huerga, CEO of Pathos AI. “Intelligence alone does not bring a therapy to market. These collaborations bring all three together. We are thrilled to deepen our work with Tempus and proud to have BMS leading our Series E as we build a self-learning drug development system designed to adapt clinical trials and improve the likelihood of success.” “AI has the greatest potential when it is grounded in high-quality data and applied by scientists with deep understanding of diseases and drug development,” said Simon Davies, SVP, Head of Data and Quantitative Sciences, Bristol Myers Squibb. “Our investment in Pathos reflects our commitment to applying advanced AI and data science across research and development to accelerate innovation for patients. By combining AI-driven insights with our neuroscience expertise, we hope to deepen our understanding of disease progression, improve clinical-trial design and ultimately advance new treatment options. Collaborating with Pathos and Tempus allows us to interrogate Alzheimer’s and other neurological diseases at scale, strengthening our pipeline and advancing precision medicine for patients in need.” “Making meaningful progress against a disease as devastating as Alzheimer’s requires unprecedented data scale and computing power,” said Eric Lefkofsky, Founder and CEO of Tempus. “These collaborations unite BMS’s deep expertise, Pathos’s drug development agentic AI and Tempus’ data infrastructure. Together, we have a unique opportunity to uncover novel insights and accelerate much-needed treatments for Alzheimer’s patients.” About Pathos AI Pathos AI is an AI and technology company developing drugs. The company redesigns drug development from first principles: identifying clinical assets, making portfolio decisions with continuously updated probability-of-success calculations, and guiding clinical trials with AI-native monitoring. Pathos’s pipeline includes clinical-stage programs in metastatic castration-resistant prostate cancer, multiple myeloma, MET-altered non-small-cell lung cancer, ER+/HER2‐ breast cancer, and TROP2/HER3-expressing solid tumors. The company is based in New York City. For more information, visit pathos.com .
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