MDL-4102

CEO Daniel Haders, PhD, will highlight upcoming catalyst events for the company’s two lead assets: MDL-001, a first-in-class, universal, direct-acting therapeutic for influenza-like-illness (ILI) and chronic hepatitis, targeting the novel RdRp Thumb-1 site, and MDL-4102, a first-in-class therapeutic for various cancers and inflammatory diseases, targeting the epigenetic reader and master regulator of gene transcription, BRD4. SAN DIEGO — Model Medicines , an AI-first biotechnology company developing first-in-class therapeutics against multi-indication biological choke points, today announced that it will share its near-term catalysts for its two lead assets at the 2026 BIO International Convention, held June 22–25 at the San Diego Convention Center. Model Medicines will host partnering meetings throughout the convention and showcase its end-to-end AI drug discovery platform and two lead drug candidates, MDL-001 and MDL-4102. Both programs are advancing toward regulatory filings in 2026 and 2027. Daniel Haders, PhD, Co-Founder and Chief Executive Officer, will present the company’s platform and pipeline during the convention. Bio International Convention 2026 Date: Wednesday, June 24, 2026 Time: 3:30 PM Location: Theater 1 Engineering First-in-Class, Pipeline in a Pill Programs Model Medicines engineers first-in-class, pipeline-in-a-pill therapeutics against biological choke points. These targets share four key criteria: they are structurally conserved, functionally essential, disease-driving, and have multi-indication potential. Both lead candidates, MDL-001 and MDL-4102, originated from GALILEO™, the company’s end-to-end design, discovery, and development engine. "Model Medicines is moving faster than we thought possible. The proof is two first-in-class medicines headed for regulatory filings in 2026 and 2027," said Daniel Haders, PhD, Co-Founder and Chief Executive Officer of Model Medicines. "MDL-001 is positioned to become the world's first universal ILI and chronic hepatitis antiviral, and MDL-4102 is succeeding against a target that defeated an entire generation of inhibitors. The science behind the programs is validated and published. We have reached an inflection point, and we’re only accelerating." A Universal ILI and Chronic Hepatitis Therapeutic: Aggregating a Multi-Hundred Million Patient Population with Multi-Billion Dollar Revenue Potential Unmet Medical Need: Endemic viral respiratory illnesses caused by influenza, RSV, and coronaviruses impose a global disease burden of hundreds of millions of infections and hundreds of thousands of deaths annually. Chronic hepatitis B and C infections persist in 254 million and 58 million people worldwide, respectively. No oral, direct-acting antiviral is approved for more than one viral family, leaving humanity vulnerable to the annual respiratory tripledemic, chronic hepatitis co-infections and pandemics. Target Discovery : The dominant view holds that non-nucleoside antivirals cannot achieve cross-family activity because allosteric sites are not conserved. Model Medicines overturned this assumption by demonstrating that the RdRp Thumb-1 allosteric pocket is conserved across ssRNA viral families. The company validated this conserved target with MDL-001, the first Thumb-1 inhibitor shown to block multiple viral families. Indications and Market : MDL-001 is being developed across major respiratory infections, including influenza, COVID-19, and RSV, as well as chronic hepatitis infections, including HCV, HBV, and HDV. These indications represent an estimated combined global market opportunity exceeding $30 billion annually. Data : Model Medicines has now completed the preclinical proof-of-concept package for MDL-001, demonstrating nanomolar cross-family potency in the respiratory tripledemic viruses and chronic hepatitis, and efficacy equivalent or superior to approved standards of care in influenza, SARS-CoV-2, RSV, and hepatitis C. Validation : The virology program, the discovery of the RdRp Thumb-1 site, and MDL-001 preclinical data have been peer-reviewed, accepted, and showcased at IDWeek 2025 [1] , AASLD 2025 [2] , HepDART 2025 [3] , CROI 2026 [4] , ESCMID Global 2026 [5] , SERVC 2026 [6] , and EASL 2026 [7] . The full preclinical data readout for MDL-001 can be found here . The scientific foundation and preclinical findings for the discovery of the conserved RdRp Thumb-1 pocket [8] and MDL-001 [9] have been published. Catalyst : MDL-001 is currently completing IND-enabling studies. IND submission is targeted for late 2026, with clinical trials to commence in early 2027. A Transcriptional Regulation Program: Multi-Hundred Million Patient Population and Multi-Billion Dollar Revenue Potential Unmet Medical Need : BRD4 acts as a master transcriptional regulator and drives pathology across a vast spectrum of high-burden diseases where current therapeutic options are insufficient or non-existent. Despite the clinical promise of epigenetic modulation, high-mortality cancers remain aggressive and resistant to standard care. In fibrosis, many conditions lack effective disease-modifying treatments capable of halting or reversing disease progression. Broader applications extend to indications in cardiovascular and immunology. Target History : Previous development of BET inhibitors has been systematically halted by dose-limiting toxicities, specifically BRD3-mediated thrombocytopenia. Market : The ability to safely target BRD4 represents an estimated global market opportunity exceeding $60 billion. Data : Class-leading selectivity index and therapeutic index. The program successfully dissociates the therapeutic potential of BRD4 inhibition from the clinical toxicity that derailed predecessors. The discovery of MDL-4102 is a direct result of Model Medicines' record-setting 325-billion-molecule ultra-large virtual screen conducted in 2025 with Google Cloud. [10] Validation : The scientific foundation for the targeting of BRD4 has been validated through the company’s publications. [11] Catalyst : MDL-4102 is currently undergoing IND-enabling studies. IND submission is targeted for 2027. GALILEO™: A Multimodal AI Discovery and Development Engine Redefining Scale and Novelty GALILEO™ is a proprietary, end-to-end multimodal AI architecture that simultaneously processes diverse biological and chemical data to navigate expansive molecular spaces. By integrating advanced data pipelines, sophisticated modeling techniques, and cutting-edge drug design, the platform effectively unlocks and targets elusive, historically "undruggable" biological choke points. This comprehensive approach allows Model Medicines to systematically collapse traditional discovery timelines from years to months. To translate this massive data advantage into viable therapeutics, GALILEO™ deploys a sophisticated ensemble of generative AI models alongside zero-shot machine learning techniques. Together, this ensemble empowers Model Medicines to efficiently prioritize and optimize clinical-track assets with inherently high multi-indication potential. The platform creates highly innovative, structurally distinct drug candidates. This unique capability de-risks early-stage development, avoids traditional clinical friction, and powers Model Medicines' "pipeline-in-a-pill" strategy to solve the world's most critical unmet medical needs. Model Medicines’ GALILEO™ platform has set new benchmarks in AI-driven discovery, and chemical space exploration. The company has developed an ensemble of specialized AI modules that each model a different facet of pre-IND testing. A recently published example is AmesNet. This module predicts Ames mutagenicity and delivered best-in-class performance on out-of-domain data, outperforming approaches from the FDA (DeepAmes), MIT (ChemProp), Baidu Research (GROVER), and the University of Sydney. [12] To demonstrate scale, in 2025, the platform executed the largest machine learning-driven virtual screen in history, a 325-billion-molecule throughput campaign that directly resulted in the identification of MDL-4102. [13] This success builds upon GALILEO™’s generative capacity, which utilizes sophisticated ensemble models to explore a chemical solution space exceeding 52 trillion compounds. [14] By combining this extreme scale with high-fidelity predictive models, Model Medicines is effectively collapsing discovery timelines from years to months, unlocking therapeutically viable candidates within expansive chemical landscapes previously thought unreachable. About Model Medicines Model Medicines is an AI-first biotechnology company engineering first-in-class small molecules that target the biological linchpins underlying disease. The company’s research spans infectious disease, oncology, and inflammation, with programs designed around conserved molecular choke points that drive multiple pathologies. Model Medicines has discovered a direct-acting, non-nucleoside, broad-spectrum antiviral (MDL-001) and a potent, selective, and novel BRD4 inhibitor (MDL-4102). Its work demonstrates how large-scale computation can uncover entirely new classes of drugs once thought unreachable. Model Medicines is advancing a new generation of therapeutics that redefine what is possible in modern drug discovery. Learn more at . Media Contact Patrick O’Neill Head of Partnerships & Investor Relations media@modelmedicines.com [1] MDL-001: A Broad-Spectrum Antiviral Targeting the Thumb-1 Domain of Viral Polymerases, Open Forum Infectious Diseases, Volume 13, Issue Supplement_1, January 2026, ofaf695.084, [2] MDL-001 As A Next Generation HCV Thumb-1 inhibitor With Clinical-Stage Safety, The Liver Meeting: 2025 Abstracts. (2025). Hepatology (Baltimore, Md.), 82(S1), S1–S2308. Abstract 0088. [3] Oral Thumb-1 polymerase inhibitor MDL-001 achieves preclinical HCV and HBV proof-of-concept, including HCV/HBV co-infection and equivalence to sofosbuvir. Paper presented at: HEPDART 2025; December 7–11, 2025. [4] MDL-001, a novel oral thumb-1 polymerase inhibitor, shows efficacy in HCV/HBV in vitro and in vivo. Paper presented at: Conference on Retroviruses and Opportunistic Infections (CROI); February 22–25, 2026; Denver, CO. Abstract 589. [5] MDL-001, an oral direct-acting Thumb-1 polymerase inhibitor, demonstrates broad-spectrum activity against influenza viruses, respiratory syncytial virus, and SARS-CoV-2 with oral proof-of-concept in mice. Abstract presented at: ESCMID Global 2026; April 18, 2026; Munich, Germany. Abstract 5803. MDL-001, an oral direct-acting Thumb-1 polymerase inhibitor, demonstrates single-agent efficacy against HCV/HBV co-infection in vitro, and achieves HCV and HBV preclinical proof-of-concept. Abstract presented at: ESCMID Global 2026; April 18, 2026; Munich, Germany. Abstract 5778. [6] MDL-001, an oral direct-acting Thumb-1 polymerase inhibitor, demonstrates broad-spectrum activity against influenza viruses, respiratory syncytial virus, and SARS-CoV-2 with oral proof-of-concept in mice. Paper presented at: the 18th Southeastern Regional Virology Conference (SERVC 2026), April 24–26, 2026. [7] MDL-001, an oral direct-acting Thumb-1 polymerase inhibitor, demonstrates efficacy against HCV/HBV co-infection in vitro, and achieves HCV and HBV preclinical proof-of-concept, including equivalence to sofosbuvir, Journal of Hepatology, Volume 84, Supplement 1, May 2026, Pages S877-S878, THU-580. (26)02352-4/abstract [8] "The RdRp Thumb-1 Pocket is a Conserved Target for Broad-Spectrum Antiviral Development " bioRxiv, 2026, bioRxiv [9] "MDL-001: an Oral, Direct-Acting Universal Antiviral for Influenza-Like Illness (ILI) and Chronic Hepatitis." bioRxiv, 2026, bioRxiv [10] Google Cloud. Google Cloud to host second-annual Cancer AI Symposium in New York City [Internet]. New York: PRNewswire; 2025 Oct 30 [cited 2026 Feb 23]. Available from: [11] "ChemPrint: An AI-Driven Framework for Enhanced Drug Discovery, 2024, bioRxiv [12] AmesNet: A Task-Conditioned Deep Learning Model with Enhanced Sensitivity and Generalization in Ames Mutagenicity Prediction. bioRxiv, 2026 . [13] "Record-Scale AI Screening with Model Medicines on Google Cloud: GALILEO™ Achieves 325 Billion Molecule Throughput for Oncology Drug Discovery." Model Medicines, 30 Oct. 2025. [14] GALILEO generatively expands chemical space and achieves one-shot identification of a library of novel, specific, next generation broad-spectrum antiviral compounds at high hit rates. bioRxiv , 2025.