Emunkitug

CAMBRIDGE, MA – August 22, 2024 – HiFiBiO Therapeutics, a clinical stage immune modulation biotechnology company today announced its participation in the 2024 Annual Congress of the European Society for Medical Oncology (ESMO), taking place September 13-17 in Barcelona, Spain. The company will present compelling Phase 1 trial data on two novel monoclonal antibodies: the first-in-class TNFR2 agonist HFB200301 (NCT05238883) and the best-in-class BTLA antagonist HFB200603 (NCT05789069). These programs have shown promise both as monotherapy and in combination with anti-PD-1, demonstrating the capability to elicit a robust anti-cancer immune response, even in IO refractory tumors. Harnessing its innovative Drug Intelligence Science (DIS®) platform, HiFiBiO is at the forefront of advancing these therapies by specifically selecting tumor types, optimizing dosing regimens, and identifying predictive biomarkers to increase the probability of clinical success. The insights gained from these Phase 1 trials will play a critical role in guiding Phase 2 dosing strategies and patient selection criteria. HiFiBiO’s novel immunotherapies and comprehensive translational strategy demonstrate the company’s deep commitment to innovative research and developing impactful therapies to address unmet medical needs. HiFiBiO is now applying this strategy to inflammation and immunology, with plans to submit an IND application for a novel BTLA agonist by the end of September. Details on the poster presentations are as follows: Title: Model-informed dose optimization of HFB200301, a TNFR2 agonist monoclonal antibody (mAb), in monotherapy and in combination with the anti-PD-1 mAb tislelizumab (TIS), in patients (pts) with advanced solid tumors. Presentation Number: 1011P Session Date: Saturday, 14 September 2024 Speaker: Desamparados Roda Perez, MD, PhD, Hospital Clínico Universitario de Valencia View the poster here. Title: Phase I dose escalation study of HFB200603, a best-in-class BTLA antagonist monoclonal antibody (mAb), in monotherapy and in combination with the anti-PD-1 mAb Tislelizumab (TIS) in adult patients (pts) with advanced solid tumors. Presentation Number: 1006P Session Date: Saturday, 14 September 2024 Speaker: María de Miguel, MD, PhD, MBA, START Madrid – CIOCC HM Sanchinarro View the poster here. The initial data from these abstracts will be available on the ESMO website starting on September 9 at 0:05 CEST. Additionally, the posters will be accessible on the HiFiBiO Therapeutics website following the live presentation. About HiFiBiO Therapeutics HiFiBiO Therapeutics is a clinical-stage biotech driving a robust clinical pipeline of transformative immunotherapies targeting cancer and autoimmune diseases. HiFiBiO achieves an unprecedented understanding of immune modulation in human diseases by pioneering a unique high-resolution translational platform, Drug Intelligence Science (DIS®), which combines unique single-cell capabilities with AI/ML approaches. Using patient samples, DIS® enables the discovery of novel targets, effective antibody drugs, and predictive biomarkers to enhance the probability of success for immunotherapies. Moreover, HiFiBiO has established partnerships with major multinational pharmaceutical and biotech companies and has been recognized as one of the 2023 Fierce 15 biotech companies. For additional information, please visit www.hifibio.com HiFiBiO® is a trademark of HiFiBiO Therapeutics and its affiliates

CAMBRIDGE, MA – May 24, 2024 – HiFiBiO Therapeutics, an innovative clinical stage biotechnology company committed to improving patient lives with single cell precision, today announced its participation in the 2024 Annual Meeting of the American Society of Clinical Oncology (ASCO), set for May 31-June 4, 2024, in Chicago, IL. The company will present Phase 1 trial data on two novel agonists: the first-in-class TNFR2 agonist HFB200301 (NCT05238883) and the next-generation OX40 agonist HFB301001 (NCT05229601). These agonists were developed using HiFiBiO’s innovative Drug Intelligence Science (DIS®) platform, which incorporates microfluidic single-cell technology and advanced AI/ML data analysis to assess patient tumor samples. The aim is to select optimal tumor types and predictive biomarkers to enhance the probability of clinical success. Insights gained from these Phase 1 trials will guide the recommended dosages and patient stratification strategy for Phase 2. In addition to advancing Dose Expansion studies for each of the agonists, the company is also advancing a third clinical program, the best-in-class BTLA antagonist HFB200603 (NCT05789069). HiFiBiO’s novel immunotherapies and robust translational strategy demonstrate the company’s deep commitment to innovative research and its development of impactful therapies to address unmet medical needs. Details on the poster presentations are as follows: Title: Phase I dose escalation trial of the first-in-class TNFR2 agonist monoclonal antibody, HFB200301, in monotherapy and in combination with tislelizumab, an anti-PD-1 monoclonal antibody, in adult patients with advanced solid tumors Abstract Number: 2526 Session Date and Time: 6/1/2024. 9 – 12 pm CDT Presenter: Desamparados Roda, MD, PhD, Hospital Clínico Universitario de Valencia View the full poster here. Title: A phase I monotherapy dose escalation study of HFB301001, a novel next generation OX40 agonist monoclonal antibody, in adult patients with advanced solid tumors Abstract Number: 2531 Session Date and Time: 6/1/2024. 9 – 12 pm CDT Presenter: Anthony El-Khoueiry, MD, University of Southern California Norris Comprehensive Cancer Center View the full poster here. About HFB200301 HFB200301 is a first-in-class, agonistic monoclonal antibody targeting TNFR2. It is designed to stimulate both innate and adaptive immune responses. The stimulation of T-cells and NK-cells within the tumor microenvironment is expected to enhance anti-tumor immunity effectively. To enhance the probability of clinical success, HiFiBiO Therapeutics is leveraging its DIS® platform to select tumor types most likely to respond to HFB200301, based on target biology and single-cell insights from patient-derived tumors, including refractory tumors. About HFB301001 HFB301001 is a next-generation, agonistic monoclonal antibody targeting OX40. Prior OX40 agonist antibodies have demonstrated promising preclinical activity but had limited clinical impact, likely due to their pharmacological properties. HFB301001 overcomes these limitations by binding to a unique, non-competing epitope, thus preserving the OX40/OX40L interaction. Moreover, HFB301001 does not decrease OX40 surface levels upon co-stimulation. To enhance the probability of clinical success, HiFiBiO Therapeutics is leveraging its DIS® platform to select tumor types most likely to respond to HFB301001, based on target biology and single-cell insights from patient-derived tumors, including refractory tumors. About HiFiBiO Therapeutics HiFiBiO Therapeutics is a clinical-stage US biotech with a global footprint driving a robust clinical pipeline of transformative immunotherapies targeting cancer and autoimmune diseases. HiFiBiO achieves an unprecedented understanding of immune modulation in human diseases by pioneering a unique high-resolution translational platform, Drug Intelligence Science (DIS®), which combines unique single-cell capabilities with AI/ML approaches. Using patient samples, DIS® enables the discovery of novel targets, effective antibody drugs, and predictive biomarkers to enhance the probability of success for immunotherapies. Moreover, HiFiBiO has established partnerships with major multinational pharmaceutical and biotech companies and has been recognized as one of the 2023 Fierce 15 biotech companies. For additional information, please visit www.hifibio.com HiFiBiO Therapeutics and the HiFiBiO Therapeutics logo are trademarks of HiFiBiO and its affiliates.