Bonus Biogroup Appoints Renowned Cell Therapy Leader, Professor Edwin M. Horwitz, MD, PhD, to its Advisory Board

HAIFA, Israel, July 14, 2025 (GLOBE NEWSWIRE) -- Bonus Biogroup (TASE: BONS), a late-stage biotechnology company priming immunomodulatory and regenerative mesenchymal stem cells (MSC) to develop novel tissue engineering and cell therapy solutions, announced the appointment of Professor of Cell Therapy and Pediatric Medicine, Edwin M. Horwitz, MD, PhD, to its Advisory Board. Prof. Horwitz's appointment further enhances Bonus Biogroup's scientific leadership at a critical juncture as the company advances toward Phase 3 clinical trials for its two flagship therapeutic candidates: BonoFill™ – an autologous tissue-engineered, live human bone graft for treating large or nonhealing bone defects, and MesenCure™ – an allogeneic cell therapy for treating inflammation and tissue damage.

Dr. Shai Meretzki, Founder and CEO of Bonus Biogroup, commented, "Prof. Horwitz is an internationally recognized leader in cell therapy, with over three decades of experience in translational science, clinical hematology and oncology, and stem cell therapy. He brings unparalleled expertise in MSC biology and clinical application, particularly in transplant medicine and immune modulation. His addition to our Advisory Board underscores Bonus Biogroup's commitment to advancing the field through distinguished leadership, scientific excellence, and a focus on innovation. Prof. Horwitz is a pioneer in stem cell research and played a foundational role in defining the key characteristics of MSCs—a contribution that continues to shape global research and therapeutic development. His insights will be instrumental in expanding our clinical programs and advancing our mission of delivering transformative cell therapies to patients with urgent unmet needs."

Currently, Prof. Horwitz serves as Marcus Professor of Cellular Therapy and Professor of Pediatrics at the Emory University School of Medicine and Director of Transplantation Biology and Therapeutics at the Aflac Cancer and Blood Disorders Center at Children's Healthcare of Atlanta.

Speaking on his appointment, Prof. Horwitz remarked, "I am honored to join Bonus Biogroup at such a pivotal moment in its growth. The company's commitment to developing scientifically rigorous, patient-focused therapies that address pressing and prevalent clinical needs closely aligns with my vision for the future of regenerative medicine. I look forward to contributing to Bonus Biogroup's continued success and to helping unlock the full potential of cell-based treatments."

Prof. Horwitz also serves as Editor-in-Chief of Cytotherapy, the official journal of the International Society for Cell & Gene Therapy (ISCT), where he previously served as President (2010–2012) and was the founding chair of the MSC Committee. The ISCT is the leading professional organization in the company's field of activity. Prof. Horwitz is a prolific scholar and thought leader. He has authored more than 210 scientific publications, which have been cited over 38,000 times, placing him among the top ten globally ranked authors in cell therapy¹. His leadership continues to shape the global dialogue around scientific standards, regulatory frameworks, and innovation in cell-based therapies.

About BonoFill: An autologous live human bone graft

BonoFill is a tissue-engineered human bone graft designed for bone repair, regeneration, and reconstruction. The graft is developed from autologous (patient-derived) cells to minimize the risk of rejection. These cells are cultured in a bioreactor on a 3D scaffold for 2-3 weeks, resulting in a large volume of bone tissue suitable for transplantation. Bonus Biogroup has completed a Phase 2 clinical trial to treat bone deficiencies in the face, demonstrating a 90% success rate and a significant reduction in healing time. The company plans to initiate a Phase 3 study for the same indication in 2026. Additionally, a Phase 2 clinical trial is underway to treat large bone defects in the limbs. Unlike traditional autologous bone grafting, which is the current standard treatment for critical bone loss, BonoFill eliminates the need for bone harvesting, offering a safer, patient-friendly alternative produced entirely in the lab. Furthermore, the reduced complexity of the surgical procedure using BonoFill may accelerate the healing process. The company estimates that the combined total addressable market (TAM) opportunity in the United States for BonoFill in the orthopedic and craniomaxillofacial applications, including dental applications, for which we are currently conducting clinical trials, to be approximately $25.0 billion in 2030 when factoring in the savings opportunity offered by BonoFill if integrated with the current standard of care (SOC).

About MesenCure: An allogeneic cell therapy for inflammation and tissue damage

MesenCure is an allogeneic cell therapy investigational drug comprising enhanced adipose tissue-derived MSCs designed to treat inflammation and tissue damage, including pneumonia and respiratory distress. Bonus Biogroup believes MesenCure's therapeutic effect stems from leveraging multiple mechanisms of action, enhanced through a proprietary cell priming process, to mitigate inflammation and promote tissue regeneration. A Phase 2 trial in severely ill patients with respiratory distress due to COVID-19 pneumonia demonstrated a 68% reduction in mortality and a 57% decrease in invasive ventilation for patients treated with MesenCure on top of the SOC compared to the SOC alone. In February 2025, the FDA cleared an IND application for MesenCure, permitting the company to proceed with a Phase 3 clinical trial to test the safety and efficacy of MesenCure for treating severely ill patients affected by respiratory distress due to COVID-19 pneumonia. We are working to broaden the scope of this Phase 3 clinical trial to test the safety and efficacy of MesenCure for treating respiratory distress from all causes, including acute respiratory distress syndrome (ARDS). Pending the FDA's clearance of the amendment of the clinical protocol to include the broader indication, we plan to launch a Phase 3 clinical trial to test MesenCure for treating respiratory distress from all causes, including ARDS patients, in late 2025. The Company estimates that the market potential of MesenCure for treating all-cause ARDS in the United States alone could reach approximately $9.4 billion by 2030 based on the savings opportunity MesenCure offers if integrated with the current SOC.

About Bonus Biogroup

Bonus Biogroup Ltd. is a biotechnology company conducting advanced clinical studies focused on developing next-generation therapies in regenerative medicine for cell and tissue regeneration. The company is dedicated to creating effective and safe tissue engineering and cell therapy products to treat common and severe conditions with limited treatment options while ensuring broad accessibility through cost-effective solutions. Bonus Biogroup develops cutting-edge priming technologies to enhance the regenerative capabilities of mesenchymal cells—promoting tissue regeneration and reducing inflammation, as well as advanced methods for cell production.

The development of Bonus Biogroup's clinical-stage products and additional products and applications in the preclinical stage leverages the Company's proprietary technologies and expertise. The Company's strong intellectual property portfolio comprises six patent families, encompassing seventy-one granted patents and ten pending patent applications, covering multiple countries worldwide.

Forward-Looking Statements

Bonus Biogroup's assessments regarding the medical effect and/or commercial potential of its products and/or the resulting economic opportunities, and the Company's ability to continue the process of their development, including conducting studies and arriving at a product that can be medically applied in humans, for the duration and expected dates to perform any stage in any experiment and publish its results and obtain regulatory approvals for marketing the product, are forward-looking statements, as defined by the Securities Law of 1968, which are based on the Company's estimates and on the information in its possession at the time of reporting. There is no certainty that these estimates will materialize, in whole or in part, among others, due to dependence on the actions of third parties, which are not under the Company's control, on the development of future therapies, on future studies' results, if any, due to the possibility of delay in obtaining approval from relevant authorities and/or change in the relevant conditions and/or feasibility tests that the Company may conduct and/or delay in performing studies and/or need to perform further experiments and/or failure of experiments and/or technological changes and/or the development and/or marketing of similar and/or more efficient competing products and/or the lack of resources and/or the realization of any of the risk factors associated with the research and/or studies and/or its results.

An original Hebrew version of the Company's Immediate Report to the Tel Aviv Stock Exchange (TASE) related to the reported matter is available on the

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