Bonus BioGroup Receives Approval to Expand Phase-II Clinical Trials for its COVID-19 Treatment to Medical Centers Across Israel

Bonus BioGroup LTD or "the Company" (BONS.TA), an Israeli clinical-stage biotechnology company, has received official approval from the Israeli Ministry of Health to expand its phase II clinical trials for its MesenCure treatment to health centers and hospitals nationwide. MesenCure leverages advances in cell therapy to treat COVID-19 patients suffering from life-threatening pneumonia, acute respiratory distress, and associated complications caused by the immune system's hyper-inflammatory response (cytokine storm) to the virus.

The Israeli Ministry of Health's decision regarding MesenCure coincides with a dramatic surge in infections and hospitalizations fueled by the more infective Delta-variant, which threatens to swamp the public health system in Israel and worldwide. Despite high rates of vaccination, current rates of infection are approaching those seen at the height of the pandemic. Consequently, as countries worldwide explore viable alternatives to broad economic shutdowns, focus has been redirected towards establishing a modus vivendi with COVID-19 that places emphasis on reducing the number of hospitalized and severely ill patients.

As announced in May and July 2021, Bonus BioGroup's phase I/II clianical trials saw complete success in treating severe COVID-19 patients at Haifa's Rambam Health Care Campus. All trial participants were admitted with severe COVID-19, and 90% suffered from comorbidities posing an elevated risk for serious illness, complications, and a mortality rate of over 35%. Despite these significant complicating factors, patients were released from the hospital after a median duration of one day following the MesenCure treatment.

Notwithstanding the severe condition of participating patients upon admittance, each of the three MesenCure doses administered to patients resulted in a significant decrease of diffuse inflammation. A cumulative effect was also recorded after administering each of the three doses in reducing the risk of multiorgan dysfunction, heart damage, kidney damage, and venous thromboembolism caused by the body's hyperinflammatory response to the virus.

Beyond its direct impact on attenuating hyper-inflammation, MesenCure has proven highly successful in improving additional parameters such as patient prognosis, recovery, and the chance of survival. Furthermore, patients reported improvements in subjective parameters, including mobility, self-care capacity, and routine operations performance.

Given MesenCure's seeming effectiveness in treating severe COVID-19 patients with pre-existing conditions and high-risk comorbidities, this novel treatment has been seized upon as a potential solution for relieving overburdened hospital systems. By doing so, MesenCure can help prevent the imposition of economically damaging measures such as general lockdowns or closures. In the weeks since the conclusion of the phase I/II trial, Bonus BioGroup has moved onto a phase II clinical trial that will include up to 50 participants suffering from severe COVID-19 in order to continue evaluating the efficacy and safety of MesenCure.

Hailing from the cutting-edge fields of regenerative medicine and cell therapy, Bonus BioGroup's MesenCure consists of allogeneic mesenchymal stromal cells that have been primed to enhance their immunomodulatory capabilities. Once injected into the patient, the cells target the inflamed lungs, depress the cytokine storm, and promote the healing of the respiratory system and other internal organs adversely affected by COVID-19.

Beyond its current application to infections by SARS-CoV-2 variants, MesenCure is potentially applicable to a range of additional conditions. These conditions include asthma, chronic obstructive pulmonary disease, and other lower respiratory tract diseases caused by viruses, bacterial infection, or exposure to chemical insults. Above and beyond the current demand for COVID-19 therapeutic solutions, MesenCure's potential global market is forecasted to exceed $43 billion by 2026.

The decision to expand MesenCure's phase II trial to medical centers across Israel is indicative of the high-hopes both private and public sector stakeholders have for the use of this revolutionary treatment method in a wide variety of different conditions and illnesses. Moreover, as the prospects for a COVID-19-free world fade from the immediate horizon, MesenCure may be the key to lowering rates of severe illness and hospitalization in order to keep public health systems within their capacities while preventing further rounds of withering economic closures against the backdrop of the Delta variant's global surge.

About Bonus BioGroup

Since its establishment, Bonus BioGroup has worked to develop cell therapies and tissue-engineered products for bone regeneration. The main component of the viable bone graft developed by the Company are mesenchymal stromal cells isolated from the patient's adipose tissue. During the outbreak of the COVID-19 pandemic, the Company started to study these mesenchymal cells and their potential applications to attenuating the associated hyper-inflammatory response (i.e., cytokine storm) provoked by COVID-19 and other diseases. In the development of MesenCure, Bonus BioGroup applied a variety of unique technologies and proprietary knowledge, some of which are currently in development by the Company, and some of which are part of the Company's broad intellectual property portfolio.