Bonus Biogroup is delighted to share that it was invited to feature its progress in several R&D programs at the annual meeting of the International Society for Cell and Gene Therapy conference (ISCT 2023) [1]. Held in Paris from May 31 to June 3, 2023, the Company was privileged to present at three conference sessions.

The Company was excited to announce the establishment of its AI-based bioinformatics unit at the conference. The unit is dedicated to researching and developing cell therapy applications to augment clinical and economic efficiency. Preliminary results from bioinformatics and AI-based analyses demonstrate the capability to characterize and possibly harness the natural variation between cells derived from different donors or to decrease this variance to meet clinical, technological, or operational needs.

In addition, the conference served as a platform for the Company to showcase its triumphs in treating acute respiratory distress with MesenCure, an advanced cell therapy for inflammation and tissue damage. It also shared its accomplishments in treating critical-sized bone defects using BonoFill, a live human bone graft. Additional products resulting from the Company's rigorous R&D activity were also presented.

Employing computer and life science experts, the Bioinformatics Unit is designed to streamline R&D processes, attain optimal clinical outcomes, and decrease the complexity and cost of cellular drug production. This is achieved by characterizing the genetic material (DNA or RNA) and products of living cells foundational to the Company's products and analyzing them using cutting-edge artificial intelligence (AI) tools. This process also aids the Company in identifying novel R&D trajectories and potential intellectual property.

The ISCT, being the premier professional association in the Company's field of operation [2], draws scientists, physicians, industrialists, and opinion leaders from across the globe to its annual conference. Recognizing the importance of the Society and Bonus Biogroup's leading role in cell therapy, the Company chose to reveal the preliminary results of the Bioinformatics Unit at a special session invited by Sartorius. In this session, the Company showcased various strategies applied in developing its products to achieve optimal clinical performance, including using AI tools [3].

Dr. Shai Meretzki, CEO of Bonus Biogroup, expressed: "AI tools are revolutionizing every conceivable field, including cell therapy. Bonus Biogroup, being a cell therapy pioneer, recognized AI's potential early and established an evolving bioinformatics unit in late 2022 that leverages advanced AI tools. We anticipate the unit's operations to drive significant growth for the Company. We've accumulated vast information about the biological infrastructure of our products and now possess sophisticated analytical tools further to develop this information into clinically and economically significant products. Announcing the unit's establishment and initial products at the ISCT meeting will further enhance our reputation as a leading-edge cellular medicine and tissue engineering company. We thank the ISCT and Sartorius for their invitation to highlight our successes in various R&D programs."

Furthermore, the Company shared preliminary results from a collaborative study with the Institute for Biological Research in Israel. The study is designed to test the effectiveness of MesenCure, a Bonus Biogroup product, in treating acute respiratory distress and rehabilitating lung tissue damage from exposure to various biological agents [4]. Preliminary findings may suggest MesenCure's effectiveness in treating acute lung injury and resultant pneumonia, even those not induced by a coronavirus, leading to acute respiratory distress syndrome. This complements the Company's success in establishing the efficacy and safety of the drug in phase II clinical trial for treating pneumonia and respiratory distress in severe COVID-19 patients.

Finally, the Company will also present new developments in rehabilitating blood vessels in bone tissue using a hybrid tissue graft designed to treat bone deficiency in conditions with significant damage to the tissue blood supply. This hybrid graft may particularly benefit patients suffering from bone avascular necrosis (AVN), which affects around 15,000 new cases annually in the US alone [5]. The AVN treatment market is growing at approximately 6% per annum and is projected to reach $1 billion by 2028 [6].

Bonus Biogroup – the Company

Since its inception, Bonus BioGroup has been involved in cellular medicine and tissue engineering. To date, the Company has two products in clinical development: BonoFill - a viable human bone graft for the regeneration and reconstruction of bone tissue, and MesenCure - a cell therapy for acute inflammation, including acute respiratory distress in severe COVID patients. In addition, the Company has a variety of other technologies and products in preclinical development.

The main building block utilized to produce BonoFill bone graft is mesenchymal cells extracted from the patient's adipose tissue. Alongside the development of BonoFill, the Company developed a cell therapy based on mesenchymal cells isolated from adipose tissue of healthy donors that are professionalized to enhance their ability to counteract acute inflammation, including cytokine storms prevalent in COVID patients and other diseases. These efforts led to the development of the professionalized cell therapy product MesenCure.

In light of the Company's demonstration of the efficacy of MesenCure in treating severe COVID patients, the Company has expanded its efforts to examine the potential of MesenCure to treat other conditions involving systemic inflammations and multi-organ injuries. Such conditions include CRS caused by biological therapies or hematopoietic stem cell transplantation.

In developing its drug products, Bonus BioGroup uses unique technologies and knowledge developed in-house. The Company's rich intellectual property, including six families of patents and patent applications, encompasses twenty-eight approved patents and fifteen patent applications in many countries worldwide.

BonoFill – a viable human bone graft

Bone deficiencies can result from various causes, including aging, infections, arthritis accompanied by bone loss, trauma (accident or fall), and tumors. Bonus Biogroup develops viable human bone grafts based on cells sampled from the patient (autologous tissue). Growing bone grafts outside the patient's body allow their on-demand manufacturing to provide effective bone grafts for various medical conditions involving bone loss, including oral and maxillofacial surgery, cranial surgery, orthopedic surgery, and plastic surgery.

MesenCure cell therapy

The cell therapy MesenCure consists of professionalized mesenchymal cells. MesenCure is designed to treat acute inflammations and subsequent conditions. These conditions may include life-threatening pneumonia and respiratory distress, whether caused by the coronavirus, any other virus or bacterial infection, or whether caused by other conditions underlined by a hyperactive immune system. The efficacy of MesenCure, as demonstrated in the clinical trial for treating severe COVID patients, is presumably attributed to the professionalization of the mesenchymal cells comprising MesenCure. This professionalization enhances the cells' natural ability to attenuate the inflammation and cytokine storm, which, without MesenCure, could lead to life-threatening multi-organ damage. Furthermore, the cells comprising the drug product MesenCure affect inflammation and cytokine storm through various mechanisms. Therefore, MesenCure may have a broader and more robust effect on diverse populations of patients than drugs acting via a single mechanism.

Company estimations regarding 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 cancer 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.

Sincerely,

Bonus BioGroup Ltd.

By: Yossi Rauch (Chairman of the Board) and Dr. Shai Meretzki (CEO and Director)

[1] International Society for Cell & Gene Therapy ("ISCT") 2023 annual meeting: https://www.isctglobal.org/isct2023/home

[2] https://isctglobal.org/page/AboutUs

[3] Priming the Cellular Orchestra: Fine-Tuning MSCs for Clinical Success (Friday, Jun 02, 2023).

[4] For details, see the Immediate Report Dated May 22, 2023 (REF: 2023-01-054261), included herein as a reference

[5] https://www.ncbi.nlm.nih.gov/books/NBK499954/

[6] https://www.coherentmarketinsights.com/market-insight/avascular-necrosis-market-2218