Bonus Biogroup is pleased to announce the successful demonstration of MesenCure's effectiveness in treating osteoarthritis in preclinical trials (hereafter: "the trial for osteoarthritis treatment") [1]. This achievement follows a clinical trial that underscored MesenCure's success in mitigating inflammation and tissue damage [2].

Osteoarthritis is the foremost joint disorder in the Western world, impacting approximately 23% of individuals aged 50-69 [3]. The prevalence increases in older people, with knee osteoarthritis being the most common, affecting around 10% of men and 13% of women over 60.

Cartilage tissue, cushioning bone ends, plays a pivotal role in shock absorption. Its strength, flexibility, and load-bearing attributes are essential for joint function and smooth movement. Osteoarthritis is characterized by the degradation of this cartilage, leading to pain, stiffness, and other bone changes. These symptoms can cause joint swelling, edema, and reduced weight-bearing capacity. Alarmingly, over 10% of osteoarthritis patients eventually require joint replacement surgery [4].

In the trial for osteoarthritis treatment, MesenCure™ showcased efficacy in three primary areas:

• A remarkable reduction in knee pain marked by a significant 86% average improvement (p<0.01) in the weight-bearing capacity of the treated knee and limb compared to the control group;
• A marked decrease in knee cartilage degradation, cartilage calcification, and other bone changes as determined through a pathological assessment comparing MesenCure-treated joints to controls;
• A notable reduction in joint inflammation and edema (Synovial Reaction) against the control group;

Bonus Biogroup's scientists presented these results at the Advanced Therapies Europe 2023 conference [5]. This international event, held from September 5-7, 2023, in Portugal, saw the Company's participation upon special invitation.

In contrast to MesenCure™, existing osteoarthritis treatments primarily focus on symptom relief without providing a definitive cure. Such treatments include anti-inflammatory drugs, analgesics, and joint lubricants.

According to Precedence Research [6], the global osteoarthritis treatment market was valued at $8.3 billion in 2022. With a 9.4% annual growth rate, it's forecasted to hit $20.2 billion by 2032. This market represents only a fraction of the broader medical expenses for these patients, estimated at $11 billion annually in the U.S. alone, with an added annual revenue loss of over $71 billion among osteoarthritis patients [7].

Dr. Tomer Bronshtein, VP of Business Development at Bonus Biogroup, led a special session at the conference titled "Ensuring the Continued Development and Application of Autologous Therapies Through Long-Term Durable Effect & Demonstration of Disease Modification" [8]. He also highlighted Bonus Biogroup's advancements in advanced therapies, MesenCure and BonoFill, for various indications. The focus remains on ensuring treatment accessibility, affordability, and value for all stakeholders.

Dr. Shai Meretzki, CEO of Bonus Biogroup, stated, "We're excited to expand our joint treatment solutions. We recently announced a pioneering achievement in joint fusion in the ankle and foot using BonoFill—a lab-grown human bone graft, eliminating the need for traditional bone harvesting [9]. Today, we're sharing our initial success with MesenCure in treating osteoarthritis. As innovators in bone and joint treatments, we're grateful to the organizers of Advanced Therapies 2023 for the opportunity to share our achievements and lead a pivotal discussion in advanced therapies."

About Bonus Biogroup

Bonus Biogroup Ltd. is a clinical-stage biotechnology company dedicated to developing advanced therapies in tissue regeneration and biotech products using tissue engineering and cell therapy. The Company currently has two products in clinical development: BonoFill™, a live tissue-engineered human bone graft intended for bone tissue regeneration and rehabilitation, and MesenCure, a cell therapy designed to treat inflammation and tissue damage, including pneumonia and respiratory distress. Bonus Biogroup also maintains a variety of technologies and products in the preclinical development phase.

The development of these products involves the application of unique technologies and knowledge proprietary to Bonus Biogroup. The Company's robust intellectual property portfolio includes six families of patents and patent applications, comprised of twenty-eight approved patents and fifteen patent applications, spanning numerous countries worldwide.

About BonoFill™ – Living Human Bone Graft

Bonus Biogroup has announced results from twenty out of thirty bone grafts in Phase II clinical trial for treating facial bone deficiencies, following a six-month observation period after each transplantation. The Company has completed the recruitment of all participants and is conducting a multicenter Phase II clinical trial to treat critical-sized bone defects in limb, hand, or foot bones at five medical centers in Israel using BonoFill™.

Bone deficiencies can arise due to aging, infections, osteoarthritis, traumas, and tumors. To mitigate the risk of rejection, Bonus Biogroup developed a living human bone graft using cells sampled from the patient. This lab-grown bone ensures effective bone grafts are readily available for various medical needs, including oral and maxillofacial surgery, skull surgery, orthopedic surgery, and plastic surgery, where bone tissue is lacking.

About the drug MesenCure

Bonus Biogroup has completed a Phase II clinical trial for treating pneumonia and life-teetering respiratory distress in severe COVID-19 patients using the cell therapy drug MesenCure. Clinical trial results indicate that MesenCure reduced the mortality rate of severe COVID-19 patients by 68% compared to the control group, with the survival rate standing at 94% for the 50 severe patients treated with the drug.

MesenCure, comprised of professionalized mesenchymal cells, aims to treat inflammation and tissue damage, including pneumonia and respiratory distress caused by the coronavirus or other viruses, bacterial infections, or other sources of immune overactivity, inflammation, or tissue damage.

The drug's effectiveness is attributed to the professionalization of the comprising cells, which enhances their natural ability to heal inflammation and tissue damage. The cells constituting MesenCure also affect inflammation and promote tissue regeneration through various mechanisms, potentially offering a broader and superior effect on diverse populations suffering from inflammation and tissue damage from multiple causes compared to drugs with a single mechanism of action.

Given the successful demonstration of MesenCure's effectiveness in treating acute respiratory distress in severe COVID-19 patients, the Company has broadened its efforts to investigate the potential efficacy of the drug and its derivatives in treating other indications such as cytokine release syndrome resulting from immunotherapy treatments to activate the immune system against cancer or from hematopoietic stem cell transplantation, as well as in tissue rehabilitation and healing.

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)

References

1. Experiments were conducted using a standard model for treating osteoarthritis. Rats were induced with osteoarthritis in the knees through surgical injury to the knee joint (medial meniscus tear). For more information refer to: https://doi.org/10.1016/j.joca.2022.01.010
2. For more information, see the Immediate Report Dated January 10, 2022 (REF: 2022-01-005083), included herein as a reference.
3. https://doi.org/10.1016/S2665-9913(23)00163-7
4. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4711057/
5. https://advancedtherapieseurope.phacilitate.com/stream/innovation-showcase/
6. https://www.precedenceresearch.com/osteoarthritis-therapeutics-market
7. https://www.medicalnewstoday.com/articles/prevalence-of-osteoarthritis
8. https://advancedtherapieseurope.phacilitate.com/stream/ensuring-the-continued-development-and-application-of-autologous-therapies-through-long-term-durable-effect-demonstration-of-disease-modification/
9. For more information, see the Immediate Report Dated August 27, 2023 (REF: 2023-01-098490), included herein as a reference.