Bonus Biogroup is pleased to announce that the Japan Patent Office has granted a patent providing Bonus Therapeutics, a wholly-owned subsidiary of the Company, exclusive rights to use and commercialize cell characterization for transplantation [1]. These specialized cells are integral to "BonoFill," a living human bone graft developed by Bonus Biogroup. The patented process involves a unique gene expression profile of bone-forming cells extracted from human adipose tissue and cultivated in a 3-dimensional culture. This Approved Patent in Japan will be in effect until July 11, 2037.

The Company anticipates the market potential for various applications of BonoFill to address bone deficiencies will reach approximately $70 billion annually in the United States [2] and about $24 billion in Japan [3].

Japan is particularly significant due to its robust market and supportive stance on cell therapy and tissue engineering products like BonoFill and MesenCure. This environment is fostered by a progressive regulatory framework, aimed at fast-tracking the approval and marketing of advanced therapeutic products [4].

Before the Japanese patent's approval, the Company's pioneering technology, characterized by therapeutically active cells with a distinctive gene expression profile, had already been patented in Russia [5] and India [6]. These patents secure the Company's exclusive rights to use and commercialize a living human bone graft in these countries until July 11, 2037. Additionally, patent applications for this technology have been filed in the United States, Europe, China, Australia, and Israel.

The Japanese patent significantly enhances the Company's competitive position and extends its exclusivity in using and commercializing a living human bone graft in Japan's advanced market. This patent complements the competitive protection provided by the Company's existing patents and patent applications. The protection covers the entire bone rehabilitation market, catering to all clinical indications requiring bone deficiency filling, including oral and maxillofacial surgery, orthopedic surgery, plastic surgery, and other relevant indications.

Dr. Shai Meretzki, CEO of Bonus Biogroup, stated: "Japan is a pivotal market for cell therapy and tissue engineering products like BonoFill and MesenCure. The newly granted patent in Japan, echoing the patents in Russia and India, enhances and deepens the exclusivity of commercialization and use of a living human bone graft, especially regarding the unique cells in BonoFill™ and their genetic profiles. This accomplishment is a significant milestone in our quest to offer a safe, efficient, and swift remedy for bone deficiencies by providing a living, evolving human bone graft."

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. Japanese Patent No. JP7268943B2
2. BonoFill 2030 Market Projection: Refer to the Immediate Report dated July 11, 2023 (Reference: 2023-01-078258), which is incorporated herein by reference.
3. Market Size Estimation for Japan (2030): Calculated based on Japan's projected population (121 million) compared to the projected U.S. population (350 million) for 2030, and then applied to the forecasted U.S. market size for that year ($70 billion as Total Addressable Market).
4. Japan's Conditional Approval Pathway for Regenerative Medicines: http://www.lisata.com/wp-content/uploads/2021/02/Sietsema-et-al.-2018-RAPS-1.pdf
5. Russian Patent No. 2788112
6. Indian Patent No. 440625