Bonus Biogroup is pleased to announce the compelling findings after the six-month follow-up period for twenty out of thirty transplants of BonoFill, our living human bone graft, in Phase II Clinical trial for treating facial bone deficiencies in the upper or lower jaw bones. The significant interim results include the following:

• Complete success in bone reconstruction was achieved in 90% of the transplants (p<0.001) [1]. The regenerated bone allows for further reconstructive procedures, such as dental implants.
• Rapid and complete healing and maximal bone regeneration were observed within three months after the BonoFill transplant, resulting in a threefold increase in height compared to the bone before transplantation (p<0.0001) [2]. This accelerated recovery time is two to three times faster than standard treatments [3], enabling patients to resume their daily routines, including comprehensive dental rehabilitation, quickly.
• The newly formed bone in the patient's body exhibits biological and mechanical characteristics identical to natural bone.
• BonoFill demonstrated an impeccable safety profile with no observed side effects.

The enrollment of all participants in the Phase II clinical trial for treating facial bone deficiencies, which includes thirty transplants, has been completed [4].

Dr. Efraim Zur, the lead oral and maxillofacial surgeon of the clinical trial, has accepted an invitation from the International Association of Oral and Maxillofacial Surgery (IAOMS) to present the successful clinical results at their annual conference in Vancouver, Canada, held from June 8th to 11th, 2023.

BonoFill offers a compelling alternative to autologous bone transplants, where the bone is harvested from other areas of the patient's body, shaped to the desired form, and implanted at the site of the defect. This process can lead to complications such as damage to blood vessels and nerves at the bone harvesting site and the risk of infections. BonoFill therapy eliminates the need for bone harvesting, eliminating these potential risks.

Furthermore, BonoFill has a distinct advantage over bone substitutes derived from human cadavers or animal bones, typically used for relatively small bone deficiencies [5]. In our clinical trial for treating facial bone deficiencies, BonoFill was successfully implanted in volumes ranging from 14 to 40 milliliters, demonstrating its efficacy in treating massive bone deficiencies.

The application of the BonoFill therapy is fast, simple, and does not necessitate an operating room; it can also be performed in a dental clinic. These features may expand the applicability of BonoFill therapy and its availability to many patients, as well as speed up and improve their chances of recovery and reduce additional risks and costs associated with surgery and recovery.

Facial bone deficiencies can result from bone resorption or absence due to inflammatory diseases, age-related bone loss, trauma, tumor and cyst removal, and congenital and developmental defects. Additionally, bone grafting is often required when there is insufficient bone to support dental implants. By 2025, Bonus Biogroup estimates a projected demand of approximately 3.4 million facial bone transplants annually in the United States alone, representing a potential market worth $7.7 billion and potentially double that globally.

BonoFill is derived from cells sampled from the patient's adipose tissue, cultivated outside the body in a controlled process using a three-dimensional culture on a mineral scaffold. Following transplantation, the lab-grown bone culture aids in bone and tissue regeneration without triggering immune rejection. The clinical trial for treating facial bone deficiencies is being conducted in Israel alongside another Phase II clinical trial at five additional medical centers to treat critical-sized limb bone defects.

"Patients treated with BonoFill experienced rapid healing of extensive and complex bone deficiencies, without the occurrence of infections or significant complications commonly associated with standard treatments," stated Dr. Efraim Tzur, former Director of the Oral and Maxillofacial Unit at Shamir Medical Center (Assaf Harofeh) and a specialist in oral and maxillofacial surgery. "After the follow-up period, it became evident that the bone regenerated through BonoFill implantation is stronger and expected to provide superior support for rehabilitative procedures, including inserting, maintaining, and preserving dental implants. I am grateful to the International Association for Oral and Maxillofacial Surgery for the opportunity to present the successful outcomes of this clinical trial at their annual conference and the Company's plans for the further clinical development of BonoFill in Phase III. This sets a course towards establishing BonoFill as an innovative and game-changing solution for treating facial and other bone deficiencies." The IAOMS is the leading global professional association in its field [6]. Its annual conference, which is the highlight of the association's activities, attracts scientists, doctors, and industry leaders from around the world.

Meanwhile, Bonus Biogroup continues to record patient success in Phase II clinical trials for treating critical-sized limb bone defects where other surgical treatments have failed. Orthopedic doctors and surgeons from various medical centers, who have treated various bone deficiencies using BonoFill, presented these successes at an international conference on innovation in healthcare - The Future Health Matrix [7], as well as at the 42nd annual conference of the Israeli Orthopedic Association [8].

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. According to a two-sided one-sample Z test for proportions against null proportion of 50%
2. According to a two-sided t-test for bone height measured based on radiological assessment.
3. Karagah et al. Effect of Sinus Floor Augmentation with Platelet-Rich Fibrin Versus Allogeneic Bone Graft on Stability of One-Stage Dental Implants: A Split-Mouth Randomized Clinical Trial. Int J Environ Res Public Health. 2022 Aug 4;19(15):9569. doi: 10.3390/ijerph19159569. PMID: 35954926; PMCID: PMC9367838.
4. On June 11, 2023.
5. Jamcoski et al. 15-Year Retrospective Study on the Success Rate of Maxillary Sinus Augmentation and Implants Influence of Bone Substitute Type, Presurgical Bone Height, and Membrane Perforation during Sinus Lift. Biomed Res Int. 2023 Feb 20;2023:9144661.
6. https://www.iaoms.org/
7. For details, see the Immediate Report Dated December 7, 2022 (REF: 2022-01-148102), included herein as a reference.
8. For details, see the Immediate Report Dated January 25, 2023 (REF: 2023-01-011610), included herein as a reference.