F-1/A: Bonus Biogroup Launches US IPO Amidst Going Concern Doubts

Sentiment:

Amendment to Registration Statement for Initial Public Offering 31 March 2026 5:30 PM

Bonus Biogroup Ltd., a clinical-stage biotechnology company, is launching an initial public offering of 3,750,000 American Depositary Shares on Nasdaq to fund its advanced cell therapy and tissue engineering programs, despite recurring losses and substantial doubt about its ability to continue as a going concern.

Delay expectedDuring the height of the COVID-19 pandemic in 2020 and 2021, elective surgeries were sometimes ceased, and lockdowns resulted in delays in the recruitment of patients to clinical trials, including for the transplantation of BonoFill.The company is working to broaden the scope of MesenCure's Phase III clinical trial to treat respiratory distress from all causes, including ARDS patients, pending FDA clearance of the amendment of the clinical protocol. This indicates a potential delay in initiating the broader trial if clearance is not timely.The issuance of ordinary shares and warrants from recent PIPE transactions (November 2024, 2025, and 2026) is subject to TASE Listing Approval and has not yet occurred, indicating a delay in formalizing these capital raises.

Capital raiseThe company is conducting an initial public offering of 3,750,000 American Depositary Shares (ADSs) at an estimated price range of $4.00 to $6.00 per ADS, with estimated net proceeds of approximately $16.2 million.The underwriter has an option to purchase up to an additional 562,500 ADSs.In November 2024, the company conducted private placements (PIPE Transactions) issuing 31,006,250 ordinary shares and 15,503,125 warrants for gross proceeds of NIS 4,961,000 (approximately $1,360,000).Between March and November 2025, the company conducted private placements (PIPE Transactions) issuing 32,027,495 ordinary shares and 16,013,752 warrants for gross proceeds of NIS 9,028,343 (approximately $2,830,000).Between January and March 2026, the company conducted private placements (PIPE Transactions) issuing approximately 21,626,559 ordinary shares and 10,813,284 warrants for total gross proceeds of approximately NIS 12,292,370 (approximately $3,853,000), with $1,342,000 still pending receipt.

Worse than expectedThe company has suffered recurring losses from its operations, with a net comprehensive loss of NIS 24.5 million (approximately $7.7 million) for the year ended December 31, 2025.The company has negative cash flows from operating activities, amounting to NIS 14.9 million (approximately $4.7 million) for the year ended December 31, 2025.The independent registered public accounting firm has included an explanatory paragraph in its report expressing substantial doubt about the company's ability to continue as a going concern.As of December 31, 2025, the company had only NIS 228,000 (approximately $71,000) in cash and cash equivalents, which is not sufficient to implement its business plans for the next 12 months without the anticipated IPO proceeds.

Summary

Bonus Biogroup is a clinical-stage biotechnology company developing next-generation therapies: BonoFill (autologous tissue-engineered bone graft) and MesenCure (allogeneic cell therapy for inflammation and tissue damage).
The company is offering 3,750,000 American Depositary Shares (ADSs), each representing 30 ordinary shares, at an estimated price range of $4.00 to $6.00 per ADS in its initial public offering in the United States.
Net proceeds from the offering are estimated at approximately $16.2 million (or $18.9 million if the underwriter's option is fully exercised), based on a $5.00 per ADS midpoint.
Proceeds will be allocated: $6.1 $7.1 million for preclinical and early clinical R&D, $5.3 $6.2 million for MesenCure's planned Phase III trial, $1.6 $1.9 million for BonoFill's planned Phase III trial, and the remainder for working capital.
BonoFill has completed a Phase I/II clinical trial for maxillofacial bone defects (90% efficacy in achieving bone reconstruction for dental implant placement) and plans a Phase III trial in the US in 2026.
A multi-center Phase II study for BonoFill in limb bone defects is ongoing, with enrollment expected to complete in 2026 and interim results in 2026, final results in 2027.
MesenCure completed a Phase II study in 2022 for COVID-19 related respiratory distress, showing a 68% reduction in 30-day mortality and a 57% decrease in invasive ventilation risk compared to a control group.
The FDA cleared MesenCure's IND application in February 2025 for a Phase III trial in COVID-19 related respiratory distress, with plans to broaden the scope to all-cause ARDS and launch the trial in 2026.
The company reported a net comprehensive loss of NIS 24.5 million (approximately $7.7 million) for the year ended December 31, 2025, a decrease from NIS 27.8 million in 2024.
Cash and cash equivalents were NIS 228,000 (approximately $71,000) as of December 31, 2025.
The independent auditor's report includes an explanatory paragraph expressing substantial doubt about the company's ability to continue as a going concern due to recurring losses and negative operating cash flows.
The estimated total addressable market (TAM) opportunity in the United States for BonoFill is approximately $25.0 billion by 2030, and for MesenCure in all-cause ARDS is approximately $9.4 billion by 2030, based on internal estimates and potential healthcare cost savings.
The company has an intellectual property portfolio of 71 granted patents and 10 pending applications across six patent families as of March 2026.
Recent private placements in November 2024, 2025, and 2026 raised approximately NIS 26.28 million (approximately $8.2 million) in gross proceeds, involving the issuance of ordinary shares and warrants.

Sentiment

Score: 3

Explanation: StockSavvy.ai views this filing with low sentiment due to the explicit 'going concern' warning from auditors, significant accumulated losses, and minimal cash reserves. While the IPO and positive early clinical data for its product candidates offer a lifeline and future potential, the immediate financial instability and the inherent high risks of clinical-stage biotechnology temper enthusiasm.

Positives

BonoFill Phase I/II trial for maxillofacial bone defects showed 90% efficacy in achieving bone reconstruction sufficient for dental implant placement, with faster healing times (3 months vs. 6-9 months for SOC).
MesenCure Phase II trial for COVID-19 related respiratory distress demonstrated a significant 68% reduction in 30-day mortality and a 57% reduction in the risk of progressing to invasive ventilation.
FDA cleared MesenCure's IND application in February 2025, allowing progression to a Phase III clinical trial.
The company possesses advanced proprietary technology and know-how in MSC production, growth, and priming, which is believed to offer enhanced therapeutic potential and create a barrier to entry for competitors.
A robust intellectual property portfolio includes 71 granted patents and 10 pending applications across six patent families.
Manufacturing facilities in Haifa, Israel, are cGMP certified by the Israel Ministry of Health and designed for scalability to meet clinical development and initial commercial demands.
Potential for pipeline expansion into additional indications for BonoFill (osteoporosis, spine, joint reconstruction) and MesenCure (CKD, OA, CRS, other respiratory conditions).
Experienced management team with deep scientific expertise in biotechnology, regenerative medicine, cell therapy, tissue engineering, regulatory affairs, clinical development, and cGMP manufacturing.
The IPO is expected to provide approximately $16.2 million in net proceeds, significantly bolstering the company's financial resources for upcoming clinical trials.

Negatives

The company has incurred significant losses since inception, with a net comprehensive loss of NIS 24.5 million (approximately $7.7 million) in 2025.
The independent auditor's report includes an explanatory paragraph expressing substantial doubt about the company's ability to continue as a going concern.
Cash and cash equivalents were very low at NIS 228,000 (approximately $71,000) as of December 31, 2025, indicating insufficient resources for the next 12 months without the IPO proceeds.
The company has never generated any revenue from product sales and does not anticipate doing so in the next several years.
The company is a clinical-stage biotechnology company with a limited operating history, making future profitability uncertain.
An ongoing ISA investigation and potential proceedings against the company and its senior management (Dr. Meretzki and Mr. Rauch) regarding alleged securities law and money laundering offenses could have an adverse effect on the business and financial condition.
The company relies on third-party vendors for preclinical and clinical studies and raw material manufacturing, posing risks if these parties fail to meet obligations or quality standards.
The estimated total addressable market opportunities for BonoFill and MesenCure are based on internal assumptions and estimates, which may prove incorrect and adversely affect potential revenue.
The company has no experience producing product candidates at commercial scale and lacks an established marketing and sales organization, which will be expensive and time-consuming to develop.

Risks

Substantial doubt about the company's ability to continue as a going concern, which could prevent obtaining new financing on reasonable terms or at all.
Limited operating history and significant losses since inception, with no revenue from product sales and no guarantee of future profitability.
Need to raise substantial additional funding before becoming profitable, with no assurance that financing will be available on acceptable terms or at all.
Dependence on the success of lead product candidates (BonoFill and MesenCure) which are still in clinical development and may not receive regulatory approval.
Regulatory approval processes are lengthy, time-consuming, expensive, and inherently unpredictable, with no guarantee of success.
Positive results in previous preclinical and clinical studies may not be replicated in future studies, leading to development delays or failure to obtain marketing approval.
Difficulty enrolling patients in clinical studies could delay or prevent completion of trials.
Product candidates or their administration may cause undesirable side effects, delaying or preventing regulatory approval, limiting commercial profile, or resulting in negative consequences post-approval.
Reliance on third parties to conduct preclinical and clinical studies and manufacture raw materials and products, with risks of non-compliance, missed deadlines, or limited capacity.
Sharing trade secrets and intellectual property with third parties increases the risk of misappropriation or disclosure by competitors.
Market opportunities for product candidates may be smaller than estimates, adversely affecting potential revenue.
Intense competition in the pharmaceutical, cellular, and tissue-based product markets from companies with greater resources and more advanced products.
Inability to obtain and maintain effective patent rights for product candidates or underlying technology, or protect trade secrets, could impair competitive position.
Risk of third-party claims of intellectual property infringement, leading to costly litigation or licensing requirements.
Internal computer systems or those of contractors may fail or suffer security breaches, disrupting development programs and business operations.
ISA investigation and potential proceedings against the company and senior management may have an adverse effect on business and financial condition.
Political, economic, and military instability in Israel or the Middle East may adversely affect business operations.
Operations may be disrupted by the obligation of management or key personnel to perform military service in Israel.
Provisions of Amended and Restated Articles of Association and Israeli law could delay, prevent, or make a change of control more difficult or costly.
Israeli government and third-party grants for R&D activities may impose restrictions on transfer of funded know-how or manufacturing outside of Israel, requiring additional payments or approvals.
Exposure to currency and interest rate fluctuations, particularly as operations expand in the United States.
Significant product liability risks inherent in the development, testing, manufacturing, and marketing of therapeutic treatments, with potential for insufficient insurance coverage.
Employees may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.
Security breaches and other disruptions could compromise information, expose the company to liability, and harm reputation and business.
Litigation or claims arising in or outside the ordinary course of business could negatively affect business operations and financial condition.
Lack of a public market in the United States for ADSs prior to this offering, and no assurance of an active or sustained trading market.
Price volatility of ordinary shares and ADSs due to various factors, many beyond the company's control.
Immediate dilution of investment for new ADS purchasers due to the offering price being substantially higher than net tangible book value.
Broad discretion in the use of net proceeds from the offering, which may not be used effectively.
Sales of a substantial number of ordinary shares or ADSs could depress market price.
Incurrence of additional significant costs as a result of listing on Nasdaq and becoming a public company subject to SEC reporting requirements.
Potential classification as a Passive Foreign Investment Company (PFIC) for U.S. federal income tax purposes, leading to negative tax consequences for U.S. taxpayers.

Future Outlook

The company plans to initiate Phase III clinical trials for BonoFill in maxillofacial bone defects in the US in 2026, and for MesenCure in all-cause respiratory distress in the US in 2026, pending FDA clearance for the broader indication. Interim Phase II results for BonoFill in limb bone defects are expected in 2026, with final results in 2027, potentially leading to a Phase III IND submission in 2028. Regulatory marketing approval applications for MesenCure in the US are targeted for 2028. The company also intends to expand preclinical efforts for additional indications for both product candidates and new tissue engineering solutions. The company believes the IPO proceeds, combined with existing cash, will fund operations for at least the next 12 months, but additional funding will be required to complete R&D and commercialization.

Management Comments

Management believes BonoFill, if approved, may offer a more efficient, patient-friendly, and provider-friendly alternative to autografting by leveraging cells from adipose tissue and eliminating the need for bone harvesting.
Management believes BonoFill could be integrated into the standard of care for non-emergency, elective bone grafting procedures due to its potential benefits.
Management believes MesenCure has the potential to be indicated for both ICU patients suffering from ARDS and pre-ICU patients experiencing less defined respiratory distress.
Management believes MesenCure is designed as a disease-modifying therapy rather than a symptom-management treatment, distinguishing it from current ARDS treatments.
Management believes MesenCure is positioned for potential expansion into broader respiratory indications, including pneumonia, asthma, and COPD.
Management believes the company's advanced proprietary technology platform will allow for the development of various products across the next-generation therapeutics spectrum.
Management believes its production, enabling automation, relatively short manufacturing time, and minimal manual manipulations, can be readily scaled to meet anticipated demands.
Management believes the leadership team is well-positioned to steer the company through clinical development, regulatory approval, and commercialization.
Management believes that integrating BonoFill into the current SOC, if regulatory approvals are obtained, has the potential for direct cost savings to the healthcare system.
Management believes MesenCure could potentially reduce mortality rates and the intensity and duration of hospitalization.
Management believes MesenCure has the potential to alleviate the burden on ICUs and hospitals while reducing direct hospitalization costs.

Industry Context

StockSavvy.ai notes that Bonus Biogroup operates in the highly competitive and rapidly evolving fields of cell therapy and tissue engineering, targeting significant unmet medical needs in bone regeneration and acute respiratory distress. The company's focus on personalized autologous bone grafts (BonoFill) and enhanced allogeneic cell therapy for inflammation (MesenCure) positions it against established biomedical companies offering traditional bone graft substitutes (e.g., Medtronic, DePuy Synthes) and emerging cell therapy developers (e.g., Novadip Biosciences, EpiBone, Laboratorios Salvat for bone; Mesoblast, Direct Biologics for ARDS). While existing treatments for ARDS are primarily supportive, MesenCure aims to be a disease-modifying therapy, potentially offering a paradigm shift if approved. The estimated total addressable markets of $25.0 billion for BonoFill and $9.4 billion for MesenCure by 2030 highlight substantial opportunities, but also the intense competition and high development risks inherent in these innovative therapeutic areas.

Comparison to Industry Standards

BonoFill is designed to provide all four essential functions for effective bone regeneration (osteoconduction, osteoinduction, osteogenesis, and osseointegration), which the company believes offers advantages over existing bone graft substitutes (BGS) that typically do not provide all these functions.
BonoFill's autologous nature, derived from patient's adipose tissue, aims to optimize treatment outcomes, minimize immune reactions, and eliminate graft failure risks, addressing limitations of autografting (long surgery times, donor-site morbidities, slow healing, need for revision surgeries).
BonoFill's reported healing time of approximately three months is two to three times faster than current standard treatments for comparable bone regeneration, which typically require six to nine months.
MesenCure's Phase II results showing a 68% reduction in 30-day mortality and a 57% decrease in invasive ventilation risk for COVID-19 related respiratory distress are significant compared to current supportive standard of care for ARDS, which lacks definitive cures and has high mortality rates (27-45%).
MesenCure's unique priming process for MSCs is designed to enhance therapeutic potency and utility, distinguishing it from natural MSCs which were ineffective in preclinical models (e.g., LPS-induced ALI model where MesenCure significantly reduced lung edema while natural MSCs did not).
The company's ability to produce MesenCure with a shelf life of up to seven days at 2-8°C without cryopreservation addresses a common industry challenge of maintaining cell viability and potency during transport and storage, which is often diminished with cryopreservation.
The estimated potential healthcare cost savings of approximately $31,000 per patient for orthopedic applications and $2,100 for dental applications with BonoFill, and $41,000 per patient for ARDS with MesenCure, are presented as a key advantage over existing SOC, which incurs high costs (e.g., $108,000-$158,000 average direct hospitalization costs for ARDS).

Management Changes

Role	Previous Person	New Person	Effective Date	Reason
VP Finance	Yehonatan Livne (CFO)	Meital Enbar	December 2024	Yehonatan Livne resigned from the company.

Corporate Governance

Change Type	Description	Effective Date	Impact Assessment
Compensation Policy Approval	Shareholders approved an amended compensation policy for office holders, designed to correlate executive compensation with business objectives and long-term success.	November 2023	Aims to attract, motivate, and retain highly skilled personnel by linking variable compensation to long-term performance and measurable criteria.
Board Composition	The board of directors is divided into three staggered classes, with directors (other than external directors) serving until the third annual general meeting following their appointment.	Immediately prior to Nasdaq listing	May have the effect of delaying or making an unsolicited acquisition of the company more difficult.
Quorum Requirement for General Meetings	Quorum requires at least two shareholders holding one-third (1/3) of total outstanding voting rights. For adjourned meetings, any number of shareholders constitutes a quorum, unless convened by a shareholder, then one-third (1/3) still required.	Immediately prior to Nasdaq listing	Influences the ease of passing resolutions at shareholder meetings, potentially making it easier to proceed with adjourned meetings.
Director Nomination Process	Nominations for directors are generally made by the board of directors. Shareholders holding at least 5% of voting rights (for companies traded outside Israel) may request to add a director election/removal item to the agenda.	Ongoing	Provides a mechanism for shareholder input on board composition, though the board retains significant influence.
Exclusive Forum Provision (Israeli Law)	Unless consented otherwise, competent courts of Tel Aviv, Israel, are the sole and exclusive forum for derivative actions, breach of fiduciary duty claims, and claims under Israeli Companies Law or Israeli Securities Law.	Immediately prior to Nasdaq listing	Limits shareholders' ability to choose a judicial forum for certain disputes, potentially discouraging lawsuits against the company, its directors, officers, and employees under Israeli law.
Exclusive Forum Provision (US Federal Law)	Unless consented otherwise, US federal district courts are the exclusive forum for claims arising under the Securities Act.	Immediately prior to Nasdaq listing	Limits shareholders' ability to choose a judicial forum for Securities Act claims, potentially increasing litigation costs for shareholders if they prefer state courts.

Legal Proceedings

In February 2022, two class action lawsuits were filed against the company and Dr. Meretzki, alleging unlawful actions to inflate share value and ensure TASE index inclusion. These claims were withdrawn by the applicants in June 2024 without consideration or compensation.
On February 28, 2024, the Israeli Securities Authority (ISA) conducted a search of the company's offices and questioned several directors and officers, including Dr. Meretzki and Mr. Rauch, regarding alleged securities law offenses and money laundering related to influencing TASE index inclusion and reporting violations.
In early January 2026, the Tel Aviv District Attorney Office (Tax and Economy) informed Dr. Meretzki and Mr. Rauch that the ISA investigation concluded and the file was transferred for examination of potential criminal charges. The outcome and impact on the business and financial condition are currently uncertain, but the company believes it has proper defense arguments.

Related Party Transactions

The 2012 Acquisition Agreement, as amended, remains in effect, stipulating that 538,545,451 additional shares allocated to Offerees (including current directors and executive officers) are subject to a lock-up until the US Listing Date and forfeiture if US listing does not occur by June 30, 2026.
A Patent License Agreement, amended in 2012 and 2021, with Dr. Shai Meretzki (CEO and controlling shareholder) and other individuals, grants the company exclusive worldwide rights to a patent application in exchange for 5% royalties on licensed product sales and 12.5% of one-time payments from commercial transactions related to the IP. The licensors have termination rights under certain conditions.
Service agreements with Meretzki Consulting and Development Ltd. (affiliated with Dr. Shai Meretzki) and I. Rauch & Co. Financial Consultants Ltd. (affiliated with Yosef Rauch, Chairman) provide for fixed monthly payments (NIS 106,000 for Meretzki, NIS 80,000 for Rauch, plus social benefits) and annual bonuses tied to share price performance relative to the Tel Aviv BioMed index, with a portion payable in cash and a portion in company shares. Additional cash bonuses are tied to US stock market listing and capital raises.
In April 2022, a services agreement with Gil Shapira (director) for consulting and project management services related to office relocation involved a payment of NIS 450,000 and issuance of options to purchase 750,000 ordinary shares (which expired in August 2024).
In January 2022, the company permitted employees (including Dr. Ben David, an executive officer) to defer payment of exercise prices for 8,425,000 options, totaling NIS 4,651,000. These non-recourse loans were extended until June 30, 2026, with a portion of Dr. Ben David's loan (NIS 630,000) waived against the sale of shares.

Stakeholder Impact

Shareholders: Will experience immediate dilution from the IPO. Existing shareholders (including officers and directors) hold a significant portion of voting securities (48.23% prior to offering, 41.79% after), allowing them to exert significant influence. The 'going concern' issue poses a substantial risk to investment value. The IPO provides capital for continued development, which could positively impact long-term value if successful.
Employees: The company's future success depends on retaining senior management and attracting qualified personnel. The ISA investigation and potential proceedings could create uncertainty and impact employee morale. Share-based compensation plans are in place to incentivize employees.
Customers (future): If product candidates receive regulatory approval and achieve market acceptance, patients will benefit from new treatment options for severe conditions with limited alternatives. The company aims to provide safe, effective, and affordable therapies.
Healthcare Providers/Payors: BonoFill and MesenCure are designed to offer potential cost savings to healthcare systems by reducing surgery times, hospitalization duration, and the need for revision surgeries or invasive ventilation, if approved and adopted.
Regulatory Authorities: The company is subject to extensive regulation by the FDA, EMA, and Israeli Ministry of Health. Compliance with these regulations is critical for product development and commercialization.

Next Steps

Complete the ongoing Phase II clinical study for BonoFill in long and short limb bone defects, with enrollment expected in 2026 and interim results in 2026, final results in 2027.
Submit an IND application to the FDA for BonoFill in maxillofacial bone defects and, subject to regulatory clearance, launch a Phase III clinical trial in the United States in 2026.
Seek FDA clearance for an amendment to MesenCure's clinical protocol to broaden the scope of its Phase III trial to include all-cause ARDS patients.
Launch a Phase III clinical trial for MesenCure in all-cause respiratory distress in the United States in 2026, pending FDA clearance of the protocol amendment.
If successful, use Phase III trial results to submit regulatory marketing approval applications for MesenCure in the United States by 2028.
If successful, use Phase II trial results for BonoFill in limb bone defects as the basis for submitting an IND application to the FDA and initiating a Phase III trial in 2028.
Build a robust commercialization plan, including accelerating trial progress, optimizing trial design, setting up multiple clinical sites, and scaling up production.
Establish strategic partnerships with leading pharmaceuticals commercialization and distribution partners in the United States.
Expand preclinical efforts to explore additional indications for BonoFill (osteoporosis, spine, joint reconstruction) and MesenCure (CKD, OA, CRS, other respiratory conditions), and new tissue engineering solutions.
Promote awareness and KOL support of product candidates through conferences, scientific publications, educational campaigns, and strategic partnerships.
Receive TASE Listing Approval for shares and warrants issued in the November 2024, 2025, and 2026 PIPE Transactions and issue the securities.
Receive the remaining $1,342,000 from the 2026 PIPE Transactions.

Key Dates

Date	Description
October 4, 1981	Company incorporated in Israel as Pointout (Israel) Ltd.
January 15, 1989	Company changed name to Pointout Projects Ltd.
March 22, 1993	Company changed name to Oceana Advanced Industries Ltd.
August 20, 1993	Company became a public company in Israel; ordinary shares listed on TASE.
October 2008	Patent License Agreement signed with Dr. Shai Meretzki and others.
July 2008	Bonus Therapeutics Ltd. (subsidiary) founded.
January 2012	Private Placement Agreement entered to acquire Bonus Therapeutics Ltd.; Patent License Agreement amended and restated.
April 2012	Transactions under Private Placement Agreement consummated; company began operating as a pre-clinical-stage biotechnology company.
May 20, 2012	Company name changed to Bonus Bio Group Ltd.
October 3, 2013	Company name changed to Bonus Biogroup Ltd. (current name).
2013	2013 Stock Option Plan initially adopted.
November 2016	Shareholders approved 2017 Addendum to Private Placement Agreement, waiving milestones and issuing Additional Shares.
January 2017	Additional Shares issued to Offerees.
July 2019	FDA granted 510(k) clearance for Bonus Therapeutics Mixing and Delivery System.
September 2020	Alon Ariel and Margalit Assayag joined the board of directors.
September 2021	Patent License Agreement further amended.
January 2022	Options to purchase 8,425,000 ordinary shares exercised by employees and an executive officer; deferred payment of exercise price permitted.
February 2022	Two requests for approval of class action lawsuits submitted to Haifa District Court against the company and Dr. Meretzki.
March 2022	Company relocated to new headquarters and manufacturing facilities in Haifa, Israel.
April 2022	Services agreement with Gil Shapira for consulting and project management services.
May 2022	Shareholders approved services agreement with Gil Shapira.
December 2022	Dr. Dror Ben-David appointed Chief Operations Officer.
May 2023	Further extension approved for repayment of deferred exercise prices until December 31, 2025.
August 7, 2023	Board of directors approved allocation of 6,700,000 options to three service providers.
September 28, 2023	Board of directors approved allocation of 87,400,000 options to employees, officers, directors, and service providers.
October 7, 2023	Hamas attacks on Israel, leading to Israel-Hamas-Hezbollah war.
November 2023	Shareholders approved amended compensation policy; new service agreements with Meretzki Consulting and Development Ltd. and I. Rauch & Co. Financial Consultants Ltd. effective October 1, 2023.
November 14, 2023	General meeting of shareholders approved 2023 Agreement for CEO and Chairman of the Board.
February 28, 2024	ISA investigators conducted a search of company offices; several directors and officers summoned for questioning.
June 5, 2024	Applicants filed request to withdraw class action claims.
June 7, 2024	Dr. Shai Meretzki's term as director of Sartorius Israel Ltd. ended.
June 13, 2024	District Court approved withdrawal of class action claims.
July 2024	Mrs. Assayag began serving as an external director at Blue-Wave Capital Ltd.
August 2024	Options granted to Mr. Gil Shapira expired.
October 2024	Israel Ministry of Health certified BonoFill and MesenCure manufacturing under cGMP for Phase III trials.
November 2024	Company conducted private placements (November 2024 PIPE Transactions) for NIS 4,961,000.
November 2024	Ceasefire between Israel and Lebanon (with respect to Hezbollah) announced.
December 2024	Meital Enbar appointed VP Finance; Yehonatan Livne resigned as CFO.
February 2025	FDA cleared IND application for MesenCure, removing clinical hold for Phase III trial in COVID-19 related respiratory distress.
April 29, 2025	Shareholders approved extension of US Listing Deadline Date to June 30, 2026; 2025 Addendum to Private Placement Agreement effective.
May 22, 2025	Tel Aviv District Court approved amendment to terms of non-tradable warrants, extending exercise period to June 30, 2027.
June 2025	Ceasefire between Israel and Iran announced.
October 2025	Ceasefire between Israel and Hamas announced.
November 2025	Company conducted private placements (2025 PIPE Transactions) for NIS 9,028,343.
December 2025	Further extension approved for repayment of deferred exercise prices until June 30, 2026.
January 2026	Tel Aviv District Attorney Office (Tax and Economy) sent letters to Dr. Meretzki and Mr. Rauch regarding ISA investigation.
January-March 2026	Company conducted private placements (2026 PIPE Transactions) for approximately NIS 12,292,370.
February 2026	Hostilities between Israel and Iran escalated again.
Late February 2026	United States, together with Israel, launched a major joint military campaign of air and missile strikes against targets in Iran.
Early March 2026	Resumed conflicts with Hezbollah.
Late March 2026	Resumed involvement of the Houthi movement through missile attacks against Israel.
March 31, 2026	F-1/A filing date.
June 30, 2026	Deadline for US listing to avoid forfeiture of 538,545,451 ordinary shares.
July 2027	Current lease for facilities ends, with option to extend for 36 months.
June 30, 2027	Expiration date for 2012 Warrants.
January 12, 2027	Expiration date for First Series Warrants and Second Series Warrants.
January 26, 2027	Expiration date for Third Series Warrants.
January 30, 2027	Expiration date for Fourth Series Warrants.
March 1, 2027	Expiration date for Fifth Series Warrants.
2028	Planned initiation of BonoFill Phase III trial for limb bone defects; expected submission of regulatory marketing approval applications for MesenCure in the United States.
April 2029	Expiration date for BTH-P-001 patent family (bone-like prosthetic implants).
November 2029	Expiration date for CLR-BTH-P-001 patent family (implantable liposome embedded matrix composition).
April 2035	Expiration date for BTH-P-002 patent family (bone repair compositions).
September 2036	Expiration date for BTH-P-005 patent family (microcapillary network-based scaffold).
July 2037	Expiration date for BTH-P-004 patent family (cell compositions for tissue regeneration) and potential patents from pending applications.
May 2042	Potential expiration date for patents from BTH-P-007 patent family (compositions of cells with an enhanced therapeutic capacity).

Keywords

Biotechnology, Cell Therapy, Tissue Engineering, BonoFill, MesenCure, Bone Regeneration, Respiratory Distress, ARDS, Autologous, Allogeneic, Clinical Stage, IPO, Nasdaq, SEC Filing, F-1/A, Biopharma, Medical Devices, Israel Innovation Authority, Clinical Trials, FDA Approval, IFRS

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