Announcement • Jul 28
SanBio Company Limited to Report Q2, 2027 Results on Sep 14, 2026 SanBio Company Limited announced that they will report Q2, 2027 results on Sep 14, 2026 Breakeven Date Change • Jul 24
No longer forecast to breakeven The 4 analysts covering SanBio no longer expect the company to break even during the foreseeable future. The company was expected to make a profit of JP¥1.19b in 2028. New consensus forecast suggests the company will make a loss of JP¥2.27b in 2029. Major Estimate Revision • Jun 16
Consensus revenue estimates increase by 16% The consensus outlook for revenues in fiscal year 2027 has improved. 2027 revenue forecast increased from JP¥400.0m to JP¥464.4m. Forecast losses expected to reduce from -JP¥66.90 to -JP¥60.48 per share. Biotechs industry in Japan expected to see average net income decline 20% next year. Consensus price target down from JP¥1,800 to JP¥1,660. Share price fell 5.1% to JP¥1,182 over the past week. Price Target Changed • Jun 05
Price target decreased by 14% to JP¥1,800 Down from JP¥2,100, the current price target is an average from 5 analysts. New target price is 43% above last closing price of JP¥1,263. Stock is down 63% over the past year. The company is forecast to post a net loss per share of JP¥66.90 next year compared to a net loss per share of JP¥52.55 last year. Major Estimate Revision • Apr 17
Consensus revenue estimates increase by 22% The consensus outlook for revenues in fiscal year 2027 has improved. 2027 revenue forecast increased from JP¥3.47b to JP¥4.23b. Forecast losses expected to reduce from -JP¥68.53 to -JP¥62.44 per share. Biotechs industry in Japan expected to see average net income decline 32% next year. Consensus price target broadly unchanged at JP¥2,100. Share price rose 5.7% to JP¥2,099 over the past week. Major Estimate Revision • Apr 07
Consensus EPS estimates fall by 55% The consensus outlook for fiscal year 2027 has been updated. 2027 expected loss increased from -JP¥44.09 to -JP¥68.53 per share. Revenue forecast of JP¥3.47b unchanged since last update. Biotechs industry in Japan expected to see average net income decline 51% next year. Consensus price target broadly unchanged at JP¥2,060. Share price rose 9.8% to JP¥1,955 over the past week. Major Estimate Revision • Mar 27
Consensus EPS estimates fall by 21% The consensus outlook for fiscal year 2027 has been updated. 2027 expected loss increased from -JP¥39.72 to -JP¥47.91 per share. Revenue forecast of JP¥3.42b unchanged since last update. Biotechs industry in Japan expected to see average net income decline 41% next year. Consensus price target of JP¥2,100 unchanged from last update. Share price fell 2.0% to JP¥1,880 over the past week. Major Estimate Revision • Mar 24
Consensus EPS estimates fall by 81% The consensus outlook for fiscal year 2027 has been updated. 2027 expected loss increased from -JP¥21.95 to -JP¥39.72 per share. Revenue forecast of JP¥3.42b unchanged since last update. Biotechs industry in Japan expected to see average net income decline 41% next year. Consensus price target up from JP¥2,050 to JP¥2,100. Share price fell 7.0% to JP¥1,847 over the past week. Announcement • Mar 17
SanBio Company Limited, Annual General Meeting, Apr 22, 2026 SanBio Company Limited, Annual General Meeting, Apr 22, 2026. Breakeven Date Change • Mar 17
No longer forecast to breakeven The 4 analysts covering SanBio no longer expect the company to break even during the foreseeable future. The company was expected to make a profit of JP¥3.82b in 2028. New consensus forecast suggests the company will make a loss of JP¥2.41b in 2029. Major Estimate Revision • Jan 06
Consensus revenue estimates fall by 41% The consensus outlook for revenues in fiscal year 2026 has deteriorated. 2026 revenue forecast decreased from JP¥50.0m to JP¥29.3m. Forecast losses increased from -JP¥50.74 to -JP¥54.39 per share. Biotechs industry in Japan expected to see average net income growth of 10% next year. Consensus price target broadly unchanged at JP¥2,050. Share price rose 3.6% to JP¥1,750 over the past week. Price Target Changed • Jan 06
Price target increased by 8.7% to JP¥2,250 Up from JP¥2,070, the current price target is an average from 5 analysts. New target price is 29% above last closing price of JP¥1,750. Stock is up 133% over the past year. The company is forecast to post a net loss per share of JP¥49.86 next year compared to a net loss per share of JP¥41.85 last year. Announcement • Nov 07
SanBio Company Limited has filed a Follow-on Equity Offering in the amount of ¥14.922 billion. SanBio Company Limited has filed a Follow-on Equity Offering in the amount of ¥14.922 billion.
Security Name: Shares
Security Type: Common Stock
Securities Offered: 6,000,000
Price\Range: ¥2487
Discount Per Security: ¥109.36 Announcement • Oct 28
SanBio Company Limited to Report Q3, 2026 Results on Dec 15, 2025 SanBio Company Limited announced that they will report Q3, 2026 results on Dec 15, 2025 Price Target Changed • Oct 10
Price target increased by 17% to JP¥2,028 Up from JP¥1,735, the current price target is an average from 4 analysts. New target price is 47% below last closing price of JP¥3,850. Stock is up 260% over the past year. The company is forecast to post a net loss per share of JP¥46.21 next year compared to a net loss per share of JP¥41.85 last year. Announcement • Sep 14
SanBio Company Limited to Report Q2, 2026 Results on Sep 12, 2025 SanBio Company Limited announced that they will report Q2, 2026 results on Sep 12, 2025 Major Estimate Revision • Jul 04
Consensus revenue estimates increase by 291%, EPS downgraded The consensus outlook for fiscal year 2026 has been updated. 2026 revenue forecast increased from JP¥44.0m to JP¥172.0m. EPS estimate fell from -JP¥41.26 to -JP¥48.65 per share. Biotechs industry in Japan expected to see average net income decline 21% next year. Consensus price target up from JP¥1,560 to JP¥1,735. Share price was steady at JP¥2,173 over the past week. Price Target Changed • Jul 02
Price target increased by 19% to JP¥1,735 Up from JP¥1,460, the current price target is an average from 4 analysts. New target price is 20% below last closing price of JP¥2,174. Stock is up 111% over the past year. The company is forecast to post a net loss per share of JP¥48.65 next year compared to a net loss per share of JP¥41.85 last year. New Risk • Jun 15
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -JP¥3.6b This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-JP¥3.6b free cash flow). Share price has been highly volatile over the past 3 months (16% average weekly change). Earnings are forecast to decline by an average of 3.5% per year for the foreseeable future. Revenue is less than US$1m. Minor Risk Currently unprofitable and not forecast to become profitable over next 3 years (JP¥2.7b net loss in 3 years). Announcement • May 29
SanBio Co., Ltd. Announces Results of the Third Commercial Production Run to Meet the Approval Conditions for the Shipment of AKUUGO Suspension for Intracranial Implantation SanBio Co. Ltd. announced on April 18, 2025, that the expected yield from the third manufacturing of AKUUGO® Suspension for Intracranial Implantation was successfully secured, regarding the three production runs required for the release of shipments. The Company has completed specification testing and characteristic analysis for the third manufacturing run and has confirmed its results. The third manufacturing run cleared all specification requirements and was deemed compliant as well. With the fulfilment of the shipment conditions for AKUUGO, the company plans to promptly file a partial change application and proceed with obtaining full product approval. Announcement • May 03
SanBio Company Limited to Report Q1, 2026 Results on Jun 13, 2025 SanBio Company Limited announced that they will report Q1, 2026 results on Jun 13, 2025 Price Target Changed • Mar 22
Price target increased by 10% to JP¥1,320 Up from JP¥1,195, the current price target is an average from 4 analysts. New target price is approximately in line with last closing price of JP¥1,360. Stock is up 134% over the past year. The company is forecast to post a net loss per share of JP¥29.41 next year compared to a net loss per share of JP¥41.86 last year. Price Target Changed • Mar 18
Price target increased by 33% to JP¥1,500 Up from JP¥1,130, the current price target is an average from 3 analysts. New target price is 16% above last closing price of JP¥1,297. Stock is up 120% over the past year. The company is forecast to post a net loss per share of JP¥40.86 next year compared to a net loss per share of JP¥41.85 last year. New Risk • Feb 27
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 0.1% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (9.6% average weekly change). Earnings are forecast to decline by an average of 0.1% per year for the foreseeable future. Revenue is less than US$1m. Minor Risk Currently unprofitable and not forecast to become profitable over next 3 years (JP¥4.0b net loss in 3 years). New Risk • Feb 07
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of Japanese stocks, typically moving 8.8% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (8.8% average weekly change). Revenue is less than US$1m. Minor Risk Currently unprofitable and not forecast to become profitable over next 3 years (JP¥3.9b net loss in 3 years). Announcement • Feb 06
SanBio Company Limited Announces Results of the Second Commercial Production Run of AKUUGO SanBio Company Limited announced on December 6, 2024, that it had secured the planned production yield for the second commercial production run of AKUUGO® Suspension for Intracranial Implantation (INN: vandefitemcel), conducted to meet the shipment conditions required for obtaining product approval. The Company has completed specification testing and characteristic analysis for the second manufacturing run and has confirmed its results. The second manufacturing run cleared all specification requirements and was deemed compliant. The third manufacturing run has already commenced. With the compliance of this manufacturing run, the company will run one more manufacturing compliant with necessary specifications and plans to file a partial change application and subsequently obtain approval for the partial change to meet the shipment conditions. As a result, the anticipated timing for AKUUGO® to become eligible for shipment remains unchanged, with shipment expected to begin in the second quarter of the fiscal year ending January 31, 2026 (May-July 2025). AKUUGO suspension for intracranial implantation (INN: vandefitemcel) is a human (allogeneic) bone marrow-derived modified mesenchymal stem cell that is produced by modifying and culturing mesenchymal stem cells derived from the bone marrow aspirate of healthy adults. The transplantation of AKUUGO into damaged nerve tissues in the brain is expected to trigger the release of FGF-2 (a type of protein) and other substances, which in turn will promote the natural regenerative ability of damaged nerve cells and induce proliferation and differentiation of nerve cells. Announcement • Jan 28
SanBio Company Limited to Report Fiscal Year 2025 Results on Mar 17, 2025 SanBio Company Limited announced that they will report fiscal year 2025 results on Mar 17, 2025 New Risk • Dec 16
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 7.6% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (11% average weekly change). Earnings are forecast to decline by an average of 7.6% per year for the foreseeable future. Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (JP¥3.2b net loss in 3 years). Shareholders have been diluted in the past year (4.8% increase in shares outstanding). Announcement • Dec 04
SanBio Company Limited announced that it expects to receive ¥1.99992672 billion in funding from Athos Capital Limited SanBio Company Limited announced a private placement to issue 2,295,600 common shares at issue price of ¥871.2 per share for gross proceeds of ¥1,999,926,720 on December 2, 2024. The transaction includes participation from new investor,Athos Asia Event Driven Master Fund. The transaction will happen through third party allocation. The issue date will be December 18, 2024. The transaction has been approved at board of director meeting of the company. The company will incur issuance cost of ¥98,996,000 and the net proceeds will be ¥1,900,930,720. Announcement • Nov 17
SanBio Company Limited Announces the Results of the First Commercial Production Run of AKUUGO SanBio Co. Ltd. announced on July 31, 2024, that it had obtained conditional and time-limited approval for AKUUGO suspension for intracranial implantation from the Ministry of Health, Labour and Welfare and that it planned to conduct about two commercial production runs to meet the shipment conditions required under this approval. They hereby provide the results of the first production run. The first production run did not meet the specification standards. However, only one specification value was non-compliant, while all other specification values, including the yield--a key issue identified during the approval review process--were compliant. Moreover, the results of the characterization analysis were equivalent to those of the clinical trials product. They anticipated some non-conforming products due to batch-to-batch variability arising from the heterogeneity of cells, a critical raw material for AKUUGO®, and they consider the non-conformity of the first manufacturing lot to be within expectations. Regarding the outlook, since the manufacturing process has already been established and approved, they have commenced the second production run. After obtaining manufacturing results that conform to the specifications for the second time, they will file an application for a partial change and aim to obtain approval for the subsequent partial change. As a result, the expected timeline for completing the two commercial production runs required to begin shipments of AKUUGO® has been delayed by a quarter, from the first quarter of the fiscal year ending January 2026 (February-April 2025) to the second quarter of the same fiscal year (May-July 2025). This matter will have only a minimal impact on the financial performance of the current fiscal year. Announcement • Oct 29
SanBio Company Limited to Report Q3, 2025 Results on Dec 16, 2024 SanBio Company Limited announced that they will report Q3, 2025 results on Dec 16, 2024 New Risk • Sep 18
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 1.8% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (19% average weekly change). Earnings are forecast to decline by an average of 1.8% per year for the foreseeable future. Revenue is less than US$1m. Minor Risks Less than 1 year of cash runway based on current free cash flow (-JP¥4.8b). Currently unprofitable and not forecast to become profitable over next 3 years (JP¥1.7b net loss in 3 years). Shareholders have been diluted in the past year (5.7% increase in shares outstanding). Announcement • Jul 31
Sanbio Co., Ltd. Obtains Marketing Approval for AKUUGO Suspension for Intracranial Implantation SanBio Co. Ltd. announced that on July 31, 2024, it obtained conditional and time-limited marketing approval for the human somatic stem cell-processed product "AKUUGO suspension for intracranial implantation" in Japan, for the indication of improving chronic motor paralysis resulting from traumatic brain injury. Details of product overview and conditional and time-limited marketing approved for AKUUGO are provided in the attached reference material. The company expects shipment and sales to begin in the first quarter of the fiscal year ending January 31, 2026. Moreover, to satisfy the conditions for full approval, the company plan to conduct post-marketing clinical trials and other necessary studies within the seven-year marketing authorization period with the aim of obtaining full approval. Based on track record of having obtained conditional and time- limited marketing approval for AKUUGO, the company plan to reallocate resources concentrated on the SB623 program for TBI to expanding indications and regions for the product. Through AKUUGO, company hope to bring hope to the lives of as many TBI patients as possible. The approval of AKUUGO was based on the results of the global Phase 2 clinical trial SanBio conducted in Japan and the United States. Dr. Nobuhito Saito, Professor of Neurology at the University of Tokyo led the clinical trial, commented as follows. Thaw the cell suspension for intracranial implants, wash it with the dedicated preparation solution, and adjust the concentration of the cell suspension to 1.67 x 106 cells/100uL using the dedicated preparation solution. Cleanse the micro-syringe fixed with the cannula from the dedicated delivery device set with the dedicated preparation solution before filling it with the prepared cell suspension. Date of marketing approval, July 31, 2024, Product image, Vial containing cell suspension for intracraial implantation, Dry shipper, Hard case and dry shipper for transportation, Dedicated preparation solution, Dedicated preparation solution, dedicated preparation solution, Dedicated delivery device set, Outer package for dedicated delivery device set. Condition of approval. Considering the limited manufacturing record for the Product, the Company shall promptly collect information on the Product's quality based on a pre-determined plan, and evaluate and report on the equivalence/homogeneity, in terms of quality, of the investigational product (clinical trials product) and the Product intended for commercial distribution. Based on the evaluation results, the Company shall apply for a partial change of approved matters. It shall not ship the Product until the partial change application has been approved. The Company must ensure that the Product is used in medical facilities fully equipped to handle emergencies, by physicians who possess sufficient knowledge and experience in the diagnosis and treatment of traumatic brain injury and stereotactic treatment. Announcement • Jul 27
SanBio Company Limited to Report Q2, 2025 Results on Sep 17, 2024 SanBio Company Limited announced that they will report Q2, 2025 results on Sep 17, 2024 Price Target Changed • Jul 01
Price target increased by 20% to JP¥960 Up from JP¥800, the current price target is an average from 5 analysts. New target price is 21% below last closing price of JP¥1,218. Stock is up 98% over the past year. The company is forecast to post a net loss per share of JP¥41.16 next year compared to a net loss per share of JP¥40.48 last year. Price Target Changed • Jun 20
Price target increased by 23% to JP¥983 Up from JP¥800, the current price target is an average from 5 analysts. New target price is 16% above last closing price of JP¥848. Stock is up 27% over the past year. The company is forecast to post a net loss per share of JP¥38.58 next year compared to a net loss per share of JP¥40.48 last year. New Risk • Jun 13
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 1.0% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-JP¥4.8b free cash flow). Share price has been highly volatile over the past 3 months (13% average weekly change). Earnings are forecast to decline by an average of 1.0% per year for the foreseeable future. Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (JP¥2.4b net loss in 3 years). Shareholders have been diluted in the past year (5.8% increase in shares outstanding). Announcement • Jun 13
SanBio Company Limited Announces Update on Status of Manufacturing and Marketing Approval for Sb623 Chronic Traumatic Brain Injury Program in Japan On March 26, 2024, SanBio Co. Ltd. (the "Company") provided an update on the progress toward obtaining marketing approval of SB623 to treat chronic traumatic brain injury (TBI) in Japan, stating it was concluded to continue the deliberation at a later date by the Pharmaceutical Affairs and Food Sanitation Council's Subcommittee on Regenerative Medicine Products (the "Subcommittee") and company planned to engage in further consultations with the regulatory authorities and to submit additional information such as additional data addressing quality. the Ministry of Health, Labour and Welfare announced that the Pharmaceutical Affairs and the Subcommittee will hold a meeting on June 19, and company learned that the Subcommittee will deliberate, among others, on whether to grant marketing approval for the regenerative medicine "AKUUGO suspension for intracranial implantation", whether to stipulate conditions and a time limit for the approval, and whether to designate a reexamination period. Accordingly, the Subcommittee will determine whether to grant the Company's development product SB623 marketing approval in the meeting. SB623 (INN: vandefitemcel) is a human (allogeneic) bone marrow-derived modified mesenchymal stem cell that is produced by modifying and culturing mesenchymal stem cells derived from the bone marrow aspirate of healthy adults. Implantation of SB623 cells into injured nerve tissues in the brain is expected to trigger the brain's natural regenerative ability to restore lost functions. SB623 is currently being investigated for the treatment of several conditions including chronic neurological motor deficit resulting from traumatic brain injury and ischemic stroke. Announcement • May 05
SanBio Company Limited to Report Q1, 2025 Results on Jun 13, 2024 SanBio Company Limited announced that they will report Q1, 2025 results on Jun 13, 2024 New Risk • Apr 02
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 3.6% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-JP¥4.8b free cash flow). Share price has been highly volatile over the past 3 months (15% average weekly change). Earnings are forecast to decline by an average of 3.6% per year for the foreseeable future. Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (JP¥2.9b net loss in 3 years). Shareholders have been diluted in the past year (6.4% increase in shares outstanding). Price Target Changed • Mar 28
Price target decreased by 30% to JP¥1,214 Down from JP¥1,742, the current price target is an average from 5 analysts. New target price is 188% above last closing price of JP¥421. Stock is down 38% over the past year. The company is forecast to post a net loss per share of JP¥68.35 next year compared to a net loss per share of JP¥40.48 last year. Announcement • Mar 19
SanBio Company Limited, Annual General Meeting, Apr 24, 2024 SanBio Company Limited, Annual General Meeting, Apr 24, 2024. Agenda: To consider to reduce the amounts of stated capital and capital reserves and to make an appropriation of other capital surplus. Price Target Changed • Mar 18
Price target increased by 18% to JP¥2,100 Up from JP¥1,782, the current price target is an average from 5 analysts. New target price is 184% above last closing price of JP¥740. Stock is up 5.4% over the past year. The company is forecast to post a net loss per share of JP¥63.15 next year compared to a net loss per share of JP¥95.98 last year. Breakeven Date Change • Jan 31
Forecast to breakeven in 2027 The 4 analysts covering SanBio expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of JP¥712.0m in 2027. Average annual earnings growth of 62% is required to achieve expected profit on schedule. Announcement • Jan 28
SanBio Company Limited to Report Fiscal Year 2024 Results on Mar 18, 2024 SanBio Company Limited announced that they will report fiscal year 2024 results on Mar 18, 2024 Announcement • Jan 25
Sanbio Co., Ltd. Provides Update on Status of Manufacturing and Marketing Approval for Sb623 Chronic Traumatic Brain Injury Program in Japan SanBio Co. Ltd. provided an update on the progress toward obtaining marketing approval of SB623 to treat chronic traumatic brain injury (TBI) in Japan, stating it aims to achieve approval by March 2024 and is actively engaged in the review process. Amidst this situation, the Ministry of Health, Labour and Welfare announced on January 22 that the Pharmaceutical Affairs and Food Sanitation Council's Subcommittee on Regenerative Medicine Products (the "Sub committee") would hold a meeting on February 5. However, developmental product SB623, which is undergoing approval review as a treatment for TBI under the framework of the Sakigake Designation System, was not included in the agenda for this meeting. New Risk • Dec 15
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -JP¥6.1b This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-JP¥6.1b free cash flow). Share price has been highly volatile over the past 3 months (8.8% average weekly change). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (JP¥280m net loss in 3 years). Shareholders have been diluted in the past year (6.5% increase in shares outstanding). Announcement • Dec 14
SanBio Company Limited Provides Update on Status of Manufacturing and Marketing Approval for SB623 Chronic Traumatic Brain Injury (TBI) Program in Japan SanBio Company Limited provided an update on the progress toward obtaining marketing approval of SB623 to treat chronic traumatic brain injury (TBI) in Japan, stating that the Company was focused on resolving the issue related to the production yield and responding to production-related review by regulatory authorities, with the goal of obtaining approval by the end of the current fiscal year. The Company hereby provides another progress update, to ensure timely disclosure to concerned patients and their families, as well as shareholders and investors who await the approval of SB623. SB623 is undergoing approval review under the framework of the Sakigake Designation System as a treatment for chronic effects associated with TBI. The production yield-related issue has been resolved, and the review process is proceeding to a conclusion. However, given the status of the review process, it will take some more time until approval is granted, and for this reason, the Company now expects to obtain approval in March 2024. Although the timing of approval is outside of the Company's control, SanBio will continue to work as one and do utmost to obtain approval. Announcement • Oct 14
SanBio Company Limited to Report Q3, 2024 Results on Dec 14, 2023 SanBio Company Limited announced that they will report Q3, 2024 results on Dec 14, 2023 Announcement • Jul 29
SanBio Company Limited to Report Q2, 2024 Results on Sep 15, 2023 SanBio Company Limited announced that they will report Q2, 2024 results on Sep 15, 2023 Major Estimate Revision • Jul 28
Consensus revenue estimates fall by 15% The consensus outlook for revenues in fiscal year 2024 has deteriorated. 2024 revenue forecast decreased from JP¥459.0m to JP¥389.0m. Forecast losses increased from -JP¥74.33 to -JP¥80.94 per share. Biotechs industry in Japan expected to see average net income growth of 39% next year. Consensus price target broadly unchanged at JP¥1,824. Share price was steady at JP¥596 over the past week. Price Target Changed • Jun 15
Price target increased by 13% to JP¥2,290 Up from JP¥2,022, the current price target is an average from 4 analysts. New target price is 276% above last closing price of JP¥609. Stock is down 44% over the past year. The company is forecast to post a net loss per share of JP¥72.57 next year compared to a net loss per share of JP¥95.98 last year. Breakeven Date Change • Jun 01
No longer forecast to breakeven The 4 analysts covering SanBio no longer expect the company to break even during the foreseeable future. The company was expected to make a profit of JP¥1.27b in 2026. New consensus forecast suggests the company will make a loss of JP¥1.44b in 2026. Announcement • May 13
SanBio Company Limited to Report Q1, 2024 Results on Jun 14, 2023 SanBio Company Limited announced that they will report Q1, 2024 results on Jun 14, 2023 Price Target Changed • Mar 20
Price target increased by 12% to JP¥2,465 Up from JP¥2,192, the current price target is an average from 4 analysts. New target price is 251% above last closing price of JP¥702. Stock is down 50% over the past year. The company is forecast to post a net loss per share of JP¥59.64 next year compared to a net loss per share of JP¥95.98 last year. Breakeven Date Change • Mar 16
No longer forecast to breakeven The 5 analysts covering SanBio no longer expect the company to break even during the foreseeable future. The company was expected to make a profit of JP¥1.27b in 2026. New consensus forecast suggests the company will make a loss of JP¥203.3m in 2026. Price Target Changed • Feb 20
Price target increased by 12% to JP¥2,465 Up from JP¥2,192, the current price target is an average from 4 analysts. New target price is 265% above last closing price of JP¥675. Stock is down 57% over the past year. The company is forecast to post a net loss per share of JP¥99.89 next year compared to a net loss per share of JP¥90.31 last year. Announcement • Feb 03
SanBio Company Limited to Report Fiscal Year 2023 Results on Mar 16, 2023 SanBio Company Limited announced that they will report fiscal year 2023 results on Mar 16, 2023 Breakeven Date Change • Jan 31
Forecast to breakeven in 2026 The 4 analysts covering SanBio expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of JP¥954.5m in 2026. Average annual earnings growth of 47% is required to achieve expected profit on schedule. Announcement • Jan 20
SanBio Co., Ltd. Announces Board Changes SanBio Co. Ltd. announced that at a meeting held on January 20, 2023, its Board of Directors resolved to make the following changes to senior management (representative director and corporate officer). Representative Director, Executive Vice President, and COO Akihiro Tsujimura has submitted his resignation for personal reasons and the Company has accepted it. Due to the resignation of Mr. Tsujimura, Corporate Officer and Business Head (Japan/Asia) Naoki Tsukahara will be appointed executive corporate officer responsible for HR, Japan Regulatory Affairs & Quality Compliance Japan, and Japan/Asia business, and will take over some of the responsibilities of Mr. Tsujimura. Effective date of change is January 20, 2023. Announcement • Dec 16
SanBio Company Limited Provides Earnings Guidance for the Fiscal Year Ending January 31, 2023 SanBio Company Limited provided earnings guidance for the Fiscal Year Ending January 31, 2023. For the full year, the company expected Operating loss of JPY 8,131 million; Net loss attributable to owners of parent to be JPY 5,684 million and net loss per share of JPY 95.36. Board Change • Nov 16
Less than half of directors are independent No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 3 experienced directors. 4 highly experienced directors. 1 independent director (3 non-independent directors). Independent External Director Noboru Kotani was the last independent director to join the board, commencing their role in 2013. The following issues are considered to be risks according to the Simply Wall St Risk Model: Minority of independent directors. Insufficient board refreshment. Announcement • Oct 01
SanBio Company Limited to Report Q3, 2023 Results on Dec 15, 2022 SanBio Company Limited announced that they will report Q3, 2023 results on Dec 15, 2022 Announcement • Sep 14
Sanbio Company Limited Provides Earnings Guidance for the Fiscal Year Ending January 31, 2023 SanBio Company Limited provided earnings guidance for the Fiscal Year Ending January 31, 2023. For the full year, the company expected Operating loss of JPY 8,131 million; Net loss attributable to owners of parent to be JPY 5,684 million and net loss per share of JPY 95.36. Price Target Changed • Jul 23
Price target decreased to JP¥2,233 Down from JP¥2,567, the current price target is an average from 7 analysts. New target price is 70% above last closing price of JP¥1,312. Stock is up 7.5% over the past year. The company is forecast to post a net loss per share of JP¥85.62 next year compared to a net loss per share of JP¥90.31 last year. Announcement • Jul 22
SanBio Company Announces Update on Status of Manufacturing and Marketing Approval for SB623 Chronic Traumatic Brain Injury (TBI) Program in Japan Japan's Ministry of Health, Labour, and Welfare (MHLW) on July 20 announced that the Regenerative Medicine Subcommittee (lower panel of Pharmaceutical Affairs and Food Sanitation Council) meeting will be held on August 3. SanBio's SB623, currently undergoing review in the Sakigake Designation System for the treatment of traumatic brain injury, is not included in the topic of deliberations. SanBio's corporate policy is to refrain from setting or disclosing a target timing for approval, as there are many factors outside of the company's control. Do recognize that, based on public perceptions regarding the Sakigake Designation System, there may be expectations for a September approval among patients and family members as well as shareholders and investors. Had SB623 been included in the meeting agenda, a September approval was a possibility. Now believe that a September approval is unlikely. Pledge to work diligently as one team to facilitate the review of this truly innovative product to ensure the swiftest possible regulatory approval and achieve SanBio's first to market. Take this opportunity to reassure all stakeholders that work continues steadily to ensure that not a day is wasted in bringing approval to reality. SB623 (INN: vandefitemcel) is a human (allogeneic) bone marrow-derived modified mesenchymal stem cell that is produced by modifying and culturing mesenchymal stem cells derived from the bone marrow aspirate of healthy adults. Implantation of SB623 cells into injured nerve tissues in the brain is expected to trigger the brain's natural regenerative ability to restore lost functions. SB623 is currently being investigated for the treatment of several conditions including chronic neurological motor deficit resulting from traumatic brain injury and ischemic stroke. Announcement • Jul 02
Keizo Nakada to Join Sanbio as Corporate Officer and Head of Production The SanBio Group announced that Mr. Keizo Nakada joined the Group as a new Corporate Officer and Head of Production on July 1, 2022. Previously, at Santen Pharmaceutical Co. Ltd., Mr. Nakada gained experience setting up overseas plants and serving as the head of a domestic plant. Afterward, as an executive officer and head of Product Supply Department, he established a stable global product supply system while successfully reducing costs. Later, as an executive officer in charge of production departments at Bushu Pharmaceuticals Ltd. and Taiko Pharmaceutical Co. Ltd., Mr. Nakada assumed responsibility for domestic production plants, supply chain management, quality control, and technological development. At the same time, he fully optimized the supply chains of these companies, achieving dramatic increases in production capacity. Price Target Changed • Jun 24
Price target decreased to JP¥2,200 Down from JP¥2,467, the current price target is an average from 5 analysts. New target price is 91% above last closing price of JP¥1,154. Stock is down 20% over the past year. The company is forecast to post a net loss per share of JP¥100 next year compared to a net loss per share of JP¥90.31 last year. Announcement • Jun 14
SanBio Company Limited Provides Consolidated Earnings Guidance for the First Half and Full Year Ending January 31, 2023 SanBio Company Limited provided consolidated earnings guidance for the first half and full year ending January 31, 2023. For the first half, the company expects operating loss of JPY 3,067 million, net loss attributable to owners of parent of JPY 3,169 million and net loss per share of JPY 61.19.For the full year, the company expects operating loss of JPY 5,858 million, net loss attributable to owners of parent of JPY 5,997 million and net loss per share of JPY 115.79. Announcement • Jun 01
SanBio Company Limited Appoints Andrew Liu as Chief Strategy Officer SanBio Company Limited announced as follows the appointment of Andrew Liu as Chief Strategy Officer of the SanBio Group, effective May 16, 2022. Board Change • Apr 27
Less than half of directors are independent Following the recent departure of a director, there is only 1 independent director on the board. The company's board is composed of: 1 independent director. 3 non-independent directors. Independent External Director Noboru Kotani was the last independent director to join the board, commencing their role in 2013. The company's minority of independent directors is a risk according to the Simply Wall St Risk Model. Announcement • Apr 06
Sanbio Group Provides an Update on One-Year Analysis of the Phase 2 STEMTRA Trial SanBio Company Limited announced that SB623 met the primary endpoint and demonstrated a trend toward maintaining the improvement of function and activities of daily living in the final, one-year analysis of the Phase 2 STEMTRA trial, which evaluated the efficacy and safety of SB623 compared to sham surgery in patients with chronic motor deficit from traumatic brain injury (TBI). These results will be presented in an oral plenary session at theAmerican Academy of Neurology (AAN) Annual Meeting, taking place on April 5, 2022, in Seattle, Washington, USA. SB623 is an investigational, regenerative cell medicine comprised of bone-marrow-derived, mesenchymal stem cells that are implanted intracranially around the area of the injury. SanBio is preparing to initiate a Phase 3 trial for SB623 in the United States, where many traumatic brain injury patients currently live. Announcement • Mar 07
Sanbio Company Limited Announces Filing with Japan’S Ministry of Health, Labour, and Welfare for Manufacture and Marketing Approval as A Regenerative Medicine Product for the Investigational Product Sb623 The SanBio Group announced the completion of an application filing with Japan’s Ministry of Health, Labour, and Welfare (MHLW) for manufacture and marketing approval as a regenerative medicine product for the investigational product SB623, as a treatment for chronic motor deficit from traumatic brain injury (TBI). This application for approval is based on efficacy and safety results from the US-Japan global Phase 2 clinical trial (Study of Modified Stem Cells in Traumatic Brain Injury, or STEMTRA). STEMTRA is a randomized, double-blind, surgical sham-controlled trial evaluating the efficacy and safety of SB623 in patients with chronic motor deficits secondary to traumatic brain injury. In this study, SB623 met its primary endpoint, with patients treated with SB623 achieving statistically significant improvement in motor function compared with sham surgery. The trial also demonstrated that SB623 was generally safe and well tolerated. Price Target Changed • Feb 14
Price target increased to JP¥2,900 Up from JP¥2,660, the current price target is an average from 3 analysts. New target price is 109% above last closing price of JP¥1,385. Stock is down 19% over the past year. The company is forecast to post a net loss per share of JP¥89.16 next year compared to a net loss per share of JP¥65.37 last year. Announcement • Dec 17
SanBio Company Limited Provides Consolidated Earnings Guidance for the Fiscal Year Ending January 31, 2022 SanBio Company Limited provided consolidated earnings guidance for the fiscal year ending January 31, 2022. For the period, the company expects Operating loss of JPY 5,786 million; Ordinary loss of JPY 5,876 million; Net loss attributable to owners of parent of JPY 5,877 million and Net loss per share of JPY 113.49. Executive Departure • Jul 13
Corporate Officer & Business Head of Japan/Asia Hiroshi Yamamoto has left the company On the 1st of July, Hiroshi Yamamoto's tenure as Corporate Officer & Business Head of Japan/Asia ended after 2.4 years in the role. We don't have any record of a personal shareholding under Hiroshi's name. Hiroshi is the only executive to leave the company over the last 12 months. The current median tenure of the management team is 1.50 years, which is considered inexperienced in the Simply Wall St Risk Model. Price Target Changed • Jul 07
Price target increased to JP¥2,660 Up from JP¥2,417, the current price target is an average from 3 analysts. New target price is 99% above last closing price of JP¥1,337. Stock is down 17% over the past year. Announcement • Jun 15
SanBio Company Limited Provides Consolidated Earnings Guidance for the First Half and Full Year of the Fiscal Year Ending January 31, 2022 SanBio Company Limited provided consolidated earnings guidance for the first half and full year of the fiscal year ending January 31, 2022. For the first half, the company expected operating loss of JPY 3,492 million, ordinary loss of JPY 3,550 million and net loss attributable to owners of parent of JPY 3,551 million or JPY 68.57 per share.
For the full year, the company expected operating loss of JPY 5,786 million, ordinary loss of JPY 5,876 million and net loss attributable to owners of parent of JPY 5,877 million or JPY 113.49 per share. Announcement • Mar 01
Sanbio Company Limited Presents STEMTRA Phase 2 Trial Results At the 44Th Annual Meeting of the Japan Society of Neurotraumatology The SanBio Group announcde that Masahito Kawabori, Specially Appointed Associate Professor of the Department of Neurosurgery and Neuronal Cell Therapy, Hokkaido University Hospital presented the results of the global Phase 2 clinical trial of SB623 targeting chronic effects associated with traumatic brain injury (STEMTRA study) during Symposium 3, Brain Protection and Regenerative Medicine, of the 44th Annual Meeting of the
Japan Society of Neurotraumatology in Takamatsu, Kagawa Prefecture. The STEMTRA study was a randomized, double-blind, surgical sham-controlled, global Phase 2 trial to evaluate the efficacy and safety of SB623 in patients with chronic motor deficit resulting from traumatic brain injury. The primary endpoint of the study was met, with patients who received SB623 demonstrating statistically significant improvement in motor functions compared to the control group patients who received sham surgery. Further, interim analysis based on data obtained six months after the administration of SB623 or sham surgery indicated that SB623 was well-tolerated. The SanBio Group, based on the study results, aims to apply for manufacture and marketing approval for SB623 as a regenerative medicine product by utilizing Japan's conditional and time-limited approval system for regenerative medicine products. Announcement • Jan 28
SanBio Company Limited to Report Fiscal Year 2021 Results on Mar 17, 2021 SanBio Company Limited announced that they will report fiscal year 2021 results on Mar 17, 2021 Announcement • Jan 06
SanBio Company Limited Announces Publication of STEMTRA Phase 2 Interim Analysis for SB623 in Neurology The SanBio Group announced that the interim analysis from the Company's SB623 Phase 2 clinical "STEM cell therapy for TRAumatic brain injury" (STEMTRA) trial was published in the January 4, 2021 online issue of Neurology®, the medical journal of the American Academy of Neurology. The full manuscript, entitled "Cell Therapy for Chronic TBI: Interim Analysis of the Randomized Controlled STEMTRA Trial" can be accessed here. STEMTRA was a Phase 2, randomized, double-blind, surgical sham-controlled, global trial evaluating the efficacy and safety of SB623 compared to sham surgery in patients with stable chronic neurological motor deficits secondary to traumatic brain injury (TBI). The study achieved its primary efficacy endpoint of significant improvement from baseline of Fugl-Meyer Motor Scale (FMMS) score at six months for SB623-treated patients. Secondary efficacy endpoints improved from baseline but were not statistically significant versus control. In the six-month, pre-specified interim analysis, treatment with SB623 cells appeared to be safe and well-tolerated. In the trial, patients were followed for efficacy and safety for up to twelve months. STEMTRA was a 12-month, Phase 2, randomized, double-blind, surgical sham-controlled, global trial evaluating the efficacy and safety of SB623 compared to sham surgery in patients with stable chronic neurological motor deficits secondary to TBI (https://clinicaltrials.gov identifier: NCT02416492). In this study, SB623 cells were implanted directly around the site of brain injury. The primary endpoint was mean change from baseline in FMMS score at six months to measure changes in motor impairment. To be eligible for this trial, patients (ages 18-75) must have been at least 12 months post-TBI and had a Glasgow Outcome Scale extended (GOS-E) score of 3-6 (e.g., moderate or severe disability). Patients must also have been able to undergo all planned neurological assessments and had no seizures in the prior three months. The STEMTRA trial treated 61 patients from 27 sites in the U.S., Japan and Ukraine. In this study, SB623 met its primary endpoint, with patients treated with SB623 achieving an average 8.3-point improvement from baseline in the FMMS, versus 2.3-points in the control group, at 6 months (p=0.040). Of patients treated with SB623, 18 (39.1%) reached a 10 or more point improvement of FMMS compared to one control patient (6.7%; p=0.039). No new safety signals were identified, and the most commonly reported adverse event was headaches. SB623 is a proprietary, cell-based investigational product made from allogeneic modified and cultured adult bone marrow-derived mesenchymal stem cells (MSCs) that undergo temporary genetic modification. Implantation of SB623 cells into injured nerve tissue in the brain is expected to trigger the brain's natural regenerative ability to recover lost motor functions. SanBio is preparing to file a Biologics License Application with the Pharmaceuticals and Medical Devices Agency in Japan for SB623 for the treatment of chronic motor deficits resulting from traumatic brain injury, while also making progress in its global development program. Further, the Company is working toward commencing clinical trials of SB623 for stroke in Japan. SB623 has been granted Sakigake designation for innovative medical products from the Ministry of Health, Labour, and Welfare of Japan, Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Association, and the Advanced Therapy Medicinal Product classification from the European Medicines Agency. 
