Reported Earnings • Aug 13
Third quarter 2026 earnings released: JP¥14.45 loss per share (vs JP¥33.20 loss in 3Q 2025) Third quarter 2026 results: JP¥14.45 loss per share (improved from JP¥33.20 loss in 3Q 2025). Revenue: JP¥287.2m (up JP¥269.2m from 3Q 2025). Net loss: JP¥115.1m (loss narrowed 49% from 3Q 2025). Over the last 3 years on average, earnings per share has increased by 5% per year but the company’s share price has fallen by 13% per year, which means it is significantly lagging earnings. New Risk • Aug 12
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 23% This is considered a minor risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Earnings have declined by 26% per year over the past 5 years. Revenue is less than US$1m (JP¥73m revenue, or US$458k). Minor Risks Share price has been volatile over the past 3 months (7.2% average weekly change). Shareholders have been diluted in the past year (23% increase in shares outstanding). Market cap is less than US$100m (JP¥3.03b market cap, or US$19.0m). Announcement • Jul 25
Kringle Pharma, Inc. Advances the Registrational Program for Oremepermin Alfa in Japan with Initiation of Additional Phase 3 in Acute Spinal Cord Injury Kringle Pharma, Inc. announced the initiation of an additional Phase 3 clinical study evaluating oremepermin alfa, recombinant human hepatocyte growth factor (HGF), for the treatment of patients with acute spinal cord injury (SCI) in Japan. Patient enrollment is expected to begin after site activation at participating study sites. The additional Phase 3 study is a multicenter, open-label, single-arm clinical trial designed to evaluate the efficacy and safety of oremepermin alfa in patients with acute cervical SCI. A total of 10 patients are planned for enrollment across three national SCI hospitals in Japan. Eligible patients are adults aged 18 to 89 years who are diagnosed with AIS grade A cervical SCI and remain neurologically complete at 72 hours (±6 hours) following injury. Participants will receive 0.6 mg of oremepermin alfa administered intrathecally once weekly for five consecutive weeks. The primary endpoint is the proportion of patients whose neurological status improves to AIS grade C or better six months after treatment initiation. Based on analyses of prior clinical studies and discussions with the PMDA, the Japanese regulatory agency,
the additional Phase 3 study incorporates refined eligibility criteria to enrich for responders. Patients with severe structural spinal cord damage on magnetic resonance imaging (MRI), including spinal cord compression of 70% or greater and cases strongly suggestive of spinal cord transection, are excluded. By reducing heterogeneity among AIS grade A patients, the study aims to more accurately assess the therapeutic effects of oremepermin alfa in patients with retained recovery potential. Acute SCI is a devastating neurological condition that can result in permanent motor, sensory, and autonomic dysfunction. Although advances in acute care and rehabilitation have improved outcomes, no widely established regenerative pharmacotherapy exists to restore neurological function, underscoring a substantial unmet medical need. Announcement • Jun 28
Kringle Pharma, Inc. to Report Q3, 2026 Results on Aug 10, 2026 Kringle Pharma, Inc. announced that they will report Q3, 2026 results on Aug 10, 2026 Reported Earnings • May 13
Second quarter 2026 earnings released: JP¥42.92 loss per share (vs JP¥43.84 loss in 2Q 2025) Second quarter 2026 results: JP¥42.92 loss per share. Net loss: JP¥314.2m (loss widened 5.0% from 2Q 2025). New Risk • Apr 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¥755m 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¥755m free cash flow). Earnings have declined by 28% per year over the past 5 years. Revenue is less than US$1m (JP¥73m revenue, or US$457k). Minor Risks Share price has been volatile over the past 3 months (8.8% average weekly change). Market cap is less than US$100m (JP¥3.70b market cap, or US$23.3m). New Risk • Feb 12
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¥755m 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¥755m free cash flow). Earnings have declined by 28% per year over the past 5 years. Revenue is less than US$1m (JP¥73m revenue, or US$474k). Minor Risk Market cap is less than US$100m (JP¥2.96b market cap, or US$19.3m). Reported Earnings • Feb 10
First quarter 2026 earnings released: JP¥28.08 loss per share (vs JP¥31.23 loss in 1Q 2025) First quarter 2026 results: JP¥28.08 loss per share (improved from JP¥31.23 loss in 1Q 2025). Net loss: JP¥201.0m (loss narrowed 5.5% from 1Q 2025). Over the last 3 years on average, earnings per share has fallen by 11% per year but the company’s share price has fallen by 27% per year, which means it is performing significantly worse than earnings. Reported Earnings • Dec 25
Full year 2025 earnings released: JP¥134 loss per share (vs JP¥118 loss in FY 2024) Full year 2025 results: JP¥134 loss per share (further deteriorated from JP¥118 loss in FY 2024). Net loss: JP¥916.0m (loss widened 21% from FY 2024). Over the last 3 years on average, earnings per share has fallen by 17% per year but the company’s share price has only fallen by 10% per year, which means it has not declined as severely as earnings. Reported Earnings • Nov 15
Full year 2025 earnings released: JP¥134 loss per share (vs JP¥118 loss in FY 2024) Full year 2025 results: JP¥134 loss per share (further deteriorated from JP¥118 loss in FY 2024). Net loss: JP¥916.0m (loss widened 21% from FY 2024). Over the last 3 years on average, earnings per share has fallen by 17% per year but the company’s share price has only fallen by 4% per year, which means it has not declined as severely as earnings. Announcement • Nov 12
Kringle Pharma, Inc., Annual General Meeting, Dec 23, 2025 Kringle Pharma, Inc., Annual General Meeting, Dec 23, 2025. Announcement • Aug 29
Kringle Pharma, Inc. to Report Fiscal Year 2025 Results on Nov 12, 2025 Kringle Pharma, Inc. announced that they will report fiscal year 2025 results on Nov 12, 2025 Reported Earnings • Aug 10
Third quarter 2025 earnings released: JP¥33.20 loss per share (vs JP¥22.96 loss in 3Q 2024) Third quarter 2025 results: JP¥33.20 loss per share (further deteriorated from JP¥22.96 loss in 3Q 2024). Net loss: JP¥227.0m (loss widened 49% from 3Q 2024). Over the last 3 years on average, earnings per share has fallen by 21% per year but the company’s share price has only fallen by 9% per year, which means it has not declined as severely as earnings. Announcement • Aug 02
Kringle Pharma, Inc. announced that it has received ¥1.003 million in funding from Evolution Capital Management LLC On August 1, 2025, Kringle Pharma, Inc. closed the transaction. Announcement • Jun 27
Kringle Pharma, Inc. to Report Q3, 2025 Results on Aug 08, 2025 Kringle Pharma, Inc. announced that they will report Q3, 2025 results on Aug 08, 2025 New Risk • Jun 11
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 9.8% 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 (9.8% average weekly change). Earnings have declined by 35% per year over the past 5 years. Revenue is less than US$1m (JP¥72m revenue, or US$496k). Minor Risk Market cap is less than US$100m (JP¥6.89b market cap, or US$47.5m). Reported Earnings • May 14
Second quarter 2025 earnings released: JP¥43.84 loss per share (vs JP¥30.66 loss in 2Q 2024) Second quarter 2025 results: JP¥43.84 loss per share (further deteriorated from JP¥30.66 loss in 2Q 2024). Net loss: JP¥299.3m (loss widened 52% from 2Q 2024). Over the last 3 years on average, earnings per share has fallen by 20% per year but the company’s share price has increased by 12% per year, which means it is well ahead of earnings. Reported Earnings • Feb 08
First quarter 2025 earnings released: JP¥31.13 loss per share (vs JP¥29.45 loss in 1Q 2024) First quarter 2025 results: JP¥31.13 loss per share (further deteriorated from JP¥29.45 loss in 1Q 2024). Net loss: JP¥212.0m (loss widened 25% from 1Q 2024). Over the last 3 years on average, earnings per share has fallen by 22% per year but the company’s share price has increased by 16% per year, which means it is well ahead of earnings. New Risk • Jan 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 8.1% 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 (8.1% average weekly change). Earnings have declined by 31% per year over the past 5 years. Revenue is less than US$1m (JP¥80m revenue, or US$507k). Minor Risks Shareholders have been diluted in the past year (13% increase in shares outstanding). Market cap is less than US$100m (JP¥6.92b market cap, or US$43.9m). Reported Earnings • Dec 28
Full year 2024 earnings released: JP¥118 loss per share (vs JP¥158 loss in FY 2023) Full year 2024 results: JP¥118 loss per share (improved from JP¥158 loss in FY 2023). Net loss: JP¥756.0m (loss narrowed 12% from FY 2023). Over the last 3 years on average, earnings per share has fallen by 25% per year but the company’s share price has increased by 7% per year, which means it is well ahead of earnings. Announcement • Nov 26
Kringle Pharma, Inc. Provides Non-Consolidated Earnings Guidance for the Fiscal Year Ending September 30, 2025 Kringle Pharma, Inc. provided Non-consolidated earnings guidance for the fiscal year ending September 30, 2025. For the year, the company expects net sales of JPY 272 million, operating loss of JPY 1,379 million, loss of JPY 1,380 million and basic loss per share of JPY 202.7. Announcement • Nov 13
Kringle Pharma, Inc., Annual General Meeting, Dec 20, 2024 Kringle Pharma, Inc., Annual General Meeting, Dec 20, 2024. Announcement • Aug 29
Kringle Pharma, Inc. to Report Fiscal Year 2024 Results on Nov 13, 2024 Kringle Pharma, Inc. announced that they will report fiscal year 2024 results on Nov 13, 2024 Announcement • Aug 22
Kringle Pharma, Inc. Provides Non-Consolidated Earnings Guidance for the Fiscal Year Ending September 30, 2024 Kringle Pharma, Inc. provided Non-consolidated earnings guidance for the fiscal year ending September 30, 2024. For the year, the company expects net sales of JPY 79 million, operating loss of JPY 1,003 million, loss of JPY 942 million and basic loss per share of JPY 147.23. Reported Earnings • May 17
Second quarter 2024 earnings released: JP¥30.66 loss per share (vs JP¥29.35 loss in 2Q 2023) Second quarter 2024 results: JP¥30.66 loss per share (further deteriorated from JP¥29.35 loss in 2Q 2023). Net loss: JP¥197.0m (loss widened 25% from 2Q 2023). Over the last 3 years on average, earnings per share has fallen by 30% per year but the company’s share price has only fallen by 9% per year, which means it has not declined as severely as earnings. Reported Earnings • Feb 11
First quarter 2024 earnings released: JP¥29.45 loss per share (vs JP¥29.18 loss in 1Q 2023) First quarter 2024 results: JP¥29.45 loss per share (further deteriorated from JP¥29.18 loss in 1Q 2023). Net loss: JP¥169.0m (loss widened 7.6% from 1Q 2023). Announcement • Nov 29
Kringle Pharma, Inc. Provides Earnings Guidance for the Fiscal Year Ending September 30, 2024 Kringle Pharma, Inc. provided earnings guidance for the fiscal year ending September 30, 2024. For the year, the company expects net sales of JPY 272 million, operating loss of JPY 1,133 million, loss of JPY 1,109 million and basic loss per share of JPY 200.86. Reported Earnings • Nov 17
Full year 2023 earnings released: JP¥158 loss per share (vs JP¥68.16 loss in FY 2022) Full year 2023 results: JP¥158 loss per share (further deteriorated from JP¥68.16 loss in FY 2022). Net loss: JP¥854.0m (loss widened 158% from FY 2022). New Risk • Oct 24
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 2.6% This is considered a minor risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (10% average weekly change). Earnings have declined by 24% per year over the past 5 years. Minor Risks Shareholders have been diluted in the past year (2.6% increase in shares outstanding). Revenue is less than US$5m (JP¥330m revenue, or US$2.2m). Market cap is less than US$100m (JP¥3.69b market cap, or US$24.6m). Announcement • Sep 02
Kringle Pharma, Inc. to Report Fiscal Year 2023 Results on Nov 13, 2023 Kringle Pharma, Inc. announced that they will report fiscal year 2023 results on Nov 13, 2023 Announcement • Aug 31
Kringle Pharma, Inc. Provides Earnings Guidance for the Fiscal Year Ending September 30, 2023 Kringle Pharma, Inc. provided earnings guidance for the fiscal year ending September 30, 2023. For the year, the company expects net sales of JPY 68 million, operating loss of JPY 993 million, loss of JPY 955 million and basic loss per share of JPY 177.35. Reported Earnings • Aug 16
Third quarter 2023 earnings released: JP¥48.79 loss per share (vs JP¥2.57 profit in 3Q 2022) Third quarter 2023 results: JP¥48.79 loss per share (down from JP¥2.57 profit in 3Q 2022). Revenue: JP¥17.0m (down 80% from 3Q 2022). Net loss: JP¥263.0m (down JP¥276.0m from profit in 3Q 2022). New Risk • Jul 21
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 3.7% This is considered a minor risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risk Earnings have declined by 21% per year over the past 5 years. Minor Risks Share price has been volatile over the past 3 months (5.3% average weekly change). Shareholders have been diluted in the past year (3.7% increase in shares outstanding). Revenue is less than US$5m (JP¥398m revenue, or US$2.8m). Market cap is less than US$100m (JP¥4.61b market cap, or US$32.5m). Announcement • May 30
Kringle Pharma, Inc. Provides Earnings Guidance for the Fiscal Year Ending September 30, 2023 Kringle Pharma, Inc. provided earnings guidance for the fiscal year ending September 30, 2023. For the year, the company expects net sales of JPY 68 million, operating loss of JPY 993 million, loss of JPY 955 million and basic loss per share of JPY 177.44. Reported Earnings • May 19
First half 2023 earnings released: JP¥58.52 loss per share (vs JP¥70.08 loss in 1H 2022) First half 2023 results: JP¥58.52 loss per share (improved from JP¥70.08 loss in 1H 2022). Revenue: JP¥34.0m (up 26% from 1H 2022). Net loss: JP¥315.0m (loss narrowed 1.3% from 1H 2022). Reported Earnings • Feb 12
First quarter 2023 earnings released: JP¥29.18 loss per share (vs JP¥29.02 loss in 1Q 2022) First quarter 2023 results: JP¥29.18 loss per share (further deteriorated from JP¥29.02 loss in 1Q 2022). Revenue: JP¥17.0m (up 31% from 1Q 2022). Net loss: JP¥157.0m (loss widened 22% from 1Q 2022). Announcement • Jan 17
Kringle Pharma, Inc. Announces First Patient Enrollment in Phase III Clinical Study for the Treatment of Vocal Fold Scar Kringle Pharma, Inc. announced that the first patient was enrolled in a placebo-controlled, double-blind Phase III study to evaluate the efficacy and safety of KP-100LI, the intracordal formulation containing recombinant human HGF, administered in patients with vocal fold scar. The first patient was screened and successfully enrolled for the study at University Hospital, Kyoto Prefectural University of Medicine. As announced in the company news release dated November 24, 2022, the study will be conducted at the five clinical trial sites across Japan including University Hospital, Kyoto Prefectural University of Medicine. Patient enrollment will subsequently start at the other four clinical sites as soon as the contracts and all preparations are completed. The Phase III study has been supported by the Japan Agency for Medical Research and Development (AMED) as its CiCLE program (Project title: Clinical development of recombinant HGF protein for the treatment of refractory fibrosis). Announcement • Jan 13
Kringle Pharma, Inc. Provides Update on Progress of Phase 3 Clinical Trial in Patients with Acute Spinal Cord Injury Kringle Pharma, Inc. provided an update on Phase 3 clinical trial of KP-100IT, the intrathecal formulation of recombinant human HGF, in patients with acute spinal cord injury. KRINGLE was previously expecting to complete patient enrollment by the end of 2022. As of 13 January 2023, however,although more than 90% of the target subjects has been recruited, patient enrollment has not been completed yet primarily due to the prolonged impact of COVID-19 pandemic. KRINGLE continues to enroll patients until it reaches the target number, in close cooperation with the clinical trial sites in order to complete the study as soon as possible. HGF was originally discovered as an endogenous mitogen for mature hepatocytes. Subsequent studiesdemonstrated that HGF exerts multiple biological functions based on its mitogenic, motogenic, anti-apoptotic, morphogenic, anti-fibrotic, and angiogenic activities, and facilitates regeneration and protection of a wide variety of organs. HGF exerts neurotrophic effects and enhances neurite outgrowth, and the therapeutic effect of HGF on spinal cord injury has been demonstrated in animal models by Professors Hideyuki Okano and Masaya Nakamura at Keio University School of Medicine. Expectations for HGF as a novel therapeutic agent are increasing for the treatment of spinal cord injury. Spinal cord injury is caused by trauma, leading to a variety of paralytic or painful symptoms. In descending order of incidence, tripping over, traffic accidents and falls from height are the main causes of spinal damage. Recently, due to the rise in the elderly population, tripping over is becoming an increasingly common cause. Reported Earnings • Dec 28
Full year 2022 earnings released: JP¥68.16 loss per share (vs JP¥72.47 loss in FY 2021) Full year 2022 results: JP¥68.16 loss per share. Revenue: JP¥391.0m (up 35% from FY 2021). Net loss: JP¥331.0m (loss widened 10.0% from FY 2021). Announcement • Dec 01
Kringle Pharma, Inc. Provides Consolidated Earnings Guidance for Year Ending September 30, 2023 Kringle Pharma, Inc. provided consolidated earnings guidance for year ending September 30, 2023 . For the period, the company expected net sales of JPY 68 million, operating loss of JPY 993 million, loss of parent of JPY 955 million, Basic loss per share of JPY 177.50 per basic share. Announcement • Nov 24
Kringle Pharma, Inc. Announces Initiation of Phase III Study of HGF in Vocal Fold Scar Kringle Pharma, Inc. announced the start of Phase III, a placebo-controlled, double-blind clinical study, to confirm the efficacy and safety of recombinant human HGF (KP-100LI) administered in patients with vocal fold scar. KRINGLE aims to develop and commercialize HGF as an innovative therapeutic agent for various fibrotic diseases, focusing on vocal fold scar as the initial target indication. KRINGLE already submitted a Phase III clinical trial application to the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan, as announced by the KRINGLE news release dated October 24, 2022. Since then, the review process by PMDA was completed and the regulatory clearance was obtained to initiate the Phase III study. KRINGLE and Kyoto Prefectural Public University Corporation (Chairman: Akihiro Kinda) have signed a clinical trial agreement for the Phase III study, and University Hospital, Kyoto Prefectural University of Medicine, is ready to enroll patients in this study. The Phase III study will be conducted at five clinical sites in Japan including University Hospital, Kyoto Prefectural University of Medicine. Each clinical site will begin screening patients subsequently once contracts and other preparations are all set. The Phase III study has been supported by the Japan Agency for Medical Research and Development(AMED) as its CiCLE program (Project title: Clinical development of recombinant HGF protein for thetreatment of refractory fibrosis). Reported Earnings • Nov 16
Full year 2022 earnings released: JP¥68.16 loss per share (vs JP¥72.47 loss in FY 2021) Full year 2022 results: JP¥68.16 loss per share. Revenue: JP¥391.0m (up 35% from FY 2021). Net loss: JP¥331.0m (loss widened 10.0% from FY 2021). Announcement • Nov 16
Kringle Pharma, Inc., Annual General Meeting, Dec 23, 2022 Kringle Pharma, Inc., Annual General Meeting, Dec 23, 2022. Board Change • Nov 16
No independent directors Following the recent departure of a director, there are no independent directors on the board. The company's board is composed of: No independent directors. 6 non-independent directors. Director & GM of Business Administration Department Koichi Murakami was the last director to join the board, commencing their role in 2021. The company's lack of independent directors is a risk according to the Simply Wall St Risk Model. Announcement • Oct 24
Kringle Pharma, Inc. Submits Clinical Trial Application Kringle Pharma, Inc. announced that the clinical trial application has successfully submitted to the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan to initiate a Phase III study of recombinant human HGF (KP-100LI) in patients with vocal fold scar. HGF, hepatocyte growth factor, is an endogenous protein responsible for regeneration and repair of tissues and organs in the human body. Its therapeutic effects have been validated in animal models of various diseases. One of the multiple biological functions of HGF is its potent antifibrotic activity, and HGF is expected to be an effective therapeutic agent for various intractable fibrotic diseases. KRINGLE is focusing on vocal fold scar as a target indication of drug development for fibrotic diseases. The investigator-initiated Phase I/II study already completed, demonstrating the safety and efficacy of intracordal administration of HGF (Hirano et al. J Tissue Eng Regen Med. 2018). The upcoming pivotal Phase III study is designed as a multicenter, randomized, placebo-controlled, double-blind, parallel-group study to confirm the safety and efficacy of KP-100LI in patients with vocal fold scar. This study will be conducted at five clinical sites in Japan including University Hospital, Kyoto Prefectural University of Medicine. The Phase III study has been supported by the Japan Agency for Medical Research and Development (AMED) as its CiCLE program (Project title: Clinical development of recombinant HGF protein for the treatment of refractory fibrosis). Announcement • Sep 10
Kringle Pharma, Inc. Announces Jointly File A Patent Application with Keio University Kringle Pharma, Inc. announced that it has jointly filed a patent application with Keio University on the combination use of recombinant human hepatocyte growth factor (HGF) with human induced pluripotent stem cell-derived neural stem/progenitor cell (hiPSC-NS/PC) as an effective treatment for spinal cord injury. The company has continued collaborative research with Professors Hideyuki Okano and Masaya Nakamura at Keio University School of Medicine since 2021, aiming to create novel therapies for spinal cord injury. As a result of this joint research, KRINGLE and Keio University already filed a patent application in March 2022, based on the improvement of functional recovery in the animal model of chronic complete spinal cord injury by transplanting hiPSC-NS/PC with the scaffold-mediated delivery of HGF. Further in the joint research, HGF administration in the acute phase, followed by transplantation of hiPSC-NS/PC in the sub-acute phase, significantly improved motor function in the animal model of severe spinal cord injury compared to each single treatment group, leading to the second patent application jointly filed by KRINGLE and Keio University. Currently, HGF monotherapy in acute spinal cord injury is being tested in a Phase III clinical trial by KRINGLE, and hiPSC-NS/PC transplantation in the sub-acute phase is ongoing in clinical research by Keio University, respectively. Therefore, a next-generation regenerative therapy combining the HGF and iPS cell technologies is expected to be put into clinical use before long for the treatment of acute and sub-acute spinal cord injuries. The preclinical results will be presented by Keio University School of Medicine during the 57th Annual Meeting of the Japan Medical Society of Spinal Cord Lesion. Announcement • Sep 01
Kringle Pharma, Inc. to Report Fiscal Year 2022 Results on Nov 14, 2022 Kringle Pharma, Inc. announced that they will report fiscal year 2022 results on Nov 14, 2022 Announcement • Aug 27
Kringle Pharma, Inc. Provides Earnings Guidance for the Year Ending September 30, 2022 Kringle Pharma, Inc. provided earnings guidance for the year ending September 30, 2022. For the year, the company expects net sales of JPY 357 million, operating loss of JPY 497 million, loss of JPY 421 million or JPY 89.24 per basic share. Reported Earnings • Aug 14
Third quarter 2022 earnings released: EPS: JP¥2.57 (vs JP¥12.50 loss in 3Q 2021) Third quarter 2022 results: EPS: JP¥2.57 (up from JP¥12.50 loss in 3Q 2021). Revenue: JP¥85.0m (flat on 3Q 2021). Net income: JP¥13.0m (up JP¥67.0m from 3Q 2021). Profit margin: 15% (up from null in 3Q 2021). Announcement • Aug 13
Kringle Pharma, Inc. Updates on the Investigator-initiated Phase 2 Study in Patients with ALS Kringle Pharma, Inc. announces that it has received the results of the investigator-initiated phase 2 clinical study evaluating its recombinant human HGF for the treatment of amyotrophic lateral sclerosis from Tohoku University, located in Miyagi, Japan. The study was a randomized, double-blind, placebo-controlled, phase 2 clinical study to evaluate the efficacy and safety of KP-100IT in a total of 46 ALS patients with Japan ALS Severity Classification of Grade 1 or 2, within 30 months of onset of the disease. KP-100IT or placebo was administered intrathecally once every two weeks, and the change in ALSFRS-R score at the 24-week treatment period was evaluated as a primary endpoint. As a result, there was no statistically significant difference between the KP-100IT group and the placebo group. No statistically significant differences were observed in the pre-specified secondary endpoints between the two groups. On the other hand, in the KP- 100IT administered group, slowing of the disease progression was observed in some cases and further detailed analysis is required to interpret the results of this study. Regarding safety, the incidence of adverse events was similar between the KP-100IT and placebo groups, confirming that the intrathecal administration of KP-100IT was well-tolerated. KRINGLE will discuss with Tohoku University to determine the potential next step of development based on the results of further detailed analysis of the study. Announcement • Jun 01
Kringle Pharma, Inc. Provides Earnings Guidance for the Fiscal Year Ending September 30, 2022 Kringle Pharma, Inc. provided earnings guidance for the fiscal year ending September 30, 2022. For the full year, the company expected net sales to be JPY 355 million, Operating loss to be JPY 1,357 million, Loss to be JPY 1,297 million and Basic loss per share to be JPY 299.22. Reported Earnings • May 17
Second quarter 2022 earnings released: JP¥40.79 loss per share (vs JP¥12.50 loss in 2Q 2021) Second quarter 2022 results: JP¥40.79 loss per share (down from JP¥12.50 loss in 2Q 2021). Net loss: JP¥190.0m (loss widened 252% from 2Q 2021). Announcement • May 14
Kringle Pharma, Inc. Provides an Update on Progress of Phase 3 Clinical Trial in Patients with Acute Spinal Cord Injury Kringle Pharma, Inc. provides an update on Phase 3 clinical trial of KP-100IT, the intrathecal formulation of recombinant human HGF, in patients with acute spinal cord injury. This trial is currently ongoing at five clinical trial sites in Japan, with the estimated enrollment of 25 participants. Since the start of the trial in July 2020, patient enrollment was progressing approximately at the expected pace until recently. Due to the impact of the latest re-expansion of COVID-19 in Japan, however, the enrollment pace is slowing down and the enrollment has not reached the target number as of May 13, 2022. Under those uncertain circumstances of the COVID-19 pandemic, KRINGLE has submitted the notification to PMDA (Pharmaceuticals and Medical Devices Agency) to extend the study period for six months. KRINGLE continues close collaboration with the clinical trial sites aiming to complete the patient enrollment in the second half of 2022, expecting the last patient out in the first half of 2023. HGF was originally discovered as an endogenous mitogen for mature hepatocytes. Subsequent studies demonstrated that HGF exerts multiple biological functions based on its mitogenic, motogenic, anti-apoptotic, morphogenic, anti-fibrotic, and angiogenic activities, and facilitates regeneration and protection of a wide variety of organs. HGF exerts neurotrophic effects and enhances neurite outgrowth, and the therapeutic effects of HGF on spinal cord injury and ALS have been demonstrated in animal models by Professors Hideyuki Okano and Masaya Nakamura at Keio University School of Medicine and Professor Masashi Aoki at Tohoku University School of Medicine, respectively. Expectations for HGF as a novel therapeutic agent are increasing for such intractable neuronal diseases. Board Change • Apr 27
No independent directors Following the recent departure of a director, there are no independent directors on the board. The company's board is composed of: No independent directors. 6 non-independent directors. Director & GM of Business Administration Department Koichi Murakami was the last director to join the board, commencing their role in 2021. The company's lack of independent directors is a risk according to the Simply Wall St Risk Model. Announcement • Feb 28
Kringle Pharma, Inc. Provides Earnings Guidance for the Fiscal Year Ending September 30, 2022 Kringle Pharma, Inc. provided earnings guidance for the fiscal year ending September 30, 2022. For the period, the company expects net sales to be JPY 355 million, operating loss to be JPY 1,357 million, loss to be JPY 1,297 million and basic loss per share to be JPY 299.22. Reported Earnings • Feb 16
First quarter 2022 earnings: Revenues and EPS in line with analyst expectations First quarter 2022 results: JP¥29.02 loss per share. Revenue: JP¥13.0m (down 97% from 1Q 2021). Net loss: JP¥129.0m (down 358% from profit in 1Q 2021). Revenue was in line with analyst estimates. Reported Earnings • Dec 19
Full year 2021 earnings: Revenues and EPS in line with analyst expectations Full year 2021 results: JP¥72.51 loss per share (up from JP¥2,119 loss in FY 2020). Revenue: JP¥289.8m (down 38% from FY 2020). Net loss: JP¥301.2m (loss widened 157% from FY 2020). Revenue was in line with analyst estimates. Announcement • Dec 17
Kringle Pharma, Inc. Provides Earnings Forecast for the Fiscal Year Ending September 30, 2022 Kringle Pharma, Inc. provided earnings forecast for the fiscal year ending September 30, 2022. For the year, the company expects net sales of YEN 355 million, operating loss of YEN 1,357 million, net loss of YEN 1,297 million and loss per basic share of YEN 299.22. Announcement • Dec 09
Kringle Pharma, Inc Announces Last Patient Out in Phase 2 Study of Kp-100It for the Treatment of Als Kringle Pharma, Inc. announced that the last patient has now completed the treatment and follow-up in the randomized, double-blind, placebo-controlled Phase 2 study of KP-100IT in ALS. The study outline is registered in the UMIN Clinical Trials Registry with the ID No. UMIN000022050. KP-100IT, the intrathecal formulation of recombinant human hepatocyte growth factor, is a novel investigational drug that has neurotrophic activities in the central nervous system. KRINGLE successfully completed open-label, dose-escalating Phase 1 study in ALS patients and confirmed safety and pharmacokinetics profiles of the intrathecal administration of KP-100IT. These clinical results werepublished in The Journal of Clinical Pharmacology 2019, 59(5) 677687. Following the Phase 1 study, an investigator-initiated Phase 2 study was started by Professor Masashi Aoki, Department of Neurology in Tohoku University School of Medicine, on the basis of collaboration between KRINGLE and Tohoku University. HGF was originally discovered as an endogenous mitogen for mature hepatocytes. Subsequent studies demonstrated that HGF exerts multiple biological functions based on its mitogenic, motogenic, anti-apoptotic, morphogenic, anti-fibrotic and angiogenic activities, and facilitates regeneration and protection of a wide variety of organs including not only liver, but also kidneys, heart, lungs, nerve tissues and skin. Therapeutic effects of HGF administration in model animals of intractable diseases have been reported in many scientific papers, and expectations for HGF as a novel therapeutic agent for intractable diseases are increasing. Announcement • Aug 21
Kringle Pharma, Inc. Provides Earnings Guidance for the Fiscal Year Ending September 30, 2021 Kringle Pharma, Inc. provided earnings guidance for the Fiscal Year Ending September 30, 2021. For the year, the company expects net sales of JPY 227 million. Operating loss was JPY 388 million. Ordinary loss was JPY 328 million. Loss was JPY 330 million. Basic loss per share were JPY 80.67. Announcement • Mar 05
Kringle Pharma, Inc. to Report Q2, 2021 Results on May 14, 2021 Kringle Pharma, Inc. announced that they will report Q2, 2021 results on May 14, 2021 Announcement • Dec 30
Kringle Pharma, Inc. to Report Q1, 2021 Results on Feb 12, 2021 Kringle Pharma, Inc. announced that they will report Q1, 2021 results on Feb 12, 2021 Announcement • Dec 29
Kringle Pharma, Inc. has completed an IPO in the amount of ¥580 million. Kringle Pharma, Inc. has completed an IPO in the amount of ¥580 million.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 580,000
Price\Range: ¥1000
Discount Per Security: ¥80
Transaction Features: Sponsor Backed Offering