New Risk • Jun 29
New minor risk - Financial data availability The company's latest financial reports are more than 6 months old. Last reported fiscal period ended October 2025. This is considered a minor risk. If the company has not reported its earnings on time, it may have been delayed due to audit problems or it may be finding it difficult to reconcile its accounts. Currently, the following risks have been identified for the company: Minor Risks Latest financial reports are more than 6 months old (reported October 2025 fiscal period end). Share price has been volatile over the past 3 months (8.3% average weekly change). Announcement • Jun 12
Heartseed Announces First Patient Dosed In Phase I/II Clinical Trial Of HS-005 For Cardiac Remuscularization Therapy Heartseed Inc. announced that the first patient with heart failure caused by dilated cardiomyopathy has been dosed in the domestic clinical trial (EMERALD study) of HS-005 (allogeneic iPS cell-derived cardiomyocyte spheroids administered via catheter), which is being developed by the Company. The Independent Safety Monitoring Committee approved the continuation of the trial for dilated cardiomyopathy cohort based on the evaluation of four-week post-administration data from this case. This trial is a company-sponsored clinical trial aimed at expanding the application of the therapy not only to severe heart failure caused by ischemic heart disease, but also by dilated cardiomyopathy. A total of 14 patients, consisting of seven patients in each disease cohort, will be enrolled to evaluate the safety and efficacy of the therapy. There is no revision to the latest earnings forecast for the fiscal year ending December 31, 2026. Heartseed Inc. announced the successful dosing of the first patient in its domestic Phase I/II clinical trial (EMERALD study) of HS-005, allogeneic iPS cell-derived cardiomyocyte spheroids administered via catheter, targeting severe heart failure caused by ischemic heart disease or dilated cardiomyopathy. This study marks the world's first clinical trial to administer iPS cell-derived cardiomyocyte spheroids using a catheter. HS-005 is a therapeutic program currently under development, in which allogeneic iPS cell-derived cardiomyocyte spheroids (micro-tissues of cardiomyocytes) produced based on Heartseed's proprietary technology are administered into the patient's myocardium using a dedicated delivery catheter system. While Heartseed's lead pipeline, HS-001, requires open-heart surgery, HS-005 utilizes a catheter for delivery from the inside of the heart (endocardial delivery), aiming to realize a next-generation, minimally invasive cardiac regenerative medicine. Heartseed has been advancing the EMERALD study in Japan aiming at the development of HS-005, and the administration to the first patient suffering from heart failure due to dilated cardiomyopathy was successfully completed in late March 2026 at Shinshu University Hospital. The patient's postoperative course has been generally uneventful, and the patient has already been discharged from the hospital. The independent Safety Monitoring Committee has evaluated 4-week data on this patient and has given approval for the study to continue in the dilated cardiomyopathy cohort. Heartseed will continue to advance the clinical evaluation of HS-005. The cell utilized by Heartseed in cardiac remuscularization therapy is allogeneic iPS cell-derived, highly purified ventricular cardiomyocyte product formulated in spheroids. The non-clinical studies confirmed that forming micro-tissue-like spheroids enhances the cell retention rate and viability compared to single cells in their administration. When administering cardiomyocyte spheroids into the myocardial layer of the heart, HS-001 uses a proprietary delivery needle (SEEDPLANTER) and guide adapter developed in-house for epicardial delivery. In contrast, HS-005 utilizes a catheter system for endocardial delivery. The administered cardiomyocytes are expected to be engrafted into the patient's myocardium, promoting “remuscularization” and improving cardiac contractility. Additionally, they are anticipated to secrete various angiogenic factors, promoting neovascularization (formation of new blood vessels) around the administration sites. The EMERALD study is the Phase I/II clinical trial to proceed the development of HS-005 program which utilizes a catheter system for endocardial delivery to administer cardiomyocyte spheroids. In the EMERALD study, it aims at treating severe heart failure with reduced ejection fraction (HFrEF) with underlying ischemic heart disease as well as dilated cardiomyopathy, planning to enroll 7 patients in each cohort, for a total of 14 patients, to evaluate the safety and efficacy of the therapy. A phase I/II study of Endocardial delivery for Myocardial Regeneration using Allogeneic iPS cell-derived Cardiomyocyte Spheroids for Heart Failure with Systolic Dysfunction (EMERALD study) jRCT registration number: jRCT2033250454. The development of HS-005 utilized data obtained through the following support provided by Japan Agency for Medical Research and Development (AMED): Basic Technology Development Project for Industrialization of Regenerative Medicine and Gene Therapy (Support for Accelerating the Development of Regenerative Medicine Seeds) "Evaluation of Quality and Safety and Regulatory Affairs for Transitioning to Clinical Trials Toward the Industrialization of iPS cell-Derived Regenerative Cardiomyocyte Transplantation Therapy" (Representative: Keiichi Fukuda) (Fiscal year 2018-Fiscal year 2020). Valuation Update With 7 Day Price Move • Jun 08
Investor sentiment improves as stock rises 15% After last week's 15% share price gain to JP¥1,616, the stock trades at a trailing P/E ratio of 62.4x. Average trailing P/E is 30x in the Biotechs industry in Asia. Total loss to shareholders of 45% over the past year. Announcement • Jun 03
Heartseed Inc. to Report Q2, 2026 Results on Aug 14, 2026 Heartseed Inc. announced that they will report Q2, 2026 results on Aug 14, 2026 Valuation Update With 7 Day Price Move • May 20
Investor sentiment deteriorates as stock falls 18% After last week's 18% share price decline to JP¥1,531, the stock trades at a trailing P/E ratio of 59.1x. Average trailing P/E is 36x in the Biotechs industry in Asia. Total loss to shareholders of 41% over the past year. Announcement • May 09
Heartseed Inc. to Report Q1, 2026 Results on May 15, 2026 Heartseed Inc. announced that they will report Q1, 2026 results on May 15, 2026 Announcement • Feb 14
Heartseed Inc. Provides Non-Consolidated Earnings Guidance for the Fiscal Year Ending December 31, 2026 Heartseed Inc. provided non-consolidated earnings guidance for the fiscal year ending December 31, 2026. For the year, the company expects net sales of JPY 451 million, Operating loss of JPY 2,207 million, Loss of JPY 2,158 million and Basic loss per share of JPY 95.58. Announcement • Feb 13
Heartseed Inc., Annual General Meeting, Mar 27, 2026 Heartseed Inc., Annual General Meeting, Mar 27, 2026. Announcement • Dec 27
Heartseed Inc. to Report Fiscal Year 2025 Results on Feb 13, 2026 Heartseed Inc. announced that they will report fiscal year 2025 results on Feb 13, 2026 Valuation Update With 7 Day Price Move • Dec 22
Investor sentiment deteriorates as stock falls 15% After last week's 15% share price decline to JP¥1,806, the stock trades at a trailing P/E ratio of 69.5x. Average trailing P/E is 38x in the Biotechs industry in Asia. Total loss to shareholders of 29% over the past year. New Risk • Dec 04
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 37% 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 (17% average weekly change). Earnings are forecast to decline by an average of 37% per year for the foreseeable future. Valuation Update With 7 Day Price Move • Oct 09
Investor sentiment improves as stock rises 24% After last week's 24% share price gain to JP¥1,727, the stock trades at a trailing P/E ratio of 75.8x. Average trailing P/E is 63x in the Biotechs industry in Japan. Total returns to shareholders of 17% over the past year. Buy Or Sell Opportunity • Oct 03
Now 27% overvalued Over the last 90 days, the stock has fallen 45% to JP¥1,526. The fair value is estimated to be JP¥1,198, however this is not to be taken as a sell recommendation but rather should be used as a guide only. Announcement • Jul 31
Heartseed Inc. to Report Q3, 2025 Results on Sep 11, 2025 Heartseed Inc. announced that they will report Q3, 2025 results on Sep 11, 2025 Announcement • Apr 23
Heartseed Inc. to Report Q2, 2025 Results on Jun 12, 2025 Heartseed Inc. announced that they will report Q2, 2025 results on Jun 12, 2025 Announcement • Feb 03
Heartseed Announces Enrollment Completion in Phase 1/2 Clinical Trial Using HS-001, an Investigational Stem Cell-Derived Therapy for Advanced Heart Failure Heartseed Inc. announced the completion of patient enrollment for the 5th patient in high-dose arm, marking the 10th and final patient enrolled in its Phase I/II clinical trial (LAPiS Study) for HS-001, an allogeneic iPS cell-derived cardiomyocyte spheroid product for advanced heart failure due to ischaemic heart disease. As stated in the press release dated October 1, 2024, the Safety Monitoring Committee reviewed the safety data of the first patient in the high-dose cohort (150 million cardiomyocytes) of the LAPiS Study and recommended the continuation of enrollment for the high-dose group. Following this, patient dosing progressed smoothly, and the enrollment of all patients in the LAPiS Study has now been completed. About HS-001 and LAPiS Study: HS-001, is an allogeneic iPSC-derived, highly purified ventricular cardiomyocyte product formulated in spheroids. The micro-tissue-like spheroid preparation increases retention rate and viability of the cell graft. The spheroids are transplanted using a special administration needle (SEEDPLANTER®) and guide adapter developed for safe and efficient administration during open heart surgery. There are two expected mechanisms of action. Firstly, that the transplanted cardiomyocytes electrically couple with the patient's myocardium, improving cardiac output by remuscularization. Second, that secretion of angiogenic factors from the graft causes new blood vessel development around the transplant site (neovascularization). The LAPiS Study is a 52-week, phase 1/2, open-label, dose-escalation trial designed to evaluate the safety and efficacy of HS-001 in patients with advanced heart failure caused by ischaemic heart disease. Conducted at multiple sites in Japan, the study has successfully completed enrollment of 10 patients, divided into two cohorts: 5 in the low-dose group (50 million cardiomyocytes) and 5 in the high-dose group (150 million cardiomyocytes). HS-001 was transplanted into the diseased heart during scheduled open-heart surgeries (coronary artery bypass grafting). The primary endpoint of the study is safety at 26 weeks post-transplantation. Secondary efficacy endpoints, assessed at 26 and 52 weeks, include Left Ventricular Ejection Fraction and myocardial wall motion. Announcement • Jan 28
Heartseed Inc. to Report Q1, 2025 Results on Mar 13, 2025 Heartseed Inc. announced that they will report Q1, 2025 results on Mar 13, 2025 Announcement • Dec 13
Heartseed Inc., Annual General Meeting, Jan 24, 2025 Heartseed Inc., Annual General Meeting, Jan 24, 2025. Announcement • Oct 23
Heartseed Inc. to Report Fiscal Year 2024 Results on Dec 12, 2024 Heartseed Inc. announced that they will report fiscal year 2024 results on Dec 12, 2024 Announcement • Oct 18
Heartseed Inc. Revises Earnings Guidance for the Fiscal Year Ending October 31, 2024 Heartseed Inc. revised earnings guidance for the fiscal year ending October 31, 2024. For the year, the company expects net sales of JPY 874 million compared to Previous forecast of JPY 153 million, Operating loss of JPY 1,059 million compared to Previous forecast of JPY 1,965 million, net income of JPY 891 million compared to Previous forecast of JPY 1,798 million, and Net loss Per Shares of JPY 54.32 compared to Previous forecast of JPY 109.09. Announcement • Sep 13
Heartseed Inc. Provides Earnings Guidance for the Fiscal Year Ending October 31, 2024 Heartseed Inc. provided earnings guidance for the fiscal year ending October 31, 2024. For the fiscal year, the company expected net sales of JPY 153 million, Operating loss of JPY 1,965 million, Net loss of JPY 1,798 million and Net loss per share of JPY 109.09. Announcement • Aug 10
Heartseed Inc. to Report Q3, 2024 Results on Sep 12, 2024 Heartseed Inc. announced that they will report Q3, 2024 results on Sep 12, 2024 Announcement • Aug 01
Heartseed Inc. has completed an IPO in the amount of ¥2.089972 billion. Heartseed Inc. has completed an IPO in the amount of ¥2.089972 billion.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 1,413,700
Price\Range: ¥1160
Discount Per Security: ¥92.8
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 388,000
Price\Range: ¥1160
Discount Per Security: ¥92.8
Transaction Features: Sponsor Backed Offering Board Change • Jul 30
Less than half of directors are independent Following the recent departure of a director, there are only 2 independent directors on the board. The company's board is composed of: 2 independent directors. 6 non-independent directors. Independent Outside Director Toshiharu Furukawa was the last independent director to join the board, commencing their role in 2017. The company's minority of independent directors is a risk according to the Simply Wall St Risk Model.