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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. 공시 • 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. 공시 • 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 공시 • 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. 
