Heartseed（219A）株式概要株式会社ハートシードは、心不全に対するiPS細胞由来の心筋細胞補充療法を開発・商品化している。 詳細219A ファンダメンタル分析スノーフレーク・スコア評価0/6将来の成長2/6過去の実績3/6財務の健全性6/6配当金0/6報酬収益は年間40.96%増加すると予測されています 今年は黒字化を達成 リスク分析最新の財務報告は6か月以上前のものである JP市場と比較した過去 3 か月間の株価の変動すべてのリスクチェックを見る219A Community Fair Values Create NarrativeSee what others think this stock is worth. Follow their fair value or set your own to get alerts.Your Fair ValueJP¥Current PriceJP¥1.67k76.9% 割安 内在価値ディスカウントGrowth estimate overAnnual revenue growth rate5 Yearstime period%/yrDecreaseIncreasePastFuture-1b17b2016201920222025202620282031Revenue JP¥16.8bEarnings JP¥3.3bAdvancedSet Fair ValueView all narrativesHeartseed Inc. 競合他社3-D MatrixSymbol: TSE:7777Market cap: JP¥47.2bPharma Foods InternationalSymbol: TSE:2929Market cap: JP¥16.1bKohjin BioSymbol: TSE:177AMarket cap: JP¥4.6bDaito PharmaceuticalLtdSymbol: TSE:4577Market cap: JP¥34.0b価格と性能株価の高値、安値、推移の概要Heartseed過去の株価現在の株価JP¥1,668.0052週高値JP¥3,925.0052週安値JP¥1,343.00ベータ01ヶ月の変化8.17%3ヶ月変化-10.18%1年変化-38.15%3年間の変化n/a5年間の変化n/aIPOからの変化5.57%最新ニュースNew Risk • Jun 29New minor risk - Financial data availabilityThe 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).お知らせ • Jun 12Heartseed Announces First Patient Dosed In Phase I/II Clinical Trial Of HS-005 For Cardiac Remuscularization TherapyHeartseed 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 08Investor 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.お知らせ • Jun 03Heartseed Inc. to Report Q2, 2026 Results on Aug 14, 2026Heartseed Inc. announced that they will report Q2, 2026 results on Aug 14, 2026Valuation Update With 7 Day Price Move • May 20Investor 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.お知らせ • May 09Heartseed Inc. to Report Q1, 2026 Results on May 15, 2026Heartseed Inc. announced that they will report Q1, 2026 results on May 15, 2026最新情報をもっと見るRecent updatesNew Risk • Jun 29New minor risk - Financial data availabilityThe 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).お知らせ • Jun 12Heartseed Announces First Patient Dosed In Phase I/II Clinical Trial Of HS-005 For Cardiac Remuscularization TherapyHeartseed 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 08Investor 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.お知らせ • Jun 03Heartseed Inc. to Report Q2, 2026 Results on Aug 14, 2026Heartseed Inc. announced that they will report Q2, 2026 results on Aug 14, 2026Valuation Update With 7 Day Price Move • May 20Investor 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.お知らせ • May 09Heartseed Inc. to Report Q1, 2026 Results on May 15, 2026Heartseed Inc. announced that they will report Q1, 2026 results on May 15, 2026お知らせ • Feb 14Heartseed Inc. Provides Non-Consolidated Earnings Guidance for the Fiscal Year Ending December 31, 2026Heartseed 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.お知らせ • Feb 13Heartseed Inc., Annual General Meeting, Mar 27, 2026Heartseed Inc., Annual General Meeting, Mar 27, 2026.お知らせ • Dec 27Heartseed Inc. to Report Fiscal Year 2025 Results on Feb 13, 2026Heartseed Inc. announced that they will report fiscal year 2025 results on Feb 13, 2026Valuation Update With 7 Day Price Move • Dec 22Investor 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 04New major risk - Revenue and earnings growthEarnings 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 09Investor 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 03Now 27% overvaluedOver 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.お知らせ • Jul 31Heartseed Inc. to Report Q3, 2025 Results on Sep 11, 2025Heartseed Inc. announced that they will report Q3, 2025 results on Sep 11, 2025分析記事 • May 26Here's Why We're Not At All Concerned With Heartseed's (TSE:219A) Cash Burn SituationJust because a business does not make any money, does not mean that the stock will go down. For example, although...お知らせ • Apr 23Heartseed Inc. to Report Q2, 2025 Results on Jun 12, 2025Heartseed Inc. announced that they will report Q2, 2025 results on Jun 12, 2025お知らせ • Feb 03Heartseed Announces Enrollment Completion in Phase 1/2 Clinical Trial Using HS-001, an Investigational Stem Cell-Derived Therapy for Advanced Heart FailureHeartseed 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.分析記事 • Jan 30Here's Why We're Not At All Concerned With Heartseed's (TSE:219A) Cash Burn SituationWe can readily understand why investors are attracted to unprofitable companies. For example, although...お知らせ • Jan 28Heartseed Inc. to Report Q1, 2025 Results on Mar 13, 2025Heartseed Inc. announced that they will report Q1, 2025 results on Mar 13, 2025お知らせ • Dec 13Heartseed Inc., Annual General Meeting, Jan 24, 2025Heartseed Inc., Annual General Meeting, Jan 24, 2025.お知らせ • Oct 23Heartseed Inc. to Report Fiscal Year 2024 Results on Dec 12, 2024Heartseed Inc. announced that they will report fiscal year 2024 results on Dec 12, 2024お知らせ • Oct 18Heartseed Inc. Revises Earnings Guidance for the Fiscal Year Ending October 31, 2024Heartseed 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.お知らせ • Sep 13Heartseed Inc. Provides Earnings Guidance for the Fiscal Year Ending October 31, 2024Heartseed 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.お知らせ • Aug 10Heartseed Inc. to Report Q3, 2024 Results on Sep 12, 2024Heartseed Inc. announced that they will report Q3, 2024 results on Sep 12, 2024お知らせ • Aug 01Heartseed 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 OfferingBoard Change • Jul 30Less than half of directors are independentFollowing 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.株主還元219AJP BiotechsJP 市場7D13.6%6.7%-3.0%1Y-38.2%-27.5%40.2%株主還元を見る業界別リターン: 219A過去 1 年間で-27.5 % の収益を上げたJP Biotechs業界を下回りました。リターン対市場: 219Aは、過去 1 年間で40.2 % のリターンを上げたJP市場を下回りました。価格変動Is 219A's price volatile compared to industry and market?219A volatility219A Average Weekly Movement8.3%Biotechs Industry Average Movement7.9%Market Average Movement4.4%10% most volatile stocks in JP Market9.3%10% least volatile stocks in JP Market2.3%安定した株価: 219Aの株価は、 JP市場と比較して過去 3 か月間で変動しています。時間の経過による変動: 219Aの weekly volatility ( 8% ) は過去 1 年間安定していますが、依然としてJPの株式の 75% よりも高くなっています。会社概要設立従業員CEO（最高経営責任者ウェブサイト2015n/aKeiichi Fukudawww.heartseed.jpHeartseed Inc.は、心不全に対するiPS細胞由来の心筋細胞補充療法を開発・商品化している。同社の主力製品は、拡張型心筋症、陳旧性心筋梗塞、肥大型心筋症の拡張期など、駆出率が低下した心不全を適応症とするHS-001である。また、自己iPS細胞やHLAノックアウトiPS細胞を用いた製品の開発も行っている。加えて、分化誘導、大量培養、精製、心筋球生成技術も提供している。同社は2015年に法人化され、東京に本社を置いている。もっと見るHeartseed Inc. 基礎のまとめHeartseed の収益と売上を時価総額と比較するとどうか。219A 基礎統計学時価総額JP¥38.15b収益（TTM）JP¥592.50m売上高(TTM)JP¥3.03b64.4xPER（株価収益率12.6xP/Sレシオ219A は割高か？公正価値と評価分析を参照収益と収入最新の決算報告書（TTM）に基づく主な収益性統計219A 損益計算書（TTM）収益JP¥3.03b売上原価JP¥0売上総利益JP¥3.03bその他の費用JP¥2.43b収益JP¥592.50m直近の収益報告Oct 31, 2025次回決算日Aug 14, 2026一株当たり利益（EPS）25.90グロス・マージン100.00%純利益率19.58%有利子負債／自己資本比率0%219A の長期的なパフォーマンスは？過去の実績と比較を見るView Valuation企業分析と財務データの現状データ最終更新日（UTC時間）企業分析2026/06/30 23:26終値2026/06/30 00:00収益2025/10/31年間収益2025/10/31データソース企業分析に使用したデータはS&P Global Market Intelligence LLC のものです。本レポートを作成するための分析モデルでは、以下のデータを使用しています。データは正規化されているため、ソースが利用可能になるまでに時間がかかる場合があります。パッケージデータタイムフレーム米国ソース例会社財務10年損益計算書キャッシュ・フロー計算書貸借対照表SECフォーム10-KSECフォーム10-Qアナリストのコンセンサス予想+プラス3年予想財務アナリストの目標株価アナリストリサーチレポートBlue Matrix市場価格30年株価配当、分割、措置ICEマーケットデータSECフォームS-1所有権10年トップ株主インサイダー取引SECフォーム4SECフォーム13Dマネジメント10年リーダーシップ・チーム取締役会SECフォーム10-KSECフォームDEF 14A主な進展10年会社からのお知らせSECフォーム8-K* 米国証券を対象とした例であり、非米国証券については、同等の規制書式および情報源を使用。特に断りのない限り、すべての財務データは1年ごとの期間に基づいていますが、四半期ごとに更新されます。これは、TTM（Trailing Twelve Month）またはLTM（Last Twelve Month）データとして知られています。詳細はこちら。分析モデルとスノーフレークこのレポートを生成するために使用した分析モデルの詳細は、当社の Github ページ でご覧いただけます。また、レポートの使い方に関する ガイド や YouTube の チュートリアル もご用意しています。シンプリー・ウォールストリート分析モデルを設計・構築した世界トップクラスのチームについてご紹介します。業界およびセクターの指標私たちの業界とセクションの指標は、Simply Wall Stによって6時間ごとに計算されます。アナリスト筋Heartseed Inc. 1 これらのアナリストのうち、弊社レポートのインプットとして使用した売上高または利益の予想を提出したのは、 。アナリストの投稿は一日中更新されます。1 アナリスト機関Motoya KohtaniMizuho Securities Co., Ltd.
New Risk • Jun 29New minor risk - Financial data availabilityThe 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).
お知らせ • Jun 12Heartseed Announces First Patient Dosed In Phase I/II Clinical Trial Of HS-005 For Cardiac Remuscularization TherapyHeartseed 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 08Investor 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.
お知らせ • Jun 03Heartseed Inc. to Report Q2, 2026 Results on Aug 14, 2026Heartseed Inc. announced that they will report Q2, 2026 results on Aug 14, 2026
Valuation Update With 7 Day Price Move • May 20Investor 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.
お知らせ • May 09Heartseed Inc. to Report Q1, 2026 Results on May 15, 2026Heartseed Inc. announced that they will report Q1, 2026 results on May 15, 2026
New Risk • Jun 29New minor risk - Financial data availabilityThe 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).
お知らせ • Jun 12Heartseed Announces First Patient Dosed In Phase I/II Clinical Trial Of HS-005 For Cardiac Remuscularization TherapyHeartseed 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 08Investor 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.
お知らせ • Jun 03Heartseed Inc. to Report Q2, 2026 Results on Aug 14, 2026Heartseed Inc. announced that they will report Q2, 2026 results on Aug 14, 2026
Valuation Update With 7 Day Price Move • May 20Investor 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.
お知らせ • May 09Heartseed Inc. to Report Q1, 2026 Results on May 15, 2026Heartseed Inc. announced that they will report Q1, 2026 results on May 15, 2026
お知らせ • Feb 14Heartseed Inc. Provides Non-Consolidated Earnings Guidance for the Fiscal Year Ending December 31, 2026Heartseed 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.
お知らせ • Feb 13Heartseed Inc., Annual General Meeting, Mar 27, 2026Heartseed Inc., Annual General Meeting, Mar 27, 2026.
お知らせ • Dec 27Heartseed Inc. to Report Fiscal Year 2025 Results on Feb 13, 2026Heartseed Inc. announced that they will report fiscal year 2025 results on Feb 13, 2026
Valuation Update With 7 Day Price Move • Dec 22Investor 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 04New major risk - Revenue and earnings growthEarnings 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 09Investor 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 03Now 27% overvaluedOver 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.
お知らせ • Jul 31Heartseed Inc. to Report Q3, 2025 Results on Sep 11, 2025Heartseed Inc. announced that they will report Q3, 2025 results on Sep 11, 2025
分析記事 • May 26Here's Why We're Not At All Concerned With Heartseed's (TSE:219A) Cash Burn SituationJust because a business does not make any money, does not mean that the stock will go down. For example, although...
お知らせ • Apr 23Heartseed Inc. to Report Q2, 2025 Results on Jun 12, 2025Heartseed Inc. announced that they will report Q2, 2025 results on Jun 12, 2025
お知らせ • Feb 03Heartseed Announces Enrollment Completion in Phase 1/2 Clinical Trial Using HS-001, an Investigational Stem Cell-Derived Therapy for Advanced Heart FailureHeartseed 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.
分析記事 • Jan 30Here's Why We're Not At All Concerned With Heartseed's (TSE:219A) Cash Burn SituationWe can readily understand why investors are attracted to unprofitable companies. For example, although...
お知らせ • Jan 28Heartseed Inc. to Report Q1, 2025 Results on Mar 13, 2025Heartseed Inc. announced that they will report Q1, 2025 results on Mar 13, 2025
お知らせ • Dec 13Heartseed Inc., Annual General Meeting, Jan 24, 2025Heartseed Inc., Annual General Meeting, Jan 24, 2025.
お知らせ • Oct 23Heartseed Inc. to Report Fiscal Year 2024 Results on Dec 12, 2024Heartseed Inc. announced that they will report fiscal year 2024 results on Dec 12, 2024
お知らせ • Oct 18Heartseed Inc. Revises Earnings Guidance for the Fiscal Year Ending October 31, 2024Heartseed 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.
お知らせ • Sep 13Heartseed Inc. Provides Earnings Guidance for the Fiscal Year Ending October 31, 2024Heartseed 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.
お知らせ • Aug 10Heartseed Inc. to Report Q3, 2024 Results on Sep 12, 2024Heartseed Inc. announced that they will report Q3, 2024 results on Sep 12, 2024
お知らせ • Aug 01Heartseed 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 30Less than half of directors are independentFollowing 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.
