VivoSim Labs（4OR）株式概要バイオテクノロジー企業であるVivoSim Labs, Inc.は、ヒト疾患の主要な側面を再現する3D組織の開発に注力している。 詳細4OR 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0/6過去の実績0/6財務の健全性6/6配当金0/6報酬過去5年間の収益は年間6.9%増加しました。 リスク分析意味のある時価総額がありません ( €3M )株式の流動性は非常に低い 収益が 100 万ドル未満 ( $144K )過去1年間で株主の希薄化は大幅に進んだ すべてのリスクチェックを見る4OR Community Fair Values Create NarrativeSee what others think this stock is worth. Follow their fair value or set your own to get alerts.NEW473,437 membersJoin community and earn perksGain real feedbackFrom our editorial team, personally. Not silence.Grow your followingReal investors. The kind who actually invest, not scroll past.Unlock free accessFree premium subscription for consistent and quality authors.Learn moreCreate NarrativeBLINRODA473,437 investors already sharing narrativesYour Fair Value€Current Price€2.6529.0k% 割高 内在価値ディスカウントGrowth estimate overAnnual revenue growth rate5 Yearstime period%/yrDecreaseIncreasePastFuture-39m5m2016201920222025202620282031Revenue US$27.7kEarnings US$5.0kAdvancedSet Fair ValueView all narrativesVivoSim Labs, Inc. 競合他社EpigenomicsSymbol: DB:ECXMarket cap: €868.2kNovogeniaSymbol: MUN:7V0Market cap: €72.0mGenetic AnalysisSymbol: DB:8V8Market cap: €43.7mbioXXmedSymbol: DB:T5OMarket cap: €258.3k価格と性能株価の高値、安値、推移の概要VivoSim Labs過去の株価現在の株価US$2.6552週高値US$23.4052週安値US$2.53ベータ1.041ヶ月の変化0%3ヶ月変化-33.68%1年変化-73.11%3年間の変化-87.45%5年間の変化-97.60%IPOからの変化-99.73%最新ニュースお知らせ • Aug 03VivoSim Labs, Inc., Annual General Meeting, Sep 30, 2026VivoSim Labs, Inc., Annual General Meeting, Sep 30, 2026.お知らせ • Jul 17VivoSim Labs, Inc. announced that it expects to receive $4.000001 million in fundingVivoSim Labs, Inc. announced that it has entered into a securities purchase agreement with a single healthcare focused institutional investor for the purchase and sale of 4,705,883 common shares (or common stock equivalents in lieu thereof) pre funded warrants to purchase up to 4,705,883 shares of common stock at an issue price of $0.85 for gross proceeds of $4,000,000.55 and accompanying common warrant on July 16, 2026. The warrants will have an exercise price of $0.85 per share, will become exercisable immediately following receipt of shareholder approval and will expire five years from the initial exercise date. The closing of the offering is expected to occur on or about July 17, 2026, subject to the satisfaction of customary closing conditions. The offer and sale of the foregoing securities is being made in reliance on an exemption from the registration requirement under Section 4(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”), and/or Regulation D promulgated thereunder, and applicable state securities laws, and the securities have not been and will not initially be registered under the Securities Act, or applicable state securities laws. Accordingly, the securities may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws.お知らせ • Jul 15Vivosim Labs, Inc. Provides Revenue Guidance for Fiscal Year 2027VivoSim Labs, Inc. provided revenue guidance for fiscal year 2027. For the period, the company stated that it anticipates revenue growth of more than 500% revenue growth in the fiscal year, due to customer response to the predictive power of its NAMs models, which are building traction with a wide set of customers.お知らせ • Jun 30VivoSim Labs, Inc. announced delayed annual 10-K filingOn 06/29/2026, VivoSim Labs, Inc. announced that they will be unable to file their next 10-K by the deadline required by the SEC.お知らせ • Jun 29Vivosim Labs Demonstrates Superiority of Ai-Enabled Namkind Liver and Intestine Platforms in Liver Toxicity Prediction At European Toxicology MeetingVivoSim Labs, Inc. announced that data demonstrating the power of its advanced 3D human tissue models will be featured in two presentations at the European Society of Toxicology’s annual conference. The presentations collectively showcase the best-in-industry predictive power of VivoSim's proprietary AI-enabled NAMkind Liver and NAMkind GI platforms. In liver toxicology testing, across a set of compounds where animal models and traditional methods provide 50% to 65% sensitivity, VivoSim’s models provided greater than 90% sensitivity at detecting true positives for liver toxicity. Whereas current methodologies including animal in vivo testing can result in greater than 10% false positives, VivoSim’s liver toxicology methods result in fewer than 5% false positives. The United States Food and Drug Administration is actively encouraging human-relevant NAMs in place of animal studies, a push that is resulting in greater pharma demand for new technologies. VivoSim’s novel models offer perhaps the most predictive tool to make FDA’s vision a reality. VivoSim’s superior results are achieved by a combination of the best biological model with the most representative primary human cell types, leveraging multiple endpoints as readouts for best prediction, and training AI prediction models with multiple endpoints that provide a rich data set, yielding high prediction accuracy. In addition to testing traditional oral pill small molecules, VivoSim is establishing competitive advantages across new biotech modalities such as antibodies, siRNA, and gene therapies. The company has done extensive testing of Antibody Drug Conjugates (ADCs), with comparable accuracy results in terms of predicting the clinical profiles of ADCs for liver toxicity and diarrhea. Globally, hundreds of ADC candidates are now in active clinical development against over 50 molecular targets — 41 of them already in Phase III — and the pipeline remains overwhelmingly oncology-focused, led by HER2- and TROP2-directed programs in breast and lung cancer. Therapies still fail in human trials, most often on safety or efficacy. The findings show that the Company’s human-relevant models can predict liver and gastrointestinal toxicity — for both traditional small molecules and complex antibody-drug conjugates (ADCs) — with accuracy that tracks real clinical outcomes. The data are being presented at The 23rd International Congress of the European Society of Toxicology In Vitro (ESTIV 2026) in Maastricht, the Netherlands, which takes place from June 29 to July 2, 2026. Key highlights of the presented data demonstrating VivoSim’s ability to achieve definitive translational signatures across complex organ systems: High-Accuracy Liver Profiling: Benchmarked against a clinical small-molecule dataset of 92 compounds, the NAMkind Liver spheroid model achieved a predictive accuracy of 91%, with 90% sensitivity, 95% specificity, and 99% precision under repeat-dose conditions. The multi-endpoint profiling suite effectively minimized false negatives and successfully resolved intra-class toxicities, such as within thiazolidinediones (TZDs). Mechanistic GI Insights: Using the multicellular human intestinal barrier model (NAMkind GI), VivoSim successfully integrated multiple endpoints including barrier function to resolve distinct mechanistic classes of tyrosine kinase inhibitor (TKI)-induced diarrhea. Deconvolution of ADC Toxicity: Critically, both platforms demonstrated a unique capacity to evaluate advanced modalities by differentiating ADC risk based on structural properties. The GI model established that Trastuzumab-deruxtecan-mediated injury is exposure-dependent and payload-driven through detailed histological tracking. Meanwhile, the Liver model successfully differentiated hepatic risk based on linker stability and payload permeability when comparing Trastuzumab Emtansine and Trastuzumab Deruxtecan.お知らせ • Apr 30VivoSim Labs, Inc. Announces Availability of AI Prediction Tool Leveraging NAMkind Intestinal ModelsVivoSim Labs, Inc. had announced the availability of an AI prediction tool leveraging its NAMkind intestinal models to accurately predict the potential of a given drug compound to cause diarrhea in patients. The tool integrates its proprietary NAMkind ileum and colon tissues with advanced machine-learning analytics to identify drug-induced disruptions to intestinal epithelial integrity and function. Tissue-based assay data is used to train an AI predictive model in a process VivoSim has named VitroSense. The model was built using a training set of dozens of compounds. Using high-quality real-world 3d NAM assay results generated from the set of training compounds, the model attained a predictive accuracy of 96% for potential diarrhea. For a novel compound being investigated for the first time, such as from a client, multiple data endpoints are measured in NAMkind intestine assays and these data are fed into the AI prediction model to generate an overall assessment of diarrhea risk. VitroSense – the use of NAMkind-produced data to train predictive machine learning models. NAMkind intestine models allow for mimicking oral or IV administration route, and are excellent for antibody drug conjugate testing. Because of the advanced nature of the NAMkind intestinal model, the multilayered structure can be dosed either by mimicking oral administration or intravenous administration by exposing the relevant portion of the tissue – the epithelial lining or the stromal layer. As recently demonstrated at Society of Toxicology, NAMkind intestine models were also tested with antibody-drug conjugates (ADCs) and have the ability to detect differential effects such as antibody activity on epithelium, payload impact on epithelium, and overall ADC impact on epithelium. Permeability endpoints are sensitive to the exact chemical compound, be it ADC, antibody alone, or payload. VivoSim is now working with clients to provide an effective screen for effects on the intestinal epithelium for oncology ADC candidates. NAMKind liver and small intestine toxicology services are now available in US, Europe, and via local distributor engagement across Korea and China, with VivoSim continuing to scale capacity to support expanding global demand and urgent, real-world development needs.最新情報をもっと見るRecent updatesお知らせ • Aug 03VivoSim Labs, Inc., Annual General Meeting, Sep 30, 2026VivoSim Labs, Inc., Annual General Meeting, Sep 30, 2026.お知らせ • Jul 17VivoSim Labs, Inc. announced that it expects to receive $4.000001 million in fundingVivoSim Labs, Inc. announced that it has entered into a securities purchase agreement with a single healthcare focused institutional investor for the purchase and sale of 4,705,883 common shares (or common stock equivalents in lieu thereof) pre funded warrants to purchase up to 4,705,883 shares of common stock at an issue price of $0.85 for gross proceeds of $4,000,000.55 and accompanying common warrant on July 16, 2026. The warrants will have an exercise price of $0.85 per share, will become exercisable immediately following receipt of shareholder approval and will expire five years from the initial exercise date. The closing of the offering is expected to occur on or about July 17, 2026, subject to the satisfaction of customary closing conditions. The offer and sale of the foregoing securities is being made in reliance on an exemption from the registration requirement under Section 4(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”), and/or Regulation D promulgated thereunder, and applicable state securities laws, and the securities have not been and will not initially be registered under the Securities Act, or applicable state securities laws. Accordingly, the securities may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws.お知らせ • Jul 15Vivosim Labs, Inc. Provides Revenue Guidance for Fiscal Year 2027VivoSim Labs, Inc. provided revenue guidance for fiscal year 2027. For the period, the company stated that it anticipates revenue growth of more than 500% revenue growth in the fiscal year, due to customer response to the predictive power of its NAMs models, which are building traction with a wide set of customers.お知らせ • Jun 30VivoSim Labs, Inc. announced delayed annual 10-K filingOn 06/29/2026, VivoSim Labs, Inc. announced that they will be unable to file their next 10-K by the deadline required by the SEC.お知らせ • Jun 29Vivosim Labs Demonstrates Superiority of Ai-Enabled Namkind Liver and Intestine Platforms in Liver Toxicity Prediction At European Toxicology MeetingVivoSim Labs, Inc. announced that data demonstrating the power of its advanced 3D human tissue models will be featured in two presentations at the European Society of Toxicology’s annual conference. The presentations collectively showcase the best-in-industry predictive power of VivoSim's proprietary AI-enabled NAMkind Liver and NAMkind GI platforms. In liver toxicology testing, across a set of compounds where animal models and traditional methods provide 50% to 65% sensitivity, VivoSim’s models provided greater than 90% sensitivity at detecting true positives for liver toxicity. Whereas current methodologies including animal in vivo testing can result in greater than 10% false positives, VivoSim’s liver toxicology methods result in fewer than 5% false positives. The United States Food and Drug Administration is actively encouraging human-relevant NAMs in place of animal studies, a push that is resulting in greater pharma demand for new technologies. VivoSim’s novel models offer perhaps the most predictive tool to make FDA’s vision a reality. VivoSim’s superior results are achieved by a combination of the best biological model with the most representative primary human cell types, leveraging multiple endpoints as readouts for best prediction, and training AI prediction models with multiple endpoints that provide a rich data set, yielding high prediction accuracy. In addition to testing traditional oral pill small molecules, VivoSim is establishing competitive advantages across new biotech modalities such as antibodies, siRNA, and gene therapies. The company has done extensive testing of Antibody Drug Conjugates (ADCs), with comparable accuracy results in terms of predicting the clinical profiles of ADCs for liver toxicity and diarrhea. Globally, hundreds of ADC candidates are now in active clinical development against over 50 molecular targets — 41 of them already in Phase III — and the pipeline remains overwhelmingly oncology-focused, led by HER2- and TROP2-directed programs in breast and lung cancer. Therapies still fail in human trials, most often on safety or efficacy. The findings show that the Company’s human-relevant models can predict liver and gastrointestinal toxicity — for both traditional small molecules and complex antibody-drug conjugates (ADCs) — with accuracy that tracks real clinical outcomes. The data are being presented at The 23rd International Congress of the European Society of Toxicology In Vitro (ESTIV 2026) in Maastricht, the Netherlands, which takes place from June 29 to July 2, 2026. Key highlights of the presented data demonstrating VivoSim’s ability to achieve definitive translational signatures across complex organ systems: High-Accuracy Liver Profiling: Benchmarked against a clinical small-molecule dataset of 92 compounds, the NAMkind Liver spheroid model achieved a predictive accuracy of 91%, with 90% sensitivity, 95% specificity, and 99% precision under repeat-dose conditions. The multi-endpoint profiling suite effectively minimized false negatives and successfully resolved intra-class toxicities, such as within thiazolidinediones (TZDs). Mechanistic GI Insights: Using the multicellular human intestinal barrier model (NAMkind GI), VivoSim successfully integrated multiple endpoints including barrier function to resolve distinct mechanistic classes of tyrosine kinase inhibitor (TKI)-induced diarrhea. Deconvolution of ADC Toxicity: Critically, both platforms demonstrated a unique capacity to evaluate advanced modalities by differentiating ADC risk based on structural properties. The GI model established that Trastuzumab-deruxtecan-mediated injury is exposure-dependent and payload-driven through detailed histological tracking. Meanwhile, the Liver model successfully differentiated hepatic risk based on linker stability and payload permeability when comparing Trastuzumab Emtansine and Trastuzumab Deruxtecan.お知らせ • Apr 30VivoSim Labs, Inc. Announces Availability of AI Prediction Tool Leveraging NAMkind Intestinal ModelsVivoSim Labs, Inc. had announced the availability of an AI prediction tool leveraging its NAMkind intestinal models to accurately predict the potential of a given drug compound to cause diarrhea in patients. The tool integrates its proprietary NAMkind ileum and colon tissues with advanced machine-learning analytics to identify drug-induced disruptions to intestinal epithelial integrity and function. Tissue-based assay data is used to train an AI predictive model in a process VivoSim has named VitroSense. The model was built using a training set of dozens of compounds. Using high-quality real-world 3d NAM assay results generated from the set of training compounds, the model attained a predictive accuracy of 96% for potential diarrhea. For a novel compound being investigated for the first time, such as from a client, multiple data endpoints are measured in NAMkind intestine assays and these data are fed into the AI prediction model to generate an overall assessment of diarrhea risk. VitroSense – the use of NAMkind-produced data to train predictive machine learning models. NAMkind intestine models allow for mimicking oral or IV administration route, and are excellent for antibody drug conjugate testing. Because of the advanced nature of the NAMkind intestinal model, the multilayered structure can be dosed either by mimicking oral administration or intravenous administration by exposing the relevant portion of the tissue – the epithelial lining or the stromal layer. As recently demonstrated at Society of Toxicology, NAMkind intestine models were also tested with antibody-drug conjugates (ADCs) and have the ability to detect differential effects such as antibody activity on epithelium, payload impact on epithelium, and overall ADC impact on epithelium. Permeability endpoints are sensitive to the exact chemical compound, be it ADC, antibody alone, or payload. VivoSim is now working with clients to provide an effective screen for effects on the intestinal epithelium for oncology ADC candidates. NAMKind liver and small intestine toxicology services are now available in US, Europe, and via local distributor engagement across Korea and China, with VivoSim continuing to scale capacity to support expanding global demand and urgent, real-world development needs.お知らせ • Mar 28VivoSim Labs, Inc. has filed a Follow-on Equity Offering.VivoSim Labs, Inc. has filed a Follow-on Equity Offering. Security Name: Common Stock Security Type: Common Stock Securities Offered: 2,366,862 Security Name: Common Warrants Security Type: Equity Warrant Securities Offered: 3,550,293お知らせ • Mar 25VivoSim Labs, Inc. Releases Antibody Drug Conjugate Data and Validates NAMkind Models for ADC Toxicity PredictionVivoSim Labs, Inc. announced at the Society of Toxicology (“SOT”) meeting in San Diego, CA, that its NAMkind™ liver and NAMkind™ Intestine models have been validated for predicting toxicity and side effect profiles of antibody drug conjugates (ADCs). When considering the hundreds of ADCs in development across the globe, the potential for off-target toxicity due to their common use in oncology to deliver cytotoxic payloads, and a lack of current available scientific solutions to separate anticancer activity from unwanted cytotoxicity, the Company believes that the use of NAMkind™ models becomes a powerful tool to use in conjunction with existing methods to select and improve the best ADC candidates for drug development. Testing of approved ADC therapies in NAMkind™models shows close correlation with clinical results. VivoSim NAMkind™ liver model was shown to clearly see the toxicity of liver toxic ADCs such as gemtuzumab ozogomicin and clearly showed drugs with low liver toxicity such as enfortumab vedotin as lacking liver toxicity. Issues of linker cleavage and target engagement can be studied, as differential toxicity between drugs like trastuzumab emtansine and trastuzumab deruxtecan were demonstrated with strong comparability to clinical outcomes. NAMkind™ intestine models were also validated with ADCs and have the ability to detect differential effects such as antibody activity on epithelium, payload impact on epithelium, and overall ADC impact on epithelium. Permeability endpoints are sensitive to the exact chemical compound, be it ADC, antibody alone, or payload. NAMKind™ liver and small intestine toxicology services are now available in the US, Europe, and via local distributor engagement across Korea and China, with VivoSim continuing to scale capacity to support expanding global demand and urgent, real-world development needs.お知らせ • Feb 11VivoSim to Debut Antibody Drug Conjugate Data, Representing A Major New Market for Namkind Models, At Society of Toxicology Meeting in San DiegoVivoSim Labs, Inc. announced it will attend the Society of Toxicology meeting in San Diego, CA that takes place March 22-25 and present new data on its NAMkind liver and NAMkind Intestine model, including data on validating the models for use in predicting toxicity and side effect profiles of antibody drug conjugates (ADCs). Considering the hundreds of ADCs in development across the globe, the potential for off target toxicity due to their common use in oncology to deliver cytotoxic payloads, and a lack of current available scientific solutions to separate anticancer activity from unwanted cytotoxicity, the use of NAMkind models becomes a powerful tool to use in conjunction with existing methods to select and improve the best ADC candidates for drug development. VivoSim NAMkind models can reveal details of target engagement in organ tissues, premature linker cleavage, biomarker effects and more in complex human cell models that replicate much of the target tissue biology in a controlled experimental setting. Testing of approved ADC therapies in NAMkind models shows close correlation with clinical results. NAMkind models have now been tested against a wide set of marketed ADC molecules, showing close correlation with clinical results in terms of the toxic impact in the liver and side effect profile in the intestine (causing diarrhea). These results will be presented for the first time at SOT in San Diego. NAMkind liver and small intestine toxicology services are now available in US, Europe, and via local distributor engagement across Korea and China, with VivoSim continuing to scale capacity to support expanding global demand and urgent, real-world development needs.お知らせ • Jan 07VivoSim Labs, Inc. Appoints Amar Sethi as Chief Scientific OfficerVivoSim Labs, Inc. has appointed Dr. Amar Sethi, M.D., Ph.D. as its Chief Scientific Officer. Dr. Sethi is a transformational R&D executive with three decades of experience encompassing pharmaceutical drug development, CRO leadership, translational medicine, and diagnostic innovation. He has led global Phase I–IV clinical programs, FDA breakthrough and orphan drug designations, BLA filings, and advanced biomarker strategies across metabolic disorders, nephrology, hematology, rare diseases, and cardiovascular biology. His expertise includes establishing CAP/CLIA/GCP/GLP-compliant infrastructures, scaling bioanalytical and biomarker teams, and guiding scientific strategy for both early and late-stage assets. At VivoSim, Dr. Sethi will lead scientific strategy across toxicology, translational models, bioanalytics, and next-generation new approach methodologies (NAMs) methodologies. He will expand the company’s biomarker and mechanistic insight capabilities, strengthen scientific governance for pharmaceutical sponsors, and collaborate closely with R&D, platform engineering, and AI teams to enhance multi-parametric toxicity prediction using human-relevant systems. Dr. Sethi’s career bridges drug-development leadership with biomarker innovation. At Omeros Corp, he led a pivotal global Phase 3 program for a Breakthrough Therapy/Orphan-designated biologic and supported multiple monoclonal antibody programs now approved or advancing into late stages. As President & Chief Medical Officer of Pacific Biomarkers, he drove 70% business growth, led successful M&A initiatives, and developed FDA-qualified novel biomarker platforms, including a gold-standard Acute Kidney Injury panel uniquely qualified by the FDA. His tenure at NIH and Copenhagen University Hospitals further established him as a scientific authority in clinical chemistry, cardiometabolic research, and translational diagnostics.お知らせ • Nov 04VivoSim Labs, Inc., Annual General Meeting, Dec 16, 2025VivoSim Labs, Inc., Annual General Meeting, Dec 16, 2025.お知らせ • Sep 26VivoSim Labs, Inc. has withdrawn its Follow-on Equity Offering.VivoSim Labs, Inc. has withdrawn its Follow-on Equity Offering. Security Name: Common Stock Security Type: Common Stock Security Name: Pre-Funded Warrants Security Type: Equity Warrant Security Name: Warrants Security Type: Equity Warrantお知らせ • Aug 14VivoSim Labs, Inc. Appoints Tony Lialin as Chief Commercial OfficerVivoSim Labs, Inc. announced that it has appointed Tony Lialin as its Chief Commercial Officer. Mr. Lialin brings more than two decades of experience turning breakthrough life science platforms into scalable, predictable revenue. He has built commercial teams from the ground up, forged strategic pharma partnerships, and helped scale multiple businesses that were later acquired by leading industry players. At VivoSim Labs, he will lead go-to-market strategy, partnerships, and the expansion of the Company’s San Diego-based services that combine organ-specific 3D models with AI-driven analytics to deliver decision-ready insights earlier in development.お知らせ • May 07VivoSim Labs, Inc. Presents Best-In-Class Liver Toxicology Prediction Results at Digestive Disease Week ConferenceVivoSim Labs, Inc. announced that its NAMkind platform for liver toxicology prediction, provided as a commercial service to pharmaceutical companies, was featured in an oral presentation at the Digestive Disease Week Conference (San Diego, CA, May 2-6, 2025) showing best-in-class predictive power against a set of test liver compounds. VivoSim's liver predictive power was shown to be 87.5% for a set of challenging liver toxicity cases - inclusive of classic cases of "liver tox misses" drugs with unforeseen liver toxicity found in clinical trials or drugs that were withdrawn from the market after liver toxicity issues emerged later. The platform identified correctly that 87.5% of the known liver-toxic drugs could be seen as liver toxic using NAMkind liver. This is known as the sensitivity of the platform, which at 87.5% is a world's best. VivoSim's NAMkind liver model is a physical organoid wet lab model of liver made using cells from human donors. VivoSim is also developing what it believes will be industry-best in silico predictions of liver tox. Artificial intelligence (AI) models in VivoSim's NAM kind™? services suite will be trained on extensive set of proprietary, real-world data from organoid models made from human donor cells, giving much richer and more extensive information than is possible with data from human clinical trials. VivoSim offers liver and intestinal toxicology insights using its premier new approach methodologies (NAM) models, following the announcement of FDA to phase out animal testing requirements in favor of these non-animal NAM methods. The FDA's push to phase out animal models, announced on April 10, is expected to provide a powerful accelerant to VivoSim's market adoption, disrupting a >$10B animal testing market with models that are more predictive and ethically sound. VivoSim has the capability to help transform the way drug development is done. By substantially reducing failures in clinical trials, the company believes it can help reduce the cost of development per approved drug by 50% across the industry. As a result of the inability to fully predict liver toxicity, a number of drugs still fail clinical trials at late stages or are pulled from the market after launch due to unforeseen liver toxicity. VivoSim believes it will cut the incidence of such events by 50% or more. VivoSim's N AMkind™? intestine models can also deliver readouts on endpoints that are not available to industry scientists selecting from many candidate drug molecules. As a result of the lack of such tools, a cancer patient might suffer nausea, vomiting, or intestinal problems, or a patient's needed chemotherapy dose might be lower than it could be due to such conditions. VivoSim aims to provide transformative solutions for these challenges. The FDA has laid out ambitious goals to phase out animal testing requirements as much as possible. VivoSim is launching to fill in the much-needed gap in commercially available solutions. The technology exists to achieve according to FDA Commissioner Marty A. Makary's vision, which he expressed in March 2025 with the rollout of FDA's push to move away from animal testing and towards NAM models. By leveraging AI-based computational modeling, human organ model-based lab testing, and. Any forward-looking statements contained herein are based on current expectations but are subject to a number of risks and uncertainties.お知らせ • Apr 24Vivosim Labs, Inc. Announces Emergence from Stealth Mode to Provide Technologies for FDA Turn Away from Animal Models, $10B+ MarketVivoSim Labs, Inc. announced that it has emerged from stealth mode to dramatically impact drug discovery and development. VivoSim will offer liver and intestinal toxicology insights using its premier new approach methodologies (NAM) models, following the announcement of the FDA to phase out animal testing requirements in favor of these non-animal NAM methods. The FDA's push to phase out animal models, announced on April 10, is expected to provide a powerful accelerant to VivoSim's market adoption, disrupting a > $10 billion animal testing market with models that are more predictive and ethically sound. VivoSim's models include physical organoid wet lab models of liver and intestine made using cells from human donor. VivoSim is developing what it believes will be industry-best in silico predictions of liver tox, intestinal tox, and permeability. Artificial intelligence (AI) models in VivoSim's NAMkind™? services suite will be trained on an extensive set of proprietary, real world data from organoid models made from human donor cells, giving much richer and more extensive information than is possible with data from human clinical trials. VivoSim has the capability to help transform the way drug development is done. By substantially reducing failures in clinical trials, the company believes it can help reduce the cost of development per approved drug by 50% across the industry. In development testing, VivoSim's NAM kind liver model produced liver toxicology results across a wide set of positive and negative control compounds that resulted in an industry best correlation rate with known clinical failures. As a result of the inability to fully predict liver toxicity, a number of drugs still fail clinical trials at late stages or are pulled from the market after launch due to unforeseen liver toxicity. VivoSim believes it will cut the incidence of such events by 50% or more. VivoSim's NAM Kind intestine models can deliver readouts that are not available to industry scientists selecting from many candidate drug molecules. As a result of the lack of such tools, a cancer patient might suffer nausea, vomiting, or intestinal problems, or a patient's needed chemotherapy dose might be lower than it could be due to such conditions. VivoSim aims to provide transformative solutions for these challenges. The FDA has laid out ambitious goals to phase out animal testing requirements as much as possible. VivoSim is launching to fill in the much-needed gap in commercially available solutions. The technology exists to achieve this according to FDA Commissioner Makary's vision. VivoSim is delivering on the promise of this vision, and will use its proprietary methods and cutting edge capabilities for NAMkind models that displace use of animals and provide superior outcomes for its pharmaceutical customers, ultimately delivering for on the end goal of providing better solutions for patients.お知らせ • Apr 02Organovo Provides Update on Nasdaq Continued Listing RequirementsOrganovo Holdings, Inc. gave guidance that, as its common stock has been trading above the $1.00 minimum bid price required, it expects to meet the requirements for continued listing on the Nasdaq Capital Market should the closing price of its common stock remain at similar levels. Nasdaq Compliance Update: The Company further clarified it expects to meet all requirements for continued listing on the Nasdaq Capital Market. The Company’s common stock has closed above the $1.00 minimum bid price requirement since March 21, 2025 and believes it has met the minimum stockholder equity requirements of continued listing, pending Nasdaq confirmation. Nasdaq requires a minimum of 10 consecutive trading days where the stock closes at a minimum bid price of $1.00, and the Company has closed above $1.00 since March 21, 2025.お知らせ • Mar 27+ 1 more updateEli Lilly and Company (NYSE:LLY) completed the acquisition of FXR Program and Related Assets of Organovo Holdings, Inc. (NasdaqCM:ONVO).Eli Lilly and Company (NYSE:LLY) entered into an asset purchase agreement to acquire FXR Program and Related Assets of Organovo Holdings, Inc. (NasdaqCM:ONVO) for $60 million on February 23, 2025. The consideration consist of (i) an upfront cash payment equal to $10.0 million, of which $9.0 million will be paid at closing and the remaining $1.0 million will be deposited into escrow for 15 months to satisfy any claims for indemnification under the Purchase Agreement, (ii) the assumption by Lilly of certain liabilities related to the FXR program, and (iii) potential milestone payments of up to $50 million in the aggregate, which are contingent upon the achievement of certain development, regulatory and commercial milestones. The Asset Sale is expected to close within approximately 30 days following the signing of the Purchase Agreement. Samantha Eldredge, Lucas Rachuba, Todd Schneider and Jeff Hartlin of Paul Hastings LLP acted as legal advisor for Organovo Holdings, Inc. Jeffrey D. Osterman, Joe Pari, John O'Loughlin, Matthew J. Gilroy, Regina Readling, Phillip D. Grudzina, and Adam Sternberg of Weil, Gotshal & Manges LLP acted as legal advisor for Eli Lilly and Company. Eli Lilly and Company (NYSE:LLY) completed the acquisition of FXR Program and Related Assets of Organovo Holdings, Inc. (NasdaqCM:ONVO) on March 25, 2025.お知らせ • Mar 20Organovo Announces Reverse Stock Split to Regain Compliance with Minimum Bid PriceOrganovo Holdings, Inc. announced that it will effect a 1-for-12 reverse stock split of its issued and outstanding common stock that will become effective at 5:00 p.m. Eastern Time on March 20, 2025. Organovo’s common stock will commence trading on a reverse stock split-adjusted basis at the opening of the market on March 21, 2025. The reverse stock split is intended for Organovo to regain compliance with the minimum bid price requirement of $1.00 per share of common stock for continued listing on the Nasdaq Capital Market.お知らせ • Feb 26Eli Lilly and Company (NYSE:LLY) entered into an asset purchase agreement to acquire FXR Program and Related Assets of Organovo Holdings, Inc. (NasdaqCM:ONVO) for $60 million.Eli Lilly and Company (NYSE:LLY) entered into an asset purchase agreement to acquire FXR Program and Related Assets of Organovo Holdings, Inc. (NasdaqCM:ONVO) for $60 million on February 23, 2025. The consideration consist of (i) an upfront cash payment equal to $10.0 million, of which $9.0 million will be paid at closing and the remaining $1.0 million will be deposited into escrow for 15 months to satisfy any claims for indemnification under the Purchase Agreement, (ii) the assumption by Lilly of certain liabilities related to the FXR program, and (iii) potential milestone payments of up to $50 million in the aggregate, which are contingent upon the achievement of certain development, regulatory and commercial milestones. The Asset Sale is expected to close within approximately 30 days following the signing of the Purchase Agreement. Samantha Eldredge and Jeff Hartlin of Paul Hastings LLP acted as legal advisor for Organovo Holdings, Inc. Matthew Gilroy of Weil, Gotshal & Manges LLP acted as legal advisor for Eli Lilly and Company.お知らせ • Feb 15Organovo Holdings, Inc. announced delayed 10-Q filingOn 02/14/2025, Organovo Holdings, Inc. announced that they will be unable to file their next 10-Q by the deadline required by the SEC.お知らせ • Jan 18Organovo Holdings, Inc. Provides Non-Compliance UpdateAs previously reported, on July 18, 2024, Organovo Holdings, Inc., a Delaware corporation (the Company"), received a written notice (the Notice") from the Listing Qualifications Staff (the Staff") of The Nasdaq Stock Market LLC (Nasdaq") indicating that, based upon the closing bid price of the Company's common stock for the last 30 consecutive business days, the Company no longer met the requirement to maintain a minimum bid price of $1 per share, as set in Nasdaq Listing Rule 5550(a)(2) (Rule 5550(a)(2)"). In accordance with Nasdaq Listing Rule 5810(c)(3)(A), the Company was provided an initial period of 180 calendar days, or until January 14, 2025, to regain compliance. On January 16, 2025, the Staff provided a notice to the Company (the Nasdaq Notice") that the Company had not regained compliance with Rule 5550(a)(2) and is not eligible for a second 180 calendar day compliance period as the Company does not comply with the requirements for initial listing on The Nasdaq Capital Market. The Nasdaq Notice further indicated that, unless the Company timely requests a hearing before a Hearings Panel (the Panel"), the Company's common stock would be subject to delisting. As a result, the Company intends to timely request a hearing. The hearing request will automatically stay any delisting or suspension action pending the hearing and the expiration of any extension period granted by the Panel following the hearing. In that regard, pursuant to the Nasdaq Listing Rules, the Panel has the discretion to grant a further extension not to exceed July 15, 2025. Following the hearing request, the Company's common stock will continue to be listed on The Nasdaq Capital Market under the symbol ONVO." The Company intends to present its plan to the Panel, which compliance plan is expected to include conducting a reverse stock split if necessary to regain compliance with Rule 5550(a)(2). However, there can be no assurance that the Panel will grant a further extension or that the Company will ultimately regain compliance with all applicable requirements for continued listing on The Nasdaq Capital Market.お知らせ • Jan 02Organovo Holdings, Inc. Announces Chief Financial Officer ChangesOn December 30, 2024, the Board of Directors of Organovo Holdings, Inc. appointed Norman Staskey, age 55, as the Company’s Chief Financial Officer, effective December 30, 2024, in connection with the resignation of Tomas Hess. In this role, Mr. Staskey will serve as the Company’s principal accounting officer and principal financial officer. The Company believes that Mr. Staskey’s experience will be a strong addition to the Company’s leadership, in particular his background in mergers and acquisitions activity given the Company’s interest in potential strategic transactions involving other pharmaceutical companies. The Company currently engages Danforth Advisors, LLC, a financial consulting firm, pursuant to the terms of that certain consulting agreement, dated August 25, 2020, by and between the Company and Danforth, as amended (the “Consulting Agreement”), to provide Chief Financial Officer consulting services on a part-time basis for the Company, and Mr. Staskey will provide his part time services under such agreement. The Company employs full time internal senior finance staff to assure continuity. With Danforth’s assistance, the Company has identified Mr. Staskey as a strong executive to serve as the Company’s President, Chief Financial Officer and Principal Financial Officer. Mr. Staskey is a seasoned executive with significant experience in managing and leading teams as well as overseeing the financial and operational responsibilities of private and publicly traded life sciences companies. He has served as a Senior Director of Danforth since May 2021. Mr. Staskey has served as the Chief Financial Officer of Azitra, Inc. since October 2022. From September 2014 to May 2021, Mr. Staskey was employed by EY (formally Ernst & Young), most recently as a managing director in EY’s Financial Accounting and Advisory services practice. Mr. Staskey received his B.S. of Business Administration from Cleveland State University and is a Certified Public Accountant in the State of Ohio. On December 23, 2024, Mr. Hess, the Company’s former Chief Financial Officer, notified the Company of his intent to resign and resigned effective December 24, 2024, from his part-time role to pursue retirement. Mr. Hess’s resignation is not a result of any disagreement with the Company or any matter relating to its accounting or financial policies or procedures.お知らせ • Nov 20Organovo Holdings, Inc. Presents Clinical Data of FXR314 in Phase 2 MASH in an Oral Presentation at The Liver MeetingOrganovo Holdings, Inc. announced that its oral presentation of its lead clinical stage drug FXR314 by Dr. Eric Lawitz of the Texas Liver Institute and the University of Texas Health San Antonio was featured at The Liver Meeting, sponsored by the American Association for the Study of Liver Diseases (AASLD). The meeting was held November 15-19, 2024 in San Diego, California. The presentation entitled “Pharmacokinetics, Safety and Efficacy of the Novel Non-bile Acid FXR Agonist FXR314 in Patients with Metabolic Dysfunction-Associated Steatohepatitis: Results from a Phase 2 Study” was presented on Sunday, November 17 in the MASLD and MASH – New therapies session. Dr. Lawitz shared the complete details of the 16-week, randomized, placebo-controlled, multi-center Phase 2 study of FXR314 in MASH patients. A total of 214 patients were randomized in a 1:1:1 ratio to either 3 mg or 6 mg of FXR314, or placebo. Study results demonstrated statistically significant reduction in liver fat content from baseline in patients receiving FXR314 compared to placebo, and a safety profile demonstrating significantly lower pruritus rates than seen with other FXR agonists. Study subjects receiving FXR314 achieved statistically significant reduction in liver fat content from baseline, with LS mean %reduction at end of treatment of 22.8% (p=0.0010) with 3 mg and 17.5% (p=0.0267) with 6 mg doses of FXR314 compared to 6.1% in the placebo group. The proportion of subjects with >30% magnetic resonance imaging-derived proton density fat fraction (MRI-PDFF) reduction was 29.2% (p=0.0023) and 32.2% (p=0.0020) for 3 mg and 6 mg FXR314, respectively, compared to 9.5% with placebo. Investigators observed improvements in hepatocellular damage and liver function based on serological measures, with no evidence of worsening of liver fibrosis. FXR314 was also found to be safe and well tolerated. Treatment-emergent adverse events were mostly mild to moderate in severity, with incidence comparable between FXR314 3 mg, 6 mg, and placebo. Drug-related treatment discontinuation was low in frequency and similar across groups. FXR314 did not demonstrate significant adverse events typical of the FXR class, including pruritus (3 mg 2.8%, 6 mg 4.2% and placebo 2.8%) and LDL-C levels (change from baseline of 1.5%, 4.5% and -3.6% for 3mg, 6mg, and placebo groups respectively).お知らせ • Sep 19Organovo Holdings, Inc., Annual General Meeting, Nov 20, 2024Organovo Holdings, Inc., Annual General Meeting, Nov 20, 2024.New Risk • Aug 06New major risk - Financial positionThe company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -US$12m 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 (-US$12m free cash flow). Share price has been highly volatile over the past 3 months (15% average weekly change). Earnings are forecast to decline by an average of 4.4% per year for the foreseeable future. Shareholders have been substantially diluted in the past year (65% increase in shares outstanding). Revenue is less than US$1m (US$73k revenue). Market cap is less than US$10m (€7.07m market cap, or US$7.71m). Minor Risk Currently unprofitable and not forecast to become profitable next year (US$15m net loss next year).Reported Earnings • Aug 06First quarter 2025 earnings released: US$0.23 loss per share (vs US$0.46 loss in 1Q 2024)First quarter 2025 results: US$0.23 loss per share (improved from US$0.46 loss in 1Q 2024). Net loss: US$3.34m (loss narrowed 17% from 1Q 2024). Revenue is forecast to grow 39% p.a. on average during the next 2 years, compared to a 20% growth forecast for the Biotechs industry in Europe. Over the last 3 years on average, earnings per share has fallen by 4% per year but the company’s share price has fallen by 58% per year, which means it is performing significantly worse than earnings.お知らせ • Jul 25Organovo Holdings Receives Non-Compliance Letter from Nasdaq Regarding Minimum Bid Price RequirementOn July 18, 2024, Organovo Holdings, Inc., a Delaware corporation (the Company"), received a written notice (the Notice") from the Listing Qualifications Staff of the Nasdaq Stock Market LLC (Nasdaq") indicating that, based upon the closing bid price of the Company's common stock for the last 30 consecutive business days, the Company no longer meets the requirement to maintain a minimum bid price of $1 per share, as set forth in Nasdaq Listing Rule 5550(a)(2) (Rule 5550(a)(2)"). In accordance with Nasdaq Listing Rule 5810(c)(3)(A), the Company has been provided with an initial period of 180 calendar days, or until January 14, 2025, to regain compliance. In order to regain compliance with the minimum bid price requirement, the closing bid price of the Company's common stock must be at least $1 per share for a minimum of ten consecutive business days during this 180-day period. The Notice provides that the Nasdaq staff will provide written confirmation to the Company if the Company regains compliance with Rule 5550(a)(2). If the Company does not regain compliance with Rule 5550(a)(2) by January 14, 2025, the Company may be eligible for an additional compliance period of 180 calendar days. To qualify, the Company would be required to meet the continued listing requirement for market value of publicly held shares and all other initial listing standards for the Nasdaq Capital Market, with the exception of the bid price requirement, and would need to provide written notice to Nasdaq of its intention to cure the bid price deficiency during the second compliance period. However, if it appears to the Nasdaq staff that the Company will not be able to cure the deficiency, or if the Company is otherwise not eligible, Nasdaq would notify the Company that its securities will be subject to delisting. In the event of such a notification, the Company may appeal the Nasdaq staff's determination to delist its securities, but there can be no assurance the Nasdaq staff would grant any request for continued listing. The Notice has no immediate effect on the listing or trading of the Company's common stock and the Company's common stock will continue to trade on the Nasdaq Capital Market under the symbol ONVO". The Company intends to monitor the closing bid price of its common stock and consider its available options if its common stock does not trade at a level likely to result in the Company regaining compliance with Rule 5550(a)(2) by January 14, 2025, including effecting a reverse stock split, which would be subject to the prior approval of the Company's stockholders. There can be no assurance that the Company will be able to regain compliance with Nasdaq's minimum bid price requirement or that the Company will maintain its compliance with the other listing requirements necessary for the Company to maintain the listing of its common stock on the Nasdaq Capital Market.New Risk • Jun 13New major risk - Shareholder dilutionThe company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 65% This is considered a major 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 (30% average weekly change). Earnings are forecast to decline by an average of 1.6% per year for the foreseeable future. Shareholders have been substantially diluted in the past year (65% increase in shares outstanding). Revenue is less than US$1m (US$109k revenue). Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (US$15m net loss in 2 years). Market cap is less than US$100m (€12.7m market cap, or US$13.7m).New Risk • Jun 05New major risk - Revenue and earnings growthEarnings are forecast to decline by an average of 1.6% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (30% average weekly change). Earnings are forecast to decline by an average of 1.6% per year for the foreseeable future. Revenue is less than US$1m (US$109k revenue). Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (US$15m net loss in 2 years). Shareholders have been diluted in the past year (49% increase in shares outstanding). Market cap is less than US$100m (€11.9m market cap, or US$12.9m).Reported Earnings • Jun 04Full year 2024 earnings released: US$1.60 loss per share (vs US$1.98 loss in FY 2023)Full year 2024 results: US$1.60 loss per share (improved from US$1.98 loss in FY 2023). Net loss: US$14.7m (loss narrowed 15% from FY 2023). Revenue is forecast to grow 59% p.a. on average during the next 2 years, compared to a 18% growth forecast for the Biotechs industry in Europe. Over the last 3 years on average, earnings per share has fallen by 1% per year but the company’s share price has fallen by 50% per year, which means it is performing significantly worse than earnings.お知らせ • Apr 16Organovo Holdings, Inc. Announces Positive Phase 2 Results for FXR314 in Metabolic Dysfunction-Associated Steatohepatitis Showing Both Reduction in Liver Fat Content and Strong Safety and Tolerability Compared to PlaceboOrganovo Holdings, Inc. released the complete details of its 16-week, randomized, placebo-controlled, multi-center Phase 2 study of the non-steroidal, non-bile acid FXR agonist FXR agonist FXR314 for the treatment of metabolic function-associated steatohepatitis (MASH). Study results demonstrated statistically significant reduction in liver fat content from baseline in patients receiving FXR314 compared to placebo. Study subjects receiving FXR314 achieved statistically significant reduction in liver fat Content from baseline, with LS mean% reduction at end of treatment of 22.8% (p=0.0023) with 3 mg and 17.5% (p=0.0267) with 6 mg doses of FXR314 compared to 6.1% in the placebo group. The proportion of subjects with >30% magnetic resonance imaging-derived proton density fat fraction (MRI-PDFF) reduction was 29.2% (p=0.00023) and 32.2% (p= 0.0020) for 3 mg and 6 mg FXR314, respectively, compared to 9.5% with placebo. Investigators observed improvements in liver function based on serological measures, with no evidence of worsening of liver fibrosis. FXR314 was also found to be safe and well tolerated. There was also no evidence with FXR314 of adverse events considered common in the FXR class, including measures of pruritus (3 mg 2.8%, 6 mg 4.2% and placebo 2.8%) andLDL-C levels (change from baseline of 1.5%, 4.5% and -3.6% for 3mg, 6mg, and placebo groups respectively). The clinical trial evaluated the safety, tolerability, and pharmacological activity of FXR314, as measured by reductions in liver fat content with magnetic resonance imaging-derived pro ton density fat fraction (MRI- PDFF), changes in liver enzymes, low-density lipoprotein cholesterol (LDL-C) levels, and incidence of pruritus. The treatment population were MASH patients diagnosed via biopsy, magnetic resonance elastography (MRE), or transient elastography (TE FibroScan), and who had liver fat content 10% as measured by MRI-PDFF. A total of 214 patients were randomized in a 1:1:1 ratio to either 3 mg or 6 mg of FXR314, or placebo. Treatment was administered orally once daily for 16 weeks. The Company expects that detailed findings of this study (Clinical trial registry NCT047773964) will be presented at an upcoming conference.お知らせ • Apr 13Organovo Holdings, Inc. has filed a Follow-on Equity Offering in the amount of $10 million.Organovo Holdings, Inc. has filed a Follow-on Equity Offering in the amount of $10 million. Security Name: Common Stock Security Type: Common Stock Security Name: Pre-Funded Warrants Security Type: Equity WarrantReported Earnings • Feb 09Third quarter 2024 earnings released: US$0.40 loss per share (vs US$0.38 loss in 3Q 2023)Third quarter 2024 results: US$0.40 loss per share (further deteriorated from US$0.38 loss in 3Q 2023). Net loss: US$3.60m (loss widened 10% from 3Q 2023). Revenue is forecast to grow 40% p.a. on average during the next 3 years, compared to a 13% growth forecast for the Biotechs industry in Germany. Over the last 3 years on average, earnings per share has increased by 3% per year but the company’s share price has fallen by 62% per year, which means it is significantly lagging earnings.お知らせ • Feb 09Organovo Holdings, Inc. has filed a Follow-on Equity Offering in the amount of $2.605728 million.Organovo Holdings, Inc. has filed a Follow-on Equity Offering in the amount of $2.605728 million. Security Name: Common Stock Security Type: Common Stock Transaction Features: At the Market Offeringお知らせ • Jan 25Organovo Holdings, Inc. Presents FXR314 3D Human Tissue Model FindingsOrganovo Holdings, Inc. announced the presentation of preclinical data related to the company's FXR314 development program in its proprietary 3D human tissue models of Crohn's disease and ulcerative colitis at the Crohn's and Colitis Congress being held January 25-27, 2024 in Las Vegas, Nevada. FXR314 is a clinical-stage potent, selective, orally administered non-bile acid FXR agonist being developed as a novel therapeutic approach for IBD. The presentation highlights preclinical data characterizing the activity of FXR314 in 3D models of human Crohn's disease and Ulcerative colitis. FXR314 broadly improved measures of epithelial barrier function in a subset of donors, and fibrotic markers in all Crohn's disease donors. The company plans to begin enrollment for a proof-of-concept Phase 2 ulcerative colitis study in 2024, with targeted completion in 2025. The drug’s additional promise in liver fibrosis and NASH makes it a strong candidate for development in that.New Risk • Jan 05New minor risk - Shareholder dilutionThe company's shareholders have been diluted in the past year. Increase in shares outstanding: 13% 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 Less than 1 year of cash runway based on free cash flow trend (-US$16m free cash flow). Share price has been highly volatile over the past 3 months (18% average weekly change). Revenue is less than US$1m (US$368k revenue). Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (US$18m net loss in 2 years). Shareholders have been diluted in the past year (13% increase in shares outstanding). Market cap is less than US$100m (€10.1m market cap, or US$11.0m).New Risk • Dec 07New major risk - Market cap sizeThe company's market capitalization is less than US$10m. Market cap: €9.26m (US$9.96m) This is considered a major risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. 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 (-US$16m free cash flow). Share price has been highly volatile over the past 3 months (19% average weekly change). Revenue is less than US$1m (US$368k revenue). Market cap is less than US$10m (€9.26m market cap, or US$9.96m). Minor Risk Currently unprofitable and not forecast to become profitable over next 2 years (US$18m net loss in 2 years).お知らせ • Dec 06Organovo Holdings, Inc. Provides Timing for Release of FXR314 Phase 2 NASH ResultsOrganovo Holdings, Inc. announced that it will release final and complete data from a Phase 2a trial of FXR314 in non-alcoholic steatohepatitis (NASH) patients by April 2024. The Company anticipates presentations at scientific meetings as well as publication in peer-reviewed journals. The release of this data will be the first public release of the completed clinical trial data. In an already reported interim analysis of about 60 patients after 16 weeks of treatment, FXR314 lowered liver fat content as demonstrated by a reduction in the median MRI-PDFF score of 28.6% in the 3 mg cohort and 26.9% in the 6 mg group compared with a reduction of only 1.5% in the placebo group. Post-hoc comparative assessment of relative liver fat reduction in the interim cohort found the decrease with 3 mg to be statistically significant compared to placebo (p=0.006). In a measure of activity in individual patients, FXR314 achieved greater than 30% liver fat reduction in 47% of patients (8/17) in the 3 mg cohort and 35% (6/17) in the 6 mg cohort, compared with 12% (2/17) in the placebo arm. FXR314 was generally well-tolerated in this NASH population, with no treatment-related serious adverse events (AEs). All treatment-related AEs were mild-moderate with no apparent dose relationship. Mild-moderate pruritus was reported in one patient in the 3 mg cohort and one patient in the 6 mg cohort. No pruritus-related treatment discontinuations occurred. Organovo plans to begin enrollment for a proof-of-concept Phase 2 ulcerative colitis study in 1H 2024, with targeted completion in 1H 2025. The drug’s additional promise in liver fibrosis and NASH makes it a strong candidate for development in that area through partnership collaborations with Organovo.New Risk • Oct 26New major risk - Market cap sizeThe company's market capitalization is less than US$10m. Market cap: €9.16m (US$9.68m) This is considered a major risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. 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 (-US$16m free cash flow). Share price has been highly volatile over the past 3 months (12% average weekly change). Revenue is less than US$1m (US$445k revenue). Market cap is less than US$10m (€9.16m market cap, or US$9.68m). Minor Risk Currently unprofitable and not forecast to become profitable over next 2 years (US$18m net loss in 2 years).お知らせ • Sep 14Organovo Holdings, Inc., Annual General Meeting, Oct 31, 2023Organovo Holdings, Inc., Annual General Meeting, Oct 31, 2023, at 09:00 Pacific Standard Time. Agenda: To elect each of Keith Murphy and Adam Stern as a Class III director to hold office until the 2026 Annual Meeting of Stockholders and until his respective successor is elected and qualified; to ratify the appointment of Rosenberg Rich Baker Berman P.A. as independent registered public accounting firm for the fiscal year ending March 31, 2024.お知らせ • Aug 24Organovo Holdings, Inc. Advances Clinical Timelines for FXR314 and Provides Updates on NASH Phase 2 DataOrganovo Holdings, Inc. announced more details about its clinical program for FXR314, an FXR agonist that has completed initial clinical trials. FXR314 is a drug with safety and tolerability after daily oral dosing in Phase 1 and Phase 2 trials. Further, FXR314 has FDA clinical trial authorization for a Phase 2 trial in ulcerative colitis. Organovo’s FXR program announcement updates its previous guidance on clinical trial starts for the company, with the Company accelerating its timeline to first clinical trials by approximately two years. The Company previously announced in March 2023 that it would give guidance on Phase 2 timelines for FXR314 after an internal determination of the best path forward. The Company continues to expect to file INDs starting in 2025 for fully internally developed molecules and expects to issue additional guidance on pipeline programs in the coming months. In addition, Organovo is anticipating the release of final Phase 2 data on the performance of FXR314 in NASH. Performance of the drug to date in treatment of NASH has been encouraging. Interim results in Phase 2 showed that FXR314 lowered liver fat content, with mean relative reductions of 26.9±27.8% in the 3 mg cohort and 9.3±55.8% in the 6 mg cohort, compared with 7.5±21.0% in the placebo cohort. Median liver fat reduction was 28.6% in the 3 mg cohort, 26.9% in the 6 mg cohort compared to 1.5% in the placebo arm. A post-hoc comparative assessment of relative liver fat reduction in the interim cohort found the decrease with the 3 mg dose to be statistically significant compared to placebo (p=0.006). FXR314 achieved greater than 30% liver fat reduction in 47% of patients (8/17) in the 3 mg cohort and 35% (6/17) in the 6 mg cohort, compared with 12% (2/17) in the placebo arm. To date, the drug has been generally well-tolerated, with no treatment-related serious adverse events. All treatment-related adverse events have been mild-moderate with no apparent dose relationship. Full Phase 2 data is expected to be released in the first half of 2024.お知らせ • Jun 30Organovo Holdings, Inc. announced delayed annual 10-K filingOn 06/29/2023, Organovo Holdings, Inc. announced that they will be unable to file their next 10-K by the deadline required by the SEC.Board Change • Nov 17High number of new and inexperienced directorsThere are 6 new directors who have joined the board in the last 3 years. The company's board is composed of: 6 new directors. 4 experienced directors. No highly experienced directors. Executive Chairman Keith Murphy is the most experienced director on the board, commencing their role in 2020. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of board continuity. Lack of experienced directors.お知らせ • Nov 16Organovo Announces Target Validation Ahead of Schedule, Accelerating Timeline for First Crohn’s Disease Drug CandidatesOrganovo Holdings, Inc. announced that it has successfully advanced the use of its first inflammatory bowel disease (IBD) model and has achieved the next milestone, target validation. The company announced in May 2022 that it had achieved a successful Crohn’s disease model that demonstrates key aspects of patient biology that differ from a non-diseased state and that the model would be used to find and characterize therapeutics. The Crohn’s disease model has since been utilized to understand the biology of disease and identify specific gene targets. Treating some of those targets, by introducing a compound directly to the 3D tissue model that affects the target, has now been shown to reproducibly reduce disease. Multiple targets are now considered validated, and they represent specific druggable opportunities that the company plans to leverage. Organovo plans to advance at least one target program to medicinal chemistry by the end of 2022 to build a proprietary new drug for Crohn’s disease. More than 1 million people in North America suffer from Crohn’s and its prevalence is increasing globally. Because of its progressive nature, more than 70% will require at least one surgical intervention to relieve symptoms. Current drugs can slow progression in about 50% of patients, but none are curative. Defects in the intestinal lining and inflammation can lead to abdominal pain, severe diarrhea, fatigue, weight loss, malnutrition, and lower quality of life. Chronic inflammation leads to ulcers, fistulas and bowel obstructions caused by fibrosis. Organovo believes that its 3D tissue technologies are well suited to drug and target discovery in IBD because they contain a functional intestinal epithelium that is affected by disease and a stromal layer demonstrating disease-dependent fibrosis, key targets for therapy. The drug discovery process using 3D tissues consists of several stages. Two early steps that are uniquely important in Organovo’s approach to drug discovery are creation of a disease model followed by target discovery and validation.お知らせ • Jul 28Organovo Holdings, Inc., Annual General Meeting, Sep 07, 2022Organovo Holdings, Inc., Annual General Meeting, Sep 07, 2022, at 09:00 Pacific Standard Time. Agenda: To elect each of Douglas Jay Cohen and David Gobel as a Class II director to hold office until the 2025 Annual Meeting of Stockholders and until respective successor is elected and qualified; to ratify the appointment of Mayer Hoffman McCann P.C. as an independent registered public accounting firm for the fiscal year ending March 31, 2023; to approve, on an advisory basis, the compensation of executive officers; to approve the Organovo Holdings, Inc. 2022 Equity Incentive Plan; and to consider other matters if any.お知らせ • May 18Organovo Holdings, Inc. Successfully Advances Its First Inflammatory Bowel Disease Model to the Next Step of Target Discovery and Validation for Crohn’s DiseaseOrganovo Holdings, Inc. announced that it has successfully advanced its first inflammatory bowel disease (IBD) model to the next step of target discovery and validation for Crohn’s disease. Based on its internal data and scientific results, the company believes that its first IBD model correctly demonstrates key aspects of Crohn’s patient biology that differ from a non-diseased state, and can be used to find and characterize therapeutics. More than 1 million people in North America suffer from Crohn’s and its prevalence is increasing globally. Because of its progressive nature, more than 70% will require at least one surgical intervention to relieve symptoms. Current drugs can slow progression in about 50% of patients, but none are curative. Defects in the intestinal lining and inflammation can lead to abdominal pain, severe diarrhea, fatigue, weight loss, malnutrition, and lower quality of life. Chronic inflammation leads to ulcers, fistulas and bowel obstructions caused by fibrosis. Organovo believes that its 3D tissue technologies are well suited to drug and target discovery in IBD because they contain a functional intestinal epithelium that is affected by disease and a stromal layer demonstrating disease-dependent fibrosis, key targets for therapy. Organovo previously announced that it had updated its business model to capitalize on its human 3D tissue technologies in drug discovery, building disease models to find effective therapies that are more likely to succeed in the clinic than drugs discovered using animal models.Board Change • Apr 27High number of new and inexperienced directorsThere are 6 new directors who have joined the board in the last 3 years. The company's board is composed of: 6 new directors. 4 experienced directors. No highly experienced directors. Executive Chairman & Principal Executive Officer Keith Murphy is the most experienced director on the board, commencing their role in 2020. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of board continuity. Lack of experienced directors.お知らせ • Feb 19Organovo Holdings, Inc. Announces the Hiring of Curtis Tyree, PhD, as Sr. Vice President of Strategy and Business DevelopmentOrganovo Holdings, Inc. announced the hiring of Curtis Tyree, PhD, as Sr. Vice President of Strategy and Business Development. Dr. Tyree has more than 20 years of management and R&D experience in the drug discovery industry in a variety of therapeutic areas at Ligand Pharmaceuticals, TorreyPines Therapeutics (previously Neurogenetics) and most recently served as SVP, Strategic Planning at HUYABIO International.お知らせ • Feb 04Organovo Holdings, Inc. Guides on Patent Portfolio and Successful IPR Defense of Two PatentsOrganovo Holdings, Inc. announced that two of its patents have withstood a patent challenge, and the company provided guidance on how it expects to leverage its strong patent portfolio. Organovo holds a powerful foundational patent portfolio in the 3D bioprinting space due to its licensing of pioneering work in the field and early innovations beyond that start. Organovo is focused on bringing inflammatory bowel disease (IBD) drugs to market, with multiple IND filings expected by 2025. However, the company plans to utilize licensing revenue from its patent strength to help fund development costs of new drugs. The company currently expects to achieve millions of dollars of revenue over fiscal year 2022 to fiscal year 2025 combined from licensing its patents within the field. The strength of its patents and growth in the bioprinting industry have made for an attractive business opportunity for the company. Organovo will now begin to invest resources to explore and expand business and revenue opportunities in this area. Organovo exclusively licensed early bioprinting work by Gabor Forgacs, its scientific founder, and Thomas Boland of Clemson, both bioprinting pioneers. After its founding, the company went on to innovate broadly and obtain a broad set of patents that provide formidable foundational claims in the bioprinting space. Third parties recognized Organovo’s bioprinting IP as foundational and innovative as far back as 2015. Two Organovo patents recently stood up to a major challenge. A challenger filed petitions for inter partes review with the Patent Trial and Appeal Board (“PTAB”) in the US Patent and Trade Office, asking the PTAB to invalidate those patents’ claims as obvious. The PTAB rejected the challenges and refused to institute proceedings, which means that the PTAB did not think it was likely that the challenges would be successful. There is no appeal from these decisions. Further, the patents are even stronger now that they have been tested.Board Change • Dec 30High number of new and inexperienced directorsThere are 5 new directors who have joined the board in the last 3 years. The company's board is composed of: 5 new directors. 4 experienced directors. No highly experienced directors. Executive Chairman & Principal Executive Officer Keith Murphy is the most experienced director on the board, commencing their role in 2020. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of board continuity. Lack of experienced directors.お知らせ • Nov 27Organovo Holdings, Inc. Enter into Two Lease Agreements Between Company and San Diego Inspire 1, LLCOrganovo Holdings, Inc. entered into two Lease Agreements, by and between company and San Diego Inspire 1, LLC, pursuant to which the company will temporarily lease approximately 3,212 square feet of office space (the “Temporary Lease”) located at 11585 Sorrento Valley Road, Suite 106, San Diego, California 92121 (the “Temporary Premises”), and will permanently lease approximately 8,051 square feet of office space (the “Permanent Lease”) at 11555 Sorrento Valley Road, Suite 100, San Diego, California 92121 (the “Permanent Premises”) once the tenant improvements for the Permanent Premises have been completed and it is ready for occupancy. The Temporary Lease commences on November 27, 2020 and is intended to serve as the Temporary Premises for approximately seven months, and is projected to terminate on June 30, 2021, provided that the Permanent Premises are completed and ready for company’s occupancy. In addition, under the Temporary Lease Agreement, the company will be required to pay a base rent of approximately $13,008.60 per month, for the seven months of the Temporary Lease term. The company will also be required pay its share of operating expenses, taxes and any other expenses payable under the Temporary Lease Agreement. The Permanent Lease is projected to commence on July 1, 2021 and is intended to serve as the Permanent Premises for approximately sixty-two months, expiring on August 31, 2026. In addition, under the Permanent Lease Agreement, the company has an option to extend the term of Lease Agreement for a five-year period. The company will be required to pay an initial base rent of approximately $31,398.90 per month, for the first twelve months of the Permanent Lease term, which will increase at a rate of approximately 3.08% per year. The company will also be required pay its share of operating expenses, taxes and any other expenses payable under the Permanent Lease Agreement.お知らせ • Sep 05Organovo Regains Compliance with Nasdaq Minimum Bid Price RequirementOrganovo Holdings, Inc. announced that it has regained compliance with the minimum bid price requirement for continued listing on The Nasdaq Capital Market (the “Minimum Bid Price Requirement”). On September 2, 2020, Organovo received a letter from the Listing Qualifications Department of The Nasdaq Stock Market, Inc. stating that because Organovo’s common stock had a closing bid price at or above $1.00 per share for a minimum of ten (10) consecutive business days, Organovo had regained compliance with the Minimum Bid Price Requirement and that Nasdaq had closed the matter.お知らせ • Jul 05Organovo Holdings, Inc.(NasdaqCM:ONVO) dropped from Russell Microcap Growth IndexOrganovo Holdings, Inc.(NasdaqCM:ONVO) dropped from Russell Microcap Growth Indexお知らせ • Jul 02Organovo Holdings, Inc.(NasdaqCM:ONVO) dropped from Russell Microcap IndexOrganovo Holdings, Inc.(NasdaqCM:ONVO) dropped from Russell Microcap Index株主還元4ORDE BiotechsDE 市場7D0%-0.6%0.2%1Y-73.1%5.4%3.6%株主還元を見る業界別リターン: 4OR過去 1 年間で5.4 % の収益を上げたGerman Biotechs業界を下回りました。リターン対市場: 4ORは、過去 1 年間で3.6 % のリターンを上げたGerman市場を下回りました。価格変動Is 4OR's price volatile compared to industry and market?4OR volatility4OR Average Weekly Movementn/aBiotechs Industry Average Movement6.6%Market Average Movement5.3%10% most volatile stocks in DE Market12.7%10% least volatile stocks in DE Market2.7%安定した株価: 4ORの株価は、 German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: 過去 1 年間の4ORのボラティリティの変化を判断するには データが不十分です。会社概要設立従業員CEO（最高経営責任者ウェブサイト20079n/avivosim.aiバイオテクノロジー企業であるVivoSim Labs, Inc.は、ヒト疾患の主要な側面を再現する3D組織の開発に注力している。同社の3Dヒト組織プラットフォームには、哺乳類細胞で構成される3D生体組織の作製を可能にする自動装置である同社独自のNovoGenバイオプリンターや、バイオインクの調製、複雑な構造を持つ多細胞組織のバイオプリンティングのための関連技術が含まれる。同社の主要候補はFXR314で、潰瘍性大腸炎を中心とする炎症性腸疾患を適応症とする第2/3相臨床試験中であり、脂肪肝炎を中心とする肝線維症を適応症とする第1相臨床試験を完了した。オルガノボ・ホールディングスは、ノボジェン・バイオプリンターの研究に関して、イェール大学医学部、オレゴン健康科学大学ナイト癌研究所、バージニア大学と共同研究を行っている。同社は以前はオルガノボ・ホールディングス社として知られていたが、2025年4月に社名をビボシム・ラボ社に変更した。同社は2007年に法人化され、カリフォルニア州サンディエゴに本社を置いている。もっと見るVivoSim Labs, Inc. 基礎のまとめVivoSim Labs の収益と売上を時価総額と比較するとどうか。4OR 基礎統計学時価総額€3.46m収益（TTM）-€2.15m売上高(TTM)€124.53k27.8xP/Sレシオ-1.6xPER（株価収益率4OR 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4OR 損益計算書（TTM）収益US$144.00k売上原価US$5.03m売上総利益-US$4.89mその他の費用-US$2.40m収益-US$2.49m直近の収益報告Mar 31, 2025次回決算日該当なし一株当たり利益（EPS）-0.96グロス・マージン-3,393.06%純利益率-1,727.78%有利子負債／自己資本比率0%4OR 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2025/06/17 06:49終値2025/03/20 00:00収益2025/03/31年間収益2025/03/31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、レポートの活用方法に関するガイドやYouTubeのチュートリアルも用意しています。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VivoSim Labs, Inc. 0 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。9 アナリスト機関Sean LavinBTIGCaroline CornerCantor Fitzgerald & Co.Jose De Jesus HarescoCitizens JMP Securities, LLC6 その他のアナリストを表示
お知らせ • Aug 03VivoSim Labs, Inc., Annual General Meeting, Sep 30, 2026VivoSim Labs, Inc., Annual General Meeting, Sep 30, 2026.
お知らせ • Jul 17VivoSim Labs, Inc. announced that it expects to receive $4.000001 million in fundingVivoSim Labs, Inc. announced that it has entered into a securities purchase agreement with a single healthcare focused institutional investor for the purchase and sale of 4,705,883 common shares (or common stock equivalents in lieu thereof) pre funded warrants to purchase up to 4,705,883 shares of common stock at an issue price of $0.85 for gross proceeds of $4,000,000.55 and accompanying common warrant on July 16, 2026. The warrants will have an exercise price of $0.85 per share, will become exercisable immediately following receipt of shareholder approval and will expire five years from the initial exercise date. The closing of the offering is expected to occur on or about July 17, 2026, subject to the satisfaction of customary closing conditions. The offer and sale of the foregoing securities is being made in reliance on an exemption from the registration requirement under Section 4(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”), and/or Regulation D promulgated thereunder, and applicable state securities laws, and the securities have not been and will not initially be registered under the Securities Act, or applicable state securities laws. Accordingly, the securities may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws.
お知らせ • Jul 15Vivosim Labs, Inc. Provides Revenue Guidance for Fiscal Year 2027VivoSim Labs, Inc. provided revenue guidance for fiscal year 2027. For the period, the company stated that it anticipates revenue growth of more than 500% revenue growth in the fiscal year, due to customer response to the predictive power of its NAMs models, which are building traction with a wide set of customers.
お知らせ • Jun 30VivoSim Labs, Inc. announced delayed annual 10-K filingOn 06/29/2026, VivoSim Labs, Inc. announced that they will be unable to file their next 10-K by the deadline required by the SEC.
お知らせ • Jun 29Vivosim Labs Demonstrates Superiority of Ai-Enabled Namkind Liver and Intestine Platforms in Liver Toxicity Prediction At European Toxicology MeetingVivoSim Labs, Inc. announced that data demonstrating the power of its advanced 3D human tissue models will be featured in two presentations at the European Society of Toxicology’s annual conference. The presentations collectively showcase the best-in-industry predictive power of VivoSim's proprietary AI-enabled NAMkind Liver and NAMkind GI platforms. In liver toxicology testing, across a set of compounds where animal models and traditional methods provide 50% to 65% sensitivity, VivoSim’s models provided greater than 90% sensitivity at detecting true positives for liver toxicity. Whereas current methodologies including animal in vivo testing can result in greater than 10% false positives, VivoSim’s liver toxicology methods result in fewer than 5% false positives. The United States Food and Drug Administration is actively encouraging human-relevant NAMs in place of animal studies, a push that is resulting in greater pharma demand for new technologies. VivoSim’s novel models offer perhaps the most predictive tool to make FDA’s vision a reality. VivoSim’s superior results are achieved by a combination of the best biological model with the most representative primary human cell types, leveraging multiple endpoints as readouts for best prediction, and training AI prediction models with multiple endpoints that provide a rich data set, yielding high prediction accuracy. In addition to testing traditional oral pill small molecules, VivoSim is establishing competitive advantages across new biotech modalities such as antibodies, siRNA, and gene therapies. The company has done extensive testing of Antibody Drug Conjugates (ADCs), with comparable accuracy results in terms of predicting the clinical profiles of ADCs for liver toxicity and diarrhea. Globally, hundreds of ADC candidates are now in active clinical development against over 50 molecular targets — 41 of them already in Phase III — and the pipeline remains overwhelmingly oncology-focused, led by HER2- and TROP2-directed programs in breast and lung cancer. Therapies still fail in human trials, most often on safety or efficacy. The findings show that the Company’s human-relevant models can predict liver and gastrointestinal toxicity — for both traditional small molecules and complex antibody-drug conjugates (ADCs) — with accuracy that tracks real clinical outcomes. The data are being presented at The 23rd International Congress of the European Society of Toxicology In Vitro (ESTIV 2026) in Maastricht, the Netherlands, which takes place from June 29 to July 2, 2026. Key highlights of the presented data demonstrating VivoSim’s ability to achieve definitive translational signatures across complex organ systems: High-Accuracy Liver Profiling: Benchmarked against a clinical small-molecule dataset of 92 compounds, the NAMkind Liver spheroid model achieved a predictive accuracy of 91%, with 90% sensitivity, 95% specificity, and 99% precision under repeat-dose conditions. The multi-endpoint profiling suite effectively minimized false negatives and successfully resolved intra-class toxicities, such as within thiazolidinediones (TZDs). Mechanistic GI Insights: Using the multicellular human intestinal barrier model (NAMkind GI), VivoSim successfully integrated multiple endpoints including barrier function to resolve distinct mechanistic classes of tyrosine kinase inhibitor (TKI)-induced diarrhea. Deconvolution of ADC Toxicity: Critically, both platforms demonstrated a unique capacity to evaluate advanced modalities by differentiating ADC risk based on structural properties. The GI model established that Trastuzumab-deruxtecan-mediated injury is exposure-dependent and payload-driven through detailed histological tracking. Meanwhile, the Liver model successfully differentiated hepatic risk based on linker stability and payload permeability when comparing Trastuzumab Emtansine and Trastuzumab Deruxtecan.
お知らせ • Apr 30VivoSim Labs, Inc. Announces Availability of AI Prediction Tool Leveraging NAMkind Intestinal ModelsVivoSim Labs, Inc. had announced the availability of an AI prediction tool leveraging its NAMkind intestinal models to accurately predict the potential of a given drug compound to cause diarrhea in patients. The tool integrates its proprietary NAMkind ileum and colon tissues with advanced machine-learning analytics to identify drug-induced disruptions to intestinal epithelial integrity and function. Tissue-based assay data is used to train an AI predictive model in a process VivoSim has named VitroSense. The model was built using a training set of dozens of compounds. Using high-quality real-world 3d NAM assay results generated from the set of training compounds, the model attained a predictive accuracy of 96% for potential diarrhea. For a novel compound being investigated for the first time, such as from a client, multiple data endpoints are measured in NAMkind intestine assays and these data are fed into the AI prediction model to generate an overall assessment of diarrhea risk. VitroSense – the use of NAMkind-produced data to train predictive machine learning models. NAMkind intestine models allow for mimicking oral or IV administration route, and are excellent for antibody drug conjugate testing. Because of the advanced nature of the NAMkind intestinal model, the multilayered structure can be dosed either by mimicking oral administration or intravenous administration by exposing the relevant portion of the tissue – the epithelial lining or the stromal layer. As recently demonstrated at Society of Toxicology, NAMkind intestine models were also tested with antibody-drug conjugates (ADCs) and have the ability to detect differential effects such as antibody activity on epithelium, payload impact on epithelium, and overall ADC impact on epithelium. Permeability endpoints are sensitive to the exact chemical compound, be it ADC, antibody alone, or payload. VivoSim is now working with clients to provide an effective screen for effects on the intestinal epithelium for oncology ADC candidates. NAMKind liver and small intestine toxicology services are now available in US, Europe, and via local distributor engagement across Korea and China, with VivoSim continuing to scale capacity to support expanding global demand and urgent, real-world development needs.
お知らせ • Aug 03VivoSim Labs, Inc., Annual General Meeting, Sep 30, 2026VivoSim Labs, Inc., Annual General Meeting, Sep 30, 2026.
お知らせ • Jul 17VivoSim Labs, Inc. announced that it expects to receive $4.000001 million in fundingVivoSim Labs, Inc. announced that it has entered into a securities purchase agreement with a single healthcare focused institutional investor for the purchase and sale of 4,705,883 common shares (or common stock equivalents in lieu thereof) pre funded warrants to purchase up to 4,705,883 shares of common stock at an issue price of $0.85 for gross proceeds of $4,000,000.55 and accompanying common warrant on July 16, 2026. The warrants will have an exercise price of $0.85 per share, will become exercisable immediately following receipt of shareholder approval and will expire five years from the initial exercise date. The closing of the offering is expected to occur on or about July 17, 2026, subject to the satisfaction of customary closing conditions. The offer and sale of the foregoing securities is being made in reliance on an exemption from the registration requirement under Section 4(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”), and/or Regulation D promulgated thereunder, and applicable state securities laws, and the securities have not been and will not initially be registered under the Securities Act, or applicable state securities laws. Accordingly, the securities may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws.
お知らせ • Jul 15Vivosim Labs, Inc. Provides Revenue Guidance for Fiscal Year 2027VivoSim Labs, Inc. provided revenue guidance for fiscal year 2027. For the period, the company stated that it anticipates revenue growth of more than 500% revenue growth in the fiscal year, due to customer response to the predictive power of its NAMs models, which are building traction with a wide set of customers.
お知らせ • Jun 30VivoSim Labs, Inc. announced delayed annual 10-K filingOn 06/29/2026, VivoSim Labs, Inc. announced that they will be unable to file their next 10-K by the deadline required by the SEC.
お知らせ • Jun 29Vivosim Labs Demonstrates Superiority of Ai-Enabled Namkind Liver and Intestine Platforms in Liver Toxicity Prediction At European Toxicology MeetingVivoSim Labs, Inc. announced that data demonstrating the power of its advanced 3D human tissue models will be featured in two presentations at the European Society of Toxicology’s annual conference. The presentations collectively showcase the best-in-industry predictive power of VivoSim's proprietary AI-enabled NAMkind Liver and NAMkind GI platforms. In liver toxicology testing, across a set of compounds where animal models and traditional methods provide 50% to 65% sensitivity, VivoSim’s models provided greater than 90% sensitivity at detecting true positives for liver toxicity. Whereas current methodologies including animal in vivo testing can result in greater than 10% false positives, VivoSim’s liver toxicology methods result in fewer than 5% false positives. The United States Food and Drug Administration is actively encouraging human-relevant NAMs in place of animal studies, a push that is resulting in greater pharma demand for new technologies. VivoSim’s novel models offer perhaps the most predictive tool to make FDA’s vision a reality. VivoSim’s superior results are achieved by a combination of the best biological model with the most representative primary human cell types, leveraging multiple endpoints as readouts for best prediction, and training AI prediction models with multiple endpoints that provide a rich data set, yielding high prediction accuracy. In addition to testing traditional oral pill small molecules, VivoSim is establishing competitive advantages across new biotech modalities such as antibodies, siRNA, and gene therapies. The company has done extensive testing of Antibody Drug Conjugates (ADCs), with comparable accuracy results in terms of predicting the clinical profiles of ADCs for liver toxicity and diarrhea. Globally, hundreds of ADC candidates are now in active clinical development against over 50 molecular targets — 41 of them already in Phase III — and the pipeline remains overwhelmingly oncology-focused, led by HER2- and TROP2-directed programs in breast and lung cancer. Therapies still fail in human trials, most often on safety or efficacy. The findings show that the Company’s human-relevant models can predict liver and gastrointestinal toxicity — for both traditional small molecules and complex antibody-drug conjugates (ADCs) — with accuracy that tracks real clinical outcomes. The data are being presented at The 23rd International Congress of the European Society of Toxicology In Vitro (ESTIV 2026) in Maastricht, the Netherlands, which takes place from June 29 to July 2, 2026. Key highlights of the presented data demonstrating VivoSim’s ability to achieve definitive translational signatures across complex organ systems: High-Accuracy Liver Profiling: Benchmarked against a clinical small-molecule dataset of 92 compounds, the NAMkind Liver spheroid model achieved a predictive accuracy of 91%, with 90% sensitivity, 95% specificity, and 99% precision under repeat-dose conditions. The multi-endpoint profiling suite effectively minimized false negatives and successfully resolved intra-class toxicities, such as within thiazolidinediones (TZDs). Mechanistic GI Insights: Using the multicellular human intestinal barrier model (NAMkind GI), VivoSim successfully integrated multiple endpoints including barrier function to resolve distinct mechanistic classes of tyrosine kinase inhibitor (TKI)-induced diarrhea. Deconvolution of ADC Toxicity: Critically, both platforms demonstrated a unique capacity to evaluate advanced modalities by differentiating ADC risk based on structural properties. The GI model established that Trastuzumab-deruxtecan-mediated injury is exposure-dependent and payload-driven through detailed histological tracking. Meanwhile, the Liver model successfully differentiated hepatic risk based on linker stability and payload permeability when comparing Trastuzumab Emtansine and Trastuzumab Deruxtecan.
お知らせ • Apr 30VivoSim Labs, Inc. Announces Availability of AI Prediction Tool Leveraging NAMkind Intestinal ModelsVivoSim Labs, Inc. had announced the availability of an AI prediction tool leveraging its NAMkind intestinal models to accurately predict the potential of a given drug compound to cause diarrhea in patients. The tool integrates its proprietary NAMkind ileum and colon tissues with advanced machine-learning analytics to identify drug-induced disruptions to intestinal epithelial integrity and function. Tissue-based assay data is used to train an AI predictive model in a process VivoSim has named VitroSense. The model was built using a training set of dozens of compounds. Using high-quality real-world 3d NAM assay results generated from the set of training compounds, the model attained a predictive accuracy of 96% for potential diarrhea. For a novel compound being investigated for the first time, such as from a client, multiple data endpoints are measured in NAMkind intestine assays and these data are fed into the AI prediction model to generate an overall assessment of diarrhea risk. VitroSense – the use of NAMkind-produced data to train predictive machine learning models. NAMkind intestine models allow for mimicking oral or IV administration route, and are excellent for antibody drug conjugate testing. Because of the advanced nature of the NAMkind intestinal model, the multilayered structure can be dosed either by mimicking oral administration or intravenous administration by exposing the relevant portion of the tissue – the epithelial lining or the stromal layer. As recently demonstrated at Society of Toxicology, NAMkind intestine models were also tested with antibody-drug conjugates (ADCs) and have the ability to detect differential effects such as antibody activity on epithelium, payload impact on epithelium, and overall ADC impact on epithelium. Permeability endpoints are sensitive to the exact chemical compound, be it ADC, antibody alone, or payload. VivoSim is now working with clients to provide an effective screen for effects on the intestinal epithelium for oncology ADC candidates. NAMKind liver and small intestine toxicology services are now available in US, Europe, and via local distributor engagement across Korea and China, with VivoSim continuing to scale capacity to support expanding global demand and urgent, real-world development needs.
お知らせ • Mar 28VivoSim Labs, Inc. has filed a Follow-on Equity Offering.VivoSim Labs, Inc. has filed a Follow-on Equity Offering. Security Name: Common Stock Security Type: Common Stock Securities Offered: 2,366,862 Security Name: Common Warrants Security Type: Equity Warrant Securities Offered: 3,550,293
お知らせ • Mar 25VivoSim Labs, Inc. Releases Antibody Drug Conjugate Data and Validates NAMkind Models for ADC Toxicity PredictionVivoSim Labs, Inc. announced at the Society of Toxicology (“SOT”) meeting in San Diego, CA, that its NAMkind™ liver and NAMkind™ Intestine models have been validated for predicting toxicity and side effect profiles of antibody drug conjugates (ADCs). When considering the hundreds of ADCs in development across the globe, the potential for off-target toxicity due to their common use in oncology to deliver cytotoxic payloads, and a lack of current available scientific solutions to separate anticancer activity from unwanted cytotoxicity, the Company believes that the use of NAMkind™ models becomes a powerful tool to use in conjunction with existing methods to select and improve the best ADC candidates for drug development. Testing of approved ADC therapies in NAMkind™models shows close correlation with clinical results. VivoSim NAMkind™ liver model was shown to clearly see the toxicity of liver toxic ADCs such as gemtuzumab ozogomicin and clearly showed drugs with low liver toxicity such as enfortumab vedotin as lacking liver toxicity. Issues of linker cleavage and target engagement can be studied, as differential toxicity between drugs like trastuzumab emtansine and trastuzumab deruxtecan were demonstrated with strong comparability to clinical outcomes. NAMkind™ intestine models were also validated with ADCs and have the ability to detect differential effects such as antibody activity on epithelium, payload impact on epithelium, and overall ADC impact on epithelium. Permeability endpoints are sensitive to the exact chemical compound, be it ADC, antibody alone, or payload. NAMKind™ liver and small intestine toxicology services are now available in the US, Europe, and via local distributor engagement across Korea and China, with VivoSim continuing to scale capacity to support expanding global demand and urgent, real-world development needs.
お知らせ • Feb 11VivoSim to Debut Antibody Drug Conjugate Data, Representing A Major New Market for Namkind Models, At Society of Toxicology Meeting in San DiegoVivoSim Labs, Inc. announced it will attend the Society of Toxicology meeting in San Diego, CA that takes place March 22-25 and present new data on its NAMkind liver and NAMkind Intestine model, including data on validating the models for use in predicting toxicity and side effect profiles of antibody drug conjugates (ADCs). Considering the hundreds of ADCs in development across the globe, the potential for off target toxicity due to their common use in oncology to deliver cytotoxic payloads, and a lack of current available scientific solutions to separate anticancer activity from unwanted cytotoxicity, the use of NAMkind models becomes a powerful tool to use in conjunction with existing methods to select and improve the best ADC candidates for drug development. VivoSim NAMkind models can reveal details of target engagement in organ tissues, premature linker cleavage, biomarker effects and more in complex human cell models that replicate much of the target tissue biology in a controlled experimental setting. Testing of approved ADC therapies in NAMkind models shows close correlation with clinical results. NAMkind models have now been tested against a wide set of marketed ADC molecules, showing close correlation with clinical results in terms of the toxic impact in the liver and side effect profile in the intestine (causing diarrhea). These results will be presented for the first time at SOT in San Diego. NAMkind liver and small intestine toxicology services are now available in US, Europe, and via local distributor engagement across Korea and China, with VivoSim continuing to scale capacity to support expanding global demand and urgent, real-world development needs.
お知らせ • Jan 07VivoSim Labs, Inc. Appoints Amar Sethi as Chief Scientific OfficerVivoSim Labs, Inc. has appointed Dr. Amar Sethi, M.D., Ph.D. as its Chief Scientific Officer. Dr. Sethi is a transformational R&D executive with three decades of experience encompassing pharmaceutical drug development, CRO leadership, translational medicine, and diagnostic innovation. He has led global Phase I–IV clinical programs, FDA breakthrough and orphan drug designations, BLA filings, and advanced biomarker strategies across metabolic disorders, nephrology, hematology, rare diseases, and cardiovascular biology. His expertise includes establishing CAP/CLIA/GCP/GLP-compliant infrastructures, scaling bioanalytical and biomarker teams, and guiding scientific strategy for both early and late-stage assets. At VivoSim, Dr. Sethi will lead scientific strategy across toxicology, translational models, bioanalytics, and next-generation new approach methodologies (NAMs) methodologies. He will expand the company’s biomarker and mechanistic insight capabilities, strengthen scientific governance for pharmaceutical sponsors, and collaborate closely with R&D, platform engineering, and AI teams to enhance multi-parametric toxicity prediction using human-relevant systems. Dr. Sethi’s career bridges drug-development leadership with biomarker innovation. At Omeros Corp, he led a pivotal global Phase 3 program for a Breakthrough Therapy/Orphan-designated biologic and supported multiple monoclonal antibody programs now approved or advancing into late stages. As President & Chief Medical Officer of Pacific Biomarkers, he drove 70% business growth, led successful M&A initiatives, and developed FDA-qualified novel biomarker platforms, including a gold-standard Acute Kidney Injury panel uniquely qualified by the FDA. His tenure at NIH and Copenhagen University Hospitals further established him as a scientific authority in clinical chemistry, cardiometabolic research, and translational diagnostics.
お知らせ • Nov 04VivoSim Labs, Inc., Annual General Meeting, Dec 16, 2025VivoSim Labs, Inc., Annual General Meeting, Dec 16, 2025.
お知らせ • Sep 26VivoSim Labs, Inc. has withdrawn its Follow-on Equity Offering.VivoSim Labs, Inc. has withdrawn its Follow-on Equity Offering. Security Name: Common Stock Security Type: Common Stock Security Name: Pre-Funded Warrants Security Type: Equity Warrant Security Name: Warrants Security Type: Equity Warrant
お知らせ • Aug 14VivoSim Labs, Inc. Appoints Tony Lialin as Chief Commercial OfficerVivoSim Labs, Inc. announced that it has appointed Tony Lialin as its Chief Commercial Officer. Mr. Lialin brings more than two decades of experience turning breakthrough life science platforms into scalable, predictable revenue. He has built commercial teams from the ground up, forged strategic pharma partnerships, and helped scale multiple businesses that were later acquired by leading industry players. At VivoSim Labs, he will lead go-to-market strategy, partnerships, and the expansion of the Company’s San Diego-based services that combine organ-specific 3D models with AI-driven analytics to deliver decision-ready insights earlier in development.
お知らせ • May 07VivoSim Labs, Inc. Presents Best-In-Class Liver Toxicology Prediction Results at Digestive Disease Week ConferenceVivoSim Labs, Inc. announced that its NAMkind platform for liver toxicology prediction, provided as a commercial service to pharmaceutical companies, was featured in an oral presentation at the Digestive Disease Week Conference (San Diego, CA, May 2-6, 2025) showing best-in-class predictive power against a set of test liver compounds. VivoSim's liver predictive power was shown to be 87.5% for a set of challenging liver toxicity cases - inclusive of classic cases of "liver tox misses" drugs with unforeseen liver toxicity found in clinical trials or drugs that were withdrawn from the market after liver toxicity issues emerged later. The platform identified correctly that 87.5% of the known liver-toxic drugs could be seen as liver toxic using NAMkind liver. This is known as the sensitivity of the platform, which at 87.5% is a world's best. VivoSim's NAMkind liver model is a physical organoid wet lab model of liver made using cells from human donors. VivoSim is also developing what it believes will be industry-best in silico predictions of liver tox. Artificial intelligence (AI) models in VivoSim's NAM kind™? services suite will be trained on extensive set of proprietary, real-world data from organoid models made from human donor cells, giving much richer and more extensive information than is possible with data from human clinical trials. VivoSim offers liver and intestinal toxicology insights using its premier new approach methodologies (NAM) models, following the announcement of FDA to phase out animal testing requirements in favor of these non-animal NAM methods. The FDA's push to phase out animal models, announced on April 10, is expected to provide a powerful accelerant to VivoSim's market adoption, disrupting a >$10B animal testing market with models that are more predictive and ethically sound. VivoSim has the capability to help transform the way drug development is done. By substantially reducing failures in clinical trials, the company believes it can help reduce the cost of development per approved drug by 50% across the industry. As a result of the inability to fully predict liver toxicity, a number of drugs still fail clinical trials at late stages or are pulled from the market after launch due to unforeseen liver toxicity. VivoSim believes it will cut the incidence of such events by 50% or more. VivoSim's N AMkind™? intestine models can also deliver readouts on endpoints that are not available to industry scientists selecting from many candidate drug molecules. As a result of the lack of such tools, a cancer patient might suffer nausea, vomiting, or intestinal problems, or a patient's needed chemotherapy dose might be lower than it could be due to such conditions. VivoSim aims to provide transformative solutions for these challenges. The FDA has laid out ambitious goals to phase out animal testing requirements as much as possible. VivoSim is launching to fill in the much-needed gap in commercially available solutions. The technology exists to achieve according to FDA Commissioner Marty A. Makary's vision, which he expressed in March 2025 with the rollout of FDA's push to move away from animal testing and towards NAM models. By leveraging AI-based computational modeling, human organ model-based lab testing, and. Any forward-looking statements contained herein are based on current expectations but are subject to a number of risks and uncertainties.
お知らせ • Apr 24Vivosim Labs, Inc. Announces Emergence from Stealth Mode to Provide Technologies for FDA Turn Away from Animal Models, $10B+ MarketVivoSim Labs, Inc. announced that it has emerged from stealth mode to dramatically impact drug discovery and development. VivoSim will offer liver and intestinal toxicology insights using its premier new approach methodologies (NAM) models, following the announcement of the FDA to phase out animal testing requirements in favor of these non-animal NAM methods. The FDA's push to phase out animal models, announced on April 10, is expected to provide a powerful accelerant to VivoSim's market adoption, disrupting a > $10 billion animal testing market with models that are more predictive and ethically sound. VivoSim's models include physical organoid wet lab models of liver and intestine made using cells from human donor. VivoSim is developing what it believes will be industry-best in silico predictions of liver tox, intestinal tox, and permeability. Artificial intelligence (AI) models in VivoSim's NAMkind™? services suite will be trained on an extensive set of proprietary, real world data from organoid models made from human donor cells, giving much richer and more extensive information than is possible with data from human clinical trials. VivoSim has the capability to help transform the way drug development is done. By substantially reducing failures in clinical trials, the company believes it can help reduce the cost of development per approved drug by 50% across the industry. In development testing, VivoSim's NAM kind liver model produced liver toxicology results across a wide set of positive and negative control compounds that resulted in an industry best correlation rate with known clinical failures. As a result of the inability to fully predict liver toxicity, a number of drugs still fail clinical trials at late stages or are pulled from the market after launch due to unforeseen liver toxicity. VivoSim believes it will cut the incidence of such events by 50% or more. VivoSim's NAM Kind intestine models can deliver readouts that are not available to industry scientists selecting from many candidate drug molecules. As a result of the lack of such tools, a cancer patient might suffer nausea, vomiting, or intestinal problems, or a patient's needed chemotherapy dose might be lower than it could be due to such conditions. VivoSim aims to provide transformative solutions for these challenges. The FDA has laid out ambitious goals to phase out animal testing requirements as much as possible. VivoSim is launching to fill in the much-needed gap in commercially available solutions. The technology exists to achieve this according to FDA Commissioner Makary's vision. VivoSim is delivering on the promise of this vision, and will use its proprietary methods and cutting edge capabilities for NAMkind models that displace use of animals and provide superior outcomes for its pharmaceutical customers, ultimately delivering for on the end goal of providing better solutions for patients.
お知らせ • Apr 02Organovo Provides Update on Nasdaq Continued Listing RequirementsOrganovo Holdings, Inc. gave guidance that, as its common stock has been trading above the $1.00 minimum bid price required, it expects to meet the requirements for continued listing on the Nasdaq Capital Market should the closing price of its common stock remain at similar levels. Nasdaq Compliance Update: The Company further clarified it expects to meet all requirements for continued listing on the Nasdaq Capital Market. The Company’s common stock has closed above the $1.00 minimum bid price requirement since March 21, 2025 and believes it has met the minimum stockholder equity requirements of continued listing, pending Nasdaq confirmation. Nasdaq requires a minimum of 10 consecutive trading days where the stock closes at a minimum bid price of $1.00, and the Company has closed above $1.00 since March 21, 2025.
お知らせ • Mar 27+ 1 more updateEli Lilly and Company (NYSE:LLY) completed the acquisition of FXR Program and Related Assets of Organovo Holdings, Inc. (NasdaqCM:ONVO).Eli Lilly and Company (NYSE:LLY) entered into an asset purchase agreement to acquire FXR Program and Related Assets of Organovo Holdings, Inc. (NasdaqCM:ONVO) for $60 million on February 23, 2025. The consideration consist of (i) an upfront cash payment equal to $10.0 million, of which $9.0 million will be paid at closing and the remaining $1.0 million will be deposited into escrow for 15 months to satisfy any claims for indemnification under the Purchase Agreement, (ii) the assumption by Lilly of certain liabilities related to the FXR program, and (iii) potential milestone payments of up to $50 million in the aggregate, which are contingent upon the achievement of certain development, regulatory and commercial milestones. The Asset Sale is expected to close within approximately 30 days following the signing of the Purchase Agreement. Samantha Eldredge, Lucas Rachuba, Todd Schneider and Jeff Hartlin of Paul Hastings LLP acted as legal advisor for Organovo Holdings, Inc. Jeffrey D. Osterman, Joe Pari, John O'Loughlin, Matthew J. Gilroy, Regina Readling, Phillip D. Grudzina, and Adam Sternberg of Weil, Gotshal & Manges LLP acted as legal advisor for Eli Lilly and Company. Eli Lilly and Company (NYSE:LLY) completed the acquisition of FXR Program and Related Assets of Organovo Holdings, Inc. (NasdaqCM:ONVO) on March 25, 2025.
お知らせ • Mar 20Organovo Announces Reverse Stock Split to Regain Compliance with Minimum Bid PriceOrganovo Holdings, Inc. announced that it will effect a 1-for-12 reverse stock split of its issued and outstanding common stock that will become effective at 5:00 p.m. Eastern Time on March 20, 2025. Organovo’s common stock will commence trading on a reverse stock split-adjusted basis at the opening of the market on March 21, 2025. The reverse stock split is intended for Organovo to regain compliance with the minimum bid price requirement of $1.00 per share of common stock for continued listing on the Nasdaq Capital Market.
お知らせ • Feb 26Eli Lilly and Company (NYSE:LLY) entered into an asset purchase agreement to acquire FXR Program and Related Assets of Organovo Holdings, Inc. (NasdaqCM:ONVO) for $60 million.Eli Lilly and Company (NYSE:LLY) entered into an asset purchase agreement to acquire FXR Program and Related Assets of Organovo Holdings, Inc. (NasdaqCM:ONVO) for $60 million on February 23, 2025. The consideration consist of (i) an upfront cash payment equal to $10.0 million, of which $9.0 million will be paid at closing and the remaining $1.0 million will be deposited into escrow for 15 months to satisfy any claims for indemnification under the Purchase Agreement, (ii) the assumption by Lilly of certain liabilities related to the FXR program, and (iii) potential milestone payments of up to $50 million in the aggregate, which are contingent upon the achievement of certain development, regulatory and commercial milestones. The Asset Sale is expected to close within approximately 30 days following the signing of the Purchase Agreement. Samantha Eldredge and Jeff Hartlin of Paul Hastings LLP acted as legal advisor for Organovo Holdings, Inc. Matthew Gilroy of Weil, Gotshal & Manges LLP acted as legal advisor for Eli Lilly and Company.
お知らせ • Feb 15Organovo Holdings, Inc. announced delayed 10-Q filingOn 02/14/2025, Organovo Holdings, Inc. announced that they will be unable to file their next 10-Q by the deadline required by the SEC.
お知らせ • Jan 18Organovo Holdings, Inc. Provides Non-Compliance UpdateAs previously reported, on July 18, 2024, Organovo Holdings, Inc., a Delaware corporation (the Company"), received a written notice (the Notice") from the Listing Qualifications Staff (the Staff") of The Nasdaq Stock Market LLC (Nasdaq") indicating that, based upon the closing bid price of the Company's common stock for the last 30 consecutive business days, the Company no longer met the requirement to maintain a minimum bid price of $1 per share, as set in Nasdaq Listing Rule 5550(a)(2) (Rule 5550(a)(2)"). In accordance with Nasdaq Listing Rule 5810(c)(3)(A), the Company was provided an initial period of 180 calendar days, or until January 14, 2025, to regain compliance. On January 16, 2025, the Staff provided a notice to the Company (the Nasdaq Notice") that the Company had not regained compliance with Rule 5550(a)(2) and is not eligible for a second 180 calendar day compliance period as the Company does not comply with the requirements for initial listing on The Nasdaq Capital Market. The Nasdaq Notice further indicated that, unless the Company timely requests a hearing before a Hearings Panel (the Panel"), the Company's common stock would be subject to delisting. As a result, the Company intends to timely request a hearing. The hearing request will automatically stay any delisting or suspension action pending the hearing and the expiration of any extension period granted by the Panel following the hearing. In that regard, pursuant to the Nasdaq Listing Rules, the Panel has the discretion to grant a further extension not to exceed July 15, 2025. Following the hearing request, the Company's common stock will continue to be listed on The Nasdaq Capital Market under the symbol ONVO." The Company intends to present its plan to the Panel, which compliance plan is expected to include conducting a reverse stock split if necessary to regain compliance with Rule 5550(a)(2). However, there can be no assurance that the Panel will grant a further extension or that the Company will ultimately regain compliance with all applicable requirements for continued listing on The Nasdaq Capital Market.
お知らせ • Jan 02Organovo Holdings, Inc. Announces Chief Financial Officer ChangesOn December 30, 2024, the Board of Directors of Organovo Holdings, Inc. appointed Norman Staskey, age 55, as the Company’s Chief Financial Officer, effective December 30, 2024, in connection with the resignation of Tomas Hess. In this role, Mr. Staskey will serve as the Company’s principal accounting officer and principal financial officer. The Company believes that Mr. Staskey’s experience will be a strong addition to the Company’s leadership, in particular his background in mergers and acquisitions activity given the Company’s interest in potential strategic transactions involving other pharmaceutical companies. The Company currently engages Danforth Advisors, LLC, a financial consulting firm, pursuant to the terms of that certain consulting agreement, dated August 25, 2020, by and between the Company and Danforth, as amended (the “Consulting Agreement”), to provide Chief Financial Officer consulting services on a part-time basis for the Company, and Mr. Staskey will provide his part time services under such agreement. The Company employs full time internal senior finance staff to assure continuity. With Danforth’s assistance, the Company has identified Mr. Staskey as a strong executive to serve as the Company’s President, Chief Financial Officer and Principal Financial Officer. Mr. Staskey is a seasoned executive with significant experience in managing and leading teams as well as overseeing the financial and operational responsibilities of private and publicly traded life sciences companies. He has served as a Senior Director of Danforth since May 2021. Mr. Staskey has served as the Chief Financial Officer of Azitra, Inc. since October 2022. From September 2014 to May 2021, Mr. Staskey was employed by EY (formally Ernst & Young), most recently as a managing director in EY’s Financial Accounting and Advisory services practice. Mr. Staskey received his B.S. of Business Administration from Cleveland State University and is a Certified Public Accountant in the State of Ohio. On December 23, 2024, Mr. Hess, the Company’s former Chief Financial Officer, notified the Company of his intent to resign and resigned effective December 24, 2024, from his part-time role to pursue retirement. Mr. Hess’s resignation is not a result of any disagreement with the Company or any matter relating to its accounting or financial policies or procedures.
お知らせ • Nov 20Organovo Holdings, Inc. Presents Clinical Data of FXR314 in Phase 2 MASH in an Oral Presentation at The Liver MeetingOrganovo Holdings, Inc. announced that its oral presentation of its lead clinical stage drug FXR314 by Dr. Eric Lawitz of the Texas Liver Institute and the University of Texas Health San Antonio was featured at The Liver Meeting, sponsored by the American Association for the Study of Liver Diseases (AASLD). The meeting was held November 15-19, 2024 in San Diego, California. The presentation entitled “Pharmacokinetics, Safety and Efficacy of the Novel Non-bile Acid FXR Agonist FXR314 in Patients with Metabolic Dysfunction-Associated Steatohepatitis: Results from a Phase 2 Study” was presented on Sunday, November 17 in the MASLD and MASH – New therapies session. Dr. Lawitz shared the complete details of the 16-week, randomized, placebo-controlled, multi-center Phase 2 study of FXR314 in MASH patients. A total of 214 patients were randomized in a 1:1:1 ratio to either 3 mg or 6 mg of FXR314, or placebo. Study results demonstrated statistically significant reduction in liver fat content from baseline in patients receiving FXR314 compared to placebo, and a safety profile demonstrating significantly lower pruritus rates than seen with other FXR agonists. Study subjects receiving FXR314 achieved statistically significant reduction in liver fat content from baseline, with LS mean %reduction at end of treatment of 22.8% (p=0.0010) with 3 mg and 17.5% (p=0.0267) with 6 mg doses of FXR314 compared to 6.1% in the placebo group. The proportion of subjects with >30% magnetic resonance imaging-derived proton density fat fraction (MRI-PDFF) reduction was 29.2% (p=0.0023) and 32.2% (p=0.0020) for 3 mg and 6 mg FXR314, respectively, compared to 9.5% with placebo. Investigators observed improvements in hepatocellular damage and liver function based on serological measures, with no evidence of worsening of liver fibrosis. FXR314 was also found to be safe and well tolerated. Treatment-emergent adverse events were mostly mild to moderate in severity, with incidence comparable between FXR314 3 mg, 6 mg, and placebo. Drug-related treatment discontinuation was low in frequency and similar across groups. FXR314 did not demonstrate significant adverse events typical of the FXR class, including pruritus (3 mg 2.8%, 6 mg 4.2% and placebo 2.8%) and LDL-C levels (change from baseline of 1.5%, 4.5% and -3.6% for 3mg, 6mg, and placebo groups respectively).
お知らせ • Sep 19Organovo Holdings, Inc., Annual General Meeting, Nov 20, 2024Organovo Holdings, Inc., Annual General Meeting, Nov 20, 2024.
New Risk • Aug 06New major risk - Financial positionThe company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -US$12m 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 (-US$12m free cash flow). Share price has been highly volatile over the past 3 months (15% average weekly change). Earnings are forecast to decline by an average of 4.4% per year for the foreseeable future. Shareholders have been substantially diluted in the past year (65% increase in shares outstanding). Revenue is less than US$1m (US$73k revenue). Market cap is less than US$10m (€7.07m market cap, or US$7.71m). Minor Risk Currently unprofitable and not forecast to become profitable next year (US$15m net loss next year).
Reported Earnings • Aug 06First quarter 2025 earnings released: US$0.23 loss per share (vs US$0.46 loss in 1Q 2024)First quarter 2025 results: US$0.23 loss per share (improved from US$0.46 loss in 1Q 2024). Net loss: US$3.34m (loss narrowed 17% from 1Q 2024). Revenue is forecast to grow 39% p.a. on average during the next 2 years, compared to a 20% growth forecast for the Biotechs industry in Europe. Over the last 3 years on average, earnings per share has fallen by 4% per year but the company’s share price has fallen by 58% per year, which means it is performing significantly worse than earnings.
お知らせ • Jul 25Organovo Holdings Receives Non-Compliance Letter from Nasdaq Regarding Minimum Bid Price RequirementOn July 18, 2024, Organovo Holdings, Inc., a Delaware corporation (the Company"), received a written notice (the Notice") from the Listing Qualifications Staff of the Nasdaq Stock Market LLC (Nasdaq") indicating that, based upon the closing bid price of the Company's common stock for the last 30 consecutive business days, the Company no longer meets the requirement to maintain a minimum bid price of $1 per share, as set forth in Nasdaq Listing Rule 5550(a)(2) (Rule 5550(a)(2)"). In accordance with Nasdaq Listing Rule 5810(c)(3)(A), the Company has been provided with an initial period of 180 calendar days, or until January 14, 2025, to regain compliance. In order to regain compliance with the minimum bid price requirement, the closing bid price of the Company's common stock must be at least $1 per share for a minimum of ten consecutive business days during this 180-day period. The Notice provides that the Nasdaq staff will provide written confirmation to the Company if the Company regains compliance with Rule 5550(a)(2). If the Company does not regain compliance with Rule 5550(a)(2) by January 14, 2025, the Company may be eligible for an additional compliance period of 180 calendar days. To qualify, the Company would be required to meet the continued listing requirement for market value of publicly held shares and all other initial listing standards for the Nasdaq Capital Market, with the exception of the bid price requirement, and would need to provide written notice to Nasdaq of its intention to cure the bid price deficiency during the second compliance period. However, if it appears to the Nasdaq staff that the Company will not be able to cure the deficiency, or if the Company is otherwise not eligible, Nasdaq would notify the Company that its securities will be subject to delisting. In the event of such a notification, the Company may appeal the Nasdaq staff's determination to delist its securities, but there can be no assurance the Nasdaq staff would grant any request for continued listing. The Notice has no immediate effect on the listing or trading of the Company's common stock and the Company's common stock will continue to trade on the Nasdaq Capital Market under the symbol ONVO". The Company intends to monitor the closing bid price of its common stock and consider its available options if its common stock does not trade at a level likely to result in the Company regaining compliance with Rule 5550(a)(2) by January 14, 2025, including effecting a reverse stock split, which would be subject to the prior approval of the Company's stockholders. There can be no assurance that the Company will be able to regain compliance with Nasdaq's minimum bid price requirement or that the Company will maintain its compliance with the other listing requirements necessary for the Company to maintain the listing of its common stock on the Nasdaq Capital Market.
New Risk • Jun 13New major risk - Shareholder dilutionThe company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 65% This is considered a major 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 (30% average weekly change). Earnings are forecast to decline by an average of 1.6% per year for the foreseeable future. Shareholders have been substantially diluted in the past year (65% increase in shares outstanding). Revenue is less than US$1m (US$109k revenue). Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (US$15m net loss in 2 years). Market cap is less than US$100m (€12.7m market cap, or US$13.7m).
New Risk • Jun 05New major risk - Revenue and earnings growthEarnings are forecast to decline by an average of 1.6% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (30% average weekly change). Earnings are forecast to decline by an average of 1.6% per year for the foreseeable future. Revenue is less than US$1m (US$109k revenue). Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (US$15m net loss in 2 years). Shareholders have been diluted in the past year (49% increase in shares outstanding). Market cap is less than US$100m (€11.9m market cap, or US$12.9m).
Reported Earnings • Jun 04Full year 2024 earnings released: US$1.60 loss per share (vs US$1.98 loss in FY 2023)Full year 2024 results: US$1.60 loss per share (improved from US$1.98 loss in FY 2023). Net loss: US$14.7m (loss narrowed 15% from FY 2023). Revenue is forecast to grow 59% p.a. on average during the next 2 years, compared to a 18% growth forecast for the Biotechs industry in Europe. Over the last 3 years on average, earnings per share has fallen by 1% per year but the company’s share price has fallen by 50% per year, which means it is performing significantly worse than earnings.
お知らせ • Apr 16Organovo Holdings, Inc. Announces Positive Phase 2 Results for FXR314 in Metabolic Dysfunction-Associated Steatohepatitis Showing Both Reduction in Liver Fat Content and Strong Safety and Tolerability Compared to PlaceboOrganovo Holdings, Inc. released the complete details of its 16-week, randomized, placebo-controlled, multi-center Phase 2 study of the non-steroidal, non-bile acid FXR agonist FXR agonist FXR314 for the treatment of metabolic function-associated steatohepatitis (MASH). Study results demonstrated statistically significant reduction in liver fat content from baseline in patients receiving FXR314 compared to placebo. Study subjects receiving FXR314 achieved statistically significant reduction in liver fat Content from baseline, with LS mean% reduction at end of treatment of 22.8% (p=0.0023) with 3 mg and 17.5% (p=0.0267) with 6 mg doses of FXR314 compared to 6.1% in the placebo group. The proportion of subjects with >30% magnetic resonance imaging-derived proton density fat fraction (MRI-PDFF) reduction was 29.2% (p=0.00023) and 32.2% (p= 0.0020) for 3 mg and 6 mg FXR314, respectively, compared to 9.5% with placebo. Investigators observed improvements in liver function based on serological measures, with no evidence of worsening of liver fibrosis. FXR314 was also found to be safe and well tolerated. There was also no evidence with FXR314 of adverse events considered common in the FXR class, including measures of pruritus (3 mg 2.8%, 6 mg 4.2% and placebo 2.8%) andLDL-C levels (change from baseline of 1.5%, 4.5% and -3.6% for 3mg, 6mg, and placebo groups respectively). The clinical trial evaluated the safety, tolerability, and pharmacological activity of FXR314, as measured by reductions in liver fat content with magnetic resonance imaging-derived pro ton density fat fraction (MRI- PDFF), changes in liver enzymes, low-density lipoprotein cholesterol (LDL-C) levels, and incidence of pruritus. The treatment population were MASH patients diagnosed via biopsy, magnetic resonance elastography (MRE), or transient elastography (TE FibroScan), and who had liver fat content 10% as measured by MRI-PDFF. A total of 214 patients were randomized in a 1:1:1 ratio to either 3 mg or 6 mg of FXR314, or placebo. Treatment was administered orally once daily for 16 weeks. The Company expects that detailed findings of this study (Clinical trial registry NCT047773964) will be presented at an upcoming conference.
お知らせ • Apr 13Organovo Holdings, Inc. has filed a Follow-on Equity Offering in the amount of $10 million.Organovo Holdings, Inc. has filed a Follow-on Equity Offering in the amount of $10 million. Security Name: Common Stock Security Type: Common Stock Security Name: Pre-Funded Warrants Security Type: Equity Warrant
Reported Earnings • Feb 09Third quarter 2024 earnings released: US$0.40 loss per share (vs US$0.38 loss in 3Q 2023)Third quarter 2024 results: US$0.40 loss per share (further deteriorated from US$0.38 loss in 3Q 2023). Net loss: US$3.60m (loss widened 10% from 3Q 2023). Revenue is forecast to grow 40% p.a. on average during the next 3 years, compared to a 13% growth forecast for the Biotechs industry in Germany. Over the last 3 years on average, earnings per share has increased by 3% per year but the company’s share price has fallen by 62% per year, which means it is significantly lagging earnings.
お知らせ • Feb 09Organovo Holdings, Inc. has filed a Follow-on Equity Offering in the amount of $2.605728 million.Organovo Holdings, Inc. has filed a Follow-on Equity Offering in the amount of $2.605728 million. Security Name: Common Stock Security Type: Common Stock Transaction Features: At the Market Offering
お知らせ • Jan 25Organovo Holdings, Inc. Presents FXR314 3D Human Tissue Model FindingsOrganovo Holdings, Inc. announced the presentation of preclinical data related to the company's FXR314 development program in its proprietary 3D human tissue models of Crohn's disease and ulcerative colitis at the Crohn's and Colitis Congress being held January 25-27, 2024 in Las Vegas, Nevada. FXR314 is a clinical-stage potent, selective, orally administered non-bile acid FXR agonist being developed as a novel therapeutic approach for IBD. The presentation highlights preclinical data characterizing the activity of FXR314 in 3D models of human Crohn's disease and Ulcerative colitis. FXR314 broadly improved measures of epithelial barrier function in a subset of donors, and fibrotic markers in all Crohn's disease donors. The company plans to begin enrollment for a proof-of-concept Phase 2 ulcerative colitis study in 2024, with targeted completion in 2025. The drug’s additional promise in liver fibrosis and NASH makes it a strong candidate for development in that.
New Risk • Jan 05New minor risk - Shareholder dilutionThe company's shareholders have been diluted in the past year. Increase in shares outstanding: 13% 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 Less than 1 year of cash runway based on free cash flow trend (-US$16m free cash flow). Share price has been highly volatile over the past 3 months (18% average weekly change). Revenue is less than US$1m (US$368k revenue). Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (US$18m net loss in 2 years). Shareholders have been diluted in the past year (13% increase in shares outstanding). Market cap is less than US$100m (€10.1m market cap, or US$11.0m).
New Risk • Dec 07New major risk - Market cap sizeThe company's market capitalization is less than US$10m. Market cap: €9.26m (US$9.96m) This is considered a major risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. 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 (-US$16m free cash flow). Share price has been highly volatile over the past 3 months (19% average weekly change). Revenue is less than US$1m (US$368k revenue). Market cap is less than US$10m (€9.26m market cap, or US$9.96m). Minor Risk Currently unprofitable and not forecast to become profitable over next 2 years (US$18m net loss in 2 years).
お知らせ • Dec 06Organovo Holdings, Inc. Provides Timing for Release of FXR314 Phase 2 NASH ResultsOrganovo Holdings, Inc. announced that it will release final and complete data from a Phase 2a trial of FXR314 in non-alcoholic steatohepatitis (NASH) patients by April 2024. The Company anticipates presentations at scientific meetings as well as publication in peer-reviewed journals. The release of this data will be the first public release of the completed clinical trial data. In an already reported interim analysis of about 60 patients after 16 weeks of treatment, FXR314 lowered liver fat content as demonstrated by a reduction in the median MRI-PDFF score of 28.6% in the 3 mg cohort and 26.9% in the 6 mg group compared with a reduction of only 1.5% in the placebo group. Post-hoc comparative assessment of relative liver fat reduction in the interim cohort found the decrease with 3 mg to be statistically significant compared to placebo (p=0.006). In a measure of activity in individual patients, FXR314 achieved greater than 30% liver fat reduction in 47% of patients (8/17) in the 3 mg cohort and 35% (6/17) in the 6 mg cohort, compared with 12% (2/17) in the placebo arm. FXR314 was generally well-tolerated in this NASH population, with no treatment-related serious adverse events (AEs). All treatment-related AEs were mild-moderate with no apparent dose relationship. Mild-moderate pruritus was reported in one patient in the 3 mg cohort and one patient in the 6 mg cohort. No pruritus-related treatment discontinuations occurred. Organovo plans to begin enrollment for a proof-of-concept Phase 2 ulcerative colitis study in 1H 2024, with targeted completion in 1H 2025. The drug’s additional promise in liver fibrosis and NASH makes it a strong candidate for development in that area through partnership collaborations with Organovo.
New Risk • Oct 26New major risk - Market cap sizeThe company's market capitalization is less than US$10m. Market cap: €9.16m (US$9.68m) This is considered a major risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. 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 (-US$16m free cash flow). Share price has been highly volatile over the past 3 months (12% average weekly change). Revenue is less than US$1m (US$445k revenue). Market cap is less than US$10m (€9.16m market cap, or US$9.68m). Minor Risk Currently unprofitable and not forecast to become profitable over next 2 years (US$18m net loss in 2 years).
お知らせ • Sep 14Organovo Holdings, Inc., Annual General Meeting, Oct 31, 2023Organovo Holdings, Inc., Annual General Meeting, Oct 31, 2023, at 09:00 Pacific Standard Time. Agenda: To elect each of Keith Murphy and Adam Stern as a Class III director to hold office until the 2026 Annual Meeting of Stockholders and until his respective successor is elected and qualified; to ratify the appointment of Rosenberg Rich Baker Berman P.A. as independent registered public accounting firm for the fiscal year ending March 31, 2024.
お知らせ • Aug 24Organovo Holdings, Inc. Advances Clinical Timelines for FXR314 and Provides Updates on NASH Phase 2 DataOrganovo Holdings, Inc. announced more details about its clinical program for FXR314, an FXR agonist that has completed initial clinical trials. FXR314 is a drug with safety and tolerability after daily oral dosing in Phase 1 and Phase 2 trials. Further, FXR314 has FDA clinical trial authorization for a Phase 2 trial in ulcerative colitis. Organovo’s FXR program announcement updates its previous guidance on clinical trial starts for the company, with the Company accelerating its timeline to first clinical trials by approximately two years. The Company previously announced in March 2023 that it would give guidance on Phase 2 timelines for FXR314 after an internal determination of the best path forward. The Company continues to expect to file INDs starting in 2025 for fully internally developed molecules and expects to issue additional guidance on pipeline programs in the coming months. In addition, Organovo is anticipating the release of final Phase 2 data on the performance of FXR314 in NASH. Performance of the drug to date in treatment of NASH has been encouraging. Interim results in Phase 2 showed that FXR314 lowered liver fat content, with mean relative reductions of 26.9±27.8% in the 3 mg cohort and 9.3±55.8% in the 6 mg cohort, compared with 7.5±21.0% in the placebo cohort. Median liver fat reduction was 28.6% in the 3 mg cohort, 26.9% in the 6 mg cohort compared to 1.5% in the placebo arm. A post-hoc comparative assessment of relative liver fat reduction in the interim cohort found the decrease with the 3 mg dose to be statistically significant compared to placebo (p=0.006). FXR314 achieved greater than 30% liver fat reduction in 47% of patients (8/17) in the 3 mg cohort and 35% (6/17) in the 6 mg cohort, compared with 12% (2/17) in the placebo arm. To date, the drug has been generally well-tolerated, with no treatment-related serious adverse events. All treatment-related adverse events have been mild-moderate with no apparent dose relationship. Full Phase 2 data is expected to be released in the first half of 2024.
お知らせ • Jun 30Organovo Holdings, Inc. announced delayed annual 10-K filingOn 06/29/2023, Organovo Holdings, Inc. announced that they will be unable to file their next 10-K by the deadline required by the SEC.
Board Change • Nov 17High number of new and inexperienced directorsThere are 6 new directors who have joined the board in the last 3 years. The company's board is composed of: 6 new directors. 4 experienced directors. No highly experienced directors. Executive Chairman Keith Murphy is the most experienced director on the board, commencing their role in 2020. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of board continuity. Lack of experienced directors.
お知らせ • Nov 16Organovo Announces Target Validation Ahead of Schedule, Accelerating Timeline for First Crohn’s Disease Drug CandidatesOrganovo Holdings, Inc. announced that it has successfully advanced the use of its first inflammatory bowel disease (IBD) model and has achieved the next milestone, target validation. The company announced in May 2022 that it had achieved a successful Crohn’s disease model that demonstrates key aspects of patient biology that differ from a non-diseased state and that the model would be used to find and characterize therapeutics. The Crohn’s disease model has since been utilized to understand the biology of disease and identify specific gene targets. Treating some of those targets, by introducing a compound directly to the 3D tissue model that affects the target, has now been shown to reproducibly reduce disease. Multiple targets are now considered validated, and they represent specific druggable opportunities that the company plans to leverage. Organovo plans to advance at least one target program to medicinal chemistry by the end of 2022 to build a proprietary new drug for Crohn’s disease. More than 1 million people in North America suffer from Crohn’s and its prevalence is increasing globally. Because of its progressive nature, more than 70% will require at least one surgical intervention to relieve symptoms. Current drugs can slow progression in about 50% of patients, but none are curative. Defects in the intestinal lining and inflammation can lead to abdominal pain, severe diarrhea, fatigue, weight loss, malnutrition, and lower quality of life. Chronic inflammation leads to ulcers, fistulas and bowel obstructions caused by fibrosis. Organovo believes that its 3D tissue technologies are well suited to drug and target discovery in IBD because they contain a functional intestinal epithelium that is affected by disease and a stromal layer demonstrating disease-dependent fibrosis, key targets for therapy. The drug discovery process using 3D tissues consists of several stages. Two early steps that are uniquely important in Organovo’s approach to drug discovery are creation of a disease model followed by target discovery and validation.
お知らせ • Jul 28Organovo Holdings, Inc., Annual General Meeting, Sep 07, 2022Organovo Holdings, Inc., Annual General Meeting, Sep 07, 2022, at 09:00 Pacific Standard Time. Agenda: To elect each of Douglas Jay Cohen and David Gobel as a Class II director to hold office until the 2025 Annual Meeting of Stockholders and until respective successor is elected and qualified; to ratify the appointment of Mayer Hoffman McCann P.C. as an independent registered public accounting firm for the fiscal year ending March 31, 2023; to approve, on an advisory basis, the compensation of executive officers; to approve the Organovo Holdings, Inc. 2022 Equity Incentive Plan; and to consider other matters if any.
お知らせ • May 18Organovo Holdings, Inc. Successfully Advances Its First Inflammatory Bowel Disease Model to the Next Step of Target Discovery and Validation for Crohn’s DiseaseOrganovo Holdings, Inc. announced that it has successfully advanced its first inflammatory bowel disease (IBD) model to the next step of target discovery and validation for Crohn’s disease. Based on its internal data and scientific results, the company believes that its first IBD model correctly demonstrates key aspects of Crohn’s patient biology that differ from a non-diseased state, and can be used to find and characterize therapeutics. More than 1 million people in North America suffer from Crohn’s and its prevalence is increasing globally. Because of its progressive nature, more than 70% will require at least one surgical intervention to relieve symptoms. Current drugs can slow progression in about 50% of patients, but none are curative. Defects in the intestinal lining and inflammation can lead to abdominal pain, severe diarrhea, fatigue, weight loss, malnutrition, and lower quality of life. Chronic inflammation leads to ulcers, fistulas and bowel obstructions caused by fibrosis. Organovo believes that its 3D tissue technologies are well suited to drug and target discovery in IBD because they contain a functional intestinal epithelium that is affected by disease and a stromal layer demonstrating disease-dependent fibrosis, key targets for therapy. Organovo previously announced that it had updated its business model to capitalize on its human 3D tissue technologies in drug discovery, building disease models to find effective therapies that are more likely to succeed in the clinic than drugs discovered using animal models.
Board Change • Apr 27High number of new and inexperienced directorsThere are 6 new directors who have joined the board in the last 3 years. The company's board is composed of: 6 new directors. 4 experienced directors. No highly experienced directors. Executive Chairman & Principal Executive Officer Keith Murphy is the most experienced director on the board, commencing their role in 2020. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of board continuity. Lack of experienced directors.
お知らせ • Feb 19Organovo Holdings, Inc. Announces the Hiring of Curtis Tyree, PhD, as Sr. Vice President of Strategy and Business DevelopmentOrganovo Holdings, Inc. announced the hiring of Curtis Tyree, PhD, as Sr. Vice President of Strategy and Business Development. Dr. Tyree has more than 20 years of management and R&D experience in the drug discovery industry in a variety of therapeutic areas at Ligand Pharmaceuticals, TorreyPines Therapeutics (previously Neurogenetics) and most recently served as SVP, Strategic Planning at HUYABIO International.
お知らせ • Feb 04Organovo Holdings, Inc. Guides on Patent Portfolio and Successful IPR Defense of Two PatentsOrganovo Holdings, Inc. announced that two of its patents have withstood a patent challenge, and the company provided guidance on how it expects to leverage its strong patent portfolio. Organovo holds a powerful foundational patent portfolio in the 3D bioprinting space due to its licensing of pioneering work in the field and early innovations beyond that start. Organovo is focused on bringing inflammatory bowel disease (IBD) drugs to market, with multiple IND filings expected by 2025. However, the company plans to utilize licensing revenue from its patent strength to help fund development costs of new drugs. The company currently expects to achieve millions of dollars of revenue over fiscal year 2022 to fiscal year 2025 combined from licensing its patents within the field. The strength of its patents and growth in the bioprinting industry have made for an attractive business opportunity for the company. Organovo will now begin to invest resources to explore and expand business and revenue opportunities in this area. Organovo exclusively licensed early bioprinting work by Gabor Forgacs, its scientific founder, and Thomas Boland of Clemson, both bioprinting pioneers. After its founding, the company went on to innovate broadly and obtain a broad set of patents that provide formidable foundational claims in the bioprinting space. Third parties recognized Organovo’s bioprinting IP as foundational and innovative as far back as 2015. Two Organovo patents recently stood up to a major challenge. A challenger filed petitions for inter partes review with the Patent Trial and Appeal Board (“PTAB”) in the US Patent and Trade Office, asking the PTAB to invalidate those patents’ claims as obvious. The PTAB rejected the challenges and refused to institute proceedings, which means that the PTAB did not think it was likely that the challenges would be successful. There is no appeal from these decisions. Further, the patents are even stronger now that they have been tested.
Board Change • Dec 30High number of new and inexperienced directorsThere are 5 new directors who have joined the board in the last 3 years. The company's board is composed of: 5 new directors. 4 experienced directors. No highly experienced directors. Executive Chairman & Principal Executive Officer Keith Murphy is the most experienced director on the board, commencing their role in 2020. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of board continuity. Lack of experienced directors.
お知らせ • Nov 27Organovo Holdings, Inc. Enter into Two Lease Agreements Between Company and San Diego Inspire 1, LLCOrganovo Holdings, Inc. entered into two Lease Agreements, by and between company and San Diego Inspire 1, LLC, pursuant to which the company will temporarily lease approximately 3,212 square feet of office space (the “Temporary Lease”) located at 11585 Sorrento Valley Road, Suite 106, San Diego, California 92121 (the “Temporary Premises”), and will permanently lease approximately 8,051 square feet of office space (the “Permanent Lease”) at 11555 Sorrento Valley Road, Suite 100, San Diego, California 92121 (the “Permanent Premises”) once the tenant improvements for the Permanent Premises have been completed and it is ready for occupancy. The Temporary Lease commences on November 27, 2020 and is intended to serve as the Temporary Premises for approximately seven months, and is projected to terminate on June 30, 2021, provided that the Permanent Premises are completed and ready for company’s occupancy. In addition, under the Temporary Lease Agreement, the company will be required to pay a base rent of approximately $13,008.60 per month, for the seven months of the Temporary Lease term. The company will also be required pay its share of operating expenses, taxes and any other expenses payable under the Temporary Lease Agreement. The Permanent Lease is projected to commence on July 1, 2021 and is intended to serve as the Permanent Premises for approximately sixty-two months, expiring on August 31, 2026. In addition, under the Permanent Lease Agreement, the company has an option to extend the term of Lease Agreement for a five-year period. The company will be required to pay an initial base rent of approximately $31,398.90 per month, for the first twelve months of the Permanent Lease term, which will increase at a rate of approximately 3.08% per year. The company will also be required pay its share of operating expenses, taxes and any other expenses payable under the Permanent Lease Agreement.
お知らせ • Sep 05Organovo Regains Compliance with Nasdaq Minimum Bid Price RequirementOrganovo Holdings, Inc. announced that it has regained compliance with the minimum bid price requirement for continued listing on The Nasdaq Capital Market (the “Minimum Bid Price Requirement”). On September 2, 2020, Organovo received a letter from the Listing Qualifications Department of The Nasdaq Stock Market, Inc. stating that because Organovo’s common stock had a closing bid price at or above $1.00 per share for a minimum of ten (10) consecutive business days, Organovo had regained compliance with the Minimum Bid Price Requirement and that Nasdaq had closed the matter.
お知らせ • Jul 05Organovo Holdings, Inc.(NasdaqCM:ONVO) dropped from Russell Microcap Growth IndexOrganovo Holdings, Inc.(NasdaqCM:ONVO) dropped from Russell Microcap Growth Index
お知らせ • Jul 02Organovo Holdings, Inc.(NasdaqCM:ONVO) dropped from Russell Microcap IndexOrganovo Holdings, Inc.(NasdaqCM:ONVO) dropped from Russell Microcap Index
