Ankündigung • Apr 30
VivoSim Labs, Inc. Announces Availability of AI Prediction Tool Leveraging NAMkind Intestinal Models VivoSim 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. Ankündigung • Mar 28
VivoSim 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 Ankündigung • Mar 25
VivoSim Labs, Inc. Releases Antibody Drug Conjugate Data and Validates NAMkind Models for ADC Toxicity Prediction VivoSim 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. Reported Earnings • Feb 13
Third quarter 2026 earnings released: US$1.03 loss per share (vs US$2.29 loss in 3Q 2025) Third quarter 2026 results: US$1.03 loss per share (improved from US$2.29 loss in 3Q 2025). Net loss: US$2.69m (loss narrowed 22% from 3Q 2025). Over the last 3 years on average, earnings per share has increased by 67% per year but the company’s share price has fallen by 61% per year, which means it is significantly lagging earnings. Ankündigung • Feb 11
VivoSim to Debut Antibody Drug Conjugate Data, Representing A Major New Market for Namkind Models, At Society of Toxicology Meeting in San Diego VivoSim 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. Ankündigung • Jan 07
VivoSim Labs, Inc. Appoints Amar Sethi as Chief Scientific Officer VivoSim 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. New Risk • Nov 09
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -US$10m 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$10m free cash flow). Share price has been highly volatile over the past 3 months (20% average weekly change). Shareholders have been substantially diluted in the past year (103% increase in shares outstanding). Revenue is less than US$1m (US$140k revenue). Market cap is less than US$10m (US$5.67m market cap). Reported Earnings • Nov 09
Second quarter 2026 earnings released: US$0.98 loss per share (vs US$1.70 loss in 2Q 2025) Second quarter 2026 results: US$0.98 loss per share (improved from US$1.70 loss in 2Q 2025). Net loss: US$2.55m (flat on 2Q 2025). Over the last 3 years on average, earnings per share has increased by 50% per year but the company’s share price has fallen by 52% per year, which means it is significantly lagging earnings. Ankündigung • Nov 04
VivoSim Labs, Inc., Annual General Meeting, Dec 16, 2025 VivoSim Labs, Inc., Annual General Meeting, Dec 16, 2025. Ankündigung • Sep 26
VivoSim 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 New Risk • Sep 16
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of American stocks, typically moving 18% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$10m free cash flow). Share price has been highly volatile over the past 3 months (18% average weekly change). Shareholders have been substantially diluted in the past year (103% increase in shares outstanding). Revenue is less than US$1m (US$142k revenue). Minor Risk Market cap is less than US$100m (US$12.4m market cap). Reported Earnings • Aug 14
First quarter 2026 earnings released: US$1.14 loss per share (vs US$2.74 loss in 1Q 2025) First quarter 2026 results: US$1.14 loss per share (improved from US$2.74 loss in 1Q 2025). Net loss: US$2.84m (loss narrowed 15% from 1Q 2025). New Risk • Aug 14
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -US$10m 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$10m free cash flow). Shareholders have been substantially diluted in the past year (103% increase in shares outstanding). Revenue is less than US$1m (US$142k revenue). Market cap is less than US$10m (US$4.84m market cap). Minor Risk Share price has been volatile over the past 3 months (11% average weekly change). Ankündigung • Aug 14
VivoSim Labs, Inc. Appoints Tony Lialin as Chief Commercial Officer VivoSim 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. Reported Earnings • Jun 06
Full year 2025 earnings released: US$1.70 loss per share (vs US$19.25 loss in FY 2024) Full year 2025 results: US$1.70 loss per share (improved from US$19.25 loss in FY 2024). Net loss: US$2.49m (loss narrowed 83% from FY 2024). Over the last 3 years on average, earnings per share has increased by 19% per year but the company’s share price has fallen by 58% per year, which means it is significantly lagging earnings. Board Change • May 14
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 5 experienced directors. No highly experienced directors. Independent Director Alison Milhous was the last director to join the board, commencing their role in 2020. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model. Ankündigung • May 07
VivoSim Labs, Inc. Presents Best-In-Class Liver Toxicology Prediction Results at Digestive Disease Week Conference VivoSim 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. Ankündigung • Apr 24
Vivosim Labs, Inc. Announces Emergence from Stealth Mode to Provide Technologies for FDA Turn Away from Animal Models, $10B+ Market VivoSim 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. Ankündigung • Apr 02
Organovo Provides Update on Nasdaq Continued Listing Requirements Organovo 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. Ankündigung • Mar 20
Organovo Announces Reverse Stock Split to Regain Compliance with Minimum Bid Price Organovo 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. Ankündigung • Feb 26
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. 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. Ankündigung • Feb 15
Organovo Holdings, Inc. announced delayed 10-Q filing On 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. Ankündigung • Jan 18
Organovo Holdings, Inc. Provides Non-Compliance Update As 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. Ankündigung • Jan 02
Organovo Holdings, Inc. Announces Chief Financial Officer Changes On 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. Ankündigung • Nov 20
Organovo Holdings, Inc. Presents Clinical Data of FXR314 in Phase 2 MASH in an Oral Presentation at The Liver Meeting Organovo 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). New Risk • Nov 19
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of American stocks, typically moving 10.0% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. 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). Earnings are forecast to decline by an average of 11% per year for the foreseeable future. Shareholders have been substantially diluted in the past year (74% increase in shares outstanding). Revenue is less than US$1m (US$103k revenue). Market cap is less than US$10m (US$6.42m market cap). Minor Risks Currently unprofitable and not forecast to become profitable next year (US$15m net loss next year). Share price has been volatile over the past 3 months (10.0% average weekly change). Major Estimate Revision • Nov 15
Consensus EPS estimates upgraded to US$0.75 loss The consensus outlook for fiscal year 2025 has been updated. 2025 losses forecast to reduce from -US$0.88 to -US$0.75 per share. Revenue forecast unchanged from US$201.0k at last update. Biotechs industry in the US expected to see average net income decline 14% next year. Consensus price target down from US$6.10 to US$5.40. Share price rose 4.1% to US$0.42 over the past week. Ankündigung • Sep 19
Organovo Holdings, Inc., Annual General Meeting, Nov 20, 2024 Organovo Holdings, Inc., Annual General Meeting, Nov 20, 2024. Reported Earnings • Aug 06
First quarter 2025 earnings: EPS and revenues exceed analyst expectations 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 exceeded analyst estimates by 30%. Earnings per share (EPS) also surpassed analyst estimates by 30%. Revenue is forecast to grow 39% p.a. on average during the next 2 years, compared to a 18% growth forecast for the Biotechs industry in the US. 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 59% per year, which means it is performing significantly worse than earnings. Ankündigung • Jul 25
Organovo Holdings Receives Non-Compliance Letter from Nasdaq Regarding Minimum Bid Price Requirement On 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 14
New major risk - Shareholder dilution The 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 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). Share price has been volatile over the past 3 months (13% average weekly change). Market cap is less than US$100m (US$13.7m market cap). New Risk • Jun 05
New major risk - Revenue and earnings growth Earnings 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 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). Share price has been volatile over the past 3 months (13% average weekly change). Shareholders have been diluted in the past year (49% increase in shares outstanding). Market cap is less than US$100m (US$12.9m market cap). Reported Earnings • Jun 04
Full year 2024 earnings: Revenues exceed analysts expectations while EPS lags behind 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 exceeded analyst estimates. Earnings per share (EPS) missed analyst estimates by 14%. 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 the US. 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. Ankündigung • Apr 16
Organovo 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 Placebo Organovo 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. New Risk • Apr 16
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of American stocks, typically moving 13% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risk Revenue is less than US$1m (US$242k revenue). Minor Risks Share price has been volatile over the past 3 months (13% average weekly change). Shareholders have been diluted in the past year (15% increase in shares outstanding). Market cap is less than US$100m (US$10.1m market cap). Ankündigung • Apr 13
Organovo 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 10
Third quarter 2024 earnings: EPS exceeds analyst expectations while revenues lag behind 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 missed analyst estimates by 93%. Earnings per share (EPS) exceeded analyst estimates by 2.4%. Revenue is forecast to grow 40% p.a. on average during the next 3 years, compared to a 17% growth forecast for the Biotechs industry in the US. Ankündigung • Feb 09
Organovo 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 Ankündigung • Jan 25
Organovo Holdings, Inc. Presents FXR314 3D Human Tissue Model Findings Organovo 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 04
New minor risk - Shareholder dilution The 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). 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). Share price has been volatile over the past 3 months (16% average weekly change). Shareholders have been diluted in the past year (13% increase in shares outstanding). Market cap is less than US$100m (US$11.5m market cap). New Risk • Dec 07
New major risk - Market cap size The company's market capitalization is less than US$10m. Market cap: 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 (17% average weekly change). Revenue is less than US$1m (US$368k revenue). Market cap is less than US$10m (US$9.96m market cap). Minor Risk Currently unprofitable and not forecast to become profitable over next 2 years (US$18m net loss in 2 years). Ankündigung • Dec 06
Organovo Holdings, Inc. Provides Timing for Release of FXR314 Phase 2 NASH Results Organovo 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. Major Estimate Revision • Nov 16
Consensus revenue estimates decrease by 25%, EPS upgraded The consensus outlook for fiscal year 2024 has been updated. 2024 revenue forecast fell from US$300.0k to US$230.0k. EPS estimate increased from -US$1.77 to -US$1.75 per share. Biotechs industry in the US expected to see average net income growth of 5.7% next year. Consensus price target of US$12.15 unchanged from last update. Share price rose 4.1% to US$1.52 over the past week. New Risk • Nov 08
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of American stocks, typically moving 16% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks 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 (16% average weekly change). Revenue is less than US$1m (US$445k revenue). Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (US$18m net loss in 2 years). Market cap is less than US$100m (US$12.4m market cap). New Risk • Oct 26
New major risk - Market cap size The company's market capitalization is less than US$10m. Market cap: 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). Revenue is less than US$1m (US$445k revenue). Market cap is less than US$10m (US$9.68m market cap). Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (US$18m net loss in 2 years). Share price has been volatile over the past 3 months (9.8% average weekly change). Ankündigung • Sep 14
Organovo Holdings, Inc., Annual General Meeting, Oct 31, 2023 Organovo 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. Ankündigung • Aug 24
Organovo Holdings, Inc. Advances Clinical Timelines for FXR314 and Provides Updates on NASH Phase 2 Data Organovo 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. Ankündigung • Jun 30
Organovo Holdings, Inc. announced delayed annual 10-K filing On 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 16
High number of new and inexperienced directors There 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. Board Change • Apr 27
High number of new and inexperienced directors There 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. Board Change • Dec 30
High number of new and inexperienced directors There 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.