VIVS

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Exhibit 99.1

VivoSim Provides Financial and Listing Compliance Update

San Diego, CA — August 6, 2026 — VivoSim Labs, Inc. (Nasdaq: VIVS) (the “Company” or “VivoSim”), a provider of next-generation New Approach Methodologies (NAM) 3d human cellular models for preclinical safety, today announced that on August 4, 2026, we received notice from the Listing Qualifications Staff of The Nasdaq Stock Market LLC indicating that the Company has regained compliance with Nasdaq Listing Rule 5550(b)(1) which requires registrants to maintain a minimum stockholders’ equity of $2.5M.

Subsequent to the filing of its recent Annual Report on Form 10-K for the fiscal year ended March 31, 2026, filed with the SEC on July 14, 2026 (the “Form 10-K”), the Company received a $5.0 million milestone payment from Eli Lilly and Company, and $1.0 million of additional cash was released from escrow on July 22, 2026, both in connection with the Company’s previous sale of its FXR program to Eli Lilly and Company. The Company also completed a financing on July 17, 2026, issuing pre-funded warrants and common warrants at a combined purchase price of $0.85 per share of common stock underlying the pre-funded warrants and received gross proceeds of $4.0 million, with net proceeds of approximately $3.6 million.

The Company is drawing attention to these events because the timing of the events means they were not reflected in the Company’s audited financial statements for the year ended March 31, 2026 included in Form 10-K and will not be in the financial statements in the Company’s upcoming Quarterly Report on Form 10-Q filing for the period ended June 30, 2026.

As of August 3, 2026, the Company’s cash on hand was approximately $10.1 million. Due to the significant events described above that occurred in July after the close of both the last fiscal year, the year ended March 31, 2026 and the first quarter of this fiscal year 2027, the quarter ending June 30, 2026, the Company is providing this additional information to investors in order to complement the financial statements previously included in the Company’s annual and quarterly filings with the SEC in order to provide stockholders and the public with updated information.

As of June 30, 2026, the Company had 3,194,295 shares of common stock outstanding, and as of August 3, 2026, the Company had 13,390,789 shares of common stock outstanding, which reflects 9,896,718 shares of common stock issued between July 15, 2026 and July 31, 2026 upon exercise of certain warrants to purchase common stock.

The Company reiterates its previously announced guidance that it anticipates 500%+ revenue growth in Fiscal Year 2027 given its progress in marketing contract research services using NAMs models to pharmaceutical companies.

Preliminary Financial Information

The unaudited financial information presented in this press release is preliminary and may change. The Company undertakes no obligation to update or supplement the information provided in this press release. The preliminary financial information included in this press release reflects the Company’s current estimates based on information available as of the date hereof and has been prepared by the Company’s management. This preliminary financial information should not be viewed as a substitute for full financial statements prepared in accordance with the Generally Accepted Accounting Principles and is not necessarily indicative of the results to be achieved for any future periods. This preliminary financial information could be impacted by the effects of financial closing procedures, final adjustments and other developments.

About VivoSim Labs

VivoSim Labs, Inc. (“VivoSim” and the “Company”), is a pharmaceutical and biotechnology services company that is focused on providing testing of drugs and drug candidates in three-dimensional (“3D”) human tissue models of liver and intestine. The Company offers partners liver and intestinal toxicology insights using its new approach methodologies (“NAM”) models. The Company anticipates accelerated adoption of human tissue models following the U.S. Food and Drug Administration (“FDA”) Roadmap to refine animal testing requirements in favor of these non-animal NAM methods. VivoSim Labs operates from San Diego, CA. Visit www.vivosim.ai.

Forward-Looking Statements

Any statements contained in this press release that do not describe historical facts constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. Any forward-looking statements contained herein are based on current expectations but are subject to a number of risks and uncertainties. Forward-looking statements include statements regarding the Company’s cash on hand, revenue growth guidance and the Company’s progress in marketing contract research services using NAMs models to pharmaceutical companies. Such forward-looking statements are not

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Exhibit 99. 1

Organovo Provides Update on Cash and Nasdaq Continued Listing Requirements

San Diego, CA – April 2, 2025 – Organovo Holdings, Inc. (Nasdaq: ONVO) (“Organovo” or the “Company”), a clinical stage biotechnology company focused on developing novel treatment approaches in inflammatory bowel disease (IBD), today reported preliminary unaudited cash for the fiscal year ending March 31, 2025, and net cash utilization results for the fiscal fourth quarter of 2025. The Company expects to release full fiscal second-quarter financial results the week of June 9-13, 2025. The Company also 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.

Cash

The Company’s preliminary cash and cash equivalents balance was approximately $11.3 million as of the end of the fiscal year on March 31, 2025. Organovo’s preliminary net cash utilization during the fourth quarter from January 1, 2025 to March 31, 2025 was approximately $2.0 - $2.2 million.

The preliminary financial information presented in this press release is based on Organovo’s current expectations and may be adjusted as a result of, among other things, the completion of customary annual audit procedures.

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.

Potential Receipt of Future Milestone Payments

Although the Company does not control the clinical development of products for which it may receive milestone payments, it currently reasonably expects to receive a $5M milestone payment within the next 12 months associated with the anticipated start of a Phase 2 clinical trial for the FXR agonist that it recently sold. In connection with the sale of the FXR agonist, the Company may receive future milestones of up to an aggregate of $50M, which is inclusive of the $5M milestone payment that would be received upon the commencement of a Phase 2 clinical trial.

About Organovo

Organovo is a clinical stage biotechnology company that is developing drugs that are demonstrated to be effective in three-dimensional (3D) human tissues as candidates for drug development. The company has proprietary technology used to build 3D human tissues that mimic key aspects of native human tissue composition, architecture, function, and disease. For more information visit Organovo's website at www.organovo.com.

Forward Looking Statements

Any statements contained in this press release that do not describe historical facts constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. Any forward-looking statements contained herein are based on current expectations but are subject to a number of risks and uncertainties, including the completion of the audit of its financial statements, general economic and market factors, and global economic and marketplace uncertainties. Forward-looking statements include statements regarding the Company’s expectation that it will meet the requirements for continued listing on the Nasdaq Capital Market, the Company’s expectations regarding its cash and cash equivalents balance and net cash utilization and the potential receipt of any milestone payments associated with the FXR agonist,. Such forward-looking statements are not guarantees of performance and actual actions or events could differ materially from those contained in such statements. For example, there can be no assurance that the Company will meet the bid price requirement or the minimum value of stockholders’ equity requirement during any compliance period or otherwise in the future, that the Company will otherwise meet Nasdaq compliance standards, or that the Company can ultimately meet or maintain compliance with applicable Nasdaq continued listing requirements. These risks and uncertainties and other factors are identified and described in more detail in the Company’s filings with the SEC, including its Annual Report on Form 10-K filed with the SEC on May 31, 2024, as such risk factors are updated in its most recently filed Quarterly Report on Form 10-Q filed with the SEC on February 19, 2025. You should not place undue reliance on these forward-looking statements, which speak only as of the date that they were made. These cautionary statements should be considered with any written or oral f

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Exhibit 99.1

Investor & Press Contact:

Steve Kunszabo

Organovo Holdings, Inc.

+1 (858) 224-1092

skunszabo@organovo.com

ORGANOVO UPDATES KEY CLINICAL DEVELOPMENT GOALS;  COMPANY REPORTS PRELIMINARY FISCAL FOURTH-QUARTER 2019 RESULTS

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Pre-Investigational New Drug (“IND”) meeting with the FDA expected to be held in calendar 2020

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Submit first IND in calendar 2021

SAN DIEGO – May 22, 2019 – Organovo Holdings, Inc. (NASDAQ:ONVO) (“Organovo”), a biotechnology company pioneering the development of 3D bioprinted tissues aimed at treating a range of serious adult and pediatric liver diseases, today updated its key clinical development goals and reported its preliminary fiscal fourth-quarter 2019 financial results.

“We have determined that we need to conduct additional preclinical studies, optimize our manufacturing processes, and most importantly to generate decisive scientific data regarding the prolonged functionality and therapeutic benefits of our liver tissue patch,” said Taylor J. Crouch, CEO, Organovo.  “As a result, our preclinical development will be extended into calendar 2020, and consequently we also now expect to have our pre-IND meeting with the FDA in calendar 2020, rather than the latter part of this calendar year.  This change in our timeline also pushes the start of our IND-enabling studies back, with our revised plan now supporting an IND submission and the start of first-in-human trials in calendar 2021.  Accordingly, we intend to devote substantially all of our financial and operating resources to meet these critical timelines.”

Crouch continued, “The most recent data we’ve generated from a much larger group of animal studies provides differing results from what we observed in our earlier pilot studies.  We continue to see statistically meaningful reduction in toxic globules in the Alpha-1-antitrypsin

animal models over a three-month period.  However, in these and other animal models, we are also seeing evidence of shorter tissue duration than we observed in previous studies, as measured by human protein output and the quantity of hepatocytes.  We’ll continue to examine all aspects of our manufacturing process, with the goal of improving the durability and optimizing the functionality of our tissues.”

Crouch concluded, “At the same time, we’ve had good progress in other critical elements of our development program.  We’ve explored alternate placement and implantation strategies and have shown the ability to apply multiple tissue patches of varying sizes to the animals using different adhesion methods.  In addition, we’ve initiated early work with larger NovoTissues® to focus on surgical approaches for human implantation.  We’ve also successfully engrafted our therapeutic tissue onto a fibrotic animal liver, an important step in evaluating the patch’s versatility as we consider end-stage liver disease indications.  From a safety perspective, although definitive IND-enabling toxicology studies have not been performed yet, no adverse effects have been detected to date on liver enzymes or histology in over 500 animals treated with our liver patches.  Finally, we have reviewed our operational capabilities to prepare our Chemistry Manufacturing and Controls plan.  Assuming successful outcomes of our additional preclinical studies, we plan to move forward with our objective to implement clinical scale manufacturing and quality processes in advance of our first-in-human trials.  These achievements and challenges are natural parts of the innovation process for novel cell-based therapies.”

Key Clinical Development Goals & Outlook

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The Company believes its healthy therapeutic liver tissue patch has the potential to treat a broad range of liver disease indications.  Its initial Phase I trial is expected to target patients with end-stage liver disease, and subject to favorable outcomes in that trial, Organovo intends to explore the benefits of its NovoTissues® in one or more inborn errors of metabolism disease areas such as Alpha-1 antitrypsin deficiency.  The Company may also study its product as a bridge-to-transplant.  All of these diseases represent high unmet need areas where Organovo believes its liver patches may provide a meaningful benefit to patients.

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Organovo expects to hold a pre-IND meeting with the FDA in calendar 2020 for its lead program with the intent to begin IND-enabling studies in the second half of calendar 2020.

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Organovo expects to file for its first IND in calendar 2021.

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As of March 31, 2019, the Company had a cash and cash equivalents balance of $36.5 million.  Organovo expects a net cash utilization(1) rate of $20.0 million to $22.0 million in fiscal 2020, and believes it has sufficient funds, along with the continued usage of its at-the-market (“ATM”) facility, to meet its operating and capital requirements through its forecasted IND submission in calendar 2021.

Other Developments

•

Organovo b

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Exhibit 99.1

Investor & Press Contact:

Steve Kunszabo

Organovo Holdings, Inc.

+1 (858) 224-1092

skunszabo@organovo.com

ORGANOVO AFFIRMS KEY CLINICAL DEVELOPMENT GOALS;  COMPANY REPORTS FISCAL THIRD-QUARTER 2019 RESULTS

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Pre-Investigational New Drug (“IND”) meeting with the FDA expected to be held in calendar 2019

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Submit first IND in calendar 2020

SAN DIEGO – February 7, 2019 – Organovo Holdings, Inc. (NASDAQ:ONVO) (“Organovo”), a biotechnology company pioneering the development of 3D bioprinted tissues aimed at treating a range of serious adult and pediatric liver diseases, today affirmed its key clinical development goals and reported its fiscal third-quarter 2019 financial results.

“We remain on track to submit our first IND in calendar 2020,” said Taylor J. Crouch, CEO, Organovo.  “While this is our most important clinical development goal over the next two years, we’re taking a number of important steps along the way to support that milestone.  In calendar 2019, we expect to hold a pre-IND meeting with the FDA on our lead program, and plan to begin our IND-enabling toxicity study.  To facilitate these important objectives and to ensure our readiness for first-in-human trials, we’re conducting proof-of-concept studies in multiple disease areas, running dose ranging studies and enhancing our tissue design.”

Crouch continued, “We also continue to generate favorable preclinical results in our liver therapeutic tissue program as we focus increasingly on end-stage liver disease and a select group of inborn errors of metabolism.  At industry meetings over the last several months, we’ve presented data on the performance of our tissues in animal models for Alpha-1-antitrypsin deficiency (“A1AT”) and hereditary tyrosinemia Type 1 (“HTT1”).  For both rare diseases, our tissues demonstrated engraftment, retention and functionality post-implantation, while reducing

disease hallmarks in the A1AT animal studies and improving the median survival rate for treated animals in the HTT1 studies.  Our objective in implanting a healthy tissue patch is to restore function or offset the deficiencies related to a specific condition.  We hope to serve as a ‘bridge to transplant’ for these patients with limited treatment options, with an ultimate goal of delaying or reducing the overall need for transplant.”

Crouch concluded, “We’re also building upon our cell and in vitro tissue platform, and through our partners at UC San Diego, recently presented data on the ongoing development of our non-alcoholic steatohepatitis (“NASH”) liver tissue model at the NASH-TAG 2019 Conference.  Dr. David Brenner, vice chancellor for health sciences at the University of California, San Diego, presented important findings from a series of studies that showed disease induction in our 3D bioprinted liver tissue model, treatment with two clinical compounds, and a reduced disease phenotype in the treated tissues.  We also continue to work with our clients on several custom projects for our liver tissue research services including the exploration of drug combination studies in our NASH disease model.”

Key Clinical Development Goals & Outlook

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The Company believes that development of its healthy therapeutic liver tissue patch can treat a broad range of liver disease indications.  Organovo continues to conduct supportive proof-of-concept studies in multiple indications aimed at treating end-stage liver disease and inborn errors of metabolism.

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Organovo expects to hold a pre-IND meeting with the FDA in calendar 2019 for its lead program.

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The Company plans to begin the IND-enabling toxicity study for its lead program in the second half of calendar 2019.

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Organovo expects to file for its first IND in calendar 2020.

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The Company will continue to opportunistically generate revenue to support its therapeutic research mission by leveraging its cell and in vitro tissue platform.

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Organovo plans to continue expanding its global IP portfolio, which currently includes over 100 patents and pending applications.

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As of December 31, 2018, the Company had a cash and cash equivalents balance of $35.2 million.  Organovo now expects an improved net cash utilization(1) rate of $20.5 million to $21.5 million in fiscal 2019, and believes it has sufficient funds to meet its operating and capital requirements through fiscal 2020.

Fiscal Third-Quarter 2019 Highlights

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Net loss was $6.4 million, a $1.4 million improvement over the year-ago period, as total costs and expenses declined 19 percent to $7.3 million, primarily due to lower employee costs related to the Company’s organizational restructuring and prioritization of R&D projects.

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Net cash utilization was $4.0 million, an improvement from $6.5 million in the prior-year quarter.

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Total revenue was $0.8 million, a 32 percent decrease from the year-ago period, primarily driven by lower grant revenue.

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During the fiscal t

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EXHIBIT 99.1

Investor & Press Contact:

Steve Kunszabo

Organovo Holdings, Inc.

+1 (858) 224-1092

skunszabo@organovo.com

ORGANOVO AFFIRMS KEY CLINICAL DEVELOPMENT GOALS;  COMPANY REPORTS FISCAL SECOND-QUARTER 2019 RESULTS

-    Pre-Investigational New Drug (“IND”) meeting with the FDA expected to be held in calendar 2019

-    Second orphan designation anticipated in first half of calendar 2019

-    Submit first IND in calendar 2020

SAN DIEGO – November 8, 2018 – Organovo Holdings, Inc. (NASDAQ:ONVO) (“Organovo”), a biotechnology company pioneering the development of 3D bioprinted tissues aimed at treating a range of serious adult and pediatric liver diseases, today affirmed its key clinical development goals and reported its fiscal second-quarter 2019 financial results.

“During the fiscal second quarter, we affirmed our key clinical development and operating goals,” said Taylor J. Crouch, CEO, Organovo.  “We remain on track for a pre-IND meeting with the FDA for our lead indication in calendar 2019 and expect to begin our IND-enabling toxicity study to support multiple orphan disease indications in the second half of calendar 2019.  In addition, we plan to conduct proof-of-concept animal studies in multiple rare diseases.  We’ve also made strong progress in pursuing a second orphan designation, and anticipate we’ll now receive a response from the FDA in the first half of calendar 2019.”

Crouch continued, “We continue to generate favorable preclinical results in our liver therapeutic tissues program and will present data at next week’s Liver Meeting® on the performance of our tissues in an animal model of hereditary tyrosinemia Type 1 (“HT-1”).  This rare disease is often characterized by severe liver damage and limited treatment options.  In early studies in established animal models for HT-1, our tissues demonstrated engraftment, retention and functionality post-implantation, while also showing an improvement in the median survival rate for treated animals.  Much like with Alpha-1 antitrypsin deficiency (“A1AT”), the same healthy

tissue construct allows us to potentially treat a broad range of target indications.  Our objective in implanting a healthy tissue patch is to restore function or offset the deficiency of a specific enzyme abnormality.  Our ultimate goal, which we hope to evaluate in future studies, is delaying or reducing the need for a transplant.”

Crouch concluded, “We also continue to build upon our cell and in vitro tissue platform, including the launch of a new RNASeq data library by our Samsara division, and several custom projects for our liver tissue research services including disease modeling and toxicology.”

Key Clinical Development Goals & Outlook

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The Company continues to conduct supportive proof-of-concept studies in multiple orphan disease indications aimed at treating inborn errors of metabolism.

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Organovo expects to hold a pre-IND meeting with the FDA in calendar 2019 for its lead rare disease program.

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The Company believes that development of its healthy therapeutic liver tissue patch can treat a broad range of rare disease indications.  The Company is pursuing a second orphan designation with the FDA, which it now anticipates receiving in the first half of calendar 2019.

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Organovo plans to begin its IND-enabling toxicity study to support multiple indications including A1AT in the second half of calendar 2019.

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The Company expects to file for its first IND in calendar 2020.

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Organovo will continue to opportunistically generate revenue to support its therapeutic research mission by leveraging its cell and in vitro tissue platform.

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Samsara Sciences, the Company’s wholly-owned subsidiary, recently launched a new product offering an RNA-Seq data library with matched sets of human liver tissues and cell types isolated from a range of healthy and diseased donors.  This cost-effective solution enables customers to mine data for discovery and validation of disease and cell type-specific markers.

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Organovo plans to continue expanding its global IP portfolio, which currently includes over 100 patents and pending applications.

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As of September 30, 2018, the Company had a cash and cash equivalents balance of $37.4 million.  Organovo continues to expect a net cash utilization(1) rate of $22 million to $24 million in fiscal 2019, and believes it has sufficient funds to meet its operating and capital requirements through fiscal 2020.

Fiscal Second-Quarter 2019 Financial Highlights

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Net loss was $5.8 million, a $3.6 million improvement over the year-ago period, as total costs and expenses declined 36 percent to $7.0 million, primarily due to lower employee and lab supply costs related to the Company’s organizational restructuring and prioritization of R&D projects.

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Net cash utilization was $4.3 million, an improvement from $8.3 million in the prior-year quarter.

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Total revenue was $0.9 milli

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Exhibit 99.1

Investor & Press Contact:

Steve Kunszabo

Organovo Holdings, Inc.

+1 (858) 224-1092

skunszabo@organovo.com

ORGANOVO REPORTS FISCAL FIRST-QUARTER 2019 RESULTS; COMPANY OUTLINES AND EXPANDS KEY CLINICAL DEVELOPMENT GOALS

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Pre-Investigational New Drug (“IND”) meeting with the FDA expected to be held in calendar 2019

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Lead IND program for Alpha-1-antitrypsin deficiency (“A1AT”) expected to commence IND-enabling studies in second half of calendar 2019 and to submit an IND in calendar 2020

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CMO Dr. Steven G. Hughes appointed to lead therapeutic tissue development program

SAN DIEGO – August 9, 2018 – Organovo Holdings, Inc. (NASDAQ:ONVO) (“Organovo”), a biotechnology company pioneering the development of 3D bioprinted tissues aimed at treating a range of serious adult and pediatric liver diseases, today reported its fiscal first-quarter 2019 financial results.

“During the fiscal first quarter, we refined our operating and scientific goals,” said Taylor J. Crouch, CEO, Organovo.  “We have concentrated our financial resources around supporting our healthy liver therapeutic tissue development, which has the potential to address a number of serious unmet medical needs, encompassing an addressable peak worldwide sales opportunity greater than $4 billion.”

Crouch continued, “On July 31st, we held a pre-pre-IND meeting with the FDA to review our IND planning for our lead program in A1AT.  In light of this meeting’s outcome, we intend to submit our pre-IND meeting package to the FDA in calendar 2019.  Based on anticipated study

designs for our IND-enabling work, we continue to target calendar 2020 for filing our IND, with the possibility of commencing human trials that same year.”

Crouch concluded, “We’ll also continue to opportunistically generate revenue to support our therapeutics program by leveraging our cell and in vitro tissue platform including providing funded access to our developmental non-alcoholic steatohepatitis (“NASH”) platform to clients for their own R&D programs.”

Key Clinical Development Goals & Outlook

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Organovo expects to hold a pre-IND meeting with the FDA in calendar 2019 for its lead program in A1AT, commence IND-enabling studies in the second half of calendar 2019 and file for an IND in calendar 2020.

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The Company plans to nominate a second indication in the rare disease space in calendar 2019, which has the potential to closely follow its lead program into human clinical trials.  The Company will also likely pursue orphan drug designation with the FDA for this second indication in calendar 2019.

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Organovo will continue to opportunistically generate revenue to support its therapeutic research mission by leveraging its cell and in vitro tissue platform.

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The Company plans to continue expanding its global IP portfolio, which currently includes over 100 patents and pending applications.

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As of June 30, 2018, the Company had a cash and cash equivalents balance of $39.6 million.  Organovo expects to have a net cash utilization(1) rate of $22 million to $24 million in fiscal 2019, and believes it has sufficient funds to meet its operating and capital requirements into fiscal 2020.

Fiscal First-Quarter 2019 Financial Highlights

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Net loss was $7.4 million, a $2.7 million improvement over the year-ago period, as total costs and expenses declined 26 percent to $8.3 million, primarily due to lower employee and lab supply costs related to the Company’s organizational restructuring and prioritization of R&D projects.

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Net cash utilization was $7.1 million, an improvement from $10.7 million in the prior-year quarter.

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Total revenue was $0.7 million, a 30 percent decrease from the year-ago period, primarily driven by lower revenue from liver tissue disease modeling research services.

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During the fiscal first quarter, the Company generated net proceeds of approximately $3.0 million from the issuance of 2.1 million shares of common stock in at-the-market offerings at a weighted average price of $1.44 per share.

Definitions & Supplemental Financial Measures

(1)

In addition to disclosing financial results that are determined in accordance with U.S. GAAP, the Company provides net cash utilization as a supplemental measure to help investors evaluate the Company’s fundamental operational performance.  The Company defines net cash utilization as the net decrease in cash and cash equivalents during the reporting period less proceeds from the sale of common stock and the exercise of warrants and stock options during the reporting period.  Net cash utilization is an operational measure that should be considered as additional financial information regarding our operations.  This operational measure should not be considered without also considering our results prepared in accordance with U.S. GAAP, and should not be considered as a substitute for, or superior to, our U.S. GAAP results.  The Company believes

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Exhibit 99.1

Investor & Press Contact:

Steve Kunszabo

Organovo Holdings, Inc.

+1 (858) 224-1092

skunszabo@organovo.com

ORGANOVO REPORTS FISCAL FOURTH-QUARTER AND FULL-YEAR 2018 RESULTS; COMPANY ANNOUNCES KEY GOALS FOR FISCAL-YEAR 2019

-Lead Investigational New Drug (“IND”) program for Alpha-1-antitrypsin deficiency (“A1AT”) received FDA’s orphan drug designation and is on track for commencing IND-enabling studies in fiscal 2019

-Second IND-track program in orphan liver disease expected to be nominated in fiscal 2019

SAN DIEGO – May 31, 2018 – Organovo Holdings, Inc. (NASDAQ:ONVO) (“Organovo”), a biotechnology company pioneering the development of 3D bioprinted tissues aimed at treating a range of serious adult and pediatric liver diseases, today reported its fiscal fourth-quarter and full-year 2018 financial results and announced its key goals for fiscal-year 2019.

“Fiscal 2018 was an important transition year for us as we demonstrated preclinical safety and efficacy proof-of-concept data for our NovoTissues® liver implant in animal models of A1AT,” said Taylor J. Crouch, CEO, Organovo.  “We concluded the year by achieving orphan drug designation from the FDA for this first IND-track program and we look forward to nominating a second IND program within fiscal 2019.  Our healthy liver therapeutic tissue has the opportunity to address a number of rare, serious unmet medical needs which often lead to liver transplant, and as such, we’re planning to explore additional NovoTissues indications within the spectrum of inborn errors of metabolism, acute on chronic liver failure, and other debilitating liver diseases.  We estimate that the unique benefits of bridging patients to transplant or even providing a therapeutic alternative to transplant has the potential to create an addressable peak

worldwide sales opportunity in excess of $4 billion.  Our first target indication of A1AT alone has the potential to approach $1 billion in peak sales.”

Crouch continued, “We’ll also continue to demonstrate the robust functionality of our tissues within our in vitro testing operations, where we’re creating a series of disease conditions that can subsequently be ‘treated’ with promising new drug candidates.  In fiscal 2019, we aim to expand the scope of non-alcoholic steatohepatitis (“NASH”) conditions exhibiting the key components of the disease to support high value drug discovery and development.  We believe our platform represents the only comprehensive, non-clinical way to investigate key aspects of drug efficacy and safety utilizing histology, which is the gold standard of diagnosing and measuring response in NASH.”

Crouch concluded, “As we continue to demonstrate the remarkable utility of our 3D bioprinted tissues, we are focused on critical advances to medicine that our platform may provide, spanning our current support of NASH R&D through to a range of potentially breakthrough clinical applications enabled by our NovoTissues platform.  We believe our technology has the potential to transform the care of patients with debilitating and often fatal liver diseases.”

Fiscal-Year 2019 Goals & Outlook

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Organovo intends to continue preclinical development and commence IND-enabling studies for its A1AT liver therapeutic tissue program in fiscal 2019.

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The Company plans to pursue orphan drug designation for a second rare disease indication with the FDA, with the objective of ending fiscal 2019 with two liver therapeutic tissue programs on track for an IND targeted for calendar 2020.

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In support of its in vitro testing operations, Organovo expects to significantly expand its comprehensive NASH profiling platform, creating a range of drug profiling conditions to facilitate partnering in drug discovery and development.

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The Company plans to continue expanding its global IP portfolio, which currently includes over 100 patents and pending applications.

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As of March 31, 2018, the Company had a cash and cash equivalents balance of $43.7 million.  Organovo expects to have a net cash utilization(1) rate of $22 million to $24 million in fiscal 2019, and believes it has sufficient funds to meet its operating and capital requirements into fiscal 2020.

Fiscal Fourth-Quarter 2018 Financial Highlights

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Total revenue was $1.1 million, a 36 percent gain from the year-ago period, primarily driven by higher cell-based product and grant revenue.

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Research and development costs decreased 28 percent year-over-year to $4.0 million, primarily due to lower employee and lab supply costs related to the Company’s organizational restructuring and prioritization of R&D projects.

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Negative Adjusted EBITDA(2) was $5.7 million, as compared to $8.3 million for the year-ago period.

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During the fiscal fourth quarter, the Company generated net proceeds of approximately $2.1 million from the issuance of 1.5 million shares of common stock in at-the-market offerings at a we

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EXHIBIT 99.1

Investor Contact:

Press Contact:

Steve Kunszabo

Jessica Yingling

Organovo Holdings, Inc.

Little Dog Communications

+1 (858) 224-1092

+1 (858) 480-2411

skunszabo@organovo.com

jessica@litldog.com

ORGANOVO ANNOUNCES FISCAL THIRD-QUARTER 2018 RESULTS; COMPANY UPDATES FULL-YEAR FISCAL 2018 OUTLOOK

SAN DIEGO – February 8, 2018 – Organovo Holdings, Inc. (NASDAQ:ONVO) (“Organovo”) today reported financial results for the fiscal third quarter of 2018 and updated its full-year fiscal 2018 outlook.  The Company reported fiscal third-quarter total revenue of $1.2 million.  Total revenue was unchanged from the prior-year period and decreased 15 percent versus the fiscal second quarter of 2018.  Net loss was $7.8 million, or $0.07 per share, for the fiscal third quarter of 2018, as compared to $9.6 million, or $0.09 per share, for the fiscal third quarter of 2017.  Negative Adjusted EBITDA(1) for the third quarter was $5.2 million, as compared to $7.3 million for the prior-year period.

“Our liver therapeutic tissue program continues to make excellent progress in achieving critical regulatory and scientific milestones,” said Taylor J. Crouch, CEO, Organovo.  “With the U.S. Food and Drug Administration (“FDA”) recently granting orphan designation for our NovoTissues® treatment of Alpha-1 antitrypsin deficiency (“A1AT”), our path to commercializing this novel therapeutic comes with significant developmental and economic incentives.  With few alternative therapies and a high annual cost of care, patient need is great in treating this rare, debilitating liver disease.  We’ve also begun new studies in a second therapeutic indication within the category of inborn errors of metabolism, Fumarylacetoacetate Hydrolase (“FAH”) deficiency, and look forward to reporting proof-of-principle data in the coming months.”

Crouch continued, “In our commercial segment, we continue to shift our R&D and business development efforts to high-value liver disease modeling services.  We’re seeing meaningful

early uptake as we transition away from routine toxicology projects, with nearly all of our service revenue in the fiscal third quarter representing disease modeling studies.  With approximately 250 global programs pursuing treatments in the areas of non-alcoholic fatty liver disease (“NAFLD”) and non-alcoholic steatohepatitis (”NASH”), we believe being a pioneer in this area translates into the best path forward for boosting our revenue growth.  Sophisticated clients are already partnering with us in a multi-faceted approach to develop custom tissue models, allowing us to target the entire drug discovery and development spectrum.  We continue to expect deeper engagement from our customers over the next several months.”

Crouch concluded, “We have the ability to monetize our platform in many ways, including the provision of primary human cells for research applications, compound screening in disease models, licensing agreements that capitalize on our technology, and the ongoing development of novel therapeutics.  We’ll continue to direct our resources at all of these opportunities as we focus on long-term value creation.”

Third-Quarter Organovo Business Highlights

Revenue

•

Total revenue was $1.2 million, unchanged from the year-ago period.  Higher grant revenue related to the Company’s National Institutes of Health (“NIH”) project offset lower revenue from collaborative agreements.

•

Product and service revenue was $0.8 million, up 19 percent from the prior-year period, largely driven by an increase in liver disease modeling studies and sales from human cell and tissue products.

Operating Expenses

•

Cost of revenues was $0.2 million, a decrease of 9 percent from the prior-year period, reflecting a greater contribution from higher-margin primary human cell and tissue products.

•

Research and development costs decreased 20 percent year-over-year to $4.0 million, primarily due to lower employee and lab supply costs related to the Company’s organizational restructuring and prioritization of R&D projects.

•

Selling, general and administrative expenses decreased 12 percent from the prior-year period to $4.9 million, reflecting lower employee and non-cash stock-based compensation expenses, which offset $0.8 million in severance and other costs related to the Company’s organizational restructuring.

Liquidity & Capital Resources

•

The Company ended the fiscal third quarter with a cash and cash equivalents balance of $47.3 million.

•

During the fiscal third quarter, the Company generated net proceeds of approximately $3.1 million from the issuance of 2.3 million shares of common stock in at-the-market (“ATM”) offerings at a weighted average price of $1.42 per share.  Through January 31, 2018, the Company generated additional net proceeds of approximately $2.1 million from the issuance of 1.5 million shares of common stock in ATM offerings at a weighted aver

EX-99.1

2 onvo-ex991_6.htm

EX-99.1

onvo-ex991_6.htm

Exhibit 99.1

Investor Contact:

Press Contact:

Steve Kunszabo

Organovo Holdings, Inc.

+1 (858) 224-1092

skunszabo@organovo.com

Jessica Yingling

Little Dog Communications

+1 (858) 480-2411

jessica@litldog.com

ORGANOVO ANNOUNCES FISCAL SECOND-QUARTER 2018 RESULTS; COMPANY SHIFTS COMMERCIAL FOCUS TO HIGHER-VALUE DISEASE MODELING OPPORTUNITIES AND UPDATES FULL-YEAR FISCAL 2018 OUTLOOK

SAN DIEGO – November 9, 2017 – Organovo Holdings, Inc. (NASDAQ:ONVO) (“Organovo”) today reported financial results for the fiscal second quarter of 2018 and updated its full-year fiscal 2018 outlook.  The Company is shifting the focus of its commercial and platform development efforts toward higher-demand and higher-value disease modeling services, and is deprioritizing routine toxicology research services.  While Organovo has had meaningful early uptake for its disease modeling studies, these revenues are not anticipated to offset a smaller than expected contribution from toxicology research services in the remaining months of its 2018 fiscal year.  As a result, the Company has lowered its fiscal 2018 total revenue outlook.  The Company believes its focus on disease modeling platforms coupled with its IND-track therapeutics program will best unlock the value of its 3D tissue printing capabilities.  As a result of its change in strategic focus and the recently announced restructuring and organizational realignment, the Company also has favorably revised its negative Adjusted EBITDA(1) guidance.

Organovo reported fiscal second-quarter total revenue of $1.4 million.  Total revenue decreased 2 percent from the prior-year period, and increased 37 percent versus the fiscal first quarter of 2018.  Net loss was $9.5 million, or $0.09 per share, for the fiscal second quarter of 2018, as compared to $9.4 million, or $0.10 per share, for the fiscal second quarter of 2017.  Negative Adjusted EBITDA(1) for the second quarter was $6.6 million, as compared to $7.1 million for the prior-year period.

“We have the ability to monetize our platform in many ways, including the provision of primary human cells for research applications, compound screening in disease models, licensing agreements that capitalize on our technology, and the ongoing development of novel therapeutics,” said Taylor J. Crouch, CEO, Organovo.  “Clients are working with us across this value chain, allowing us to target the entire drug discovery and development ecosystem.  Given the increased adoption by a number of sophisticated customers of our disease modeling capabilities, and the important role that non-alcoholic fatty liver disease (“NAFLD”) and non-alcoholic steatohepatitis (“NASH”) play in pharmaceutical R&D, we believe our move to this space represents the highest value opportunity for our commercial business.”

Crouch continued, “As we work with multiple industry leaders, we see deeper engagement from them relating to annual budget allocations and framework agreements for our services.  These are all important steps as they move from individual platform validation studies with us to dedicated research plans and meaningful annual revenue commitments tied to their specific drug development needs.  For example, a number of our customers have already indicated they’re building us into their upcoming budgets in a more meaningful way, with programs related to NASH and liver fibrosis leading the way for broader adoption.  We’ve also recently begun to utilize our platform with clients who already have drugs in clinical development, illustrating that collaboration opportunities exist in all stages of drug discovery and development.”

Crouch concluded, “Recent progress in developing our liver therapeutic tissue serves both as a way to de-risk the adoption of our services and as a chief source of validation for our customers.  Its greatest promise is as a revolutionary therapeutic application for multiple liver diseases, including alpha-1 antitrypsin deficiency.  With robust functionality and retention through 125 days post-implantation, and an approximately 75% reduction in the pathologic hallmarks of this disease in the region of implant, our advanced 3D liver model is at the leading edge of mirroring human liver function in our preclinical studies.”

Page 2/3

Second-Quarter Organovo Business Highlights

Revenue

•

Total revenue was $1.4 million, down 2 percent from the year-ago period.  The decrease was primarily driven by less revenue from previously completed collaborative research agreements, partially offset by grant payments related to the Company’s recently awarded National Institutes of Health (“NIH”) grant.

•

Product and service revenue was $0.9 million, down 8 percent from the prior-year period, largely driven by fewer customer validation projects for liver tissue toxicology research services.  This decrease was partially offset by strong gains in customer contracts for liver tissue disease modelin

EX-99.1

2 onvo-ex991_6.htm

EX-99.1

onvo-ex991_6.htm

EXHIBIT 99.1

Investor & Press Contact:

Steve Kunszabo

Organovo Holdings, Inc.

+1 (858) 224-1092

skunszabo@organovo.com

ORGANOVO ANNOUNCES PRELIMINARY FISCAL SECOND- QUARTER TOTAL REVENUE; COMPANY RESTRUCTURES TO IMPROVE OPERATIONAL EFFICIENCY

SAN DIEGO – October 4, 2017 – Organovo Holdings, Inc. (NASDAQ:ONVO) (“Organovo”) today reported preliminary unaudited total revenue for the fiscal second quarter of 2018.  The Company expects to release full fiscal second-quarter financial results on November 9, 2017.  The Company also announced a restructuring plan to improve operational efficiency.

Selected Organovo Financial Highlights

•

Preliminary fiscal second quarter total revenue is expected to be between $1.3 million and $1.4 million, consisting largely of product and service revenue.  At the midpoint, this result reflects a 2 percent decrease in total revenue versus the comparable period of fiscal 2017 and a 36 percent increase versus the fiscal first quarter of 2018.

“We are executing against our key objectives halfway through fiscal 2018, with the second quarter representing our second highest quarterly revenue to date and our third consecutive quarter of sequential product and service revenue growth,” said Taylor J. Crouch, CEO, Organovo.  “Our tissue systems continue to gain traction with biopharma clients and academic partners, with exceptionally strong engagement in developing disease models for compound screening.  We see strong indicators that one or more of our clients will move to implement our platform for larger routine use applications by the end of our current fiscal year.”

Crouch continued, “We’re also pleased that our recently announced NIH grant to study liver disease is off to such a strong start.  Non-alcoholic fatty liver disease (“NAFLD”) is a growing public health issue around the world, and we believe our ExViveTM Liver Tissue is uniquely suited to model the dynamics of non-alcoholic steatohepatitis (“NASH”) and other conditions such as liver fibrosis in a way that mimics many aspects of human livers.  Our bioprinting platform can facilitate breakthroughs in studying fatty liver disease and lead to revolutionary approaches for discovering and developing drugs in this critical, unmet disease area.”

Restructuring Plan

Organovo announced a plan to restructure its business to better focus and align resources, reducing approximately 15 positions, or 13% of its overall workforce.  The internal reorganization will improve operational efficiency, consolidate overlapping positions and streamline the Company’s management structure.  As a result, the Company expects to record a restructuring charge in the fiscal third quarter of approximately $0.9 million, primarily related to employee severance and benefits costs.  In addition, Organovo expects the workforce reduction will decrease operating costs by $1.3 million in fiscal 2018 and $2.7 million in fiscal 2019.  The reduction in future operating expenses is expected to improve the Company’s fiscal 2018 negative Adjusted EBITDA.  The actions associated with today’s restructuring announcement are anticipated to be complete by the end of calendar-year 2017.

“As we direct our strategic effort to growing liver and kidney tissue research services, and the ongoing preclinical development of our liver therapeutic tissue, we identified the opportunity to streamline our operational capabilities and align our organization more closely with achieving these precise commercial and R&D goals,” said Taylor J. Crouch, CEO, Organovo.  “We expect to achieve important process and scale efficiencies that allow us to better engage with our customers and focus on opportunities with the highest return-on-investment for our business.  Our new organizational structure also allows us to reduce costs in non-core areas, and more carefully manage our cash burn rate with an eye towards delivering long-term shareholder value.”

About Organovo Holdings, Inc.

Organovo designs and creates functional, three-dimensional human tissues for use in drug discovery, clinical development, and therapeutic applications.  The Company develops 3D human tissue systems through internal research programs and in collaboration with pharmaceutical, academic and other partners.  Organovo's 3D human tissues have the potential to transform the drug discovery process, enabling treatments to be developed more effectively and with greater relevance to performance in human trials and commercialization.  The Company’s ExViveTM Human Liver and Kidney Tissues are used in high-value drug profiling, including compound screening in disease models, toxicology, target and marker discovery/validation, and other drug testing.  The Company is also advancing a preclinical program to develop liver therapeutic tissues for critical unmet medical needs, including certain life-threatening pediatric diseases.  In addition to numerous scientific publication

EX-99.1

2 onvo-ex991_8.htm

EX-99.1

onvo-ex991_8.htm

Exhibit 99.1

Investor Contact:

Press Contact:

Steve Kunszabo

Jessica Yingling

Organovo Holdings, Inc.

Little Dog Communications

+1 (858) 224-1092

+1 (858) 480-2411

skunszabo@organovo.com

jessica@litldog.com

ORGANOVO ANNOUNCES FISCAL FIRST-QUARTER 2018 RESULTS; COMPANY AFFIRMS FULL-YEAR FISCAL 2018 OUTLOOK

SAN DIEGO – August 9, 2017 – Organovo Holdings, Inc. (NASDAQ:ONVO) (“Organovo”) today reported financial results for the fiscal first quarter of 2018 and affirmed its full-year fiscal 2018 outlook.  Organovo reported fiscal first-quarter total revenue of $1.0 million, which consisted largely of product and service revenue(1).  Total revenue increased 11 percent versus the comparable period of fiscal 2017.  Net loss was $10.1 million, or $0.10 per share, for the fiscal first quarter of 2018, as compared to $8.8 million, or $0.09 per share, for the fiscal first quarter of 2017.  Negative Adjusted EBITDA(2) for the first quarter was $7.5 million, as compared to $7.1 million for the prior-year period.

“We’re tracking to our plan through the first quarter of fiscal 2018, delivering total revenue that was in-line with our outlook and affirming our guidance across the board,” said Taylor J. Crouch, CEO, Organovo.  “We continued to see a healthy balance of new sales and repeat business during the period, with nearly 70% of orders for tissue research services coming from existing clients as we more deeply engage our customers.  Demand for compound screening in disease models is growing, with new applications frequently emerging as clients seek novel solutions in their drug discovery workflow.  Beyond recognized areas such as liver fibrosis and non-alcoholic steatohepatitis (“NASH”), recent exploratory applications include Hepatitis B and RNA therapeutics.  These are all good leading indicators of broader adoption as we seek to move customers to routine use of our solutions.”

Crouch continued, “In the therapeutics space, we continue to successfully achieve key objectives as we advance our liver therapeutic tissue.  Our bioprinted liver tissues are now thriving 90 days post-implantation in animal models, triple the duration of our earliest preclinical studies. Importantly, we’ve continued to observe strong synthetic function and meaningful improvement in liver health for treated animals.  During fiscal 2018, we’ll continue to conduct pre-GLP studies in small animal disease models for our target indications and take preliminary steps to seek orphan designation in the U.S.”

Crouch concluded, “Our long-term plan remains founded on targeting attractive and growing markets with critical unmet needs, extending our first mover advantage, and capitalizing on our technology leadership to grow our product and service offerings.”

First-Quarter Organovo Business Highlights

Revenue

•

Product and service revenue was $0.9 million, up 40 percent from the prior-year period, largely driven by an increase in customer contracts for the Company’s tissue research services.

Operating Expenses

•

Cost of revenues was $0.3 million, an increase of 79 percent from the prior-year period, reflecting a gain in product and service revenue.

•

Research and development costs increased 13 percent year-over-year to $5.0 million, primarily due to increased materials and outside services costs related to the Company’s ongoing validation studies.

•

Selling, general and administrative expenses increased 16 percent from the prior-year period to $5.9 million, reflecting higher non-cash stock-based compensation and employee related expense.

Liquidity & Capital Resources

•

The Company ended the fiscal first quarter with a cash and cash equivalents balance of $55.0 million.

•

During the fiscal first quarter, the Company generated net proceeds of approximately $3.0 million from the issuance of 1,139,489 shares of common stock in at-the-market (“ATM”) offerings at a weighted average price of $2.69 per share.

•

Working capital was $54.2 million to end the fiscal first quarter compared to $52.0 million in the prior-year quarter.

Fiscal-Year 2018 Outlook

The Company affirmed its full-year fiscal 2018 outlook for total revenue and negative Adjusted EBITDA.  The Company continues to expect:

•

Total revenue of between $6.0 million and $8.5 million for fiscal-year 2018.  Fiscal 2017 total revenue was $4.2 million.

•

Negative Adjusted EBITDA of between $29.0 million and $31.0 million for fiscal-year 2018.  Fiscal 2017 negative Adjusted EBITDA was $29.8 million.

Fiscal-Year 2018 Outlook

(June 2017)

Fiscal-Year 2018 Outlook

(August 2017)

Fiscal-Year 2018

Total Revenue

$6.0 million - $8.5 million

Affirmed

Fiscal-Year 2018 Negative

Adjusted EBITDA

$29.0 million - $31.0 million

Affirmed

A reconciliation of non-GAAP negative Adjusted EBITDA, as forecasted for fiscal 2018, to the closest corresponding GAAP measure, net loss, is not available without unreasonable efforts on a

EX-99.1

2 onvo-ex991_8.htm

EX-99.1

onvo-ex991_8.htm

Exhibit 99.1

Investor Contact:

Press Contact:

Steve Kunszabo

Jessica Yingling

Organovo Holdings, Inc.

Little Dog Communications

+1 (858) 224-1092

+1 (858) 480-2411

skunszabo@organovo.com

jessica@litldog.com

ORGANOVO ANNOUNCES FISCAL FOURTH-QUARTER and FULL-YEAR 2017 RESULTS; COMPANY ISSUES FULL-YEAR FISCAL 2018 OUTLOOK

SAN DIEGO – June 7, 2017 – Organovo Holdings, Inc. (NASDAQ:ONVO) (“Organovo”) today reported financial results for the fiscal fourth quarter of 2017 and issued its full-year fiscal 2018 outlook.  Organovo reported fiscal fourth-quarter total revenue of $0.8 million, which consisted largely of product and service revenue(1).  Total revenue increased 48 percent versus the comparable period of fiscal 2016.  Net loss was $10.7 million, or $0.10 per share, for the fiscal fourth quarter of 2017, as compared to $8.4 million, or $0.09 per share, for the fiscal fourth quarter of 2016.

“Fiscal 2017 was a year of significant commercial progress for Organovo, as we grew total revenue 185% and achieved many important scientific targets,” said Taylor J. Crouch, CEO, Organovo.  “We issued our outlook today for fiscal 2018 total revenue, which represents a robust increase in sales led by growth in tissue research services.  In addition to our established work in the toxicology space, we’re seeing strong customer demand for compound screening in disease models, including key areas such as liver fibrosis and non-alcoholic steatohepatitis (“NASH”).  With 30% of the developed world now living with progressive fatty liver disease, I believe our work and capabilities will become critical to understanding the effects of new drugs in realistically modeled patient populations.”

Crouch continued, “I’ve joined Organovo during a transformational time in its history.  The leading indicators of broader customer acceptance are taking shape.  A key component of customer adoption remains the breadth of our ongoing validation work.  I’m excited to share that we’ve now studied 46 compounds and accurately characterized the safety profile in a high percentage of the cases based on clinical correlation.  It’s important to remember that these cases included preclinical misses and approved drugs where cell and animal models did not provide an adequate safety signal.  We’ll not only focus on growing our library of core validation work over the long-term, but as we shared last quarter, we’ll continue supporting immediate customer needs related to optimized utilization and new applications.”

Crouch concluded, “As we look ahead to fiscal 2018, our core business infrastructure is at a sufficient level to support anticipated customer demand and revenue producing opportunities.  We’re focused on a precise set of goals to enable our rapid growth.  First, we expect to capitalize on future adoption of our liver and kidney tissue research services.  Ongoing validation work and business development execution with new customers will be the cornerstones for achieving this objective, while also moving existing clients quickly to repeat orders on the path to routine use of our solutions.  Second, we plan to advance our liver therapeutic tissue through preclinical studies with the goal of locking down our final tissue design and conducting successful animal disease model studies over the next 12 months.  With each incremental success against these objectives, we’re changing how drugs are developed and ultimately impacting patient outcomes where critical unmet needs exist.”

Full-Year Fiscal 2017 Organovo Business Highlights

For the full year, the Company reported total revenue of $4.2 million, which was up 185% from the year-ago period.  Total revenue included $3.2 million of product and service revenue and $1.0 million of revenue related to collaborations(2).  Organovo reported fiscal 2017 net loss of $38.4 million, or $0.39 per share, as compared to net loss of $38.6 million, or $0.43 per share, for fiscal 2016.

Fourth-Quarter Organovo Business Highlights

Revenue

•

Product and service revenue was $0.8 million, up $0.7 million from the prior-year period, largely driven by an increase in customer contracts for the Company’s tissue research services.

Operating Expenses

•

Cost of revenues was $0.2 million, reflecting the Company’s expenses related to manufacturing and delivering its product and service revenues.

•

Research and development costs increased 22 percent year-over-year to $5.5 million, primarily due to increased employee related, scientific validation work and lab supplies costs.

•

Selling, general and administrative expenses gained 30 percent from the prior-year period to $5.8 million, reflecting higher employee related and outside professional services costs.

Liquidity & Capital Resources

•

The Company ended the fiscal fourth quarter with a cash and cash equivalents balance of $62.8 million.  Organovo’s net cash utilization(3) during the period was $7.5 m

8-K 1 onvo-8k_20170209.htm 8-K

onvo-8k_20170209.htm

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): February 9, 2017

ORGANOVO HOLDINGS, INC.

(Exact name of registrant as specified in its charter)

Commission File Number: 001-35996

Delaware

27-1488943

(State or other jurisdiction

of incorporation)

(I.R.S. Employer

Identification No.)

6275 Nancy Ridge Dr.,

San Diego, California 92121

(Address of principal executive offices, including zip code)

(858) 224-1000

(Registrant’s telephone number, including area code)

(Former Name or Former Address, if Changed Since Last Report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Item 2.02 Results of Operations and Financial Condition

On February 9, 2017, Organovo Holdings, Inc. (the “Company”) issued a press release announcing financial results for its third quarter ended December 31, 2016.  A copy of the press release is attached hereto as Exhibit 99.1.

The information furnished in this Item 2.02 is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Exchange Act of 1934 or otherwise subject to the liabilities of that Section.  The information in this Item 2.02 shall not be incorporated by reference into any registration statement or other document filed with the Securities and Exchange Commission (the “SEC”).

Item 9.01 Financial Statements and Exhibits

(d)

Exhibits

99.1

Press Release, dated February 9, 2017.

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this Report to be signed on its behalf by the undersigned hereunto duly authorized.

ORGANOVO HOLDINGS, INC.

Date: February 9, 2017

/s/ Keith Murphy

Keith Murphy

Chief Executive Officer and President

Exhibit Index

Exhibit

No.

Description

99.1

Press Release, dated February 9, 2017.

8-K 1 onvo-8k_20161103.htm 8-K

onvo-8k_20161103.htm

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): November 3, 2016

ORGANOVO HOLDINGS, INC.

(Exact name of registrant as specified in its charter)

Commission File Number: 001-35996

Delaware

27-1488943

(State or other jurisdiction

of incorporation)

(I.R.S. Employer

Identification No.)

6275 Nancy Ridge Dr.,

San Diego, California 92121

(Address of principal executive offices, including zip code)

(858) 224-1000

(Registrant’s telephone number, including area code)

(Former Name or Former Address, if Changed Since Last Report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Item 2.02 Results of Operations and Financial Condition

On November 3, 2016, Organovo Holdings, Inc. (the “Company”) issued a press release announcing financial results for its second quarter and fiscal year ended September 30, 2016.  A copy of the press release is attached hereto as Exhibit 99.1.

The information furnished in this Item 2.02 is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Exchange Act of 1934 or otherwise subject to the liabilities of that Section.  The information in this Item 2.02 shall not be incorporated by reference into any registration statement or other document filed with the Securities and Exchange Commission (the “SEC”).

Item 9.01 Financial Statements and Exhibits

(d)

Exhibits

99.1

Press Release, dated November 3, 2016.

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this Report to be signed on its behalf by the undersigned hereunto duly authorized.

ORGANOVO HOLDINGS, INC.

Date: November 3, 2016

/s/ Keith Murphy

Keith Murphy

Chief Executive Officer and President

Exhibit Index

Exhibit

No.

Description

99.1

Press Release, dated November 3, 2016.

8-K 1 onvo-8k_20161011.htm

8-K - PRELIMINARY FINANCIALS

onvo-8k_20161011.htm

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): October 11, 2016

ORGANOVO HOLDINGS, INC.

(Exact name of registrant as specified in its charter)

Commission File Number: 001-35996

Delaware

27-1488943

(State or other jurisdiction

of incorporation)

(I.R.S. Employer

Identification No.)

6275 Nancy Ridge Dr.,

San Diego, California 92121

(Address of principal executive offices, including zip code)

(858) 224-1000

(Registrant’s telephone number, including area code)

(Former Name or Former Address, if Changed Since Last Report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Item 2.02 Results of Operations and Financial Condition.

On October 11, 2016, Organovo Holdings, Inc. (the “Company”) issued a press release to announce select preliminary results for the fiscal second quarter of 2017, to update its full-year fiscal 2017 outlook and to affirm its long-range outlook. A copy of this press release is furnished as Exhibit 99.1 hereto.

Item 7.01  Regulation FD Disclosure.

The information disclosed under Item 2.02 is also intended to be disclosed under this Item 7.01 and is incorporated herein by reference.

The information furnished in Items 2.02 and 7.01 to this Form 8-K, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Exchange Act or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any other filing under the Securities Act of 1933 or the Securities Exchange Act of 1934, except as expressly set forth by specific reference in such a filing.

Item 9.01 Financial Statements and Exhibits.

(d)

Exhibits

99.1

Press Release, dated October 11, 2016.

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this Report to be signed on its behalf by the undersigned hereunto duly authorized.

ORGANOVO HOLDINGS, INC.

Date: October 11, 2016

/s/ Keith Murphy

Keith Murphy

Chief Executive Officer and President

Exhibit Index

Exhibit

No.

Description

99.1

Press Release, dated October 11, 2016

8-K 1 onvo-8k_20160804.htm 8-K

onvo-8k_20160804.htm

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): August 4, 2016

ORGANOVO HOLDINGS, INC.

(Exact name of registrant as specified in its charter)

Commission File Number: 001-35996

Delaware

27-1488943

(State or other jurisdiction

of incorporation)

(I.R.S. Employer

Identification No.)

6275 Nancy Ridge Dr.,

San Diego, California 92121

(Address of principal executive offices, including zip code)

(858) 224-1000

(Registrant’s telephone number, including area code)

(Former Name or Former Address, if Changed Since Last Report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Item 2.02 Results of Operations and Financial Condition

On August 4, 2016, Organovo Holdings, Inc. (the “Company”) issued a press release announcing financial results for the first quarter of its fiscal year, which period ended June 30, 2016.  A copy of the press release is attached hereto as Exhibit 99.1.

The information furnished in this Item 2.02 is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Exchange Act of 1934 or otherwise subject to the liabilities of that Section.  The information in this Item 2.02 shall not be incorporated by reference into any registration statement or other document filed with the Securities and Exchange Commission (the “SEC”).

Item 9.01 Financial Statements and Exhibits

(d)

Exhibits

99.1

Press Release, dated August 4, 2016.

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this Report to be signed on its behalf by the undersigned hereunto duly authorized.

ORGANOVO HOLDINGS, INC.

Date: August 4, 2016

/s/ Keith Murphy

Keith Murphy

Chief Executive Officer and President

Exhibit Index

Exhibit

No.

Description

99.1

Press Release, dated August 4, 2016.

8-K 1 onvo-8k_20160609.htm 8-K

onvo-8k_20160609.htm

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): June 9, 2016

ORGANOVO HOLDINGS, INC.

(Exact name of registrant as specified in its charter)

Commission File Number: 001-35996

Delaware

27-1488943

(State or other jurisdiction

of incorporation)

(I.R.S. Employer

Identification No.)

6275 Nancy Ridge Dr.,

San Diego, California 92121

(Address of principal executive offices, including zip code)

(858) 224-1000

(Registrant’s telephone number, including area code)

(Former Name or Former Address, if Changed Since Last Report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Item 2.02 Results of Operations and Financial Condition

On June 9, 2016, Organovo Holdings, Inc. (the “Company”) issued a press release announcing financial results for its fourth quarter and fiscal year ended March 31, 2016.  A copy of the press release is attached hereto as Exhibit 99.1.

The information furnished in this Item 2.02 is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Exchange Act of 1934 or otherwise subject to the liabilities of that Section.  The information in this Item 2.02 shall not be incorporated by reference into any registration statement or other document filed with the Securities and Exchange Commission (the “SEC”).

Item 9.01 Financial Statements and Exhibits

(d)

Exhibits

99.1

Press Release, dated June 9, 2016.

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this Report to be signed on its behalf by the undersigned hereunto duly authorized.

ORGANOVO HOLDINGS, INC.

Date: June 9, 2016

/s/ Keith Murphy

Keith Murphy

Chief Executive Officer and President

Exhibit Index

Exhibit

No.

Description

99.1

Press Release, dated June 9, 2016.

8-K 1 onvo-8k_20160208.htm 8-K

onvo-8k_20160208.htm

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): February 8, 2016

ORGANOVO HOLDINGS, INC.

(Exact name of registrant as specified in its charter)

Commission File Number: 001-35996

Delaware

27-1488943

(State or other jurisdiction

of incorporation)

(I.R.S. Employer

Identification No.)

6275 Nancy Ridge Dr.,

San Diego, California 92121

(Address of principal executive offices, including zip code)

(858) 224-1000

(Registrant’s telephone number, including area code)

(Former Name or Former Address, if Changed Since Last Report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Item 2.02 Results of Operations and Financial Condition

On February 8, 2016, Organovo Holdings, Inc. (the “Company”) issued a press release announcing financial results for the third quarter of its fiscal year, which period ended December 31, 2015.  A copy of the press release is attached hereto as Exhibit 99.1.

The information furnished in this Item 2.02 is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Exchange Act of 1934 or otherwise subject to the liabilities of that Section.  The information in this Item 2.02 shall not be incorporated by reference into any registration statement or other document filed with the Securities and Exchange Commission (the “SEC”).

Item 9.01 Financial Statements and Exhibits

(d)

Exhibits

99.1

Press Release, dated February 8, 2016.

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this Report to be signed on its behalf by the undersigned hereunto duly authorized.

ORGANOVO HOLDINGS, INC.

Date: February 8, 2016

/s/ Keith Murphy

Keith Murphy

Chief Executive Officer and President

Exhibit Index

Exhibit

No.

Description

99.1

Press Release, dated February 8, 2016.

8-K 1 onvo-8k_20151109.htm 8-K

onvo-8k_20151109.htm

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): November 9, 2015

ORGANOVO HOLDINGS, INC.

(Exact name of registrant as specified in its charter)

Commission File Number: 001-35996

Delaware

27-1488943

(State or other jurisdiction

of incorporation)

(I.R.S. Employer

Identification No.)

6275 Nancy Ridge Dr.,

San Diego, California 92121

(Address of principal executive offices, including zip code)

(858) 224-1000

(Registrant’s telephone number, including area code)

(Former Name or Former Address, if Changed Since Last Report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

o

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

o

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

o

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

o

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Item 2.02 Results of Operations and Financial Condition

On November 9, 2015, Organovo Holdings, Inc. (the “Company”) issued a press release announcing financial results for the second quarter of its fiscal year, which period ended September 30, 2015.  A copy of the press release is attached hereto as Exhibit 99.1.

The information furnished in this Item 2.02 is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Exchange Act of 1934 or otherwise subject to the liabilities of that Section.  The information in this Item 2.02 shall not be incorporated by reference into any registration statement or other document filed with the Securities and Exchange Commission (the “SEC”).

Item 9.01 Financial Statements and Exhibits

(d)

Exhibits

99.1

Press Release, dated November 9, 2015.

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this Report to be signed on its behalf by the undersigned hereunto duly authorized.

ORGANOVO HOLDINGS, INC.

Date: November 9, 2015

/s/ Keith Murphy

Keith Murphy

Chief Executive Officer and President

Exhibit Index

Exhibit

No.

Description

99.1

Press Release, dated November 9, 2015.

8-K 1 onvo-8k_20150810.htm 8-K

onvo-8k_20150810.htm

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): August 10, 2015

ORGANOVO HOLDINGS, INC.

(Exact name of registrant as specified in its charter)

Commission File Number: 001-35996

Delaware

27-1488943

(State or other jurisdiction

of incorporation)

(I.R.S. Employer

Identification No.)

6275 Nancy Ridge Dr.,

San Diego, California 92121

(Address of principal executive offices, including zip code)

(858) 224-1000

(Registrant’s telephone number, including area code)

(Former Name or Former Address, if Changed Since Last Report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Item 2.02 Results of Operations and Financial Condition

On August 10, 2015, Organovo Holdings, Inc. (the “Company”) issued a press release announcing financial results for the first quarter of its fiscal year, which period ended June 30, 2015.  A copy of the press release is attached hereto as Exhibit 99.1.

The information furnished in this Item 2.02 is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Exchange Act of 1934 or otherwise subject to the liabilities of that Section.  The information in this Item 2.02 shall not be incorporated by reference into any registration statement or other document filed with the Securities and Exchange Commission.

Item 9.01 Financial Statements and Exhibits

(d)

Exhibits

99.1

Press Release, dated August 10, 2015.

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this Report to be signed on its behalf by the undersigned hereunto duly authorized.

ORGANOVO HOLDINGS, INC.

Date: August 10, 2015

/s/ Keith Murphy

Keith Murphy

Chief Executive Officer and President

Exhibit Index

Exhibit

No.

Description

99.1

Press Release, dated August 10, 2015.