VIVS

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EX-99.1

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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EX-99.1

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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onvo-ex991_6.htm

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

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