VivoSim Labs Appoints Amar Sethi, M.D., Ph.D. as Chief Scientific Officer

Rhea-AI Summary

VivoSim Labs (Nasdaq: VIVS) appointed Amar Sethi, M.D., Ph.D. as Chief Scientific Officer effective January 6, 2026. Dr. Sethi brings roughly three decades of drug-development, biomarker, CRO, and translational-medicine experience and will lead scientific strategy across toxicology, translational models, bioanalytics, and next-generation NAMs on VivoSim’s NAMkind platform.

His background includes leading global Phase I–IV programs, FDA breakthrough and orphan-designation work, BLA experience, establishing CAP/CLIA/GCP/GLP-compliant infrastructures, and advancing biomarker platforms—including an FDA-qualified Acute Kidney Injury panel. VivoSim said he will expand biomarker capabilities, strengthen scientific governance for sponsors, and collaborate with R&D, platform engineering, and AI teams to improve multi-parametric toxicity prediction.

Positive

• CSO hire with ~30 years of drug-development experience
• FDA-qualified Acute Kidney Injury biomarker panel in his track record
• 70% business growth achieved at Pacific Biomarkers under his leadership
• Experience with global Phase I–IV programs and BLA-related work

Negative

• None.

News Market Reaction

+4.62% 1.5x vol

6 alerts

+4.62% News Effect

+3.4% Peak in 10 min

+$262K Valuation Impact

$6M Market Cap

1.5x Rel. Volume

On the day this news was published, VIVS gained 4.62%, reflecting a moderate positive market reaction. Argus tracked a peak move of +3.4% during that session. Our momentum scanner triggered 6 alerts that day, indicating moderate trading interest and price volatility. This price movement added approximately $262K to the company's valuation, bringing the market cap to $6M at that time. Trading volume was above average at 1.5x the daily average, suggesting increased trading activity.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

Business growth: 70% Industry experience: Three decades

2 metrics

Business growth 70% Growth at Pacific Biomarkers under Dr. Sethi’s leadership

Industry experience Three decades Dr. Sethi’s experience in drug development and biomarkers

Market Reality Check

Price: $1.90 Vol: Volume 24,750 is below th...

normal vol

$1.90 Last Close

Volume Volume 24,750 is below the 20-day average of 33,798 (relative volume 0.73). normal

Technical Shares at $1.95 are trading below the 200-day MA of $2.22 and 63.21% under the 52-week high.

Peers on Argus

VIVS was up 3.72% pre-news while peers were mixed, with declines in CYCCP (-5.61...

1 Up

VIVS was up 3.72% pre-news while peers were mixed, with declines in CYCCP (-5.61%) and gains in MTNB (+7%) and PCSA (+5.21%), indicating stock-specific factors rather than a broad sector move.

Historical Context

1 past event · Latest: Aug 14 (Positive)

Pattern 1 events

Date	Event	Sentiment	Move	Catalyst
Aug 14	Executive appointment	Positive	-3.2%	Named a Chief Commercial Officer to scale AI-enabled 3D toxicology services.

Pattern Detected

Limited history shows the prior senior leadership appointment drew a negative price reaction despite neutral-to-positive strategic implications.

Recent Company History

This announcement adds another senior leadership hire after the Aug 14, 2025 appointment of a Chief Commercial Officer focused on scaling AI-enabled NAMkind™ toxicology services. Since then, filings highlighted tight liquidity, going-concern risk, equity issuance via an ATM, and corporate governance matters such as the 2025 annual meeting and option grants. Against that backdrop, bringing in a Chief Scientific Officer with biomarker and regulatory experience extends the leadership build-out around 3D human tissue models and AI analytics.

Market Pulse Summary

This announcement highlights VivoSim Labs’ effort to deepen its scientific leadership by appointing ...

Analysis

This announcement highlights VivoSim Labs’ effort to deepen its scientific leadership by appointing a Chief Scientific Officer with three decades of biomarker and drug-development experience. The hire builds on prior commercial leadership additions and aims to strengthen the NAMkind™ 3D human tissue and AI-analytics platform. Given earlier disclosures of tight liquidity and going-concern risk, investors may watch how this leadership expansion translates into partnerships, revenue growth, and progress in next-generation toxicology and biomarker offerings.

Key Terms

biomarker, translational medicine, orphan drug, BLA filings, +3 more

7 terms

biomarker medical

"Distinguished drug-development and biomarker leader to advance NAMkind..."

A biomarker is a measurable indicator found in the body, such as in blood or tissues, that provides information about health, disease, or how the body responds to treatment. For investors, biomarkers can signal the potential success or risk of medical products or therapies, influencing the value of related companies and industry trends. They act like signals or clues that help assess the progress of medical advancements and their market impact.

translational medicine medical

"experience encompassing pharmaceutical drug development, CRO leadership, translational medicine, and diagnostic innovation."

Translational medicine is the process of turning basic laboratory discoveries into medical tests, devices, or treatments that can be used in patients—like taking a prototype from a workshop and preparing it for everyday use. Investors care because effective translation shortens development time, lowers technical risk and uncertainty, and increases the chance that research leads to a marketable product or therapy, which influences company value and funding decisions.

orphan drug regulatory

"He has led global Phase I–IV clinical programs, FDA breakthrough and orphan drug designations..."

A drug designated for an orphan disease is a medicine developed to treat a rare condition that affects only a small number of people. Regulators often give these drugs special incentives—such as reduced costs, faster review, and temporary exclusive selling rights—to encourage development, which matters to investors because those incentives can make a small market financially viable and reduce competition, much like a temporary patent on a niche product.

BLA filings regulatory

"clinical programs, FDA breakthrough and orphan drug designations, BLA filings, and advanced biomarker strategies..."

A BLA filing is a company’s formal request to U.S. regulators for permission to sell a biologic drug or therapy, similar to submitting a permit and safety dossier before opening a factory. It matters to investors because acceptance and eventual approval let the product be marketed and generate revenue, while rejection or delays can erode value; the filing signals where a candidate sits in the regulatory process and the binary risk/reward ahead.

CLIA regulatory

"His expertise includes establishing CAP/CLIA/GCP/GLP-compliant infrastructures..."

CLIA stands for the Clinical Laboratory Improvement Amendments, a U.S. federal program that sets quality and safety standards for laboratories that test human samples. For investors, a CLIA certification is like a safety inspection or license for a lab — it signals that test results are produced under accepted quality controls, affects a lab’s ability to sell or bill certain tests, and therefore influences a company’s regulatory risk, market access, and credibility.

GCP regulatory

"His expertise includes establishing CAP/CLIA/GCP/GLP-compliant infrastructures..."

Good Clinical Practice (GCP) is an international set of rules and quality standards for how clinical trials are designed, run, recorded and reported to protect participants and ensure trial data are reliable. For investors, GCP compliance lowers regulatory and legal risk, increases the credibility of trial results, and can speed or enable product approvals—think of it as building codes that make sure a structure (the trial) is safe and the measurements you rely on are trustworthy.

monoclonal antibody medical

"supported multiple monoclonal antibody programs now approved or advancing into late stages."

A monoclonal antibody is a laboratory-made protein designed to recognize and attach to a specific target in the body, such as a disease-causing substance or cell. It functions like a highly precise lock-and-key tool, helping to treat or detect illnesses. For investors, companies developing monoclonal antibodies can represent promising opportunities in the healthcare sector, especially as these treatments often address unmet medical needs.

AI-generated analysis. Not financial advice.

Distinguished drug-development and biomarker leader to advance NAMkind™ scientific strategy, translational insights, and next-generation toxicology platforms

SAN DIEGO, Jan. 06, 2026 (GLOBE NEWSWIRE) -- VivoSim Labs, Inc. (Nasdaq: VIVS) (the “Company” or “VivoSim Labs”), 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, announces it has appointed Amar Sethi, M.D., Ph.D. as its Chief Scientific Officer. 

Dr. Sethi is a transformational R&D executive with three decades of experience encompassing pharmaceutical drug development, CRO leadership, translational medicine, and diagnostic innovation. He has led global Phase I–IV clinical programs, FDA breakthrough and orphan drug designations, BLA filings, and advanced biomarker strategies across metabolic disorders, nephrology, hematology, rare diseases, and cardiovascular biology. His expertise includes establishing CAP/CLIA/GCP/GLP-compliant infrastructures, scaling bioanalytical and biomarker teams, and guiding scientific strategy for both early and late-stage assets.

At VivoSim, Dr. Sethi will lead scientific strategy across toxicology, translational models, bioanalytics, and next-generation new approach methodologies (NAMs) methodologies. He will expand the company’s biomarker and mechanistic insight capabilities, strengthen scientific governance for pharmaceutical sponsors, and collaborate closely with R&D, platform engineering, and AI teams to enhance multi-parametric toxicity prediction using human-relevant systems.

Dr. Sethi’s career bridges drug-development leadership with biomarker innovation. At Omeros Corp, he led a pivotal global Phase 3 program for a Breakthrough Therapy/Orphan-designated biologic and supported multiple monoclonal antibody programs now approved or advancing into late stages. As President & Chief Medical Officer of Pacific Biomarkers, he drove 70% business growth, led successful M&A initiatives, and developed FDA-qualified novel biomarker platforms, including a gold-standard Acute Kidney Injury panel uniquely qualified by the FDA. His tenure at NIH and Copenhagen University Hospitals further established him as a scientific authority in clinical chemistry, cardiometabolic research, and translational diagnostics.

“VivoSim’s NAMkind platform is redefining human-relevant toxicology,” said Dr. Amar Sethi, Chief Scientific Officer, VivoSim Labs. “By integrating advanced 3D biology with AI-driven analytics, we can generate mechanistic clarity and decision-ready insights earlier—helping sponsors mitigate risk, accelerate development, and optimize portfolio strategy.”

“Amar brings an exceptional combination of scientific depth, clinical insight, and operational leadership,” said Keith Murphy, Executive Chairman, VivoSim Labs. “His expertise in biomarkers, translational medicine, and regulatory-grade data generation strengthens VivoSim at a pivotal moment. As sponsors increasingly adopt 3D NAM systems, Amar will ensure that VivoSim remains the scientific partner of choice.”

The Thorough Group, an independent recruitment firm specializing in the life sciences, assisted VivoSim with the placement of Dr. Sethi.

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") announcement on April 10, 2025 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 expansion of the Company’s San Diego-based services; the potential for the Company’s organ-specific 3D models and AI-driven analytics to deliver decision-ready insights earlier in development; the market opportunity and market size of gastrointestinal in-vitro models and toxicology services; and the ability of the Company’s services to improve signal-to-noise in dose-response calls or help project teams prioritize candidates and studies with greater confidence. Such forward-looking statements are not guarantees of performance and actual actions or events could differ materially from those contained in such statements. 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 June 5, 2025, as such risk factors are updated in its most recently filed Quarterly Report on Form 10-Q filed with the SEC on November 6, 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 forward-looking statements that the Company may issue in the future. Except as required by applicable law, including the securities laws of the United States, the Company does not intend to update any of the forward-looking statements to conform these statements to reflect actual results, later events, or circumstances or to reflect the occurrence of unanticipated events. 

Contact
Investor Relations
info@vivosim.ai
VivoSim Labs, Inc.

FAQ

Who is Amar Sethi and what role did he take at VivoSim Labs (VIVS) on January 6, 2026?

Amar Sethi, M.D., Ph.D., was appointed Chief Scientific Officer of VivoSim Labs effective January 6, 2026.

What experience does VivoSim’s new CSO bring that matters for VIVS investors?

He brings ~30 years in drug development, biomarker innovation, FDA-designation experience, BLA work, and CAP/CLIA/GCP/GLP compliance.

How will Dr. Sethi contribute to VivoSim’s NAMkind platform and services (VIVS)?

He will lead scientific strategy for toxicology and translational models, expand biomarker and mechanistic-insight capabilities, and work with AI and engineering teams to improve toxicity prediction.

Does Dr. Sethi have a record of commercial or regulatory achievements relevant to VivoSim (VIVS)?

Yes; his track record includes driving 70% business growth at Pacific Biomarkers and developing an FDA-qualified Acute Kidney Injury biomarker panel.

Will Dr. Sethi’s appointment affect VivoSim’s relationships with pharmaceutical sponsors (VIVS)?

The company says he will strengthen scientific governance for sponsors and help position VivoSim as a scientific partner for 3D NAM systems.