NanoViricides, Inc., (NYSE:NNVC)

The Growing Gap in Viral Disease Treatment

While bacterial infections are treated on “first visit” with broad spectrum antibiotics, the world still lacks effective, broad-spectrum therapies that can treat viral infections immediately after symptoms appear, without waiting for tests to determine which virus. That is why outbreaks of Mpox, RSV, Influenza, Ebola, Measles, and COVID-19 continue to surge despite rapid advances in vaccines, with millions affected globally each year.

Existing treatments are virus-specific and quickly lose effectiveness as viruses mutate into variants. In many viral infections, especially emerging and re-emerging diseases, no direct therapeutic treatment drugs exist.

The current 2025–2026 Influenza season starkly illustrates this gap: the seasonal vaccine was mismatched against the dominant H3N2 subclade K variant, rendering it substantially less effective. Existing antivirals like Tamiflu (oseltamivir) and Xofluza (baloxavir) must be taken within 48 hours of symptom onset and influenza viruses can rapidly develop resistance to both — leaving millions without effective treatment. A clinical trial of tecovirimat (TPOXX) for MPox failed to demonstrate any effectiveness over placebo (NIH, August 2024), further highlighting that even virus-specific drugs are failing. There is currently no approved drug for Measles treatment despite the global epidemic. There is currently no approved drug for Measles treatment despite the global epidemic and no approved drug to treat ebola.

The growing frequency of pandemics and falling vaccination rates highlight a major unmet medical need: a safe, nontoxic broad-spectrum antiviral therapy capable of addressing multiple viral threats simultaneously. NanoViricides’ NV-387 directly targets this global gap with its innovative Bind–Engulf–Destroy mechanism.

"Nanoviricides (NNVC), a US company, has a drug NV-387 that fulfills the unmet medical need for an effective, broad- spectrum, oral, antiviral therapy. NNVC's nano-polymer, micelle technology directly binds and destroys virus particles in the blood preventing them entering and infecting cells; in effect a highly selective, ruthless (but safe ) nanomachine"

NNVC's Mission: Meet Today's Unmet Antiviral Treatment Needs

RSV: No Treatment; Major Concern for Newborns and Early Age.

Influenza / Bird Flu: Viruses Mutate Rapidly Threatening Bird Flu Pandemic from a Drug Resistant Virus; one mutation away from transfer to Humans.

Smallpox, Mpox: BioThreat, Emerging Pandemic

COVID / Long Covid: "Out-of-Mind" but variants keep emerging

Measles: Emerging Again, Needs Drug, Vaccines Not Enough, No Treatment

Ebola: Outbreak in DRC and Uganda still spreading; no approved drug treatment exists.

Herpes Viruses: Shingles Latent "Forever"; Link to Alzheimer's

HIV/AIDS: Vaccines Failed, Current Drugs Make it "Lifelong Sentence", Continuing Decades Long Pandemic

$20B+Emperic ARI/SARI Market

$11BKnown NV-387 Markets 2025

$4.64BRSV Market by 2032

$1.17TInfluenza Drugs by 2032

NanoViricides Targets a Multi-Billion-Dollar Global Antiviral Market Opportunity

With its lead candidate NV-387, a broad-spectrum, antiviral treatment targeting Mpox, RSV, Influenza/Bird Flu, COVID/Long COVID, Measle, others with no reliance on the patient’s immune system, NanoViricides leads next-generation therapeutics designed to meet the world’s growing viral treatment demands.

The global antiviral therapeutics landscape represents an expansive multi-billion-dollar opportunity driven by rising infection rates, emerging viral threats, and limited effective treatments.

Known NV-387 markets (RSV, Influenza, COVID/long COVID, Mpox/Smallpox, Measles, Ebola) are expected to have exceeded $11 billion in 2025. [vii] In fact, if approved for emperic therapy of viral Acute or Severe Acute Respiratory Infections (ARI/SARI), NV-387 is estimated to play in a market size of well over $20 Billion as a dominant player [vi] — representing one of the largest opportunities in antiviral therapeutics.

With continuous growth as variants emerge globally, the RSV therapeutics market is expected to grow from $1.37 billion (2023) to $4.64 billion by 2032 [viii] at a robust 14.5% CAGR, while the influenza drugs market approaches $1.17 trillion by 2032 [ix]. These numbers could be larger when NV-387 is used to treat currently underserved geriatric and pediatric patients because it does not rely on the patients’ immune system!

* See our Important Notice and Disclaimer below for a detailed discussion on compensation, risks, the risks associated with forward looking statements, the need to seek the advice of a professional investment advisor before investing, and more.

NanoViricides Dual Track Clinical Strategy Explained by a Research Report: Broad-spectrum Antiviral NV-387 At Phase II Clinical Trial Stage for MPox and also for Acute Respiratory Infections of All Viruses; Phase II Clinical Trial For Ebola Possible ^[ii]

NNVC's dual-track clinical strategy is now fully operational with major regulatory milestones achieved in rapid succession:

Track 1 — MPox/Smallpox (Biodefense): The Phase II Clinical Trial for MPox treatment in the DRC has received full regulatory approval from ACOREP (November 2025) [x] and is expected to commence soon — CRO site preparations by Om Sai Clinical Research (India) are complete, staff training underway [xi], with patient enrollment and dosing expected to begin soon. The trial will evaluate safety and effectiveness of NV-387 in patients with MPox Clade I disease. An Orphan Drug Designation application for MPox has been filed with the US FDA (February 2026). [xii]

Track 2 — Respiratory Viral Diseases (Commercial): NV-387 targets Measles, RSV, Influenza, and COVID/long COVID. On May 4, 2026, the US FDA GRANTED Orphan Drug Designation [i] for NV-387 as a Treatment for Measles — qualifying for 7 years of market exclusivity, tax credits, and fee waivers. A Rare Pediatric Disease Drug Designation application has also been filed (April 2026), making NNVC eligible for a Priority Review Voucher (PRV) worth approximately $160 million [xiii] upon drug approval.

Phase II Clinical Trial of NV-387 Oral Gummies for Treatment of Ebola Approved by Pillar Committee in DRC

NV-387 has already completed a Phase I clinical trial in 2023 with no reported adverse events, demonstrating excellent safety and tolerability in humans.

Key Regulatory Milestones — Accelerating Through 2025—2026

Date	Milestone
Nov 2025	Received ACOREP (DRC) approval to start Phase II Clinical Trial for MPox
Dec 2025	Signed Master Services Agreement with OnlyOrphansCote (Dr. Timothy Cote, former Director of FDA OOPD) for orphan drug strategy covering MPox, Smallpox & Measles
Jan 2026	Highlighted NV-387 effectiveness against H3N2 Influenza amid severe flu season; market estimated at $20B+ for emperic ARI/SARI therapy
Feb 2026	Filed Orphan Drug Designation applications for BOTH Measles AND MPox with US FDA
Mar 2026	Presented at NIBA’s 152nd Investment Conference, Fort Lauderdale, FL
Apr 2026	Phase II MPox Trial ready to commence in DRC — CRO site preparations and team complete. Initiation is pending containment of Ebola outbreak.
Apr 2026	Filed Rare Pediatric Disease Drug Designation for Measles — eligible for ~$160M Priority Review Voucher
May 2026	FDA GRANTS Orphan Drug Designation for NV-387 as Measles Treatment — 7 years market exclusivity, tax credits, fee exemptions
June 2026	Phase II Clinical Trial of NV-387 Oral Gummies for Treatment of Ebola Approved by Pillar Committee in DRC

Greeting Investors: A Revolution in the Technology For Treatment of All Viral Infections*

The global rise of viral diseases — from COVID-19 and RSV to Mpox and Measles, to Hanta Virus and Ebola — continues to highlight a critical gap in modern healthcare: the lack of a single, broad-spectrum antiviral that can address multiple infections effectively. Traditional vaccines and virus-specific drugs remain limited in speed, scope, and adaptability.

NanoViricides, Inc. (NYSE American: NNVC) has developed a breakthrough solution with its lead candidate NV-387, a first-of-its-kind antiviral designed to bind, engulf, and destroy virus particles before they infect cells. In 2026, the company has achieved a rapid cadence of regulatory milestones: FDA Orphan Drug Designation granted for Measles (May 2026), Phase II MPox trial now commencing in the DRC, and a Rare Pediatric Disease Drug Designation filed that could yield a ~$160M Priority Review Voucher.

With a potential market exceeding $20 Billion for emperic antiviral therapy across major viral indications, and no approved drug for Measles or Ebola, and no effective drug for MPox, NanoViricides is positioned at the intersection of medical innovation and global preparedness. Its technology platform is built for versatility — capable of addressing emerging and even unknown viral threats without the delays of conventional drug development.

Investors* and analysts keeping a close watch on the antiviral sector should keep NanoViricides on their radar — a company with the science, data, regulatory momentum, and timing to potentially redefine the global antiviral therapeutics market.

Top Reasons to Have NNVC on Your Radar*

01

Breakthrough Lead Candidate – NV-387: A revolutionary broad-spectrum antiviral that directly targets and destroys virus particles — showing strong results against Mpox, Measles, Ebola, RSV, Influenza, and COVID-19 in animal trials. ^[xiv]
02

Proven Safety in Humans: NV-387 successfully completed Phase I human clinical trials with no reported adverse events, demonstrating excellent safety and tolerability. ^[i]
03

Advancing Toward Phase II Trials: NV-387's Phase II Clinical Trial for MPox is now ready to commence in the DRC, with full regulatory approval from ACOREP received and CRO site preparations complete. Patient enrollment and dosing are imminent, pending containment of Ebola outbreak for which a Phase II Clinical Trial of NV-387 Oral Gummies has been approved by Pillar Committee in DRC — a critical step toward demonstrating clinical effectiveness and potential drug approval. ^{[x], [v]}
04

Broad Market Opportunity: With its lead drug NV-387, NanoViricides targets a global antiviral market exceeding $11 Billion across known indications (RSV, Measles, Mpox/Smallpox, Ebola, Influenza, and COVID/Long COVID), and a potential $20 Billion+ market for emperic antiviral therapy of all respiratory viral infections. With NV-387 addressing multiple high-value segments, and other drugs in the pipeline addressing other virus families like Herpes (Shingles) and HIV, NNVC is positioned to capture a substantial share of the rapidly growing global market for antiviral drug treatments. ^[vi]
05

Dual-Track Clinical Strategy: With its dual-track strategy now fully operational — Phase II MPox trial commencing in DRC (biodefense track) and FDA Orphan Drug Designation secured for Measles (commercial respiratory track) — NanoViricides is accelerating development timelines and expanding revenue potential across both government stockpiling contracts and commercial markets. ^{[i], [v]}
06

Orphan Drug and Regulatory Designations: NV-387 has been GRANTED Orphan Drug Designation by the US FDA for Measles treatment (May 2026) — qualifying for 7 years of market exclusivity, tax credits for clinical trials, and fee exemptions. An Orphan Drug Designation application for MPox has also been filed (February 2026). Additionally, a Rare Pediatric Disease Drug Designation application has been filed for Measles, making NNVC eligible for a tradable Priority Review Voucher worth approximately $160 million upon drug approval. ^{[i], [xiii], [xii]}
07

Manufactured in the USA: NanoViricides fully owns a cGMP-capable facility in Shelton, CT with no mortgage or liens, enabling in-house production for clinical trials, quality & IP control, and cost efficiency. ^[xvi]
08

Strong Intellectual Property and Global Patents: Backed by TheraCour® nanomedicine technology with exclusive, perpetual global licenses across multiple viral diseases. ^[xvii]
09

Debt-Free Balance Sheet: NNVC maintains a debt-free financial position, with no warrants, preferred warrants, or loans, giving it strategic flexibility to pursue development and funding opportunities efficiently. ^[xviii]
10

Annual Report Highlights: The FY2025 Annual Report reflects strong asset management with over $8.5M in R&D and infrastructure investments and continued financial discipline toward Phase II readiness. ^[iii]
11

Strong Biodefense Alignment: NV-387 aligns with U.S. BARDA and Strategic National Stockpile (SNS) programs. US Government SNS stockpiling contracts for existing smallpox drugs TPOXX and TEMBEXA have been in several hundreds of millions of dollars — representing an equivalent potential opportunity for NV-387. With TPOXX's clinical trial failing to show efficacy over placebo (August 2024), NV-387 is positioned as a critical next-generation biodefense candidate.^{[x], [v]}
12

Pipeline Diversity and Expansion: NanoViricides’ multi-drug pipeline includes 10+ antiviral programs, positioning the company to address both existing diseases and future viral threats with speed and scalability. ^[xix]
13

Expert Orphan Drug Strategy Team: NanoViricides has signed a Master Services Agreement with OnlyOrphansCote, LLC — founded by Dr. Timothy Cote, former Director of the US FDA Office of Orphan Products Development (OOPD). Dr. Cote brings intimate knowledge of orphan drug laws, regulations, and the approval process, significantly strengthening NNVC’s regulatory development pathway for MPox, Smallpox, and Measles indications. ^[xx]

Company Overview

The Future of Broad-Spectrum Antiviral Therapeutics

NanoViricides, Inc. (NYSE American: NNVC) is a clinical-stage biopharmaceutical company leading a breakthrough revolution in antiviral drug development through its proprietary nanoviricide® nanomedicine platform . This platform is designed to create virus-targeted nanomachines that bind to, encapsulate, and destroy viruses — a novel “Bind–Encapsulate–Destroy” mechanism that goes beyond the capabilities of antibodies or vaccines.

Unique, Novel, Post-ImmunoTherapeutic "Bind-Encapsulate-Destroy" Mechanism

The company’s lead candidate, NV-387, is a broad-spectrum antiviral currently advancing toward Phase II clinical trials, targeting major global threats such as Ebola, Influenza/Bird Flu, RSV, MPox/Smallpox, Measles, and COVID/long COVID. Alongside, NanoViricides has developed NV-HHV-1, a topical antiviral for Shingles, Cold Sores, and Genital Ulcers, forming part of its HerpeCide™ program.

NanoViricides stands apart as one of the few biotechnology companies with its own cGMP-compliant, multi-product manufacturing facility in Shelton, CT — capable of producing both drug substances and final drug products for clinical trials. This advanced facility enables rapid clinical-scale production and significantly reduces dependency on third-party manufacturers (better quality control, lower IP risk, lower cost). Further, it is capable of initial market-scale production, enabling early revenues of approximately $100 million to $500 million per year upon drug approval.

With a strong intellectual property foundation, innovative technology, and expanding clinical pipeline, NanoViricides is positioned to redefine antiviral therapy and preparedness against future viral pandemics.

Technology

Redefining Antiviral Therapy with Cell-Mimicking Nanoviricide® Innovation

NanoViricides has developed nanoviricides® capable of binding up to 90–95% of known viruses since all of them are based on Heparin Sulfate, targeting shared viral mechanisms. Lead candidate NV-387 fights RSV, Ebola, Influenza, Smallpox/MPox, and COVID-19, while NV-HHV-1 targets Shingles and other Herpes viruses. Additional nanoviricides are in development against Dengue, Rabies, and Ebola/Marburg, showcasing the platform’s unmatched versatility.

A NanoViricide® Attacking a Virus Particle: Unique, Novel, Nanotech Design

Learn More

View Presentation Check Analyst Facts Check Facts NanoViricides In The News

In Summary…

NanoViricides, Inc. (NYSE American: NNVC) is a clinical-stage biopharmaceutical innovator pioneering the next generation of broad-spectrum antiviral therapeutics. Its proprietary nanoviricide® technology introduces a novel “Bind–Encapsulate–Destroy” mechanism designed to neutralize viruses before they infect human cells.

The company’s lead candidate, NV-387, has demonstrated exceptional safety in Phase I clinical trials (no adverse events) and strong efficacy in preclinical studies, targeting RSV, COVID-19, Influenza, Measles, MPox/Smallpox, and Ebola. In parallel to NV-387, another drug NV-HHV-1 is advancing toward clinical readiness for Shingles and other Herpes-related infections.

In 2026, NNVC has achieved landmark regulatory milestones:

FDA Orphan Drug Designation GRANTED for NV-387 as Measles Treatment (7 years market exclusivity)
Phase II MPox Clinical Trial now commencing in the DRC (full ACOREP approval received)
Rare Pediatric Disease Drug Designation filed — eligible for ~$160M Priority Review Voucher
MPox Orphan Drug Designation application filed with FDA
Expert regulatory partnership with OnlyOrphansCote (Dr. Timothy Cote, former FDA OOPD Director)
A Phase II Clinical Trial of NV-387 Oral Gummies has been approved by Pillar Committee in DRC

With a cGMP-compliant in-house manufacturing facility in Shelton, CT, NanoViricides can rapidly scale production from clinical to market supply, allowing faster commercialization.

By addressing multiple high-impact viral diseases through a single technology platform — in a market estimated at $20 Billion+ for emperic antiviral therapy — NanoViricides positions itself as a key player in global antiviral preparedness and innovation.

Keep an Eye on NNVC — A Potential Game-Changer in the Global Antiviral Drug Market

Source

i - https://finance.yahoo.com/sectors/healthcare/articles/nv-387-treatment-measles-granted-123000148.html

ii - https://s27.q4cdn.com/906368049/files/News/2025/Zacks_SCR_Research_11062025_NNVC_Bautz.pdf

iii - https://finance.yahoo.com/news/nanoviricides-dual-track-clinical-strategy-124500503.html

iv - https://finance.yahoo.com/sectors/healthcare/articles/deadly-measles-cases-accentuate-treatment-123000894.html

v - https://finance.yahoo.com/sectors/healthcare/articles/phase-ii-clinical-trial-monkeypox-123000312.html

vi - https://finance.yahoo.com/news/nanoviricides-comments-broad-spectrum-antivirals-133000955.html

vii - https://www.cognitivemarketresearch.com/covid-19-therapeutics-market-report

viii - https://finance.yahoo.com/news/respiratory-syncytial-virus-therapeutics-market-140000104.html

ix - https://www.databridgemarketresearch.com/reports/global-influenza-drug-market

x - https://finance.yahoo.com/news/nanoviricides-received-approval-start-phase-133000813.html

xi - https://finance.yahoo.com/sectors/healthcare/articles/phase-ii-clinical-trial-monkeypox-123000312.html

xii - https://finance.yahoo.com/news/mpox-orphan-drug-designation-application-133000277.html

xiii - https://finance.yahoo.com/sectors/healthcare/articles/measles-rare-pediatric-disease-drug-123000829.html

xiv - https://finance.yahoo.com/news/strong-business-case-phase-ii-103000363.html

xv - https://finance.yahoo.com/news/measles-drug-strong-activity-without-124500247.html

xvi - https://www.nanoviricides.com/about-us

xvii - https://finance.yahoo.com/news/nanoviricides-inc-filed-annual-report-124500981.html

xviii - https://simplywall.st/stocks/us/pharmaceuticals-biotech/nysemkt-nnvc/nanoviricides/health

xix - https://www.nanoviricides.com/Investor%20Info/pipeline

xx - https://finance.yahoo.com/news/nanoviricides-signed-master-services-agreement-133000310.html

Images/Video Credits

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https://pixabay.com/videos/coronavirus-covid-19-corona-virus-34824/
https://pixabay.com/photos/dna-heritage-helix-proteins-3598439/

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Equiscreen, LLC has been compensated by Interactive Offers, LLC to engage in investor awareness services for NanoViricides, Inc. (NYSE American: NNVC). NNVC is a client of Interactive Offers, LLC. A beneficial owner of Equiscreen, LLC is a minority stakeholder of Interactive Offers, LLC, owning less than 10%. Equiscreen, LLC and its affiliates are not affiliates or control persons of Interactive Offers, LLC. Equiscreen, LLC has been compensated $15,000 by Interactive Offers, LLC to engage in investor awareness services for NanoViricides, Inc. (NYSE American: NNVC). Equiscreen and its affiliated entities and partners have been compensated a total of $38,000 related to the engagement of investor awareness services for NNVC. Equiscreen, LLC and its partners and affiliates may buy and sell shares of securities or options and warrants of the companies mentioned on this website at any time.

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NanoViricides, Inc. (NYSE: NNVC) Broad-Spectrum Antiviral Drug That Works Even On Variants.